ARDvark Blog Journal of Adhesion Related Disorder

Pain in the pelvis

2012-01-27T11:52:00.000-05:00

Sunday January 8, 2012
Pain in the pelvis
WOMEN'S WORLD by DR NOR ASHIKIN MOKHTAR

The concluding article on pelvic pain, which can be caused by a wide range of conditions, some of which are easily treated, while others require more urgent medical attention.

IN my last article, I shared with readers a list of conditions that could possibly account for symptoms of pelvic or lower abdomen pain.

Some of these conditions are related to the reproductive system, while others may be related to the digestive or urinary system.

Not all causes of pelvic pain are medical emergencies – nonetheless, it is always better to see your doctor when you experience such symptoms, as there could be any number of causes.

In this article, I will continue to elaborate on more of these potential causes of pelvic pain.

Kidney stones are minerals that form in the kidney. They can be as small as a grain of sand or as big as a golf ball, so you can imagine what pain it can cause.

Endometriosis

When endometrial cells grow outside the uterus and form implants (growths) on the ovaries, bowel, rectum, bladder, and on the lining of the pelvic area, this is called endometriosis.

Pain is the most significant symptom of endometriosis. The pain could be in the lower abdomen or the lower back, before, during or after menstruation. You may also experience cramps, pain during or after sexual intercourse, or pain with bowel movements.

Unfortunately, there is no way to reverse the scarring caused by endometriosis. However, there are treatments that can stop the disease from getting worse.

In severe cases, surgery can be carried out to remove all endometrial implants and scar tissue, or more drastically, to remove your uterus, fallopian tubes and ovaries.

Vulvar pain

In some cases, the pain may originate lower down the pelvis, namely at the vaginal area. Chronic pain around the opening of the vagina is a condition called vulvodynia, where no cause is known.

The pain could be a burning, stinging, or experienced as a throbbing sensation, and it may be there constantly or come and go. Certain activities like sexual intercourse or riding a bicycle may make the pain worse.

Since there is no known cause of vulvodynia, there is no way to treat the source of the pain. However, medications and physical therapy may help to relieve the symptoms.

Interstitial cystitis

There is a condition called interstitial cystitis (IC), which is related to long-term inflammation of the bladder wall.

The pain is felt during urination and sex, as well as a sensation of pressure above the pubic area. You may also feel the need to urinate multiple times every hour throughout the course of the day.

IC also has no known cause. You should work with your doctor to try out treatments that can relieve the symptoms.

Pelvic organ prolapse

A prolapsed pelvic organ is when the organ, such as the bladder or uterus, slips out of its normal place and drops into a lower position. This happens when the ligaments or muscles supporting the organs weaken, which is usually due to age.

Prolapse can cause some form of pain or pressure in the groin or lower back and against the vaginal wall. You may also have a feeling of “fullness” in the lower belly and pain during intercourse.

Treating prolapsed organs usually requires some form of surgery, although there are now minimally invasive techniques that result in faster recovery.

Irritable Bowel Syndrome (IBS)

If you have constantly recurring stomach pain that comes with cramps, bloating and diarrhoea or constipation, you could have IBS.

IBS describes the presence of these symptoms together without any known cause. It is strongly believed that stress in your life has a lot to do with IBS, as these symptoms tend to flare up in people when they go through highly stressful or demanding periods in their life.

Lifestyle changes like modifying your diet and managing your stress can help to keep the symptoms of IBS under control.

Urinary tract infection (UTI)

Have you ever experienced pain while urinating, along with a frequent urge to urinate? You could have a urinary tract infection, which is caused by bacteria getting into the urinary tract and causing infection to the urethra, bladder, ureters or the kidneys. You may also have the feeling of pressure in your lower pelvis.

If you suspect that you have a UTI, you should see a doctor and get it treated with some simple antibiotics.

Don’t let it progress to kidney infection, which is characterised by symptoms like fever, nausea, vomiting and pain on one side of the lower back.

Kidney stones

If you see your urine turning pink or red, and you have a sudden sharp pain in the stomach or pelvic area, you may have kidney stones.

Kidney stones are minerals that form in the kidney and move to the bladder. They can be as small as a grain of sand or as big as a golf ball, so you can imagine what pain it can cause.

Your doctor can recommend treatments to remove the kidney stones, if they cannot pass out through the urine on their own.

Pelvic congestion syndrome

You’ve probably heard of varicose veins, which is when veins become swollen, twisted and filled with blood. Although varicose veins commonly occur in the legs, they can also develop in the pelvis, causing pelvic congestion syndrome.

The pelvic veins become swollen and painful, causing pain especially when you sit or stand. You may find that lying down eases the pain.

This condition is not easily diagnosed because the pelvic veins are not visible from outside the body. Your doctor will need to rule out other possible conditions.

Ask your doctor about minimally invasive surgical procedures to treat this condition.

Scar tissue or adhesions

Have you had surgery in your pelvic or lower abdominal region before? It could be surgery to remove your appendix or uterus, or a C-section for delivery.

These surgical procedures can cause scar tissue to form between organs or structures in the pelvic area, causing them to stick or adhere to each other. In normal situations, these organs should have a slippery surface, allowing them to shift easily as the body moves.

These adhesions can cause long-term abdominal or pelvic pain in some people, and even blockage of the intestines. In these situations, surgery may be needed to break the adhesions, although doctors only resort to surgery if there is no other option.

As you can see, pelvic pain can be caused by a wide range of conditions, some of which can be easily treated and others that require more urgent medical attention.

The most important thing to remember when you experience pain in the pelvis or lower abdomen area is to take note of other symptoms and things occuring in your body. For instance, take note of what you are doing when the pain occurs, and whether certain activities make it worse.

Observe your menstrual periods, bleeding, urine and bowel movements, and whether you have nausea, vomiting or fever.

Knowing these details will help your doctor to make a more accurate diagnosis. Sometimes, even after a lot of testing, the cause of pelvic pain remains a mystery. But your doctor can still help you find ways to feel better and prescribe the appropriate treatment for you.

> Datuk Dr Nor Ashikin Mokhtar is a consultant obstetrician & gynaecologist (FRCOG, UK). For further information, visit www.primanora.com. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.

http://thestar.com.my/health/story.asp?file=/2012/1/8/health/10210283&sec=health

About Adhesion Related Disorder ~ How can abdominal adhesions cause intestinal obstruction?

2012-01-26T09:43:00.000-05:00

Abdominal Adhesions
On this page:

•What are abdominal adhesions?
•What causes abdominal adhesions?
•How can abdominal adhesions cause intestinal obstruction?
•How can abdominal adhesions cause female infertility?
•What are the symptoms of abdominal adhesions?
•What are the symptoms of an intestinal obstruction?
•How are abdominal adhesions and intestinal obstructions diagnosed?
•How are abdominal adhesions and intestinal obstructions treated?
•Can abdominal adhesions be prevented?
•Points to Remember
•Hope through Research
•For More Information

What are abdominal adhesions?
Abdominal adhesions are bands of tissue that form between abdominal tissues and organs. Normally, internal tissues and organs have slippery surfaces, which allow them to shift easily as the body moves. Adhesions cause tissues and organs to stick together.

The intestines are part of the digestive system. Abdominal adhesions can cause an intestinal obstruction.

Although most adhesions cause no symptoms or problems, others cause chronic abdominal or pelvic pain. Adhesions are also a major cause of intestinal obstruction and female infertility.

What causes abdominal adhesions?
Abdominal surgery is the most frequent cause of abdominal adhesions. Almost everyone who undergoes abdominal surgery develops adhesions; however, the risk is greater after operations on the lower abdomen and pelvis, including bowel and gynecological surgeries. Adhesions can become larger and tighter as time passes, causing problems years after surgery.

Surgery-induced causes of abdominal adhesions include

•tissue incisions, especially those involving internal organs
•the handling of internal organs
•the drying out of internal organs and tissues
•contact of internal tissues with foreign materials, such as gauze, surgical gloves, and stitches
•blood or blood clots that were not rinsed out during surgery
A less common cause of abdominal adhesions is inflammation from sources not related to surgery, including

•appendicitis—in particular, appendix rupture
•radiation treatment for cancer
•gynecological infections
•abdominal infections
Rarely, abdominal adhesions form without apparent cause.

How can abdominal adhesions cause intestinal obstruction?
Abdominal adhesions can kink, twist, or pull the intestines out of place, causing an intestinal obstruction. An intestinal obstruction partially or completely restricts the movement of food or stool through the intestines. A complete intestinal obstruction is life threatening and requires immediate medical attention and often surgery.

How can abdominal adhesions cause female infertility?
Abdominal adhesions cause female infertility by preventing fertilized eggs from reaching the uterus, where fetal development takes place. Adhesions can kink, twist, or pull out of place the fallopian tubes, which carry eggs from the ovaries—where eggs are stored and released—to the uterus.

What are the symptoms of abdominal adhesions?
Although most abdominal adhesions go unnoticed, the most common symptom is chronic abdominal or pelvic pain. The pain often mimics that of other conditions, including appendicitis, endometriosis, and diverticulitis.

What are the symptoms of an intestinal obstruction?
Symptoms of an intestinal obstruction include

•severe abdominal pain or cramping
•vomiting
•bloating
•loud bowel sounds
•swelling of the abdomen
•inability to pass gas
•constipation
A person with these symptoms should seek medical attention immediately.

How are abdominal adhesions and intestinal obstructions diagnosed?
No tests are available to diagnose adhesions, and adhesions cannot be seen through imaging techniques such as x rays or ultrasound. Most adhesions are found during exploratory surgery. An intestinal obstruction, however, can be seen through abdominal x rays, barium contrast studies—also called a lower GI series—and computerized tomography.

How are abdominal adhesions and intestinal obstructions treated?
Treatment for abdominal adhesions is usually not necessary, as most do not cause problems. Surgery is currently the only way to break adhesions that cause pain, intestinal obstruction, or fertility problems. More surgery, however, carries the risk of additional adhesions and is avoided when possible.

A complete intestinal obstruction usually requires immediate surgery. A partial obstruction can sometimes be relieved with a liquid or low-residue diet. A low-residue diet is high in dairy products, low in fiber, and more easily broken down into smaller particles by the digestive system.

Can abdominal adhesions be prevented?
Abdominal adhesions are difficult to prevent; however, surgical technique can minimize adhesions.

Laparoscopic surgery avoids opening up the abdomen with a large incision. Instead, the abdomen is inflated with gas while special surgical tools and a video camera are threaded through a few, small abdominal incisions. Inflating the abdomen gives the surgeon room to operate.

If a large abdominal incision is required, a special filmlike material (Seprafilm) can be inserted between organs or between the organs and the abdominal incision at the end of surgery. The filmlike material, which looks similar to wax paper, is absorbed by the body in about a week.

Other steps during surgery to reduce adhesion formation include using starch- and latex-free gloves, handling tissues and organs gently, shortening surgery time, and not allowing tissues to dry out.

Points to Remember
•Abdominal adhesions are bands of tissue that form between abdominal tissues and organs, causing tissues and organs to stick together.
•Although most adhesions cause no symptoms or problems, others cause chronic abdominal or pelvic pain, bowel obstruction, or female infertility.
•Abdominal surgery is the most frequent cause of abdominal adhesions.
•Abdominal adhesions can kink, twist, or pull the intestines out of place, causing an intestinal obstruction.
•A complete intestinal obstruction is life threatening and requires immediate medical attention and often surgery.
•Abdominal adhesions cause female infertility by preventing fertilized eggs from reaching the uterus, where fetal development takes place.
•No tests are available to diagnose adhesions, and adhesions cannot be seen through imaging techniques such as x rays or ultrasound.
•An intestinal obstruction can be seen through abdominal x rays, barium contrast studies—also called a lower GI series—and computerized tomography.
•Surgery is currently the only way to break adhesions that cause pain, intestinal obstruction, or fertility problems.

Hope through Research
The National Institute of Diabetes and Digestive and Kidney Diseases conducts and supports basic and clinical research into many digestive disorders.

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. For information about current studies, visit http://www.clinicaltrials.gov/.

The U.S. Government does not endorse or favor any specific commercial product or company. Trade, proprietary, or company names appearing in this document are used only because they are considered necessary in the context of the information provided. If a product is not mentioned, the omission does not mean or imply that the product is unsatisfactory.

For More Information
American College of Gastroenterology
P.O. Box 342260
Bethesda, MD 20827–2260
Phone: 301–263–9000
Fax: 301–263–9025
Email: info@acg.gi.org
Internet: www.acg.gi.org

International Foundation for Functional Gastrointestinal Disorders
P.O. Box 170864
Milwaukee, WI 53217–8076
Phone: 1–888–964–2001 or 414–964–1799
Fax: 414–964–7176
Email: iffgd@iffgd.org
Internet: www.iffgd.org

You may also find additional information about this topic by visiting MedlinePlus at www.medlineplus.gov.

This publication may contain information about medications. When prepared, this publication included the most current information available. For updates or for questions about any medications, contact the U.S. Food and Drug Administration toll-free at 1–888–INFO–FDA (1–888–463–6332) or visit www.fda.gov. Consult your doctor for more information.
http://digestive.niddk.nih.gov/ddiseases/pubs/intestinaladhesions/

Texas Jury Orders Kelsey-Seybold to Pay $1.9 Million for "Secret" Surgeon

2012-01-26T05:55:00.000-05:00

Texas Jury Orders Kelsey-Seybold to Pay $1.9 Million for "Secret" Surgeon
Attorneys Randy Sorrels and Chelsie King Garza of Abraham, Watkins, Nichols, Sorrels, Agosto & Friend recently received a $1.9 million verdict from a Texas jury for a medical malpractice client.

HOUSTON, TX, January 24, 2012 /24-7PressRelease/ -- On Friday, January 20, 2012, a Harris County jury ordered Kelsey-Seybold Medical Clinic, PLLC, and its employee, Jim Patrick Benge, MD, to pay $1.9 million for permanently injuring Lauren Williams for her past and future damages, including a lifetime of colostomy care and medications.

In August 2008, Ms. Williams had a hysterectomy understanding that Dr. Benge would be her surgeon. After she went under anesthesia, a resident came in and performed at least 50 percent of the surgery without the patient's knowledge. This was the first time the resident had performed the procedure. "The jury rejected Kelsey Seybold's position that an unknown resident can perform surgery on a patient without full disclosure to the patient," said Williams' attorney Randall O. Sorrels.

During that August 2008 surgery, two of Ms. Williams' organs, including her bowel, were perforated. The injuries were not discovered until three days later at which point Ms. Williams was septic and her injuries were irreversible. Ms. Williams spent three weeks in a coma as a result, and thereafter spent months re-learning to walk, talk and care for herself. Ms. Williams now lives with a permanent colostomy and testimony was presented that she will be an intestinal cripple as she grows older, due to the dense internal adhesions resulting from gastrointestinal damage. She has undergone five major surgeries following the August 26, 2008 procedure.

Dr. Benge, his colleague Dr. Thornton (a co-defendant who was not found liable for her role in Ms. Williams' post-operative care), and the experts for Kelsey-Seybold offered testimony that a patient does not have the right to know when a resident would be operating on them or cutting inside their bodies. By virtue of this medical malpractice verdict, a Harris County jury has rejected this as the standard of care. "When a doctor agrees to perform surgery on a patient, it should be that surgeon who operates, unless the patient agrees otherwise," said Williams' lawyer Chelsie King Garza.

For further information, please contact attorney Randall O. Sorrels or attorney Chelsie King Garza by calling 713-222-7211 or via email at rsorrels@abrahamwatkins.com and cgarza@abrahamwatkins.com. Ms. Williams is available for comment upon request.

Attorneys Randall O. Sorrels and Chelsie King Garza are attorneys at the Houston law firm of Abraham, Watkins, Nichols, Sorrels, Agosto & Friend. Since 1951, the firm has advocated for the rights of thousands of catastrophically injured clients in cases involving car and truck accidents, work-related injuries, medical malpractice, defective products, aviation accidents and other types of personal injury matters. For more information on the firm, visit their website at www.abrahamwatkins.com.

http://world.einnews.com/247pr/258879

FzioMed Receives CE Mark for DYNAVISC® Gel

2012-01-24T05:37:00.000-05:00

FzioMed Receives CE Mark for DYNAVISC® Gel
New Adhesion Barrier Gel for Tendon and Peripheral Nerve Surgery

January 23, 2012 09:03 AM Eastern Time
SAN LUIS OBISPO, Calif.--(EON: Enhanced Online News)--FzioMed, Inc. is pleased to announce that it has received CE Mark approval to market DYNAVISC® adhesion barrier gel in Europe for tendon and peripheral nerve surgery.

DYNAVISC is a clear, absorbable gel supplied ready-to-use in a 1mL syringe. It is designed to coat tissues during tendon and peripheral nerve surgery. DYNAVISC gel acts as a temporary, protective barrier that separates tissues and reduces fibrosis and the formation of post-surgical adhesions.
DYNAVISC was developed by FzioMed and is based on the Company’s world-leading anti-adhesion biomaterial technology.

Adhesions are internal bands of scar tissue that can develop following surgery as the body attempts to heal. Adhesions tether tissues and surfaces that are normally not connected, later causing pain, nerve compression and impaired motion. Adhesions are a significant complication of many surgical procedures and a prevalent cause of post-surgical morbidity.

“Well over a million procedures to repair tendons are performed in the EU each year and one-third of traumatic injuries involve damage to tendons and nerves,” said John Krelle, President & CEO of FzioMed. “Adhesions can impact an otherwise successful procedure, leaving a patient with pain and diminished quality of life.”

Complete press release click here:
http://eon.businesswire.com/news/eon/20120123005273/en

U.S. to Force Drug Firms to Report Money Paid to Doctors

2012-01-22T07:22:00.000-05:00

U.S. to Force Drug Firms to Report Money Paid to Doctors
By ROBERT PEAR

Published: January 16, 2012

WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.

Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.
Click link to continue: http://www.nytimes.com/2012/01/17/health/policy/us-to-tell-drug-makers-to-disclose-payments-to-doctors.html?_r=1&pagewanted=all

Adhesion Related Disorder International Human Rights Team IHRT: Beware of the Abdo-lift....

2012-01-19T12:32:00.000-05:00

Barrier agents for adhesion prevention after gynaecological surgery.

2012-01-19T06:11:00.000-05:00

Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000475.
Barrier agents for adhesion prevention after gynaecological surgery.
Ahmad G, Duffy JM, Farquhar C, Vail A, Vandekerckhove P, Watson A, Wiseman D.
SourceStepping Hill Hospital, Obstetric & Gynaecology, 30 Badger Road, Altrincham, Cheshire, UK, WA14 5UZ. gaityahmad@hotmail.com

Abstract
BACKGROUND: Pelvic adhesion can form as a result of inflammation, endometriosis or surgical trauma. During pelvic surgery, strategies to reduce pelvic adhesion formation may include placing synthetic barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene or Fibrin sheets between the pelvic structures.

OBJECTIVES: To assess the effect of physical barriers used during pelvic surgery in women of reproductive age on pregnancy rates, pelvic pain, or postoperative adhesion reformation.

SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched September 2007) which is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, plus handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. In addition, companies were contacted for unpublished trials.

SELECTION CRITERIA: Any randomised controlled trials (RCTs) comparing the use of physical barriers versus no treatment or other physical barriers in the prevention of adhesions in women undergoing gynaecological surgery.

DATA COLLECTION AND ANALYSIS: Review authors assessed trial eligibility and quality.

MAIN RESULTS: Sixteen RCTs were included. Five trials randomised patients while the remainder randomised pelvic organs. Laparoscopy (six trials) and laparotomy (10 trials) were the primary surgical techniques. Indications for surgery included myomectomy (five trials), ovarian surgery (five trials), pelvic adhesions (four trials), endometriosis (one trial), and mixed (one trial). Eleven trials assessed Interceed versus no treatment, two assessed Interceed versus Gore-Tex, one trial assessed Gore-Tex versus no treatment, and one trial assessed Seprafilm versus no treatment. A single trial assessed Fibrin sheet versus no treatment. No studies reported pregnancy or reduction in pain as outcomes. The use of Interceed was associated with reduced incidence of pelvic adhesion formation, both new formation and reformation following laparoscopic surgery or laparotomy. However, this result should be interpreted with caution. Gore-Tex was more effective than no barrier or Interceed in preventing adhesion formation. There was only limited evidence that Seprafilm was effective in preventing adhesion formation following myomectomy and no evidence to support Fibrin sheet.

AUTHORS' CONCLUSIONS: The absorbable adhesion barrier Interceed reduces the incidence of adhesion formation following laparoscopy and laparotomy, but there are insufficient data to support its use to improve pregnancy rates. Gore-Tex may be superior to Interceed in preventing adhesion formation but its usefulness is limited by the need for suturing and later removal. There was no evidence of effectiveness of Seprafilm and Fibrin sheet in preventing adhesion formation.

Update of
Cochrane Database Syst Rev. 2000;(2):CD000475.
http://www.ncbi.nlm.nih.gov/pubmed/18425865

Is “Adhesion Related Disorder” A Chronic Disease?

2012-01-17T06:36:00.000-05:00

Is “Adhesion Related Disorder” A Chronic Disease?
Q. Is “Adhesion Related Disorder” A Chronic Disease?
A. Yes it is!
(Based on the “Centers for Disease Control and Prevention” & The National Digestive Diseases Information Clearinghouse (NDDIC) "Adhesion Related Disorder” IS considered a “Disease.”

The following information is important to take with you when you see your “Medical Appointments” or to appointments associated with applying for “Social Security Benefits” as this information correlates directly with the “debilitating and often untreatable” symptoms experienced by those afflicted with “Adhesion Related Disorder.”

Chronic Disease Overview

The profile of diseases contributing most heavily to death, illness, and disability among Americans changed dramatically during the last century. Today, chronic diseases—such as cardiovascular disease (primarily heart disease and stroke), cancer, and diabetes—are among the most prevalent, costly, and preventable of all health problems. Seven of every 10 Americans who die each year, or more than 1.7 million people, die of a chronic disease. The prolonged course of illness and disability from such chronic diseases as diabetes and arthritis results in extended pain and suffering and decreased quality of life for millions of Americans. Chronic, disabling conditions cause major limitations in activity for more than one of every 10 Americans, or 25 million people

Costs of Chronic Disease

The United States cannot effectively address escalating health care costs without addressing the problem of chronic diseases:

More than 90 million Americans live with chronic illnesses.

Chronic diseases account for 70% of all deaths in the United States.

The medical care costs of people with chronic diseases account for more than 75% of the nation’s $1.4 trillion medical care costs.

Chronic diseases account for one-third of the years of potential life lost before age 65.

Hospitalizations for pregnancy-related complications occurring before delivery account for more than $1 billion annually.

The direct and indirect costs of diabetes are nearly $132 billion a year.

Each year, arthritis results in estimated medical care costs of more than $22 billion, and estimated total costs (medical care and lost productivity) of almost $82 billion.

The estimated direct and indirect costs associated with smoking exceed $75 billion annually.

In 2001, approximately $300 billion was spent on all cardiovascular diseases. Over $129 in lost productivity was due to cardiovascular disease.

The direct medical costs associated with physical inactivity was nearly $76.6 billion in 2000.

Nearly $68 billion is spent on dental services each year.

Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333, U.S.A
Tel: (404) 639-3311 / Public Inquiries: (404) 639-3534 / (800) 311-3435

The National Digestive Diseases Information Clearinghouse (NDDIC) "Adhesion Related Disorder"

National Institutes of Health | Department of Health & Human Services

Intestinal Adhesions

Treatment

Some adhesions will cause no symptoms and go away by themselves. For people whose intestines are only partially blocked, a diet low in fiber, called a low-residue diet, allows food to move more easily through the affected area. In some cases, surgery may be necessary to remove the adhesions, reposition the intestine, and relieve symptoms. But the risk of developing more adhesions increases with each additional surgery.

Prevention

Methods to prevent adhesions include using biodegradable membranes or gels to separate organs at the end of surgery or performing laparoscopic (keyhole) surgery, which reduces the size of the incision and the handling of the organs. More...... http://www.adhesionrelateddisorder.com/ardnews9.html

DISEASE.,

Definitions of:

an impairment of health or a condition of abnormal functioning wordnet.princeton.edu/perl/webwn
A disease is any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the person affected or those in contact with the person. Sometimes the term is used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function, while in other contexts these may be considered distinguishable categories. en.wikipedia.org/wiki/Disease
a term of health status; when something is wrong with a bodily function
www.jhsph.edu/publichealthexperts/Glossary.htm
Disease can be defined in three ways: www.med.uwo.ca/ecosystemhealth/education/glossary.htm
Process injurious to health and/or longevity www.weightlosssurgery.com.au/index.php
A condition of an organic being or of one of its parts that impairs normal living functioning.
www.iffgd.org/GIDisorders/glossary.html
A condition of being sick from a particular cause. Different plants and animals often suffer from certain diseases. Some animals are known to carry diseases that effect other organisms. For example, a beetle carries a fungus which causes Dutch Elm Disease in elm trees.
www.fcps.k12.va.us/StratfordLandingES/Ecology/mpages/glossary.htm
An abnormal condition of a plant in which its physiology, morphology, and/or development is altered under the continuous influence of a pathogen. (3)
ppathw3.cals.cornell.edu/glossary/Defs_D.htm
an abnormal bodily condition of a living plant or animal that interferes with functioning and can usually be recognized by signs, symptoms, and illness. whyfiles.larc.nasa.gov/text/kids/Problem_Board/problems/biosphere/glossary.html
stress condition produced by the effects of a pathogen on a susceptible host.
scarab.msu.montana.edu/historybug/glossary.htm
Any condition that prevents the body from working as it should other that direct injury.
ricegenomics.plbr.cornell.edu/glossary.htm
A condition of an organism that impairs normal physiological function. Also see Infectious Disease.
fightaidsathome.scripps.edu/glossary.html
Any abnormality of bodily structure or function, other than those arising directly from injury. www.canadapharma.org/Patient_Pathways/Glossary_Terms/
A deleterious change in the body's condition in response to destabilizing factors, such as nutrition, chemicals, or biological agents.
highered.mcgraw-hill.com/sites/0070294267/student_view0/glossary_a-d.html
Diseases may be caused by microorganisms or by environmental factors such as a lack of available iron in the soil or excess water.
www.ottawa.ca/residents/healthy_lawns/lawns/links/glossary_en.shtm l
Illness, sickness. An interruption, cessation, or disorder of body functions, systems, or organs. Top of page
www.rationaltherapeutics.com/reference/glossary.htm
can be defined as a derangement in the function of the whole body of the host or any of its parts. www.fao.org/Wairdocs/ILRI/x5436E/x5436e04.htm
A condition of the body in which there is incorrect function due to heredity, infection, diet, or environment.
www.mdk12.org/instruction/curriculum/science/glossary.shtml
a pathological condition that is cross-culturally defined and recognized.
oregonstate.edu/instruct/anth370/gloss.html
a condition, caused by living organisms or environmental changes, that impairs the normal functions of a living organism.
www.ipmalmanac.com/glossary/index.asp
a state in which a function or part of the body is no longer in a healthy condition
lib1.store.vip.sc5.yahoo.com/lib/allergybegone/glossary.htm
A medical concept, which serves for communication between doctors. Disease does not exist as such in nature. What medicine conceives as disease is a tolerance decline accompanied by WOB complaints www.what-is-cancer.com/papers/newmedicine/glossary.html
a medically definable process, in terms of pathophysiology and pathology. Illness is what the patient experiences.
www.therubins.com/geninfo/Definit.htm
Presence of some pathology or abnormality in a part of the body. Bacteria and viruses cause many such diseases Tolerance – In pharmacology, the ability to tolerate larger and larger doses of a drug after each exposure to it.
www.uwic.ac.uk/shss/dom/newweb/General/Glossary.htm
Disorder or pathology that affects health.
www.moh.govt.nz/moh.nsf/0/15f5c5045e7a1dd4cc256b6b0002b038
Any departure from health; a particular destructive process in an organ or organism with a specific cause and symptoms.
www.michigan.gov/dnr/0,1607,7-153-10364_10950-27394--,00.htm l
Sickness, illness or loss of health.
www.sabin.org/vaccine_science_GlossaryB_D.htm

http://www.adhesionrelateddisorder.com/beyourownbestdoctor.html

Adhesion related Disorder ~ Adhesion Products Adhesion Reduction Agents

2012-01-17T06:26:00.000-05:00

Adhesion Products
Please Note:
Information provided here is intended as a lay overview only and not as any fort of endorsement. Any product described here must be used by a medical doctorin accordance with the Instructions for Use and after taking a Patient's individual circumstances into account.

Reposted from the International Adhesion Society. Please visit the International Adhesion Society at;
http://www.adhesions.org/

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http://www.adhesions.org/products.htm

Products Approved by FDA for Adhesion Prevention, Reduction in Pelvice and/or Abdominal Cavities

* INTERCEED (TC7), made by Johnson & Johnson

Placed over the site of surgical injury, this knitted fabric dissolves within 30 days or so. The idea is that the sheet keeps organs apart that would otherwise stick (adhere) together. Once healing is complete, the sheet dissolves leaving the two organs properly separated.

Since 1989, it has been approved only for open (non-keyhole) gynecologic surgery with a good record of safety and effectiveness documented in this paper authored by Dr. Wiseman in 1999.

Althought it is not approved in the USA for use in laparoscopice (key-hole) surgery, INTERCEED is often used "off-label". Only small clinical studies to evaluate INTERCEED in laparoscopy have been performed with mixed results, possibly because almost perfect control of bleeding (required for INTERCEED's action) may not have been achieved, or INTERCEED was dislodged from its site of placement.

Early studies suggested that a small amount of Heparin added to the INTERCEED may not only enhance its action, but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. Unfortunately, this work was never pursued, neither was a modified form of INTERCEED, which also functioned better than the original INTERCEED, both in the absence and presence of bleeding.

* Seprafilm, made by Genzyme (previously called HAL-F)

This film looks like a thin, slightly brittle clear "fruit roll-up" that gels soon after contact with moist body tissues. It workes and is used in much the same way as INTERCEED, except that it is also approved for General Surgery. Like INTERCEED, it is not approved in the USA for laparoscopic use, aothought with considerable technical difficulty, it can be applied in laparoscopic surgery "off-label". Approved in 1996, it has now had a long history of safety and effectiveness similar to that of INTERCEED and a number of studies have preorted its use in a variety of procedures as well as the reduction of obstruction in some cases. It should not be wrapped around the bowel that has been cut open.

Some surgeons have made a gel by cutting small pieces of Seprafilm and mixing them with saline. A study conducted by Genzyme with a standard preparation called "SepraSpray" has yielded what appear to be unimpressive results.

* Adept, marketed by Baxter

Adept is a solution containing a carbohydrate polymer. A large volume (about 3 liters) is instilled into the abdominal cavity after surgery causing them to float, keeping them apart and and preventing them from sticking to each other. Because of the the composition of the product, liquid stays in the abdominal cavity for several more days that plain saline (salt) solutions commonly used by surgeons. Altough, it has the advantage that it is easy to apply and it can be used laparoscopically, the clinical data suggest that its effectiveness is at best marginally better than salt solutions, also when used in large volume.

It should be noted that small (eg 300ml) volumes of saline used to float tissues apart do not appear to reduce adhesions, thus the data from the Adept study does suggest that large volumes of physiological saline solutions may have some benefit in reducing adhesions.

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Products not approved for Adhesions prevention, but often used "off-label" (USA)

*Note that some of these products may be approved in countries other than the USA for adhesion prevention.

* Evicel - made by Johnson & Johnson

Evicel is a type of "Fibrin Glue", a two component product made from naturally occurring molecules extracted from human blood. It is mainly used to control bleeding during surgery. A number of studies in animals and humans have suggested that fibrin glues of various types can reduce adhesions. One study using a similar, but not identical experimental version of Evicel did suggest that indeed this type of fibrin glue may reduce adhesions in humans.

Evicel has the advantage that is can easily be applied laparoscopically, it can be spayed over a large area, is a naturally occurring material and can control mild bleeding.

Other types of fibrin glue, such as Tisseel and Tissucol, made by Baxter has also been used by some surgeons to reduce adhesions.

Note - there are a number of important differences between different types of fibrin glue that could determine how effective each type is.

* Coseal, made by Baxter

Coseal is a two-component, synthetic product used to seal leakage after surgery on blood vessels. It has been sprayed or applied over areas of surgical injury to reduce adhesions both in animal models and in one human trial with 71 patients undergoing myomectomy.

Coseal is marketed in Europe not only as a sealant, but also to prevent or reduce post surgical adhesions. Coseal is the same as what was formerly known as Adhibit.

* Surgiwrap, made by MAST BioSurgery

SurgiWrap (and its cousins OrthoWrap and CardioWrap) is a clear thin sheet of a dissolvable polymer similar to the kind used in dissolvable sutures. Full clinical studies of the kind conducted for INTERCEED or Seprafilm showing that it prevents or reduces adhesions have not been published and the product is approved in the USA to “reinforce soft tissues where weakness exists”.

Based primarily on animal studies and due to technicalities in the regulation of medical devices in the USA, the company’s marketing literature for the USA states that the product “Maintains a physical barrier between opposing soft tissues” and “Retains tensile strength for 6-8 weeks ensuring tissue separation during the critical wound healing period” and implies that the product reduces or minimizes “Soft Tissue Attachments”. The company’s literature for Surgiwrap intended for marketing outside the USA clearly claims that that SurgiWrap “prevents adhesion formation”. Naturally this difference has come to the attention of American surgeons who have traveled abroad and combined with a number of reports of adverse events such as the presence of a tissue reaction and the emergence of fragments of the sheet through the vagina which in one case was reported to have “lacerated her partner”, the product does not seem to enjoy popular use.

* PRECLUDE Peritoneal Membrane made by WL Gore

This product is being discontinued after December 2011. It never had the same kind of formal approval in the USA that INTERCEED, Seprafilm or ADEPT did of adhesion prevention, but after enjoying a fairly long period of use to reconstruct tissues, for example in hernia repair, the claim was added sometime in the early 1990s “for use in peritoneal reconstruction where minimal adhesions to a prosthetic material are desired”. PRECLUDE is a thin sheet of porous ePTFE (Teflon). Although some studies showed in the 1990s that Preclude (previously known as GoreTex surgical Membrane) reduced adhesions, many surgeons were reluctant to use it since it did not degrade and required a subsequent operation to remove it.

Versions of the product to minimize adhesions in cardiac and cranial (dural) surgery.

Drugs for Adhesion Prevention

There are no drugs currently approved for the prevention or removal of adhesions. Research in this area, most of it in animals, has focused mainly on drugs that can be applied directly into the abdominal cavity at the time of surgery. Most of the drugs tested have been directed either at the clotting process (preventing or reversing the deposition of fibrin - the natural glue that causes the initial attachment or adhesion of tissues) or the inflammatory process (which results in the formation of scar).

Some promising clinical data did suggest that heparin, when applied to INTERCEED may not only enhance its action but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. This was never pursued formally. Data from the pivotal general surgical trial for Seprafilm in patients with ulcerative colitis undergoing bowel surgery did suggest that patients receiving long term corticosteroids prior to surgery had lower rates of adhesion formation than those that did not. The effect was best seen in patients also receiving Seprafilm.

Studies, never published but widely known to have been performed in the 1980s and 1990s using Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen and tolmetin applied as solutions to the peritoneal cavity failed to result in the use of these drugs clinically.

tPA (Tissue Plasminogen Activiator) is a drug causes the dissolution of fibrin. Several small pilot studies had been performed but never pursued and a recent study failed to show a difference between treatment and control groups.

Newer generations of these classes of drugs have been tested in animals, bit so far without any formal clinical trials. Other classes of drugs tested include anti-oxidants, anti-angiogenic drugs, anti-fibrotic drugs, hormonal drugs, cytokine inhibitors, anti-inflammatory cytokines and COX-2 inhibitors.

Hernia and Tissue Reconstruction Meshes

A number of products exist for the reinforcement of soft tissues after major dissections, including hernias. Adhesions to these meshes is a common problem and the designers of some products have attempted to reduce this problem. These products may feature claims akin to those of the Preclude products and include (not exhaustively): Sepramesh (Davol) and PROCEED (Johnson & Johnson).

These and other surgical meshes may be used not only in hernia repair but also for Pelvic Organ Prolapse and Stress Urinary Incontinence. Regarding these kinds of products in general, FDA has issued a Public Health Notification on October 20 2008. There was also an update on July 13, 2011 regarding complications associated with some of these meshes that when used for hernia repair complications include “adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.”

When used for Pelvic Organ Prolapse and Stress Urinary Incontinence the “most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence. In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.”

Since serious complications may occur with the use of Surgical Meshes it is important that you discuss with your doctor the risks and benefits of meshes as well as the type of mesh you may be given and its likelihood of producing an adverse reaction.

Other Products of Interest

* INSUFLOW, made by Lexion Medical
This novel device warms and humidifies the gases used to inflate the abdominal cavity during laparoscopic surgery. Because these cold, dry gases (carbon dioxide) are pumped at pressure they create a “wind-chill effect” which damages the surface layer (peritoneum) of organs in the abdominal cavity, a finding made in a study by Dr. Wiseman

Although the company does not claim it, it is well accepted that damage to the peritoneal layer contributes to the formation of adhesions. In addition use of the device helps to reduce hypothermia, postoperative pain and recovery time after surgery.

Products Marketed Outside of the USA

* SprayGel and SprayShield, made by Covidien

SprayShield is a synthetic two component product that forms a gel when applied to an organ. It is a modified version of SprayGel which demonstrated clinical effectiveness in reducing adhesions in small studies involving gynecologicand general surgery

Although all the details are unclear, it seems that SprayGel was discontinued because of problems relating to possible adverse reasons and the ability of the gel to form properly in the carbon dioxide environment that is used in laparoscopic surgery. SprayGel was, and SprayShield is marketed in Europe and we understand that a recent clinical trial in the USA was discontinued because the product failed to demonstrate efficacy.

* Hyalobarrier and Hyalobarrier Endo, made by Fidia Advanced Biopolymers, now Anika Therapeutics

Hyalobarrier, sometimes referred to as ACP Gel, is made from hyaluronic acid, a naturally occurring lubricant in the body.

Some small clinical trials have demonstrated effectiveness of in gynecologic surgery

* INTERCOAT, also known as Oxiplex AP made by Johnson & Johnson, licensed from Fziomed

This gel made is applied directly to raw surgical surfaces. Efficacy in gynecologic study was demonstrated in two small studies.

Study 1

Study 2

* Prevadh, made by Sofradim-Covidien in France

A collagen film and fleece composite that in animals was able to reduce adhesions even in the presence of bleeding and appeared safe in an uncontrolled clinical study of 78 patients.

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Products Marketed for reducing adhesions in procedures outside of the abdominal or pelvic cavities.

(This is not an exhaustive list, and it also includes products that have no formal claim of adhesion prevention)

Products (USA) Company Composition Indication
Repel CV Synthemed PLA/PEO Cardiac
TENOGLIDE Integra Collagen Tendon
Sepragel ENT

Seprapack
Genzyme Hyaluronic Acid Nasal / Sinus
Preclude Pericardial Gore ePTFE Pericardial
Preclude Dura Substitute Gore ePTFE

Products (non-USA) Company Composition Indication
INCERT-S Anika Hyaluronic Acid Spinal Surgery
ACP Gel Fidia Hyaluronic Acid Uterine Adhesions
MeroGel Fidia Hyaluronic Acid ENT
Oxiplex (also Medishield) Fziomed CMC/PEO Spinal
ADCON L Bioscompass Dextran Sulphate Spinal Surgery
ADCON T/N Biocompass Dextran Sulphate Tendon & Nerve Surgery

Products where data exists for prevention of clinical outcomes related to adhesions

Note that products may or may not have regulatory approval to market their products based on these studies. Only a selection of positive studies are shown below.

Prevention of IntraUterine Adhesions

Seprafilm Tsapanos et al., 2002

SprayGel Abbott et al., 2004

ACP Gel Guida et al., 2004

ACP Gel Acunzo et al., 2003

Intercoat Sardo et al., 2011

Prevention of adhesions after C Section

Seprafilm Fushiki H; Ikoma T; Kobayashi H, and Yoshimoto H. Efficacy of Seprafilm as an Adhesion Barrier in Cesarean Sections. Obstetric and Gynecological Treatment [Japanese]. 2005; 91(5):557-561.

Reduction of pain after adhesion-related surgery

Seprafilm Khaitan et al., 2003

Reduction of bowel obstruction

Seprafilm

Mohri et al., 2005

Fazio et al., 2006

Products where data exists for improvement of fertility after adhesion-related surgery (not necessarily with regulatory approval)

INTERCEED Sawada et al.,2000

Discontinued Products

* Sepracoat (also HAL-C), made by Genzyme was a hyaluronic acid based liquid that was used to coat tissue surfaces during surgery. It demonstrated clinical efficacy against de novo adhesions caused by tissue handling.

Its approval in the USA was rejected, and the product sold for a short time in Europe before poor sales led to its voluntary discontinuation sometime around 2000.

* INTERGEL, made by LifeCore, marketed by Johnson & Johnson was a gel of hyaluronic acid cross-linked with iron. With demonstration of clinical efficacy in the US and Europe .long it received FDA approval in 2002 after an unusual and controversial route but was withdrawn about one year later after reports of tissue reactions, increased rates of infection, late onset pain and some deaths.

Research conducted by the IAS suggested that these effects may have been more prevalent in patients who carried gene mutations for Haemochromatosis, a disorder of iron regulation, or women who had had prior hysterectomies, possibly because of an increased tendency to accumulate iron. Additional article.

* ADCON L is a gel containing Dextran Sulphate made by Gliatech for use in spinal surgery. It was approved by FDA in 1997. A version for tendon and nerve surgery was available in Europe and after a successful preclinical study conducted by Dr. Wiseman, a clinical trial, also designed by Dr. Wiseman had began to show promising results in pelvic surgery. Rapid sales of the ADCON L product began to be marred by a series of issues relating to problems in manufacturing, the company’s failure to report adverse events, and their alleged manipulation of data in a clinical trial. The company essentially placed in a “regulatory” limbo by FDA until it could, to FDA’s satisfaction put its house in order. A new management did indeed do this, but the effect of the FDA action forced the company to declare bankruptcy in 2002. Although not available in the USA, the product continues to be sold in Europe and elsewhere both in the ADCON L version and the ADCON T/N (tendon and nerve) version.

* Hyskon, made by Pharmacia, was a syrupy liquid used to expand the uterus during hysteroscpic evaluation. In the mid 1980s its was used off-label in the USA to prevent adhesions by pouring it into the abdominal cavity in the aim that it would lubricate raw tissue surfaces and prevent them from sticking. Some studies provided somewhat positive data, and while others provided the reverse and concerns of adverse reactions as well the emergence of other barriers led to its demise.

Adverse Reactions

Information about adverse reactions reported to FDA can be obtained through:

MAUDE - Manufacturer and User Facility Device Experience

If you think you have suffered an adverse reaction to any medical product, you should certainly contact your doctor and if necessary call the Emergency Services or go to the nearest Emergency Room. You are also free to report the event to the FDA by contacting the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.

Online : MedWatch Online Voluntary Reporting Form (3500)
Mail : use postage-paid FDA form 3500 available at: MedWatch Forms

Mail to:

MedWatch

5600 Fishers Lane,

Rockville, MD 20852-9787

FAX: 1-800-FDA-0178

Interested in participating in a clinical trial?

Go to ClincalTrials.gov to search for clinical trials relating to adhesions, or any other therapeutic area.

Prevention of peritoneal adhesions: A promising role for gene therapy

2012-01-17T06:18:00.001-05:00

World J Gastroenterol. 2011 December 14; 17(46): 5049–5058.
Published online 2011 December 14. doi: 10.3748/wjg.v17.i46.5049 PMCID: PMC3235588

Copyright ©2011 Baishideng Publishing Group Co., Limited. All rights reserved.
Prevention of peritoneal adhesions: A promising role for gene therapy
Hussein M Atta
Hussein M Atta, Department of Surgery, Faculty of Medicine, Minia University, El-Minia 61519, Egypt
Author contributions: Atta HM solely contributed to this paper.
Correspondence to: Hussein M Atta, MD, PhD, Professor, Department of Surgery, Faculty of Medicine, Minia University, Misr-Aswan Road, El-Minia 61519, Egypt. attahm@ems.org.egTelephone: +20-1-001407222 Fax: +20-2-22917077
Received May 15, 2011; Revised July 14, 2011; Accepted July 21, 2011.

Abstract:

Adhesions are the most frequent complication of abdominopelvic surgery, yet the extent of the problem, and its serious consequences, has not been adequately recognized. Adhesions evolved as a life-saving mechanism to limit the spread of intraperitoneal inflammatory conditions. Three different pathophysiological mechanisms can independently trigger adhesion formation. Mesothelial cell injury and loss during operations, tissue hypoxia and inflammation each promotes adhesion formation separately, and potentiate the effect of each other. Studies have repeatedly demonstrated that interruption of a single pathway does not completely prevent adhesion formation. This review summarizes the pathogenesis of adhesion formation and the results of single gene therapy interventions. It explores the promising role of combinatorial gene therapy and vector modifications for the prevention of adhesion formation in order to stimulate new ideas and encourage rapid advancements in this field.

Keywords: Peritoneal adhesions, Tissue plasminogen activator, Gene therapy, Plasminogen activator inhibitor, Tissue inhibitor of metalloproteinase, Transforming growth factor β

Full article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3235588/?tool=pubmed

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

2012-01-14T10:25:00.000-05:00

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Date Issued: July 13, 2011

Audience:

Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence
Health care providers involved in the care of patients with surgical mesh implanted to repair pelvic organ prolapse and/or stress urinary incontinence
Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence
Medical Specialties: gynecology, urogynecology, urology, general surgery, internal medicine, family practice, emergency medicine

Device:
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.

Background:
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

Purpose:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.

The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.1

Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.

From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

In particular, the literature review revealed that:

Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

Recommendations for Health Care Providers:

As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:

Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.
Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.
In addition, the FDA also recommends that health care providers:

Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
Consider these factors before placing surgical mesh:
Surgical mesh is a permanent implant that may make future surgical repair more challenging.
A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.

Recommendations for Patients:
Before Surgery
Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.

Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.

In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used:

Are you planning to use mesh in my surgery?
Why do you think I am a good candidate for surgical mesh?
Why is surgical mesh being chosen for my repair?
What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
What can I expect to feel after surgery and for how long?
Which specific side effects should I report to you after the surgery?
What if the mesh surgery doesn’t correct my problem?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
After Surgery

Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.
Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
Talk to your health care provider about any questions you may have.
If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.

FDA Activities:
The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will:

Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.
Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now being marketed and those that will be reviewed for marketing in the future.
Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements2 should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations3.

To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available:

Manufacturer's name
Product name (brand name)
Catalog number
Lot number
Size
Date of implant
Date of explant (if mesh was removed)
Details of the adverse event and medical and/or surgical interventions (if required)
Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

-Additional Information

Urogynecologic Surgical Mesh Implants4
Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July 2011) (PDF - 243KB)5
Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks6
Federal Register Notice: Urogynecologic Surgical Mesh7
Federal Register Notice Ammendment: Urogynecologic Surgical Mesh8

http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm

What is adhesion related disorder (ARD)?

2012-01-12T08:21:00.000-05:00

What is adhesion related disorder (ARD)?
Adhesion related disorder is a complex set of symptoms related to adhesions. Patient’s primary complaint is usually chronic abdominal pain. Their symptoms can be primarily in one area of the abdomen but are often generalized, vague, crampy and difficult to define. The symptoms of ARD could include:

•Chronic pain
•Infertility
•Bowel obstruction
•Gastro-esophageal reflux disease, (GERD)
•Urinary Bladder dysfunction
•Pain and difficulty having a bowel movement
•Pain on movement such as: Walking, sitting or laying in certain positions.
•Loss of Nutrients due to poor eating habits or loss of appetite.
•Loss of employment due to lost work days
•Loss of family and social life
•Emotional Disorders such as: Depression, Thoughts of Suicide, Hopelessness
Other intestinal problems can accompany the pain. Constipation or obstruction is sometimes encountered. Alternating constipation with diarrhea from partial obstruction can also be seen. Symptoms may also be related

Hope For Adhesion Pain Sufferers: Asherman’s Syndrome – could it be why you’re struggling to have a baby?

2012-01-12T08:16:00.000-05:00

Hope For Adhesion Pain Sufferers: Asherman’s Syndrome – could it be why you’re struggling to have a baby?

Health insurance rescission case upheld by California appellate court - Lexology

2012-01-11T04:47:00.000-05:00

Health insurance rescission case upheld by California appellate court - Lexology

Beyonce Says Birth ‘Natural,’ Despite Cesarean Reports

2012-01-11T04:44:00.000-05:00

Beyonce Says Birth ‘Natural,’ Despite Cesarean Reports: Royal rap couple Beyonce and Jay-Z have issued a statement that she had given birth “naturally” to daughter Blue Ivy on Jan. 7. But first reports from TMZ prompted Internet buzz over questions about whether the Cesarean birth had been planned. Some asked: “Is natural...

Robot performs hysterectomy on South Bend woman

2012-01-11T04:41:00.000-05:00

Robot performs hysterectomy on South Bend woman
South Bend, Ind.
http://www.wndu.com/hometop/headlines/Robot_performs_hysterectomy_on_South_Bend_woman_136830448.html

A South Bend woman wanted to make sure the estrogen factor that led to her breast cancer did not spread to her female organs, so her doctor offered her a laparoscopic robotic hysterectomy
Posted: 3:49 PM Jan 6, 2012
Reporter: Maureen McFadden
Email Address: maureen.mcfadden@wndu.com

FDA Whose who in adhesion barriers

2012-01-10T07:52:00.000-05:00

FDA Home; Medical Devices Databases Establishment Registration Device Listing1 to 12 of 12 Results
Results per Page 35102550100500
Product Code : MCN

Establishment
Name
Registration Number Current
Registration Yr
BAXTER AG AUSTRIA
9616848 2012
barrier, absorable, adhesion - ADEPT
Manufacturer

BAXTER HEALTHCARE CORPORATION CA/USA
2032282 2012
barrier, absorable, adhesion - Adept
Specification Developer

Covidien, formerly Confluent Surgical, Inc. MA/USA
3008196149 2012
barrier, absorable, adhesion - Spray Gel; Spray Shield
Specification Developer

Covidien, formerly US Surgical a divison of Tyco Healthcare CT/USA
1219930 2012
barrier, absorable, adhesion - Spray Gel; Spray Shield
U.S. Manufacturer of Export Only Devices

ETHICON INC SWITZERLAND
3006795579 2012
barrier, absorable, adhesion
Manufacturer

ETHICON INC SWITZERLAND
3003702646 2012
barrier, absorable, adhesion
Manufacturer

ETHICON, INC. NJ/USA
2210968 2012
barrier, absorable, adhesion
Specification Developer

ETHICON, LLC. PR/USA
2648650 2012
barrier, absorable, adhesion
Manufacturer

FZIOMED, INC. CA/USA
2031637 2012
barrier, absorable, adhesion - Ethicon Intercoat; Oxiplex/AP Gel
U.S. Manufacturer of Export Only Devices

GENZYME CORPORATION MA/USA
1220423 2012
barrier, absorable, adhesion - Seprafilm Adhesion Barrier
Manufacturer

NORAMCO, INC. GA/USA
1033845 2012
barrier, absorable, adhesion
Manufacturer

Pathfinder Cell Therapy, Inc. MA/USA
2248031 2012
barrier, absorable, adhesion - REPEL-CV
Specification Developer

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?start_search=1&establishmentName=&StateName=&CountryName=
&RegistrationNumber=&OwnerOperatorNumber=&OwnerOperatorName=&ProductCode=MCN&DeviceName=&ProprietaryName=&establishmentType=&PAGENUM=5 0

Adhesion Related Disorder International Human Rights Team IHRT: Has wanna be adhesion activist/author Karen Steward made you feel...

2012-01-10T06:23:00.000-05:00

Progel® Adhesion Barrier Sealant Receives CE Mark

2012-01-10T06:18:00.000-05:00

Progel® Adhesion Barrier Sealant Receives CE Mark
January 09, 2012 08:15 AM Eastern Time

Neomend Strengthens Position in Europe with Unique Sealant Technology

IRVINE, Calif.--(BUSINESS WIRE)--Neomend, Inc., a leading innovator in sealant and adhesion-prevention products for the surgical marketplace, announced it has received the European Union CE Mark for the company’s Progel® Adhesion Barrier (AB) product.
Read the rest of the press release here: http://www.businesswire.com/news/home/20120109005499/en/Progel%C2%AE-Adhesion-Barrier-Sealant-Receives-CE-Mark

A direct comparison of seprafilm, adept, intercoat, and spraygel for adhesion prophylaxis.

2012-01-06T05:43:00.000-05:00

J Surg Res. 2010 Jun 15;161(2):246-9. Epub 2008 Dec 10.
A direct comparison of seprafilm, adept, intercoat, and spraygel for adhesion prophylaxis.
Rajab TK, Wallwiener M, Planck C, Brochhausen C, Kraemer B, Wallwiener CW.
SourceUniversity of Tübingen, Tübingen, Germany. Taufiek.Rajab@imperial.ac.uk

Abstract
BACKGROUND: Commercially available agents for adhesion prophylaxis are legion but there is a lack of direct comparisons between them. Here we compare four of the most commonly used adhesion barriers against a control group in a clinically relevant rat model.

MATERIAL AND METHODS: Standardized lesions were created in Wistar rats using electrocautery and suturing. Subsequently, the experimental lesions were treated with Seprafilm (n = 30), Adept (n = 30), Intercoat (n = 30), Spraygel (n = 30), or no barrier (n = 30). The resulting adhesions were examined 14 d postoperatively.

RESULTS: The mean area covered by adhesion was 77% in the control group, 46% in animals treated with Seprafilm, 54% in animals treated with Adept, 55% in animals treated with Intercoat, and 68% in animals treated with Spraygel. The adhesion-free incidence was 20% (n = 6) of lesions treated with Seprafilm, 20% (n = 6) of lesions treated with Intercoat, 3% of lesions treated with Spraygel (n = 1), and 0% of lesions treated with Adept or the control group.

CONCLUSIONS: There were statistically significant differences between the barriers with regards to the area covered by adhesions and the adhesion-free incidence. In spite of this, a significant adhesion burden remains with all of the tested barriers.

http://www.ncbi.nlm.nih.gov/pubmed/19375716

EndoTimes: Endometriosis Linked to IBD

2012-01-02T07:17:00.000-05:00

EndoTimes: Endometriosis Linked to IBD

CONFLUENT SPRAYSHIELD MAUDE Adverse Event Report

2011-12-28T05:08:00.000-05:00

Another one!

CONFLUENT SPRAYSHIELD POLYMER KIT WITH SPRAYER SPRAYSHIELD KIT
Catalog Number SP10S01
Event Date 01/21/2011
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
(b)(4).

Event Description
According to the reporter: the pt experienced heavy underbelly pains two days post-operatively. The pains were described as burning. At the fourth post-operative day, the stomach had to be re-opened. There were syrinxes that were discovered where the product had been applied, which were operated upon. The pt was released from the hospital free of pain.

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

Brand Name SPRAYSHIELD POLYMER KIT WITH SPRAYER
Type of Device SPRAYSHIELD KIT
Manufacturer (Section F) CONFLUENT
101a first ave.
waltham MA 02451

Manufacturer (Section D) CONFLUENT
101a first ave.
waltham MA 02451

Manufacturer (Section G) CONFLUENT
101a first ave.

waltham MA 02451

Manufacturer Contact terry callahan
60 middletown ave.
north haven , CT 06473
(203) 492 -6273

Device Event Key 2070451
MDR Report Key 2037782
Event Key 1934758
Report Number 3003157248-2011-00007
Device Sequence Number 1
Product Code NQR
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 03/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number SP10S01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 01/24/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2037782

Prevention of peritoneal adhesions: A promising role for gene therapy

2011-12-27T14:15:00.000-05:00

More Good News for those who suffer from Adhesion Related Disorder!

Source: World J Gastroenterol

Prevention of peritoneal adhesions: A promising role for gene therapy; Atta HM; World Journal of Gastroenterology 17 (46), 5049-58 (Dec 2011)

Adhesions are the most frequent complication of abdominopelvic surgery, yet the extent of the problem, and its serious consequences, has not been adequately recognized. Adhesions evolved as a life-saving mechanism to limit the spread of intraperitoneal inflammatory conditions. Three different pathophysiological mechanisms can independently trigger adhesion formation. Mesothelial cell injury and loss during operations, tissue hypoxia and inflammation each promotes adhesion formation separately, and potentiate the effect of each other. Studies have repeatedly demonstrated that interruption of a single pathway does not completely prevent adhesion formation. This review summarizes the pathogenesis of adhesion formation and the results of single gene therapy interventions. It explores the promising role of combinatorial gene therapy and vector modifications for the prevention of adhesion formation in order to stimulate new ideas and encourage rapid advancements in this field.

http://www.docguide.com/prevention-peritoneal-adhesions-promising-role-gene-therapy?tsid=5

Breaking News! Adhesions easily visualised with simple Barium Swallow!

2011-12-21T06:40:00.008-05:00

Breaking News!

Adhesions easily visualised with simple

"NONE INVASIVE "

CONTRAST X-RAY BARIUM SWALLOW!

When taking the test, you drink a preparation containing Barium sulfate . The x-ray tracks the chalky like liquid as it makes it way through your digestive system, (inside the organs).....however it also showed what was on the OUTSIDE of the organs of the digestive track, (in the peritoneal cavity within the abdominal cavity!)

The "Contrast Barium Swallow" abdominal x-ray diagnostic was never meant to show anything else, it showed ADHESIONS attaching internal organs in the lower digestive track to the peritoneum and to other organs.

It can also show the "mis-alignment" of intestines from being pulled out of the normal alignment by adhesion attachments!

This diagnostic can also detect bowel obstructions or bowel impactions---and all of this without so much as a surgeons knife!

MORE TO COME
on this magnificent discovery in the world of
ARD!

Maybe 2012 WILL be a year of good for

"Adhesion Related Disorder"
victims!

!!!! Visible Adhesions !!!!!

"MERRY CHRISTMAS"
"HAppy Holidays"
or rather
"THank-God"

!! DEMAND THIS DIAGNOSTIC !!

The "X-Ray Barium Swallow" diagnostic test is NOT used to detect adhesions, or any other "pathological anomalies," OUTSIDE of the organs of the digestive track!

The "X-Ray Barium Swallow" is a diagnostic tool used to solely detect "pathological anomalies, obstructions and/or diseases," WITHIN the organs of the digestive track!

You MUST insist that your attending physician order this diagnostic test if you have had a previous adhesiolysis, or many of them for that matter, and are currently experiencing abdominal/pelvic pain that YOU think is associated with adhesions, or ARD!

Have it ordered for "Pain," as you see listed below!

DO NOT ALLOW YOURSELF

to be denied this diagnostic!

Barium Swallow IntroductionA barium swallow is a test that may be used to determine the cause of painful swallowing, difficulty with swallowing, abdominal pain, bloodstained vomit, or unexplained weight loss.

Barium sulfate is a metallic compound that shows up on x-ray and is used to help see abnormalities in the esophagus and stomach. When taking the test, you drink a preparation containing this solution. The x-rays track its path through your digestive system.

•These problems can be detected with a barium swallow: ◦Narrowing or irritation of the esophagus (the muscular tube between the back of the throat and the stomach)

◦Disorders of swallowing

◦Hiatal hernia (an internal defect that causes the stomach to slide partially into the chest)

◦Abnormally enlarged veins in the esophagus that cause bleeding

◦Ulcers

◦Tumors

◦Polyps (growths that are usually not cancerous, but could be precancerous)

Barium Swallow - Test Results

ALWAYS INSIST YOU RECEIVE A COPY OF THE TEST , BUT MOST IMPORTANT IS THAT YOU SECURE A VISUAL COPY OF THE FILMS OF THE X-RAY ITSELF AS IT IS IN THESE THAT YOU WILL SEE ADHESIONS IF THEY ARE VISIBLE!!!!

The "normal" pathology results your Dr. looks for and will jabber about are listed below here, just listen them out, then make sure you get a visual or the test for yourself! It is imperative that YOU look for your own results and IF adhesions can be seen in these films, you will recognize them!

Usual Test Results:
Ask your doctor for the results of your barium swallow test. You may have to wait a few days until the radiologist (a specialist in x-ray examinations) looks at the x-rays and gives your doctor the final results. Your doctor will recommend a plan of action to you based on the results.

•The x-rays will show the digestive wave (peristalsis) through the length of the esophagus. When barium reaches the end of the esophagus, the barium enters the stomach.
•The barium swallow may reveal problems in the pharynx (the back of the throat), the esophagus, or the stomach. The problems could be narrowing, tumors, polyps, ulcers (erosions), or disorders in moving food through the system. It can also show a hiatal hernia, diverticula (pouches opening along the esophagus), or varices (enlarged veins).

•If the barium swallow test shows any area of concern, your doctor may plan what other tests, procedures, treatments, or medications you may need. The treatment for problems discovered during a barium swallow vary depending on the condition. http://www.emedicinehealth.com/barium_swallow/article_em.htm

A picture is worth a 1000 word...so see for yourselves!

In 2009 a known adhesion sufferer had a GI Barium Swallow for "Chronic Abdominal Pain."

This female suffered "Adhesion Related Disorder" and had undergone multiple surgeries in which abdominal adhesion's were present and lysed in each of her each surgeries. Relief was always fleeting and the pain always returned after each surgery.

When this test was taken in 2009 she was told everything is fine and the test revealed nothing, and it was absolutely right, as long as he made his determination based on what the test was meant to show! She had NO abnormal internal organ pathology showing in this Barium Swallow! The docs said she was just fine and sent her on her way.

She had Cat scans, MRI's every test in the book, you name it and the financial toll was enormous...... and all the doctors said she was fine. They could find nothing wrong and yet she suffered so.
A subsequent surgery was scheduled and records and imagery were sent to the new surgeon.

During pre op...reviews of all the tests...these images below caught the surgeon eye!
The surgeon palpitated each area where adhesions were being visualised on these simple

"Contrast Barium Swallow X-Ray Films."
As an ARD patient advocate watched, knowing what was being seen on the screen in front of them showing what could only be "ADHESIONS," the Dr. asked the patient, "Does it hurt there? Does it hurt here?"

Each time the ARD patient confirmed her pain was exactly where the surgeon indicated it might be in her abdomen. The surgeon then told his surgery team that he wanted these films up on a screen in the operating room during the procedure!

You bet he did!

An IHRT patient advocate was scrubbed up and in the OR with the surgeon.....as you will see below, everywhere the wispy white tendrils appeared...is where he lysed adhesion! He used the images below as a guide to lysing the patients adhesions during the entire surgery. He confirmed this for us all!

After surgery, the patient, the surgeon and IHRT advocate were in somewhat of disbelief at what they had just witnessed, and they knew that these images had guided the way...the surgeon confirmed for us that indeed...this simple test reveled adhesions exquisitely!

We feel that this may finally be the end of expensive testing for adhesion patients....the statement that adhesions rarely if ever show up in any type of imaging is now a myth.
No more "Let's have a surgical look, see" to search for the always elusive adhesions.
Use these images to advocate for yourself. Ask for this simple non invasive, inexpensive test!!!!
It is not in your head....it is right there in black and white for all the world to see.
Removing personal information from these images has been difficult but this most generous adhesion sufferer has had that as her only request.
There are more images still to be placed in this posting and each image will be summarised as to what you are looking at anatomically so please check back! Approx a dozen more images from the same series coming soon!

This news is so wonderful we wanted to get it to you as soon as possible!
We wish all who suffer from adhesions all the best this holiday season and we present you a gift from an anonymous adhesion sufferer.

A simple " Contrast Barium Swallow X-Ray!"

"MERRY CHRISTMAS"
"Happy Holidays"

Surgery done by Dr Pagels

We place his information here for your convenience but urge you to exercise due diligence when deciding which surgeon is right for you!

Dr. Pagels is now Chief of Gynecology at St.Josef Krankenhaus Moers. He was chief of Gynecology at Klinikum Duisburg, when this surgery was done.
This is his address: Herr Dr. Med. Jens Pagels
St. Josef Krankenhaus Moers
Asberger Str. 4
47441 Moers
Germany
Telephone Number: +49 (0) 2841 1072430
His email address is: gyn.pagels@st-josef-moer

This first image below ...what do you see in the one o'clock position?

Do YOU think you are correct!
( NO, that is not a fetus, it is a twisted bowel!)

A Personal Case for Classical Homeopathy, Part I

2011-12-21T05:43:00.000-05:00

Exerpt from :A Personal Case for Classical Homeopathy, Part I
Judith Acosta

Many years ago, I suddenly developed abdominal pain. I had not been sick in any other way and had no idea what was happening. I went for a gynecological exam and was told I was fine. The pain continued. I went back and after numerous exams was sent from the table to the couch. The psychiatrist sent me right back to the doctor. After about a year of bouncing back and forth with increasingly intense (searing, stabbing) pain, they finally "discovered" a mass several centimeters in width in the area of my left ovary.

At this point, the surgeons were called in. I was scheduled for an emergency laparotomy. As they wheeled me in, the surgeon said to my mother, "It could be cancer." I was 26.

After surgery, as soon as I stopped vomiting, the doctor told me that it was not cancer. My mother wept. He said it was a streptococcal infection (Strep B) that had created adhesions and that I could forget about having children. He proudly went on to inform us that they had "scraped me clean" and that I'd be on antibiotics for about a month.

I did as I was told. I was raised by a doctor, surrounded by doctors and had complete faith in the system.

Within a short time a whole new sort of pain emerged, this time, however, deeper. It was more localized, again on the left side. I thought the infection had returned. The pain continued for quite a while. I went to the doctor, but there was no infection. After dismissing it (and me) for at least a year again, I finally wound up in hospital. A cyst had burst. This cycle recurred every few months. They recommended birth control pills, pain pills and pills I didn't understand. Nothing helped. By the fourth rupture and hospital visit, they recommended a full hysterectomy.
Read the entire article here: http://www.huffingtonpost.com/judith-acosta/homeopathy_b_1150591.html

Please stand by for World Wide Breaking News ~ The day that changes Adhesion Related Disorder forever

2011-12-16T06:35:00.000-05:00

We will be bringing you the story that will change the lives of those suffering from Adhesion Related Disorder forever.

This news will empower you to advocate for yourself and never again be told,

"It's all in your head!"

Behind the badge with Sheriff Stephens ~ "Back then, they called it heartburn!"

2011-12-15T08:28:00.001-05:00

Exerpt from full article: http://www.forest-blade.com/news/community/article_f9faf6aa-25d4-11e1-bbc7-0019bb2963f4.html

In the past year, however, Stephens has faced medical difficulties that made it difficult to keep pace with his many obligations. Twenty-three years ago, Stephens was diagnosed with esophageal cancer as a result of acid reflux disease. Though he's been cancer-free since then, the surgery did lasting damage.

"Back then, they called it heartburn!" he says. "They caught it early and they were able to remove the cancer fully. Through the years, the surgery caused a lot of different problems, and I've had my share of them, but I began to have trouble digesting food and it kept getting worse until this year, when I had to have serious surgery to reconstruct my digestive system."

The surgery has solved a lot of Stephens's problems with adhesions and scar tissue from previous surgeries and he is back on his feet and recovering well.

"I was blessed to get through it. It was a tough time for me and for my department," he says. "I can't say enough good words about my employees. They carried on and never missed a lick while I was down recovering from that major surgery."

What is ovarian remnant syndrome?

2011-12-15T07:45:00.000-05:00

Q:What is ovarian remnant syndrome?

A: Ovarian remnant syndrome (ORS) occurs if any ovarian tissue is left after surgery to remove both ovaries and fallopian tubes, called a bilateral salpingo-oophorectomy. The syndrome occurs if this ovarian tissue causes severe pelvic pain and/or a pelvic mass.

The condition typically occurs because of the surgical technique used to remove the ovaries. Although ORS is considered fairly rare, its incidence appears to have increased in the past 40 years, possibly related to the increased use of laparoscopic surgeries.These surgeries allow the surgeon to operate through two or three tiny incisions instead of a large abdominal incision.

Certain factors increase the risk of incomplete ovarian removal, including a history of endometriosis, pelvic inflammatory disease, previous abdominal or pelvic surgeries and pelvic adhesions. Adhesions are scar tissue that forms after pelvic or abdominal surgery and "sticks" to organs and other tissue. Adhesions make it difficult for the surgeon to completely identify and remove the ovaries because of the fibrous tissue that binds an ovary with the other structures or with the peritoneum, the membrane that covers the inside of the abdomen and pelvis.

If any ovarian tissue is left in your pelvis, it can, in some instances, continue to produce hormones.

The most common symptoms of ovarian remnant syndrome are constant, chronic pelvic pain, difficult or painful intercourse, cyclic pelvic pain, and painful urination and bowel movements.

The condition is diagnosed based on a careful medical history. One sign that there may be residual ovarian tissue is if after your ovaries were removed, you didn't immediately start hormone therapy but didn't experience menopausal symptoms, such as hot flashes. This would suggest that you may still be producing estrogens. An alternative situation is if after surgery, you started hormone therapy and then discontinued it for some reason but didn't experience these symptoms.

Your doctor may also perform an ultrasound, CT scan or MRI to identify any ovarian tissue or pelvic mass and may measure blood levels of follicle-stimulating hormone (FSH) and estradiol. Estradiol is produced by the ovaries and FSH by the pituitary gland in response to hormonal signals from the ovaries. Levels of estradiol should be very low and levels of FSH should be very high after both ovaries have been removed.

If your doctor does find ovarian tissue remnants, you may be treated with medication to suppress any ovarian function, surgery to remove the tissue, or, as a last resort, radiation to destroy the tissue.

http://www.healthywomen.org/content/ask-expert/1761/ovarian-remnant-syndrome?context=womentalk/ask-the-expert&context_title=ask-the-expert

Stand By for Breaking News!

2011-12-14T15:06:00.000-05:00

We have fantastic news coming ...please check back soon!

Marijuana, Narcotics Help Patients Reduce Chronic Pain, Study Finds

2011-12-14T06:19:00.000-05:00

WASHINGTON -- A new study out of UC San Francisco has found that medical marijuana, combined with certain opiates, appears to be a safe and effective treatment for patients with chronic pain.

The study, published this month in Clinical Pharmacology and Therapeutics, found that patients who use cannabinoids inhaled through a vaporizer, combined with long-acting morphine or long-acting oxycodone, experienced a greater reduction of pain than those who used opiates alone.

The 21 chronic pain patients involved in the study were split into two groups. Those who combined four consecutive days of exposure to vaporized cannabis with morphine experienced a 33 percent reduction in pain, while those who combined it with oxycodone saw a drop in pain of 20 percent. The study is the first to examine the combined effect of these drugs on humans.

"Pain is a big problem in America and chronic pain is a reason many people utilize the health care system," said lead author Donald Abrams, a professor of clinical medicine at UCSF and chief of the Hematology-Oncology Division at San Francisco General Hospital and Trauma Center. "And chronic pain is, unfortunately, one of the problems we're least capable of managing effectively."
Continue article here: http://www.huffingtonpost.com/2011/12/08/marijuana-narcotics-help-patients-reduce-pain_n_1137416.html

Preventing Adhesions in Obstetric and Gynecologic Surgical Procedures

2011-12-13T05:14:00.000-05:00

Preventing Adhesions in Obstetric and Gynecologic Surgical Procedures
Víctor Hugo González-Quintero, MD, MPH and Francisco E Cruz-Pachano, MD
Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Miami School of Medicine, Miami, FL Other Sections▼
AbstractAdhesion FormationAdhesion-Related MorbidityPrevention of Postoperative AdhesionsUse of Adhesion BarriersAdhesion Prevention at the Time of Cesarean DeliverySummaryReferencesAbstractAdhesive disease represents a significant cause of morbidity for postoperative patients. Most surgical procedures performed by obstetrician-gynecologists are associated with pelvic adhesions that cause subsequent serious sequelae, including small bowel obstruction, infertility, chronic pelvic pain, and difficulty in postoperative treatment, including complexity during subsequent surgical procedures. The technology of adhesion prevention has significantly progressed. There are 3 methods approved by the US Food and Drug Administration for the prevention of postoperative adhesions, including Adept®, Interceed®, and Seprafilm®. The latter barrier is the most widely studied. This article reviews the current choices available for adhesion prevention barriers as well as surgical adjuncts that traditionally have been studied for that purpose.Key words: Adhesion prevention, Postoperative morbidity, Cesarean deliveries, Gynecological surgeries
More of the abstract click here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2672996/

Perforated IUD? Try Laparoscopic Removal First

2011-12-08T06:09:00.000-05:00

Steven Fox

December 7, 2011 — A majority of intrauterine devices (IUDs) that cause uterine perforations may be safely removed with laparoscopy, rather than resorting to more invasive surgery, according to researchers who reviewed nearly 40 years of research on the topic.

On the basis of their review, Richdeep Gill, MD, from the Department of Surgery, University of Alberta, Edmonton, Canada, and colleagues suggest that the laparoscopic approach be first-line therapy in patients who present with symptoms, and that it be considered a reasonable option in patients without symptoms.

Their article appears in the January 2012 issue of Contraception .

"Uterine perforation by [IUDs] is a rare but well recognized complication," they write. However, "[o]ur review demonstrates that a majority of IUD perforations may be amenable to laparoscopic retrieval." Furthermore, they say, the location of the perforated IUD within the abdomen does not appear to be a major factor in outcomes.

According to some estimates, anywhere from 0 to 1.3 per 1000 women implanted with the devices will experience uterine perforation.

In the past, patients who presented with adhesions and perforated viscera often required laparotomy to remove their IUDs, but in recent years improvements in laparoscopic technique and technology have allowed surgeons to use the less-invasive approach to achieve the same results, the authors say.

To find out more about how advances in laparoscopic surgery have affected the management of patients with perforated IUDs, the authors conducted a systematic search of the literature from 1970 through 2009, using MEDLINE/PubMed, Embase, Cochrane Library, and OCLC PapersFirst.

The authors identified 179 cases in which surgeons attempted to use laparoscopy to remove perforated IUDs. Mean age of the patients was 26 years, with an age range from 17 to 49 years. More than three-quarters of the women had previously given birth at least twice.

The patients presented with various symptoms, the most common being pain and unexpected pregnancy, the authors say. All participants initially underwent diagnostic laparoscopy.

The authors report that this initial laparoscopy was successful in all 179 cases. Surgeons subsequently used laparoscopy to successfully remove the perforated IUDs in 64.2% (115/179) of cases.

Laparotomy was done in 34.6% (62/179) of cases, either after diagnostic laparoscopy or after laparoscopic removal had been attempted.

The presence of adhesions appeared to be a factor in unsuccessful outcomes with laparoscopy. Among women who required laparotomy to remove their IUDs, 75% (15/20) reported the presence of adhesions.

In contrast, women whose IUDs were successfully removed by laparoscopy reported a 37.7% (20/53) incidence of adhesions.

Perforated IUDs were found in a variety of locations, including the omentum (26.7%), pouch of Douglas (21.5%), colonic lumen secondary to perforation (10.4%), myometrium (7.4%), broad ligament (6.7%), free within the abdomen (5.2%), small bowel serosa (4.4%), colonic serosa (3.7%), and mesentery (3%). The remaining 11% were found in rare locations, including the bladder, appendix, abdominal wall, fallopian tube, ovary, retroperitoneum, and small bowel. The location appeared to have little effect on the outcomes, the reviewers say.

They conclude: "[T]his systematic review highlights how advances in laparoscopic technique and skill have allowed surgeons to safely retrieve IUDs without laparotomy. We recommend an attempt at laparoscopic removal as first-line treatment in symptomatic patients and as a reasonable treatment option in asymptomatic patients."

The authors have disclosed no relevant financial relationships.

Contraception. 2012;85:15-18. Abstract

Testimony on the Resorbable Adhesion Barrier REPEL-CV

2011-12-04T08:02:00.000-05:00

September 19, 2007

Testimony of Peter Lurie, M.D., M.P.H., and Eunice Yu
Public Citizen’s Health Research Group

Public Citizen’s Health Research Group opposes the approval of REPEL-CV, a resorbable polymer adhesion barrier, for the proposed indication of reduction in surgical adhesions. Minimum criteria for the approval of an adhesion barrier should be the demonstration of a clinically significant improvement and a reasonable assurance of safety. Neither is present in this case.

Background
Opening the sternum (sternotomy) during cardiac surgery can result in the formation of dense scar tissue called adhesions between the outside of the heart (epicardium) and the inner portion of the chest wall. REPEL-CV is implanted between the epicardium and the chest wall and, in theory, resorbed within 28 days. During this period, it is supposed to reduce the incidence and severity of adhesions, making subsequent surgery less difficult. It is noteworthy that the sole proposed indication (“reducing the incidence, severity and extent of post-operative adhesion formation in patients undergoing cardiac surgery via sternotomy”[1]) makes no claim of any clinical benefit to the patient.

In its pre-market application (PMA) for REPEL-CV, SyntheMed Inc. submitted a single randomized, evaluator-blinded pivotal trial of 142 pediatric patients (73 treatment, 69 control) who were expected to require at least two sternotomy procedures for repair of congenital heart malformations. The device was implanted in the first surgery and adhesions were measured in the second. In the treatment group, REPEL-CV was sutured to the margins of the open pericardium (a sac surrounding the heart) below the sternum in the first operation, while in the control group the pericardium was left open. Following various patient withdrawals and discontinuations, the trial yielded an intent-to-treat population of 56 patients in the treatment arm and 54 in the control arm, all of whom underwent the second procedure. Most study endpoints were based upon the following four-point scale developed in the feasibility trials.

Grade 0 = No adhesions

Grade 1 = Mild adhesions (filmy, non-cohesive adhesions requiring blunt dissection to separate the space between the epicardium and sternum)

Grade 2 = Moderate adhesions (filmy, non-cohesive adhesions requiring a combination of blunt and selective sharp dissection to separate the space between the epicardium and the sternum)

Grade 3 = Severe adhesions (dense, cohesive adhesions requiring extensive sharp dissection to separate the space between the epicardium and the sternum)[2]

The primary endpoint was the percentage of the surgical site with Grade 3 adhesions detected during the second surgery. Three of the four secondary endpoints also drew from this scale by measuring the prevalence of Grade 0-2 adhesions, or by characterizing the patients by their most severe adhesion grade. The final secondary endpoint measured the time required to dissect adhesions at the second sternotomy.

Efficacy
REPEL-CV Does Not Reduce the Incidence of Adhesions
The trial showed a significant reduction in the prevalence at second sternotomy of Grade 3 adhesions in patients with the REPEL-CV implant (21.3%) compared with those whose pericardiums were left open (47.3%; p=0.0008).[3] However, the product failed to actually prevent adhesions overall, whether measured by the percentage of the operative surface area with Grade 0 adhesions (mean 2.9% vs. 0.9%; p=0.32)[4] or by the percentage of patients who were completely adhesion-free (1.8% vs. 0%).[5] The product did seem to reduce the severity of adhesions. For the primary efficacy variable, there was an overall redistribution from Grade 3 adhesions into Grade 2 and Grade 1 adhesions.[6] The percentage of patients characterized by their worst adhesion showed a similar trend: REPEL-CV resulted in a “one-grade shift downwards,”[7] from Grade 3 into Grade 2. This is very different from “reducing the incidence” of adhesions, part of the indication sought by the company.

Lack of Clinical Endpoints
The above adhesion scale has never been validated with clinical outcomes such as mortality, infection, or complications of adhesions. Indeed, we are aware of no circumstance in which it has been used except for in the development of REPEL-CV. One observer suggests that pericardial adhesions “may be beneficial” for patients because adhesions prevent “excessive movement of the heart devoid of its normal pericardial support.”[8] Lack of clarity over the significance of adhesions makes the demonstration of an actual clinical benefit all the more important.

Given that the apparent purpose of adhesion prevention is the facilitation of follow-up surgeries, the only (secondary) endpoint with a resemblance to clinical significance is adhesion dissection time. Yet this endpoint was not influenced by REPEL-CV (25.9 minutes for the treatment group vs. 25.0 minutes for the control group; p=0.84).[9] The lack of a positive result for the only clinical endpoint calls into question the usefulness of the device.

The major limitations of using adhesions as the primary outcome are underscored by the history of FDA’s guidance on clinical trials for resorbable adhesion barrier devices. In its original 1999 Draft Guidance for such devices in abdominal and/or pelvic surgery, the agency made clear the importance of clinical endpoints: “Optimally, endpoints should directly address clinical outcome measures … The most direct method of providing valid scientific evidence of effectiveness is to select an appropriate clinical endpoint(s) and design a study that may demonstrate a statistically significant and clinically meaningful effect on recognized adhesion-related morbidity.”[10] After discussing particular endpoints for abdominal and pelvic surgery and acknowledging possible impediments to the use of clinical endpoints, the section concludes, “sponsors are encouraged to directly assess clinical endpoints whenever possible.”

This did not sit well with the Adhesion Barrier Task Force, which represented the manufacturers of adhesion barriers including SyntheMed’s predecessor company, Life Medical Sciences. In comments on the Draft Guidance submitted to the FDA, the Task Force declared that, “Until there is more information and standards established for conducting these studies with highly specific clinical endpoints, it would be overly burdensome to suggest that measuring specific clinical outcomes might be the means of assessing product effectiveness as this has never been accomplished to date.”[11]

The objections evidently had the desired effect. In the final Guidance, after stating that clinical outcomes are “the most direct method of providing valid scientific evidence of effectiveness,” the FDA concludes, “The clinical outcomes associated with adhesions may be reasonably assessed by parameters which are more immediately measurable and potentially less confounded.”[12] At least three of five examples of appropriate outcomes given in the final Guidance mention only adhesions; the other two are unclear.

Inadequate Blinding
While the study design rightly emphasized blinding of the evaluating surgeon at second sternotomy, this design was undermined. Although REPEL-CV should be resorbed within 28 days, “implanted test material or a fibrous capsule, or other abnormal tissue”[13] was observed in 30.4% of patients in the REPEL-CV group and 1.9% of patients in the control group at second sternotomy (p<0.0001). Finding this material during the second sternotomy would likely unblind the evaluator, potentially leading to downgrading of adhesion severity in the REPEL-CV group.

Safety
In addition to these efficacy concerns, there were troubling signs of possible dangers associated with the device. There were trends toward higher risk of death (16.4% vs. 13.0%), mediastinial infection (5.5% vs. 1.4%, or 4 vs. 1 patient), and adverse events possibly, probably or definitely related to the study (8.2% vs. 1.4%).[14] These trends were not statistically significant, but with a total population of 142 patients who underwent the first sternotomy, the study was only, by the sponsor’s own admission, “adequate to rule out a 18% disadvantage (15% [mortality rate in the control group] vs. 33% [mortality rate in the treatment group], 2.8 odds ratio) with 80% power and one-sided 5% Type I error.”[15] Thus, REPEL-CV-treated patients would have had to have died at almost three times the control rate for this study to have reached statistical significance. The consistent direction of the adverse effects observed, even if non-significant, is concerning.

Parallels with Intergel
The data on REPEL-CV bring to mind the case of Intergel, a product made from sodium hyaluronate and intended to reduce pelvic adhesions. In that case, adhesions were also shown to be reduced by the product. However, despite the use of an adhesion scale with arguably more validation than that used in the REPEL-CV study, FDA was concerned that, “There is little experience in the clinical literature correlating the [Modified American Fertility Society] score with clinical outcomes.”[16] The pivotal Intergel trial demonstrated, as here, a consistent but non-statistically significant increase in infection rates. Initially, the FDA rejected the sponsor’s application, but the company appealed to an external Dispute Resolution Panel, which recommended approval. The FDA then reversed itself and approved the device. On April 16, 2003, less than two years after the device was approved, the company removed the device from the market due to dozens of reports of post-operative pain requiring repeat surgery, foreign body reactions and tissue adherence, including three deaths.[17] This history should give one pause before approving an adhesion barrier with only surrogate endpoints and a questionable safety record.

Conclusion
SyntheMed has simply failed to demonstrate that its product will have any important impact upon the public health. To do so, the following conditions would have to be met:

1.The patients receiving the device would have to undergo resternotomy; in fact, only a minority of patients will undergo resternotomy and all implanted patients face the potential dangers of the device.
2.The product would have to reduce adhesions; in fact, the product reduces the severity but not the incidence of adhesions.
3.The adhesions would have to have clear clinical significance; in fact, their significance remains unclear and the product had no impact upon the only clinical outcome.
4.The product would have to have an appropriate safety profile; in fact, there are trends in the direction of increased infection and even increased mortality.
For these reasons, Public Citizen’s Health Research Group opposes the approval of this device.

--------------------------------------------------------------------------------

[1] SyntheMed. Proposed Package Insert for REPEL-CV. September 17th, 2007, p. 3.

[2] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 34.

[3] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, Table 17.

[4] ibid.

[5] ibid., Table 18.

[6] ibid., Table 17.

[7] ibid., p. 53.

[8] Nkere UU. Postoperative adhesion formation and the use of adhesion preventing techniques in cardiac and general surgery. ASAIO Journal 2000;46:654-6.

[9] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 40.

[10] Center for Devices and Radiological Health. Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Draft Guidance. Food and Drug Administration, December 16, 1999.

[11] Burns JW. Letter to Dockets Management Branch (Docket 99D-5199). Adhesion Barrier Task Force, March 13, 2000.

[12] Center for Devices and Radiological Health. Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry. Food and Drug Administration, June 18, 2002.

[13] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 51.

[14] ibid., Table 21.

[15] ibid., p. 47.

[16] Richter KC. Letter to Lifecore Biomedical, Inc. Office of Device Evaluation, Center for Devices and Radiological Health, November 15, 2000.

[17] Sullivan MG. Intergel sales halted pending investigation of deaths, pain. Ob/Gyn News, May 15, 2003.
http://www.citizen.org/Page.aspx?pid=731

Adhesion prevention in gynaecological surgery.

2011-12-03T07:32:00.001-05:00

J Obstet Gynaecol Can. 2010 Jun;32(6):598-608.
Adhesion prevention in gynaecological surgery.
[Article in English, French]
Robertson D, Lefebvre G, Leyland N, Wolfman W, Allaire C, Awadalla A, Best C, Contestabile E, Dunn S, Heywood M, Leroux N, Potestio F, Rittenberg D, Senikas V, Soucy R, Singh S; Society of Obstetricians and Gynaecologists of Canada.
SourceToronto ON.

Abstract
OBJECTIVES: To review the etiology and incidence of and associative factors in the formation of adhesions following gynaecological surgery. To review evidence for the use of available means of adhesion prevention following gynaecological surgery.

OPTIONS: Women undergoing pelvic surgery are at risk of developing abdominal and/or pelvic adhesive disease postoperatively. Surgical technique and commercial adhesion prevention systems may decrease the risk of postoperative adhesion formation.

OUTCOMES: The outcomes measured are the incidence of postoperative adhesions, complications related to the formation of adhesions, and further intervention relative to adhesive disease.

EVIDENCE: Medline, EMBASE, and The Cochrane Library were searched for articles published in English from 1990 to March 2009, using appropriate controlled vocabulary and key words. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, cohort studies, and meta-analyses specifically addressing postoperative adhesions, adhesion prevention, and adhesive barriers. Searches were updated on a regular basis and incorporated in the guideline to March 2009. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.

VALUES: The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care SUMMARY STATEMENTS: 1. Meticulous surgical technique is a means of preventing adhesions. This includes minimizing tissue trauma, achieving optimal hemostasis, minimizing the risk of infection, and avoiding contaminants (e.g., fecal matter) and the use of foreign materials (e.g., talcum powder) when possible. (II-2). 2. The risk of adhesions increases with the total number of abdominal and pelvic surgeries performed on one patient; every surgery needs to be carefully considered in this context. (II-2). 3. Polytetrafluoroethylene (Gore-Tex) barrier is more effective than no barrier or oxidized regenerated cellulose in preventing adhesion formation. (I). 4. Oxidized regenerated cellulose (Interceed) adhesion barrier is associated with a reduced incidence of pelvic adhesion formation at both laparoscopy and laparotomy when complete hemostasis is achieved. Oxidized regenerated cellulose may increase the risk of adhesions if optimal hemostasis is not achieved. (II-2). 5. Chemically modified sodium hyaluronate/carboxymethylcellulose (Seprafilm) is effective in preventing adhesion formation, especially following myomectomies. There is insufficient evidence on the effect of sodium hyaluronate/carboxymethylcellulose on long-term clinical outcomes such as fertility, chronic pelvic pain or small bowel obstruction. (II-2). 6. No adverse effects have been reported with the use of oxidized regenerated cellulose, polytetrafluoroethylene, or sodium hyaluronate/carboxymethylcellulose. (II-1). 7. Various pharmacological agents have been marketed as a means of preventing adhesions. None of these agents are presently available in Canada. There is insufficient evidence for the use of pharmacological agents in preventing adhesions. (III-C).

RECOMMENDATIONS: 1. Surgeons should attempt to perform surgical procedures using the least invasive method possible in order to decrease the risk of adhesion formation. (II-1B ). When feasible, for example, a laparoscopic surgical approach is preferable to an abdominal approach, and a vaginal or laparoscopic hysterectomy is preferable to an abdominal hysterectomy. 2. Precautions should be taken at surgery to minimize tissue trauma in order to decrease the risk of postoperative adhesions. These precautions include limiting packing, crushing, and manipulating of tissues to what is strictly required for safe completion of the procedure. (III-B). 3. Surgeons could consider using an adhesion barrier for patients who are at high risk of forming clinically significant adhesions (i.e., patients who have endometriosis or pelvic inflammatory disease or who are undergoing a myomectomy). If there is a risk of ongoing bleeding from the surgical site, oxidized regenerated cellulose (Interceed) should not be used as it may increase the risk of adhesions in this situation. (II-2B).

PMID:20569542[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/20569542

Risk of adhesions and medicolegal issues UK ~ So how much should we tell patients?

2011-12-03T07:22:00.000-05:00

Excerpt taken from http://onlinelibrary.wiley.com/doi/10.1576/toag.6.2.1.26993/pdf.
The Obstetrician & Gynaecologist
2004;6(2)
SUPPLEMENT
11
There are a number of quality and risk management
issues surrounding adhesions in surgery.The
surgical speciality has given rise to the highest
number and second highest value of negligence
claims reported to the UK National Health
Service Litigations Authority (NHSLA). The
highest numbers of reported Clinical Negligence
Scheme for Trusts (CNST) claims by speciality
are:
• surgery: 3365
• obstetrics and gynaecology 2237
• medicine 1278
• accident and emergency 803.23
Increasingly, complications resulting from
postoperative intra-abdominal adhesions have
been the subject of medical negligence cases.
These have included failure to diagnose adhesion related
problems, delay in diagnosis, bowel damage
at adhesiolysis, adhesive intestinal obstruction,
infertility or risk of infertility and failure to take
precautions to prevent adhesions. 24 Between
1994–1999, for example, the UK Medical
Defence Union received 77 adhesion-related
claims that resulted in 14 out of court settlements
in 11 years ranging from £7,960 to £124,261
(average £50,765 per case).24 The Medical
Defence Union is one of several insurers for the
private sector; figures are not available for claims
made by the National Health Service.
Anecdotal evidence suggests that the number of
claims and out of court settlements has increased
largely since then.
Duty of care
There is a duty of care to provide careful advice
and sufficient information upon which women
can reach a rational, informed decision on whether
to accept or refuse treatment. In negligence cases
people usually claim that insufficient information
was provided and that, if it had been provided,
consent would not have been granted.
So how is negligence established?
In order for this to be successful it is necessary to:
1) establish a duty of care
2) show a breach of this duty
3) demonstrate that this breach caused the injury.
All three aspects need to be present for negligence
to be established. Recently, in addition to this, the
UK Health Act has also established a duty of
quality.
The Bolam test of negligence (1957) had for
many years set the precedent in determining
negligence. This ruling stated that practitioners
are not negligent if they act in accordance with
practice accepted by a responsible body of
medical opinion. However, recent judgements
suggest that judges are moving away from
accepting what reasonable doctors might do,
towards supporting what reasonable patients
might expect. Recent case law suggests that the
Bolam test is being modified to enable a court to
reject medical opinion if it is not ‘reasonable or
responsible’.25 Physicians are required to understand
their obligations and have a duty to warn a
patient of any material risk inherent in a
proposed procedure, however small.
So how much should we tell patients? It is not
necessary to canvass every risk. However, it is
important to take account of the personality of
the patient, the likelihood of misfortune and what
in the way of warning is needed for the particular
patient’s welfare. Are gynaecologists and surgeons
informing patients about the risk of adhesions?
According to the International Adhesions Society
Patient Survey, the answer is no. Results from this
survey showed that adhesions were mentioned as
part of the consent process in only 10.4% of
cases.26 In 14.4% of cases, adhesions were discussed
but not as part of the consent process. For patients
undergoing adhesiolysis procedures, 54% were
given some information before surgery and 46%
were given specific information about antiadhesion
agents. In nonadhesiolysis procedures
only 10% of patients were advised about adhesions
and only 6% were given information on antiadhesion
agents.
Negligence cases relating to adhesions are
becoming more common. It is important to be
aware that the law governing negligence has
changed. Doctors are obliged to understand their
obligations and this will mean warning of the
risk of adhesions prior to abdominal or pelvic
surgery.

[Postoperative abdominal adhesions and their prevention in gynaecological surgery: I. What should you know?

2011-12-03T07:07:00.000-05:00

Gynecol Obstet Fertil. 2011 Nov 28. [Epub ahead of print]
[Postoperative abdominal adhesions and their prevention in gynaecological surgery: I. What should you know?]
[Article in French]
Audebert A, Darai E, Bénifla JL, Yazbeck C, Déchaud H, Wattiez A, Crowe A, Pouly JL.
SourceService d'endoscopie gynécologique, polyclinique de Bordeaux, 145, rue du Tondu, 33000 Bordeaux, France.

Abstract
Adhesions are the most frequent complications of abdominopelvic surgery, causing important short- and long-term problems, including infertility, chronic pelvic pain and a lifetime risk of small bowel obstruction. They also complicate future surgery with increased morbidity and mortality risk. They pose serious quality of life issues for many patients with associated social and healthcare costs. Despite advances in surgical techniques, including laparoscopy, the healthcare burden of adhesion-related complications has not changed in recent years. Adhesiolysis remains the main treatment although adhesions reform in many patients. The extent of the problem of adhesions has been underestimated by surgeons and the health authorities. There is rising evidence however that surgeons can take important steps to reduce the impact of adhesions. As well as improvements in surgical technique, developments in adhesion-reduction strategies and new agents offer a realistic possibility of reducing adhesion formation and improving outcomes for patients. This paper is the first of a two-part publication providing a comprehensive overview of the evidence on adhesions to allow gynaecological surgeons to be best informed on adhesions, their development, impact on patients, health systems and surgical outcomes. In the second paper we review the various strategies to reduce the impact of adhesions and improve surgical outcomes to assist fellow surgeons in France to consider the adoption of adhesion reduction strategies in their own practice.

http://www.ncbi.nlm.nih.gov/pubmed/22129851

Adhesiolysis ~ 3-D Imaging of adhesiolysis and what you can expect from this procedure

2011-12-03T06:55:00.001-05:00

3-D Imaging of adhesiolysis and what you can expect from this procedure.

http://www.youtube.com/watch?v=0EtueSRTRyY

Severe inflammatory reaction induced by peritoneal trauma is the key driving mechanism of postoperative adhesion formation

2011-12-02T06:30:00.000-05:00

Many factors have been put forward as a driving mechanism of surgery-triggered adhesion formation (AF). In this study, we underline the key role of specific surgical trauma related with open surgery (OS) and laparoscopic (LS) conditions in postoperative AF and we aimed to study peritoneal tissue inflammatory reaction (TIR), remodelling specific complications of open surgery (OS) versus LS and subsequently evaluating AF induced by these conditions.

Methods: A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups.

Specific traumatic OS conditions were induced by midline incision line (MLI) extension and tissue drying and specific LS conditions were remodelled by CO2 insufflation. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale.
http://7thspace.com/headlines/399719/severe_inflammatory_reaction_induced_by_peritoneal_
trauma_is_the_key_driving_mechanism_of_postoperative_adhesion_formation_.html

Statistical analysis was performed by the non parametric t test and two-way ANOVA using Bonferroni post-tests.

Results: More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p<0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p<0.05 at the 24th and 72nd; p<0.01 - 120th and p<0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p>0.05).

However larger adhesion size (41.6733.63) was observed after OS in comparison with LS (20.3116.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p=0.03).

Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.

Conclusions: MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences.

CO2 insufflation however, led to moderate inflammation and less adhesion formation.

Author: Sergei PismenskyZhomart KalzhanovMarina EliseevaIoannis KosmasOspan Mynbaev
Credits/Source: BMC Surgery 2011, 11:30

AdeTherapeutics, Inc.: Health Canada Approves Clinical Trial for Adhesion Prevention

2011-11-30T06:39:00.000-05:00

press release

Nov. 28, 2011, 11:21 a.m. EST

SASKATOON, Saskatchewan, Nov 28, 2011 (BUSINESS WIRE) -- AdeTherapeutics, Inc. received Health Canada approval in November to conduct a double-blind randomized placebo controlled study in 30 patients to test its therapeutic to reduce adhesion (scar tissue) formation following laparoscopic procedure to remove an ectopic pregnancy.

Designed by surgeons, the trial is powered to potentially establish standard of care. The novel mechanism, which modulates normal healing process, is also being studied in other surgical areas of high unmet medical need.

The trial will be conducted at teaching hospitals in Canada with first patient enrolment expected in December 2011.

Click here to read the rest: http://www.marketwatch.com/story/adetherapeutics-inc-health-canada-approves-clinical-trial-for-adhesion-prevention-2011-11-28

Solos Endoscopy Poised for Tremendous Growth in Multi-Billion Dollar Endoscopic Market

2011-11-26T07:42:00.000-05:00

By Solos Endoscopy, Inc.

Solos Endoscopy, Inc.
Last modified: 2011-11-17T15:54:24Z
Published: Thursday, Nov. 17, 2011 - 7:54 am
BOSTON, Nov. 17, 2011 -- /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company is positioned for tremendous growth in the multi-billion dollar endoscopic market. Solos Endoscopy currently has its endoscopic instruments in over 60 Hospitals, Clinics, Healthcare Centers, Medical Centers and Surgery Centers across the United States with plans to market its endoscopic instrument internationally upon receiving the CE Mark.

Meltwater News Inc., a global specialist in online media monitoring, has delivered a report highlighting significant growth in the endoscopy market over the next five years. According to MarketResearch.com in its July 2011 report, the overall medical device market is very large; endoscopy is a significant component of that market. The endoscopy market is positioned for significant growth in the next 5 years. The endoscopy market worldwide was $23.3 billion in 2010 and is projected to reach nearly $24.8 billion in 2011. This is further anticipated to increase to $33.7 billion by 2016 at a compound annual growth rate (CAGR) of 6.4%.

Laparoscopy accounts for more than 26% of the total market and is expected to reach $6.8 billion by end of 2011 and to increase up to $10.6 billion by 2016 at a compound annual growth rate (CAGR) of 9.2%.

Endoscopy of the GI track for tumors, adhesions, diverticulitis, etc. is projected to experience an increase from $3.7 billion in 2011 to more than $4.9 billion in 2016, a CAGR of 5.7%.

This is due, in part, to new applications for the technology, as well as new innovations in the technology itself. The other major factor that will contribute to this growth is the recognition of this technology in emerging markets like Japan and Vietnam. Continued worldwide growth is expected in other geographic areas due to a growing middle class in countries such as India, China, Brazil, and Russia.

For more information on Meltwater News Inc., please visit; www.meltwater.com

About Solos Endoscopy, Inc.:

Solos Endoscopy, Inc. is a HealthCare instrument company whose mission is to develop and market high quality and innovative instruments for the screening, diagnosis, treatment and management of medical conditions. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.com.

Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.

Contact: Amanda Segersten, rsegersten@solosendoscopy.com

SOURCE Solos Endoscopy, Inc.

Read more: http://www.sacbee.com/2011/11/17/4061951/solos-endoscopy-poised-for-tremendous.html#ixzz1eoZSvUI f

Clinical trial will aim to reduce surgical scarring

2011-11-21T05:40:00.000-05:00

By Janet French, The StarPhoenix November 19, 2011

A Saskatoon biotechnology company is preparing to launch a clinical trial of a new drug it says could help reduce surgical complications.

Health Canada has given AdeTherapeutics permission to proceed with clinical trials for Evitar, a compound the company says can help reduce scarring from surgery.

Obstetricians and Gynecologists in Saskatoon will be the first to try out Evitar on humans, starting with women who have ectopic pregnancies. An ectopic pregnancy is a non-viable embryo that implants in tissue outside a woman’s womb. A rupture can threaten a woman’s life, and the embryo must be surgically removed.

Lead by principal investigator Dr. Donna Chizen, participating surgeons at City and Royal University hospitals will ask women diagnosed with ectopic pregnancies if they’re willing to join the trial, says Sanj Singh, president and CEO if AdeTherapeutics.

“The patients will be more than willing (to join) because the ectopics lead to such bad complications for future pregnancies that they’re very keen on any type of treatment that will help with future fertility,” Singh said.

According to the U.S. National Institutes of Health, only a third of women who have an ectopic pregnancy are able to later have a baby.

Many surgeries leave scar tissue in their wake as the body heals imperfectly, and that scarring often causes pain and complications, Singh said.

“Ninety-three per cent of surgeries result in scar tissue,” Singh said. “One in three readmissions back in hospital are due to complications like scar tissue.”

Read more: http://www.thestarphoenix.com/health/Clinical+trial+will+reduce+surgical+scarring/5734819/story.html#ixzz1eKpvZGGL

Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.

2011-11-20T12:39:00.000-05:00

Eur J Obstet Gynecol Reprod Biol. 2010 Jun;150(2):180-9. Epub 2010 Mar 16.
Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.
Hackethal A, Sick C, Brueggmann D, Tchartchian G, Wallwiener M, Muenstedt K, Tinneberg HR.
SourceDepartment of Obstetrics and Gynaecology, Justus-Liebig-University of Giessen, Giessen, Germany. andreas.hackethal@gyn.med.uni-giessen.de

Abstract
OBJECTIVE: Intra-abdominal adhesion formation after abdominal surgery is the most common postsurgical complication, and the consequences are a considerable burden for patients, surgeons and health systems. Since a wide variety of factors influence adhesion formation, it is difficult to define clear guidelines on how to reduce adhesion formation in daily practice. Given this dilemma, this study assessed the awareness and perception of adhesion formation among gynaecologists in Germany in order to define a baseline for further research and education.

STUDY DESIGN: The Clinical Adhesion Research and Evaluation (CARE) group of the University of Giessen designed a questionnaire that was sent to the heads of all gynaecological departments in Germany. The director or one of the surgical consultants was asked to complete the questionnaire and return it for evaluation.

RESULTS: The completed questionnaire was returned by 279 of 833 gynaecological departments. Interviewed surgeons expected adhesions to form in 15% of cases after laparoscopy and 40% after laparotomy. Before surgery, 83.1% of the respondents told their patients about the risk of prior adhesion formation. More than 60% believed that postsurgical adhesion accounts for major morbidity. Infections within the abdomen, previous surgery and extensive tissue trauma were thought to have the most influence on adhesion formation. Risk of adhesion formation was thought to be highest in endometriosis and adhesiolysis surgery. The respondents agreed on performing adhesiolysis in symptomatic but not in all patients. Only 38.4% used adhesion reduction agents regularly. A total of 65.1% of a repertoire of adhesion prevention agents were familiar to the interviewed surgeons. Only 22.0% of them used anti-adhesion products in clinical practice. In general, the respondents were uncertain whether these products play an important role in adhesion reduction, represented by a range of 1.97+/-0.98% on a scale from 0 to 4.

CONCLUSIONS: Even though postoperative adhesions are recognized as a major cause for morbidity, and it is widely agreed that infections, extensive tissue trauma and surgery lead to adhesion formation, there is uncertainty about the treatment and prophylactic strategies for dealing with adhesions. This dilemma reflects the awareness and perception of gynaecologists in Germany and is an initial point for further research.

Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

PMID:20236750[PubMed - indexed for MEDLINE]

Laparoscopic Lysis of Abdominal Adhesions

2011-11-20T07:47:00.000-05:00

A really simple 3D video of what will happen to you during an adhesiolysis ~ surgery to tkae down adhesions.

December 15, 1886 Cause of Death: Adhesions of Bowels

2011-11-19T05:08:00.000-05:00

Deceased Name: Parker Boggs
Gender: Male
Date of Death: December 15, 1886
Cause of Death: Adhesions of Bowels
Age: 18
Father's Name: E. Boggs
Mother's Name: E. J.
Mother's Maiden Name: Naper
http://www.ingenweb.org/inrandolph/HealthDept/Death/RichardsonCollection.htm

Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats.

2011-11-17T15:58:00.000-05:00

J Diabetes Complications. 2011 Jan-Feb;25(1):39-43. Epub 2009 Oct 13.
Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats.
Abbasian B, Kazemini H, Esmaeili A, Adibi S.
SourceFaculty of Veterinary Medicine, Shahrekord Azad University, Shahrekord, Iran.

Abstract
BACKGROUND: Postsurgical adhesion formation is a significant clinical problem within every surgical specialty. In type I diabetic patients, the problem is more severe and wound healing is slow. A wide variety of treatments have been proposed to deal with the problems that adhesion causes. One of the modalities that have not been studied extensively yet is the use of amniotic fluid. The purpose of the present study was to evaluate the clinical value of bovine amniotic fluid (BAF) efficacy in the treatment of postsurgical adhesion formation in diabetic male rats.

MATERIALS AND METHODS: Fifty male Wistar rats in five groups were used for our study, with animal identification being facilitated by a microchip implant system. Diabetes was induced in all groups except for the control group by intraperitoneal alloxan injection (120 mg/kg). Based upon blood glucose concentration, rats received either one third of the required insulin (two groups) or all the required insulin (remaining groups). After 2 weeks, a laparotomy was performed on each rat and adhesions were scaled. Bovine amniotic fluid was then applied to two groups, and, as a control, sterilized water was applied to the other groups. After 2 weeks, a laparotomy was again performed on each rat and adhesion was rescored.

RESULTS AND CONCLUSION: Significant reductions (P<.05) in adhesions were seen with BAF only in those diabetic rats that had received the required insulin. The results of our study suggest that BAF could be effective in the treatment of adhesion formation during diabetes.

Copyright © 2011 Elsevier Inc. All rights reserved.

PMID:19828333[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/19828333

Severe inflammatory reaction induced by peritoneal trauma is the key driving mechanism of postoperative adhesion formation

2011-11-17T12:08:00.001-05:00

CO2 insufflation however, led to moderate inflammation and less adhesion formation.

http://7thspace.com/headlines/399719/severe_inflammatory_reaction_induced
_by_peritoneal_trauma_is_the_key_driving_mechanism_of_postoperative_adhesion_formation_.html

Many factors have been put forward as a driving mechanism of surgery-triggered adhesion formation (AF). In this study, we underline the key role of specific surgical trauma related with open surgery (OS) and laparoscopic (LS) conditions in postoperative AF and we aimed to study peritoneal tissue inflammatory reaction (TIR), remodelling specific complications of open surgery (OS) versus LS and subsequently evaluating AF induced by these conditions.

Methods: A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups.

Specific traumatic OS conditions were induced by midline incision line (MLI) extension and tissue drying and specific LS conditions were remodelled by CO2 insufflation. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale.

Statistical analysis was performed by the non parametric t test and two-way ANOVA using Bonferroni post-tests.

Results: More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p<0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p<0.05 at the 24th and 72nd; p<0.01 - 120th and p<0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p>0.05).

However larger adhesion size (41.6733.63) was observed after OS in comparison with LS (20.3116.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p=0.03).

Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.

Conclusions: MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences.

CO2 insufflation however, led to moderate inflammation and less adhesion formation.

Author: Sergei PismenskyZhomart KalzhanovMarina EliseevaIoannis KosmasOspan Mynbaev
Credits/Source: BMC Surgery 2011, 11:30

Agreement With Innocoll for Surgical Adhesion Barrier CollaGUARD

2011-11-17T12:04:00.000-05:00

TORONTO, ONTARIO, Nov 14, 2011 (MARKETWIRE via COMTEX) -- Envoy Capital Group Inc. /quotes/zigman/38441 CA:ECG +8.46% /quotes/zigman/38429/quotes/nls/ecgi ECGI +0.94% ("Envoy") announces that Merus Labs International Inc. (cnsx:MR) ("Merus") has entered into a License and Distribution Agreement with Innocoll in Canada for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery. Envoy and Merus Labs have agreed to amalgamate subject to shareholder and regulatory approval as earlier announced. Meetings of shareholder of Envoy and Merus have been scheduled for December 9, 2011.

"Adhesions occur after most surgical procedures, and are of major clinical, social and economic concern. The addition of CollaGUARD to our portfolio means that thousands of patients at risk of adhesion will have a clinically proven superior solution. We look forward to obtaining Health Canada approval and the launch of CollaGUARD in 2012." said Ali Moghaddam, Vice President at Merus Labs.

Dr. Michael Myers, President and CEO of Innocoll stated, "We are pleased to announce the expansion of our partnership with Merus to include CollaGUARD and we look forward to the successful launch of the product in Canada."

About CollaGUARD(R)

CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P less than 0.001) and significantly reduced the extent and severity of adhesions (P less than 0.001).

CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.

About Innocoll, Inc.

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R), CollaFilm, DermaSil(TM), CollaPress(TM) and Liquicoll(R). Approved products based on the Company's technologies include: Collatamp(R) G, Septocoll(R), CollaGUARD, Collieva(R), CollaCare(R), Collexa(R), Zorpreva(TM), and LidoColl(R).

Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com .
Read More : http://www.marketwatch.com/story/envoy-capital-announces-merus-labs-licensing-agreement-with-innocoll-for-surgical-adhesion-barrier-collaguard-2011-11-14-943190?reflink=MW_news_stmp

Small Bowel Obstruction

2011-11-12T06:56:00.000-05:00

http://www.youtube.com/watch?v=_uckguNXlc4&feature=related

Bowel Obstruction: Gas Pattern and Presentations

2011-11-12T06:47:00.000-05:00

http://www.youtube.com/watch?v=H0Rg9FvynqE&feature=related

Immune Response to Biologic Scaffold Materials

2011-11-10T19:03:00.000-05:00

Immune Response to Biologic Scaffold MaterialsCorresponding author: Stephen F. Badylak, McGowan Institute for Regenerative Medicine, University of Pittsburgh, 100 Technology Drive, Suite 200, Pittsburgh, PA 15219, P: (412) 235-5144, F: (412) 235-5110, Email: badylaks@upmc.edu

Stephen F. Badylak and Thomas W. Gilbert

McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA

Summary
In summary, allogeneic and xenogeneic biologic scaffolds composed of extracellular matrix are commonly used in numerous tissue engineering and regenerative medicine applications, and in many reconstructive surgical procedures. The effect of such scaffolds upon the host immune response has been largely unexplored. In addition, the association between the host immune response and tissue remodeling events is a factor that logically plays an important, if not determinative, role in the successful clinical application of these devices. There are many variables in the manufacturing of matrix derived scaffolds and all of these variables can affect the host immune response. An improved understanding of the immune response to biologic scaffold materials can only lead to greater safety and efficiency of devices and applications that utilize such materials.
Read Full abstract here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2605275/

Innocoll Enters Partnership With Pioneer Pharma in China for the Distribution of CollaGUARD

2011-11-09T06:17:00.000-05:00

ASHBURN, Va. ,Oct. 19, 2011 /PRNewswire/ -- Innocoll, Inc. announced it has entered into a License and Distribution Agreement with Pioneer Pharma in China for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery.

Dr. Michael Myers, President and CEO stated "This is an exciting development for Innocoll. China is becoming an increasingly important and dynamic market for medical products and we are very pleased to have established this partnership with such an innovative company as Pioneer. I look forward to exploring additional partnership opportunities between our two companies."

Mr. XinZhou Li, President and CEO from Pioneer Pharma stated "We are very excited to have finally reached the partnership agreement with Innocoll. Let us mark this day with remembrance as CollaGUARD will become a very important product in our current distribution channel. We believe that CollaGUARD® has significant market potential and Pioneer will try to make it happen. "

About CollaGUARD®

CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).

CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.

About Postoperative Adhesions

Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.

About Pioneer

Pioneer Pharma, founded in Hainan in 1996, imports and distributes high-end pharmaceutical products into China. Pioneer markets and distributes over 30 products across a wide range of therapeutic categories on behalf of its strategic partners and has filed over 10 additional products that are pending approval. The company has over 34 representative offices across China and covers over 7,500 hospitals and 40,000 drugstores.

About Innocoll, Inc.

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPress™ and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.

Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.

CONTACT: Veronica Kelly, +353 9064 86834, vkelly@innocoll-pharma.com

SOURCE Innocoll, Inc.

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http://www.prnewswire.com/news-releases/innocoll-enters-partnership-with-pioneer-pharma-in-china-for-the-distribution-of-collaguard-132127138.html

Conservative Management of Mesh-Site Infection

2011-11-08T06:18:00.000-05:00

Conservative Management of Mesh-Site Infection
in Hernia Repair
Brenda Aguilar, MD, Alyssa B. Chapital, MD,
James A. Madura, II, MD, and Kristi L. Harold, MD

JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES

Volume 20, Number 3, 2010

ª Mary Ann Liebert, Inc.

Abstract
Background: Mesh hernioplasty is the preferred surgical procedure for large abdominal wall hernias. Infection
remains one of the most challenging complications of this operation. Salvaging infected prosthetic material after
ventral hernia repair is rarely successful. Most cases require mesh excision and complex abdominal wall reconstruction,
with variable success rates. In this article, we report 3 cases of mesh salvage after laparoscopic
ventral herniorrhapy with a novel use of percutaneous drainage and antibiotic irrigation.
Results: Three patients developed infected seromas after laparoscopic ventral hernia repair. The fascial defect
of the first patient was repaired with a commercially available 20 18 cm polytetrafluoroethylene (PTFE) mesh.
A complex fluid collection developed the following month in the anterior abdominal wall overlying the patient’s
mesh. The cultures grew Staphylococcus aureus. The second patient had a 30 20 cm PTFE mesh placed, which
developed a fluid collection with Enterococcus faecalis and Escherichia coli. The third case underwent repair, using
a another commercially available 22 28 cm PTFE mesh. A fluid collection measuring 20 10 cm in the anterior
abdominal wall developed, growing Staphylococcus lugdunensis. In all 3 cases, a percutaneous drain was placed
within the fluid collection and long-term intravenous (i.v.) access was obtained. I.v. antibiotics were initiated. In
addition, gentamicin (80 mg) with 20mL of saline was infused through the drain 3 times a day. All patients have
remained free of clinical signs of infection following the completion of therapy.
Conclusions: Infected mesh after laparoscopic ventral herniorrhapy without systemic sepsis may be amenable to
nonoperative treatment. A conservative approach that includes percutaneous drainage followed by antibiotic
irrigation is a potential alternative to prosthetic removal in carefully selected patients. Further evaluation of this
technique is warranted to define the most appropriate management strategies for these patients.
Introduction
The placement of prosthetic biomaterials has become a
standard procedure during ventral hernia repair surgery.
Clinical evidence support lower recurrence rates as they
generate ‘‘tension-free’’ closure of hernia defects and provide a
permanent replacement for native fascia that frequently has
been weakened or removed by previous surgery. Reduction
of ventral hernia recurrence by 30%1–3 has been shown.
However, the lower recurrence rates come at the price of
mesh-related complications, including seromas, adhesions,
chronic severe pain, migration, and mesh-related infections.4,5
The exact incidence of mesh infections is difficult to obtain
due to the variable presentation period after surgery. Infections
can arise anywhere from 2 to 39 months6 following repair.
The incidence has been reported from 0.001 to 8%7–14
in the literature. While this appears relatively infrequent,
when compared with other device-related infections, the
clinical significance of this diagnosis portends a complex,9,10
extended course for both the patient and the surgeon.8,12
The rate of mesh infection is influenced considerably by
underlying comorbidity, immunosuppression, incision size,
obesity, history of previous hernia repair or wound infection,
and tobacco use.7–14 Unfortunately, patients with these same
risk factors are also likely to have a recurrent hernia, if the
prosthetic mesh is not utilized in the repair.8
Standard surgical practice has traditionally advocated the
removal of contaminated or exposed prosthetics. Unfortunately,
the removal of the prosthetic materials is often
technically difficult when there is good tissue incorporation
and can increase the risk of subsequent enterocutaneous fistula
formation.15 Achieving closure of the fascial defect after
mesh removal is not usually possible; therefore, a larger
ventral hernia than at the time of original repair may result.
Department of General Surgery, Mayo Clinic Hospital, Phoenix, Arizona.
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
DOI: 10.1089=lap.2009.0274
249
These issues have generated interest in a successful, conservative
treatment algorithm that does not involve mesh removal.
13,14,16,17 In this article, we describe a novel approach to
manage the complex problem of infected prosthetic mesh
following laparoscopic ventral hernia repair (LVHR).
Materials and Methods
This study was conducted by the Department of Surgery at
Mayo Clinic Hospital (Phoenix, AZ). We report 3 cases of
mesh infection after laparoscopic hernia repair with a prosthetic
mesh. The infection was diagnosed by clinical evidence
of pain, redness, induration, fever, and purulent discharge on
aspiration. We attempted to treat these cases with a conservative
approach.
After ultrasonografic confirmation of a fluid collection
surrounding the prosthetic mesh, a computed tomography
(CT)-guided placement of a drain was perform in all cases.
The skin overlying the left abdomen was sterilely prepped,
then draped to infiltrate 1% lidocaine. An 18-gauge needle
was advanced into the fluid collection. Through the needle, an
Amplatz wire was placed in the collection, the tract was
dilated with a 6.8- and 10-Fr fascial dilator, followed by the
placement of a 10-Fr locking loop all-purpose drainage catheter
that was then placed into the fluid collection. Repeat CT
was performed, confirming appropriate placement. A specimen
was sent to the lab for microbiology analysis. The tube
was secured with the skin by using a 2-0 Prolene suture. The
catheter was left to external bulb suction. The patients and
their relatives were instructed to irrigate the catheter with
gentamicin (80 mg) in 20mL of normal saline, leaving the
solution in the cavity for 30 minutes and then returning the
drain to bulb suction. This was performed 3 times per day.
We chose gentamicin as the primary antibiotic for the irrigation
therapy for its properties as a bactericidal agent at low
concentrations and its known activity against Staphylococcus
spp. as well as gram-negative cocci. Local use of gentamicin
provides much higher concentrations at wound sites, so blood
concentrations remain low, thus preventing toxicity. Special
recognition has been given to the use of gentamicin for the
treatment of infected skin cysts and other skin abscesses,
when preceded by incision and drainage to permit adequate
contact between the drug and the infecting bacteria.7
Case 1
A 50-year-old female underwent a robotic bilateral ovarian
cystectomy, at which time she had an abdominal wall mesh
place for an umbilical hernia. This mesh became infected and
was removed. Six months following removal, an LVHR was
performed with a 20 18cm polytetrafluoroethylene (PTFE)
Gore DualMesh (Creative Technologies Worldwide, Flagstaff,
AZ) for a recurrent hernia. One month later, the patient
was found to have erythema over her abdominal wall as well
as an elevated white blood cell count.ACT scan demonstrated
a complex fluid collection in the anterior abdominal wall
overlying the patient’s mesh. Percutaneous drainage of the
abscess was then undertaken, where approximately 100mL of
purulent material was aspirated. A drain was left in place. The
cultures revealed Staphylococcus aureus sensitive to ampicillin
and sulbactam. Drain irrigation with gentamicin (80 mg) in
20mLof normal saline (NS) 3 times a day as well as 1 month of
intravenous (i.v.) antibiotics was initiated. The drain and
central line were then removed. There has been no clinical
evidence of recurrent infection at 18 months of follow-up.
Case 2
A 63-year-old male with end-stage liver disease secondary
to primary sclerosing cholangitis underwent an orthotopic
liver transplant and Roux-en-Y choledochojejunostomy performed
in 2005. He subsequently developed a large ventral
hernia, which was repaired laparoscopically with a 30 20cm
PTFE Gore DualMesh in September 2007. In January 2009, the
patient underwent a routine colonoscopy and developed
Enterococcus faecalis and Escherichia coli bacteremia. An abdominal
CT scan demonstrated a fluid collection posterior to
the abdominal mesh. At that time, an external drain was
placed to treat the infection with gentamicin flushes (80mg in
20mL of NS 3 times a day), as well as i.v. antibiotics through a
peripherally inserted central catheter (PICC line), including
ceftriaxone (2 g once-daily) and ampicillin (2 g 3 times a day).
After 1 month of treatment, there were no clinical signs of
infection. The drain and antibiotics were then discontinued.
He continues to have no sign of infection currently at 11
months of follow-up.
Case 3
A 41-year-old female underwent multiple cesarean sections,
followed by the development of a ventral hernia. This
was repaired 8 times with mesh placement, in most cases. On
one occasion, the mesh had to be removed secondary to infection.
We performed an LVHR with a 22 28 cm PTFE Gore
DualMesh.
The patient presented the following month with generalized
body aches, chills, and fever. An abdominal CT scan was
performed that demonstrated a large fluid collection in the
anterior abdominal wall measuring 20 10 cm. It was drained,
producing 450mL of fluid. A percutaneous drain and a
PICC line were placed. Cultures grew 1þ S. lugdunensis. I.v.
amipicillin and sulbactam as well as gentamicin irrigation
(80mg in 20mL of NS) through the drain 3 times a day was
initiated.
At the end of treatment, a follow-up CT scan performed on
her abdomen and pelvis demonstrated improvement of the
anterior fluid collection previously drained. There remained a
seroma posterior to the mesh that was 9 cm in size without
evidence of abscess features. An attempt to aspirate the seroma
was unsuccessful due to its depth. The patient was
placed on amoxicillin=clavulanate (875 mg) by mouth twicedaily
for an additional 3 weeks of antibiotic therapy. The
anterior drain remained in place during this time and was
removed after it produced less than 10mL of serous fluid
daily. At 13 months of follow-up, she has done well with no
signs of infection.
Discussion
Surgical-site infections continue to be a major source of
morbidity throughout the world, accounting for almost 40–
60%10,18 of all postoperative infectious complications. This
concern, along with the increased costs associated with extended
hospitalization and reparative treatment, justifies
efforts to identify patient populations at risk and optimize
preoperative preparation and perioperative care. In the past
250 AGUILAR ET AL.
few years, the hernia repair with alloplastic prothesis has
become the standard treatment due to lower rates of recurrence,
when compared with simple suture closure. However,
the implantation of synthetic materials are related with
wound-associated complications in up to one third of cases.5
Mesh-related infectious complications occur in up to 13.6%
and usually require recurrent surgical intervention.12 The
more common agents associated with mesh infection are
Staphylococcus species (spp.) (especially S. aureus), Streptococcus
spp. (including group B streptococci), gram-negative
bacteria (mainly Enterobacteriaceae), and anaerobic bacteria
(including Peptostreptococcus spp.).18–21 In a study of meshrelated
infections following ventral herniorrhaphies, 63% of
the microorganisms isolated were methicillin-resistant S. aureus
(MRSA). Rarely, mesh infections are caused by Candida
spp. or Mycobacterium spp.21
Various factors are predictive of prosthetic infections, such
as patient-related illness, including diabetes mellitus, malnutrition,
chronic obstructive pulmonary disease, tobacco
and=or alcohol use, medical therapy with steroids, renal
failure, and morbid obesity.5–10,12,17,18,21 These medical comorbidities
are associated with decreased perfusion of the
skin and subcutaneous (s.c.) tissues as well as immunosuppressive
attributes. Factors directly to the operation, such as
the choice of mesh material and type of surgical procedure,
are still the subject of critical debate. In a meta-analysis of 20
trials (5016 participants) of open versus open nonmesh repair
of groin hernias, it was shown that the rate of postoperative
complications, including infections, was similar in both procedures.
4 A similar clinical trial with 200 adult umbilical
hernia repairs with or without mesh showed no differences in
results between techniques, including infection rate.21 Korenkov
et al.,22 in a clinical, randomized trial of 160 patients
with simple or complex hernias that underwent either suture
repair, autodermal skin graft, or onlay polypropylene mesh
repair, found fewer infectious complications after suture repair
(9%) than after skin graft or mesh repair (18%) for simple
hernias and 23–35% for complex hernias. White et al.23 reported
that the use of a mesh and hernia defect >10 cm were
associated with significantly more wound complications
(44 versus 26%; P<0.05), especially a increased incidence
of seroma (21 versus 7%). They also reported that patients
undergoing mesh repair were more likely to receive antibiotics
(91 versus 71%) and have s.c. drains placed (57 versus
25%), compared to simple primary repair.
The traditional surgical management for infection after
hernia repair with prosthetic materials advocates that all infected
prosthetic materials must be removed, but this leads to
a high risk of hernia recurrence. Innovative studies aim to
provide evidence that a conservative approach may be a
suitable alternative. Carbonell et al.26 studied hernia repairs
by using seven prosthetic mesh biomaterials innoculated with
bacteria in a live animal and concluded that ePTFE was the
least susceptible to infection, and with silver=chlorhexidine
coating, the prosthesis was able to kill all the inoculated
bacteria. Silver-chlorhexidine-impregnated meshes may be
the prosthetics of choice to prevent the occurrence of mesh
infection in LVHR. The literature would support that the
debridement of all purulent material and necrotic tissue is
essential, but it remains debatable whether to remove the
prostheses. Irrigation with antimicrobial solutions has been
attempted in a few trials. Trunzo et al.13 reported 2 cases of
infected seroma after laparoscopic ventral repair: A 20 23 cm
Parietex composite polyester mesh was used in 1 patient,
and a 32 33 cm piece of expanded PTFE was used in the
other. After the infections were diagnosed, the patients were
treated by abscess drainage, parenteral antibiotics, and 4
weeks of gentamicin irrigation (80mg in 30mL of solution)
via a drain 3 times per day. Both patients remained free of
clinical signs of infection at 12 and 16 months, respectively.
Ahmad et al.14 described 13 cases of open ventral hernia repair
with using polypropylene mesh resulting in infection.
They treated their patients with local management, including
incision, drainage, and debridement of the wound, followed
by irrigation with saline=povidone iodine. Eight patients
(62%) required daily dressing changes and five to seven debridements.
Three patients (23%) developed severe sepsis and
complete dehiscence of the wound. These patients averaged
10–12 debridements during recovery. Two patients (15%)
with cellulitis were discharged after 10–12 days with full recovery.
All the patients were followed for 3 months and did
not have recurrence of infection.
Some researchers believe that an individualized approach
is necessary to treat patients with mesh infections, and special
considerations must be taken regarding the type of mesh.27
The use of a multifilament polyester mesh is related to a
higher incidence of infection, small-bowel obstruction, and
enterocutaneous fistula formation than the use of other types
of mesh (e.g., knitted monofilament polypropylene, PTFE, or
woven polypropylene).2,12,19,17 Further, experimental studies
in animals relate the use of microporous mesh to a higher rate
of infections and development of seromas, whereas macroporous
material was shown to be associated with a higher
incidence of adhesive and erosive events.23–25 The ePTFE
mesh has generated conflicting theories as to its ability to be
salvaged in the face of infection. Paton et al.27 concluded that
patients with limited ePTFE mesh infections could be treated
with abscess drainage, antibiotics, and local wound care, but
more extensive infections require mesh removal. Petersen
et al.12 concluded that in their experience with 8 mesh-infected
cases, adequate drainage seemed to be sufficient for polypropylene
or polyester meshes; however, infected ePTFE
patches should be removed early. The researchers explained
that the structural matrix of ePTFE permits fluid retention and
bacterial growth due to inadecuate leucocyte invasion
through the 10-mm pores. Bellon et al.29,30 demonstrated that
S. aureus colonies produce alterations in the structure of
ePTFE. From using electron microscopy, they demonstrated
the deformation of internodal filaments and the creation of
fissures in the ePTFE microstructure, and that alteration of the
biomaterial facilitated the attachment and invasion of bacteria.
Despite these findings, we have had success with the
salvage of ePTFE after laparoscopic ventral hernia repair. In
our experience, infection of ePTFE does not always mandate
removal. Our 3 cases were successfully managed with
drainage, parenteral antibiotics, and gentamicin irrigation
through a drain, with no recurrence of infection.
Conclusions
For patients with an infected mesh in the absence of systemic
sepsis, a conservative approach that includes percutaneous
drainage, followed by antibiotic irrigation, is a potential
alternative to prosthetic removal. Further evaluation of this
MESH-SITE INFECTION 251
technique is warranted to define the most appropriate management
strategies for these patients.
Disclosure Statement
No competing financial interests exist.
References
1. Wassenaar EB, Schoenmaeckers EJ, Raymakers JT, Rakic S.
Recurrences after laparoscopic repair of ventral and incisional
hernia: Lessons learned from 505 repairs. Surg Endosc
2009;23:825–832.
2. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term
complications associated with prosthetic repair of incisional
hernias. Arch Surg 1998;133:378–382.
3. Vrijland WW, Van den Tol MP, Luijendijk RW et al. Randomized,
clinical trial of nonmesh versus mesh repair of
primary inguinal hernia. Br J Surg 2002;89:293–297.
4. Grant AM. Open mesh versus nonmesh repair of groin
hernia: Meta-analysis of randomized trials based on individual
patient data [corrected]. Hernia 2002;6:130–136.
5. Jezupovs A, Mihelsons M. The analysis of infection after
polypropylene mesh repair of abdominal wall hernia. World
J Surg 2006;30:2270–2278.
6. Delikoukos S, Tzovaras G, Liakou P, et al. Late-onset deep
mesh infection after inguinal hernia repair. Hernia 2007;11:
15–17.
7. Falagas ME, Kasiakou SK. Mesh-related infections after
hernia repair surgery. Clin Microb Infect 2005;11:3–8.
8. Kercher KW, Sing RF, Matthews BD, Heniford BT. Successful
salvage of infected PTFE mesh after ventral hernia
repair. Ostom Wound Manag 2002;48:40–45.
9. Bliziotis IA, Kasiakou SK, Kapaskelis AM, Falagas ME.
Mesh-related infection after herniarepair: Case report of an
emergencing type of foreing-body relatedinfection. Infection
2006;34:46–48.
10. Paton BL, Novitsky Y, Zerey M, et al. Management of infections
of polytetrafluoroethylene-based mesh. Surg Infect
2007;8:337–341.
11. Praveen S, Rohaizak M. Local antibiotics are equivalent
to intravenous antibiotics in the prevention of superficial
wound infection in inguinal hernioplasty. Asian J Surg 2009;
32:59–63.
12. Petersen S, Henke G, Freitag M, et al. Deep prosthesis infection
in incisional hernia repair: Predictive factors and
clinical outcome. Eur J Surg 2001;167:453–457.
13. Trunzo JA, Ponsky JL, Jin J, et al. A novel approach for
salvaging infected prosthetic mesh after ventral hernia repair.
Hernia 2009;13:545–549.
14. Ahmad S, Mufti TS, Zafar A, Akbar I. Conservative managment
of mesh-site infection in ventral hernia repair. Ayub
Med Coll Abbottabad 2007;19:75–77.
15. Fawole AS, Chaparala RP, Ambrose NS. Fate of the inguinal
hernia following removal of infected prosthetic mesh. Hernia
2006;10:58–61.
16. Luijendijk RW, Hop WC, Van den Tol MP, et al. A comparison
of suture repair with mesh repair for incisional
hernia. NEJM 2000;343:392–398.
17. Stoppa RE. The treatment of complicated groin and incisional
hernias. World J Surg 1989;13:545–554.
18. Malone DL, Genuit T, Tracy JK, et al. Surgical site infections:
Reanalysis of risk factors. J Surg Res 2002;103:89–95.
19. Demiter S, Gecim IE, Aydinuraz K, et al. Affinity of Staphylococcus
epidermidis to various prosthetic graft materials.
J Surg Res 2001;99:70–74.
20. Cobb WS, Harris JB, Lokey JS, McGill ES, et al. Incisional
herniorrhaphy with intraperitoneal composite mesh: A report
of 95 cases. Am Surg 2003;69:784–787.
21. Arroyo A,Garcia P, Perez F, et al. Randomized, clinical trial
comparing suture and mesh repair of umbilical hernia in
adults. Br J Surg 2001;88:1321–1323.
22. Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer
EA, Troidl H. Randomized, clinical trial of suture repair,
polypropylene mesh, or autodermal hernioplasty for incisional
hernia. Br J Surg 2002;89:50–56.
23. White TJ, Santos MC, Thompson JS. Factors affecting wound
complications in repair of ventral hernias. Am Surg 1998;
64:276–280.
24. Amid PK. Classification of biomaterials and their related
complications in abdominal wall hernia surgery. Hernia
1997;1:15–21.
25. Zheng F, Xu L, Verbiest L, et al. Cytokine production following
experimental implantation of xenogenic dermal collagen
and polypropylene grafts in mice. Neurourol Urodyn
2007;26:280–289.
26. Carbonell AM, Matthews BD, Dre´au D, et al. The susceptibility
of prosthetic biomaterials to infection. Surg Endosc
2005;19:430–443.
27. Paton LB, Novitsky YW, Zerey M, Sing RF, et al. Management
of infections of polytetrafluoroethylene-based mesh.
Surg Infect 2007;8:337–341.
28. Bellon JM, Bujan J, Contreras L, et al. Macrophage response
to experimental implantation of polypropylene protheses.
Eur Surg Res 1994;26:46–53.
29. Bleichrodt RP, Simmermacher RK, Van der Lei B,
Schakenraad JM. Expanded polytetrafluoroethylene patch
versus polypropylene mesh for the repair of contaminated
defects of the abdominal wall. Surg Gynecol Obstet 1993;
176:18–24.
30. Bellon JM, Contreras LA, Bujan J. Effect of relaparotomy
through previously integrated polypropylene and polytetrafluoroethylene
experimental implants in the abdominal
wall. J Am Coll Surg 1999;188:466–472.
31. Bellon JM, Jurado F, Carranza A. In vitro interaction of
bacteria with polypropylene=ePTFEprostheses. Biomaterials
2001;22:2021–2024.
Address correspondence to:
Brenda Aguilar, MD
Department of General Surgery
Mayo Clinic Hospital
5777 East Mayo Boulevard
Phoenix, AZ 85054
E-mail: Aguilar.Brenda@mayo.edu

Diagnosis and management of chronic radiation enteritis

2011-11-08T06:05:00.001-05:00

Diagnosis and management of chronic radiation enteritis
http://www.aboutcancer.com/radiation_enteritis_utd_807.htm

INTRODUCTION — Chronic radiation enteritis is a complication of radiation therapy for cancer, most commonly for rectal, prostate and pelvic malignancies. It can affect both the large and small intestine, is often progressive, and may lead to a variety of clinical consequences (such as diarrhea, nausea, weight loss, abdominal pain, intestinal obstruction, and perforation) depending upon the extent of the injury. It usually develops six or more months after radiation therapy (mean approximately 5 years, range two months to as long as 30 years. This contrasts with the timing of acute radiation enteritis (characterized by diarrhea and abdominal pain), which develops during or shortly after radiation therapy and resolves within two to six weeks.

The incidence has not been well defined, in part because of the large number of patients who died or were lost to follow-up in major studies involving radiation therapy, and because of the variability in the field size and dose of radiation. One literature review estimated that the incidence ranged from 1.2 to as high as 15 percent in patients with rectal cancer

This topic review will focus on the diagnosis and management of chronic radiation injury to the small intestines and proximal colon. Issues related to the prevention and treatment of chronic radiation proctitis (usually encountered following treatment of cancers of the rectum, cervix, uterus, prostate, urinary bladder, and testes) are presented separately.

PATHOGENESIS — Chronic radiation enteritis usually develops only after large doses of radiation therapy have been delivered (4500 to 5500 cGY); it is uncommon at lower doses. In addition to the dose of radiation, several other predisposing conditions have been described including:

Older age
Combined chemotherapy
Poor radiation technique
Postoperative radiation; in this setting, bowel loops fixed together by adhesions may prolapse into the pelvis, leading them to receive excessive radiation exposure. Adhesions due to past surgical procedures can have the same effect.
Intestinal injury is believed to be related to oxidative damage caused by the formation of free radicals. The end result is an obliterative endarteritis that leads to intestinal ischemia resulting in stricturing with ulceration and fibrosis and occasionally fistula formation. The physiologic consequences may include altered intestinal transit, reduced bile acid absorption, increased intestinal permeability, bacterial overgrowth and lactose malabsorption The resulting clinical manifestations may include nausea, vomiting, lactose intolerance, obstructive symptoms, diarrhea, weight loss, malnutrition, and bleeding (usually in patients with colonic involvement).

The prominent histopathologic features are those of an occlusive vasculitis with diffuse collagen deposition and fibrosis. The arteriolar walls may show a hyaline ring-like thickening and large foams cells beneath the intima. Mucosal ulceration, necrosis and perforation may develop as the disease progresses. Progressive fibrosis leads to stricturing with dilation of proximal segments. The intestinal segments and their associated serosa appear grossly thickened. Telangiectasias may be seen.

The precise mechanisms leading from oxidative damage to the histologic and morphologic abnormalities described above are incompletely understood. Several theories have been proposed, all of which are probably interrelated:

One model suggests that fibrosis develops from the initial mucosal injury
Another theory suggests that fibrosis develops in connective tissues where radiation has caused a decrease in cell turnover and a low rate of proliferation.
A third model focuses on the cellular responses to vascular damage caused by paracrine mediators. The signals leading to the developing of fibrosis are a topic of intensive ongoing investigation.
One study found that intestinal webs forming after radiation therapy demonstrated an impaired vasodilatory response in vitro to acetylcholine treatment. This microvascular dysfunction may lead to the formation of the abnormal tissue response seen in the wall of the intestine post-radiation therapy.

CLINICAL MANIFESTATIONS — The classical features of radiation enteritis are abdominal pain, nausea, vomiting, and diarrhea. Patients with severe disease may develop intermittent, partial, or complete small bowel obstruction

As noted above, bacterial overgrowth may lead to malabsorption and contribute to the nausea, abdominal pain and diarrhea. Bacterial overgrowth should be suspected in patients with intestinal strictures. Another clue may be the development of new lactose intolerance. Nonspecific symptoms include diarrhea, bloating, excessive gas, borborygmi, and nausea. Most such patients have only subtle laboratory or clinical findings pointing toward the diagnosis; thus a high index of suspicion is required. Rare patients with severe malabsorption may present with a more fulminant clinical and laboratory profile

DIAGNOSIS — The diagnosis is usually established by suggestive radiologic findings in patients with compatible clinical features who have a history of prior radiation exposure. The patient's previous radiation treatment record should be reviewed to determine the total dose and distribution of the radiation field. This may help to determine which intestinal segments may have received excessive radiation exposure, information that can be correlated with the radiologic findings and the clinical presentation.

We usually obtain an abdominal CT scan followed by an upper gastrointestinal series with small bowel follow through in patients with suspected small bowel disease. Additional imaging is reserved for patients in whom the diagnosis remains unclear. We generally perform a colonoscopy in patients with suspected colonic involvement.

Upper gastrointestinal series — An upper gastrointestinal series with small bowel follow-through is a useful initial test for evaluating the extent of disease although it is not as sensitive as enteroclysis.

Enteroclysis — Enteroclysis involves the instillation of contrast material (usually administered through a nasoenteric tube) into the small bowel using a pump (making it considerably less comfortable than a standard small bowel follow-through). It provides more detailed visualization of the small bowel compared with a standard upper gastrointestinal series. Suggestive findings include submucosal thickening, single or multiple stenoses, adhesions, and sinus or fistula formation. Its sensitivity and specificity for radiation enteritis have not been well-defined.

CT scan — Computed tomography may show thickening of bowel segments, but the findings are nonspecific. CT may be helpful in narrowing the differential diagnosis, particularly in distinguishing strictures due to radiation enteritis from those arising from abdominal metastases or a local recurrence

CT enteroclysis (in which a CT is performed after instilling contrast into the intestine using a nasoenteric tube) produces superior bowel opacification compared with conventional CT, and may therefore be useful for identifying low-grade or intermittent obstruction (reported sensitivity and specificity of approximately 88 and 82 percent, respectively). However, the technique is still used only in a few specialized centers. Similarly, other improvements in CT imaging of the small bowel (such as three-dimensional imaging) will likely also have a role in diagnosis of radiation enteritis but are not yet widely available

Magnetic resonance enteroclysis — Magnetic resonance enteroclysis permits visualization of the small bowel using similar principles as described above for CT enteroclysis. Initial studies suggest the results are comparable to (and possibly more sensitive than) CT enteroclysis. However, only small numbers of patients have been studied and the technique is not yet widely available.

Enteroscopy — Enteroscopy (peroral endoscopy of the small bowel using specialized endoscopes) has a limited role in the diagnosis of radiation enteritis although it may help to narrow the differential diagnosis. Enteroclysis can be performed following enteroscopy by leaving a tube inserted in the intestine upon withdrawal of the enteroscope.

Capsule endoscopy — There is no published experience with capsule endoscopy specifically for diagnosing radiation enteritis, although there is some clinical experience. However, it should probably not be performed in patients in whom there is a strong clinical suspicion for radiation enteritis because the capsule may become lodged in a strictured segment, requiring surgical removal.

Colonoscopy — Colonoscopy is helpful in evaluating colonic involvement and can also visualize the terminal ileum. Mucosal features consistent with radiation injury include pallor with friability and telangiectasias, which can be multiple, large, and serpiginous; these changes tend to be continuous. Although mucosal biopsies are not diagnostic, they can help to exclude other causes of proctitis such as infection or inflammatory bowel disease.

DIFFERENTIAL DIAGNOSIS — The differential diagnosis of chronic radiation enteritis is broad. Other diagnostic possibilities include post-surgical adhesions, malabsorption syndromes, abdominal metastases, lymphoma, Crohn's disease, infectious, ischemic or ulcerative colitis, and intestinal pseudo-obstruction.

MEDICAL MANAGEMENT — Prevention is the key to avoiding chronic radiation enteritis. Once established, treatment should be as conservative as possible focusing on relief of symptoms. Experience with specific medical treatments has been derived largely from small clinical trials and case series. Approaches used to treat small bowel disease will be summarized below while specific treatments aimed at radiation proctitis are discussed separately.

Dietary recommendations — There does not appear to be a clear-cut diet that reliably alleviates symptoms. A high fiber diet should probably not be recommended specifically since it may worsen diarrhea and urgency. Some patients may develop lactose intolerance, which may be due to bacterial overgrowth, and may improve following antibiotic treatment (see below). Others may require avoidance of lactose. Enteral formulas supplemented with glutamine may have a benefit but studies are limited

Antidiarrheal agents — Judicious use of antidiarrheal agents (such as loperamide) can help improve diarrhea, although it should not be used in patients with suspected small or large bowel obstruction. The efficacy of loperamide was evaluated in a crossover trial involving 18 patients with diarrhea due to radiation enteritis who were randomly assigned to loperamide or placebo for 14 days separated by a 14 day washout period. Loperamide was associated with a significant reduction in the frequency of bowel movements, slower intestinal transit, and improvement in the absorption of bile acids.

Antibiotics — Antibiotics may reduce symptoms in patients in whom bacterial overgrowth has developed. Specific testing for bacterial overgrowth is preferable to empiric therapy. A major drawback to empiric therapy is that treatment may require more than one antibiotic, and repeated and sometimes cyclic treatment. Because antibiotics may be associated with adverse effects, some of which may mimic symptoms of bacterial overgrowth (such as diarrhea and abdominal discomfort), establishing a firm diagnosis is important. This can usually be accomplished with a breath test.

5-ASA drugs — A case report (published nearly three decades ago) suggested a possible benefit from sulfasalazine with or without oral prednisone. There is no large published experience with either of these drugs. Discordant results have been obtained from controlled clinical trials evaluating mesalazine or sulfasalazine in the prevention of acute radiation enteritis

Hyperbaric oxygen — HBO has been used for treatment of refractory foot ulcers in diabetes and in other conditions [39]. The theoretical benefit of hyperbaric oxygen therapy (HBO) may be via inhibition of bacterial growth [40], preservation of marginally perfused tissue, and inhibition of toxin production [41].

A benefit in chronic radiation enteritis was suggested in a case report of a patient in whom 20 treatments over a one month period brought about objective improvements in symptoms and absorption of D-xylose. However, this anecdote did not give the results of long-term follow-up. Other reports have also suggested a benefit for patients with chronic radiation proctitis.

The equipment needed for hyperbaric oxygen treatment is expensive and not widely available. Thus, at the present time, it is not a practical means of treating chronic radiation enteritis outside of centers specializing in this approach, particularly since its effectiveness has not been well-studied.

Parenteral nutrition — A mainstay of the medical therapy of severe chronic radiation enteritis has been total parenteral nutrition (TPN), the success of which is similar for other intestinal disorders requiring TPN. One of the largest series included 54 patients who required home TPN mostly because of intestinal obstruction (27 patients), short bowel syndrome (17 patients), malabsorption (five patients), fistula formation (three patients), and dysmotility (two patients). TPN was initiated a median of 20 months after radiation therapy and was administered for a median of 20 months. Cumulative 5-year survival was 64 percent. Most early deaths were due to recurrent cancer. Similar survival estimates were reached in other series .

SURGERY — As noted above, surgery for radiation enteritis should be avoided if possible because of several inherent difficulties in operating on patients with chronic radiation injury

Diffuse fibrosis and adhesions between bowel loops can make resection technically challenging.
The risk of a leak is high when creating an anastomosis between irradiated tissues. Furthermore, it can be difficult to distinguish healthy tissue for irradiated tissue by gross inspection alone; intraoperative endoscopy may be helpful in this setting, but experienced is limited.
Extensive resection may be required, potentially leading to short bowel syndrome.
Despite attempts at conservative management, approximately one-third of patients progress to the point where surgery is required. Most surgical series of patients treated for radiation enteritis are small; the most common indications for surgery have been persistent ileus, intestinal fistulization, and massive adhesions. Surgical mortality rates are as high as 10 to 22 percent and many patients require more than one laparotomy

An illustrative series focused on 109 patients who underwent surgery during a 10 year period. Five patients died postoperatively (all of whom had undergone resection) while 33 (30 percent) had postoperative complications. Complications were more likely in patients who underwent emergency surgery. Repeat surgery was required in 40 percent of patients during a 40 month follow-up period. Overall survival in patients without a cancer recurrence was 85 percent at year one, and 69 percent at year five.

Strictureplasty may offer a less invasive approach to the management of strictures, but experience is limited. The role of small bowel transplantation in this setting is still being determined; its role, if any, will probably be only in children

SUMMARY AND RECOMMENDATIONS — Chronic radiation enteritis may lead to a variety of clinical consequences (such as diarrhea, nausea, weight loss, abdominal pain, intestinal obstruction and perforation) depending upon the extent of the injury. It usually develops six or more months after radiation therapy (mean approximately 5 years, range two months to as long as 30 years).

The diagnosis is usually established by suggestive radiologic findings in patients with compatible clinical features who have a history of prior radiation exposure. The patient's previous radiation treatment record should be reviewed to determine the total dose and distribution of the radiation field. This may help to determine which intestinal segments may have received excessive radiation exposure, information that can be correlated with the radiologic findings and the clinical presentation. We usually obtain an abdominal CT scan and an upper gastrointestinal series with small bowel follow-through. Further testing with an enteroclysis (standard, CT, or MRI depending upon local expertise) can be performed if the above is unrevealing and clinical suspicion remains.

Management should be conservative, addressing the predominant symptoms.

Patients with diarrhea, abdominal pain, nausea or bloating should undergo breath testing for bacterial overgrowth and treated with antibiotics if bacterial overgrowth is confirmed. Avoidance of lactose may benefit other patients while antidiarrheal agents (such as loperamide) may also be helpful. Loperamide should be avoided in patients with obstructive symptoms.
Patients with intermittent obstructive symptoms may benefit from a low residue diet, although dietary tolerance is variable. Radiologic evaluation may help to identify the strictured segment, information which may be critical should strictureplasty or surgery be ultimately required. The narrowed segment may not always be visible with an upper gastrointestinal series, particularly in patients with intermittent symptoms. Such patients may require enteroclysis as described above.
Despite conservative measures, surgery will be required in approximately 30 percent of patients. This is usually due to persistent ileus, intestinal fistulization, and massive adhesions.
Prognosis is variable since the disease is progressive. Early mortality is usually due to cancer recurrence. Five-year survival is approximately 70 percent in those without cancer recurrence, although many patients continue to have troubling digestive symptoms for the remainder of their lives.

Intensive, ongoing research on mechanisms related to fibrogenesis may eventually produce effective means to prevent or reverse disease progression once it has been established. However, at the present time, prevention during radiation therapy is central to reducing the risk of developing chronic radiation enteritis.

Scientists uncover the secrets behind rapid tissue repair

2011-11-05T10:01:00.000-04:00

10 October 2011

UK researchers have discovered how cells detect and respond to tissue damage. Their findings could open up new opportunities for improving tissue repair in patients after illness or surgery. When a tissue is wounded, cells detect damage via changes in their environment. Plasma leaking from broken blood vessels causes fibroblast cells to migrate into the damaged tissue, making the wound contract and plugging it by depositing substances such as collagen, which gives structural support to the tissue.

Now, researchers at the University of Bristol and the Wellcome Trust Centre for Cell-Matrix Research, University of Manchester - funded by the Wellcome Trust - have examined the signalling process that occurs in damaged tissues and identified the cellular mechanisms responsible for activating repair.

Lead author Dr Mark Bass said: "Each of these processes requires the turnover of cellular adhesions [repeated sticking and unsticking of cells], and the challenge has been to determine how cells detect tissue damage and modify their adhesive properties accordingly."

Using an imaging technique known as atomic force microscopy, the team were able to show how a protein, syndecan-4, triggers the uptake and redeployment of adhesive molecules. This novel sequence of signals enables fibroblasts and other cells to respond to changes in tissue structure and migrate along the matrix fibres which make up the skin. By moving towards a damage signal, cells are able to arrive at the wound far more quickly than if they searched for it randomly. This results in a very efficient healing response.

Dr Bass added: "We find that this signalling cascade is essential for efficient healing; this opens up considerable opportunities for improving tissue repair in patients."

Image: A scanning electron micrograph of the underside of a sticking plaster used to treat a razor blade cut. Credit: Anne Weston, LRI, CRUK, Wellcome Images.

Reference
Bass MD et al. A syndecan-4 hair trigger initiates wound healing through caveolin- and RhoG-regulated integrin endocytosis. Developmental Cell 2011 (epub ahead of print).
http://www.wellcome.ac.uk/News/2011/News/WTVM053022.htm

MAUDE Adverse Event Report ~ Abdolift and Spray Gel

2011-11-04T09:01:00.002-04:00

FDA Home> Medical Devices> DatabasesMAUDE Adverse Event Report
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

CONFLUCENT SPRAYGEL ADHESION BARRIER SYSTEM Back to Search Results

Model Number PK-A-6010
Event Date 02/07/2003
Event Type Injury Patient Outcome Required Intervention;
Event Description
The pt reported that she had problems with adhesions and pain. She had surgery performed at endogyn in another country, to remove the adhesions. The procedure was performed using a gasless laparoscopy technique with an abdominal wall retractor. The adhesions returned within 2 months of the surgery and after 6 months the adhesions became calcified. The pt claims that the surgery has damaged her internalorgans. She believes that the method of using the abdominal wall retractor with gasless laparoscopy is detrimental to the pt. She subsequently had additional surgery performed in the united states because of problems related to the surgery in another country.

Manufacturer Narrative
Confluent surgical was named as the mfr in medwatch report. The device named in the report is "abdominal wall retractor" Abdolift. Confluent surgical does not mfr, market, or distribute this device. When contacted by confluent, the reporter stated that the confluent product used in the surgery is spraygel. The "abdominal wall retractor", which is mfg by another co, was also used in the surgery. The event did not occur in the united states, it occurred in another country. Spraygel is not marketed or distributed in the united states. The reporter's complaint concerned the method of gasless laparoscopy and the use of the abdominal wall retractor, not the use of spraygel.

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

Brand Name SPRAYGEL ADHESION BARRIER SYSTEM
Manufacturer (Section F) CONFLUCENT
boston MA *

Manufacturer (Section D) CONFLUENT SURGICAL INC.
waltham MA *

Manufacturer Contact amita shah
101a first ave
waltham , MA 02451
(781) 839 -1726

Device Event Key 830606
MDR Report Key 878848
Event Key 806304
Report Number 3003157248-2007-00001
Device Sequence Number 1
Product Code MCN
Report Source Manufacturer
Source Type Other
Reporter Occupation Patient
Type of Report Initial
Report Date 05/14/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 06/25/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number PK-A-6010
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received 05/14/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/25/2007 Patient Sequence Number: 1
# Treatment Treatment Date
ABDOMINAL WALL RETRACTOR USED IN GASLESS
2,LAPAROSCOPY

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=878848
---Page Last Updated: 10/31/2011

Current Trials from Clinicaltrials.gov ~ Keyword Adhesiolysis

2011-11-04T08:41:00.000-04:00

Current Trials from Clinicaltrials.gov ~ Keyword Adhesiolysis
http://www.clinicaltrials.gov/ct2/results?term=adhesiolysis
Found 13 studies with search of: adhesiolysis

Hide studies that are not seeking new volunteers.
Hide studies with unknown recruitment status. Display Options Rank Status Study
1 Active, not recruiting The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs Condition: Tissue Adhesions
Intervention: Procedure: Adhesiolysis

2 Enrolling by invitation A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections Condition: Low Back Pain
Interventions: Procedure: Caudal Epidural Injection; Procedure: percutaneous adhesiolysis

3 Active, not recruiting Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain Condition: Chronic Low Back Pain
Interventions: Procedure: Percutaneous adhesiolysis with hypertonic saline neurolysis; Device: RK needle and Racz catheter system; Drug: local anesthetic, steroid, 10% sodium chloride solution

4 Enrolling by invitation Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients Condition: Low Back Pain
Interventions: Drug: Celestone; Drug: Substitute Celestone; Drug: Substitute Hypertonic Sodium Chloride; Drug: Substitute hypertonic sodium chloride and Celestone

5 Not yet recruiting Adhesiolysis in Chronic Abdominal Pain Condition: Chronic Abdominal Pain
Interventions: Procedure: Laparoscopic adhesiolysis; Procedure: Placebo-surgery

6 Recruiting Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh Conditions: Ventral Hernia; Adhesions
Intervention: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

7 Not yet recruiting Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion Condition: Intestinal Obstruction
Intervention: Procedure: Conservative treatment versus surgical treatment

8 Not yet recruiting An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen Condition: Open Abdomen
Intervention: Procedure: Adhesion Reduction Plan

9 Recruiting Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions. Conditions: Safety of Intervention; Efficacy of Intervention; Cost Effectiveness
Interventions: Procedure: VATS hyperthermic chemoperfusion; Procedure: Bedside talc slurry pleurodesis

10 Completed Study of Fluid Collection of the Chest in Children With Pneumonia Conditions: Community Acquired Bacterial Pneumonia; Paraneumonic Effusion
Intervention: Procedure: Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage

11 Unknown † Seprafilm® for Prevention of Adhesions at Repeat Cesarean Condition: Adhesion Formation After Primary Cesarean Delivery
Interventions: Device: Seprafilm®; Other: Control

12 Unknown † Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair Conditions: Hernia, Ventral; Body Image; Respiratory Function Tests; Quality of Life; Laparoscopy
Interventions: Procedure: Laparoscopic repair; Procedure: Open midline incisional hernia repair

13 Recruiting Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor Conditions: Advanced Cancers; Sarcoma
Interventions: Procedure: Hyperthermic Peritoneal Perfusion (HIPEC); Drug: Cisplatin

Innocoll Announces European Approval for CollaGUARD®, Surgical Adhesion Barrier

2011-11-04T06:29:00.000-04:00

ASHBURN, Va., Oct. 11, 2011 /PRNewswire/ -- Innocoll, Inc. announces the approval of CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery. The product will be launched this year through a network of distribution partnerships. The company also plans to seek approval in a number of additional territories, including Australia, Canada, the MENA region, South East Asia, and to initiate the studies required for registration in the US.

Dr. Michael Myers, President and CEO commented, "EU registration for CollaGUARD represents an important milestone for Innocoll. This is the first significant approval for a product developed using our proprietary CollaFilm™ technology and we are on track to launch this year. With Cogenzia® ready to start Phase 3 testing and following the recent announcement of positive XaraColl® Phase 2 clinical data coupled with US/EU approval of a broad range of advanced woundcare products, Innocoll is assembling an exciting portfolio of late stage assets. We look forward to further positive developments for our products and technologies throughout 2012 and beyond."

About CollaGUARD®

CollaGUARD is a transparent bioresorbable film of 100% type I collagen that has been developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. CollaGUARD is implanted at the time of surgery and serves as a temporary barrier to separate apposing adhesiogenic surfaces throughout the normal tissue repair process. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).

CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.

About Postoperative Adhesions

Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.

About Innocoll, Inc.

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPressTM and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.

Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.

SOURCE Innocoll, Inc.

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Dolphin-Assisted Therapy: Something Magical in the Water

2011-11-03T08:10:00.000-04:00

Excerpt from Huffington Post

In an ongoing pilot study -- Researching the Effects of Dolphin Assisted Therapy at CDTC on Brain Activity -- in cooperation with the German Society of Air and Space Medicine and Research, DolphinAid and the Neurological Clinic Vogtareuth, scientists used water-proof EEG equipment to measure how human brain waves change in interactions with dolphins. The preliminary results have been called "promising." Other research, including an accredited project on children, dolphins and depression, is noted below.(1)

One hypothesis suggests that our brain waves sync to be in resonance with the frequencies of those of dolphins when we're exposed to them. Our normal activity in everyday thought is in beta wavelength. Upon exposure to dolphins, our brainwaves have been measured to go into alpha (the relaxation, effortless alertness, peak performances, daydreaming state, producing lower anxiety and better immune system function) and theta (the meditative state). Moreover, an increase by significant measure of hemispheric synchronization (the balancing of right and left hemispheres in the brain, which is associated with heightened awareness and increased ability to learn) was registered. (2)

Since our normal activity in everyday thought is in beta, we go into alpha during the "ah-ha" phenomenon when we have a great idea while driving or showering. You've doubtless had that wonderful experience. It's a gestalt, out of time, not a linear thought to be explained in one word after another, even as you read these consecutive words here. Rather it is grasped as a whole and then later translated into its discrete units. Einstein explained it to a friend this way: "Thoughts did not come in any verbal formation. I rarely think in words at all. A thought comes, and I try to express it in words afterward." That time-free knowing is exhilarating for certain. And this may partly explain the feeling.

Then there's the sonar.
Dolphins use their sonar/ultrasound to scan the world around them. Medical science uses ultrasound in pregnancies and for diagnostic information, to promote healing and to destroy cataracts, kidney stones and gallstones. Sounds in general can influence our biology, such as our heart rate. Ultrasonic energy from dolphins, is four times stronger than that applied medically. The medium through which it is transmitted, water, has an efficiency of delivering sound that is 60 times more efficient than air.

Because our bodies are primarily made of water, including the fluid that moves from the brain to the spinal cord, this interaction may be extremely defining. It may even help to reduce adhesions and scarring from old surgeries. (3) (4) They read the world around them, almost like an X-ray, with this capacity which even the Navy has discovered very useful. This is likely how Mateo knew about the boy's surgery. (5)
Click here to read entire article: http://www.huffingtonpost.com/judith-simon-prager-phd/dolphin-assisted-therapy_b_996389.html

Deaths from painkiller overdose triple in decade

2011-11-02T08:00:00.000-04:00

By STEPHANIE NANO - Associated Press

AP – 13 hrs ago..

NEW YORK (AP) — The number of overdose deaths from powerful painkillers more than tripled over a decade, the government reported Tuesday — a trend that a U.S. health official called an epidemic, but one that can be stopped.

Prescription painkillers such as OxyContin, Vicodin and methadone led to the deaths of almost 15,000 people in 2008, including actor Heath Ledger. That's more than three times the 4,000 deaths from narcotics in 1999.

Such painkillers "are meant to help people who have severe pain," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention in Atlanta, which issued the report. "They are, however, highly addictive."

The report shows nearly 5 percent of Americans ages 12 and older said they've abused painkillers in the past year — using them without a prescription or just for the high. In 2008-09 surveys, Oklahomans reported the highest rate of abuse; the lowest was in Nebraska and Iowa.

The overdose deaths reflect the spike in the number of narcotic painkillers prescribed every year — enough to give every American a one-month supply, Frieden said.

Prescriptions rose as doctors aimed to better treat pain and as new painkillers hit the market.

Frieden and White House drug czar Gil Kerlikowske, who joined him at CDC headquarters in Atlanta, said states need to take sharp actions to reverse the long-running trend.

States oversee prescription practices and can rigorously monitor prescriptions and crack down on "pill mills" and "doctor shopping" by patients, Frieden said.
Click here to read the rest: http://news.yahoo.com/deaths-painkiller-overdose-triple-decade-160401910.html

Companies pitch ideas to angel investors at MedVentures

2011-11-01T07:52:00.000-04:00

Bill Hethcock

Staff Writer - Dallas Business Journal

Email Dallas Business Journal by Bill Hethcock, Staff Writer

Date: Thursday, October 6, 2011, 3:00pm CDT - Last Modified: Thursday, October 6, 2011, 3:02pm CDT

I spent the morning at the MedVentures conference in Frisco, hosted by the North Texas Enterprise Center.

The conference is where companies with ideas and plans for medical instruments and devices, diagnostic equipment and other health-related products make their pitch for advice and, more importantly, money from venture capital and angel investors to get their businesses off the ground.

Interesting products in development by some of the presenting companies include:

• Coltrix Biomedical, a Fort Worth-based preclinical-stage company whose mission is to deliver collagen-based medical devices that improve surgical outcomes, has a product called Collapatch. It's a membrane that prevents the formation of adhesions, an internal form of scarring, after surgery. These adhesions result in 300,000 readmissions annually to U.S. hospitals at a cost of $1.3 billion.

• Plano-based Neuro Resource Group .Neuro Resource Group Latest from The Business Journals Emerging Tech Fund faces possible cutsDataInfoCom granted .6M from ETFDataInfoCom granted .6M from ETF Follow this company .'s InterX is a non-invasive solution for acute and chronic pain. Clinical trials have demonstrated InterX significantly reduces pain and decreases the intake of opioids and other pain medication.

• Arcos Inc., based in Houston, has developed decision-support software to battle sepsis, a severe illness in which the bloodstream is overwhelmed by bacteria. In one test, the "Sepsis Toolkit" enabled one hospital to lower its severe sepsis mortality from 34 percent to 14 percent.

Bill covers health care, law, education and nonprofits.

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Dr. OZ Adhesions

2011-10-28T08:48:00.001-04:00

Dr. Oz Small Bowel Obstruction | Bloating-Vomiting-Pain

Dr. Oz Small Bowel Obstruction: A mysterious condition making you bloated, its more serious than you may realize. Have you ever been warned of the possibility of a small bowel obstruction, it is something that may happen in one third of all people after belly surgery and it is more serious than you may even realize. It is not only uncomfortable but is also life threatening!
Read the rest here: http://healthybodydaily.com/dr-oz-health-conditions/dr-oz-small-bowel-obstruction
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Health director defends handling of Penan child’s birth ~ C Section Adhesions

2011-10-27T08:29:00.000-04:00

Health director defends handling of Penan child’s birth

MIRI: The State Health Department yesterday said standard care and management were provided to a Penan mother Seri Yung and her baby by its staff in Limbang and Miri hospitals but apologised for not waiving the charges.
In a statement, its state director Dr Zulkifli Jantan said complications due to lack of oxygen supply (hypoxic ischaemic encephalopathy) was the cause of the infant’s death. It was brought about by the extra long time needed in the ceasarian operation due to massive adhesions present.

“The department would like to state that all reasonable care and management have been duly provided to both Seri Yung and her infant while in Limbang and Miri hospitals,” he said.

The statement was in response to a letter highlighted through Batu Lintang assemblyman See Chee How that a Penan couple from Limbang was requesting an inquest into the death of their infant and case management.

The couple also alleged that they were verbally abused, and were forced to borrow money to pay the RM180 hospital charges.

The department apologised over the flap (on hospital charges), saying it was due to miscommunication. The patient had described herself as a Rela staff and not as a Penan, and therefore was charged accordingly.

“If she had presented herself as a Penan who could not afford the charges, the fee exemption could have been activated on the spot. For this (misunderstanding), we would like to tender our sincere apologies,” Dr Zulkifli said.

He said Seri had a previous Ceasarian operation to deliver her first baby in 2006, and in the recent case, an emergency operation was needed due to the prolonged labour.

She came to Limbang hospital at the early stage of her labour, diagnosed as a high risk patient and was sent by an ambulance to Miri Hospital on Oct 15 as her condition warranted it.

Labour commenced spontaneously in Miri Hospital and normal delivery trial was planned as previous Ceasarian operation did not contraindicate such, and the condition of mother and infant were monitored accordingly throughout.

“However, progress was slow and the infant began showing signs of distress, and a Ceasarian section was carried out but it was 30 minutes longer than normal due to extensive adhesions affecting the uterus and abdominal wall as a result of previous Ceasarian operation, “ he added.

The patient recovered from the operation without complications, and doctors at the Miri Hospital explained to her and her husband the whole incident, including about the infant.

The infant showed poor oxygenation upon birth at 4/10 in the first minute assessment and improved to 5/10 in five minutes. Emergency and intensive care was provided from birth until the infant girl passed away on Oct 17 caused by lack of oxygen due to longer than expected operation.

“The situation could not have been dealt with in a different way. Although it is common to have some adhesions from a previous Ceasarian operation, it is not common to have the extensive adhesions that this unfortunate patient had,” he added.

Dr Zulkifli said that the care and management of the mother and infant from Limbang to Miri hospitals were correct and appropriate.

The date mentioned by See (Chee How) contradicted with the department’s chronology of event. The infant was reported to have died on Oct 15 after Seri Yung was transferred to Miri hospital on Oct 13.

The Batu Lintang assemblyman said nothing short of a public apology from Miri Hospital would suffice as the couple was hurt and disappointed for losing their baby girl and also subject to needless criticism and humiliations for their financial hardships.

Meanwhile, on the imposition of RM180 hospital charges, the Miri Hospital director Dr Jack Wong said a breakdown in communication could be the cause.

He said the hospital could not ascertain at that point of time, the status of the patients (Seri and daughter) – whether they were entitled to a waiver of the hospital charges.

“However, we are prepared to waive the charges and to meet Seri and her husband, Roy Dumani. We will work out a mechanism to help solve the problems,” said Dr Wong.

On allegations of verbal abuse by the hospital staff, Dr Wong said investigation was being carried out.

Read more: http://www.theborneopost.com/2011/10/21/health-director-defends-handling-of-penan-child%e2%80%99s-birth/#ixzz1bz6LzV8X

Adhesion-Prevention Strategy in C-Sections: Focus on Risk Reduction

2011-10-26T05:51:00.000-04:00

Adhesion-Prevention Strategy in C-Sections: Focus on Risk Reduction
By Victor Hugo Gonzalez-Quintero, M.D., M.P.H. Interim Director, Division of Maternal Fetal Medicine Associate Professor of Clinical Obstetrics and Gynecology Director, Residency Program | October 26, 2011
University of Miami/Jackson Memorial Medical Center

--------------------------------------------------------------------------------

http://hcp.obgyn.net/pregnancy-and-birth/content/article/1760982/1977693

Cesarean deliveries are now the most commonly performed abdominal surgery in the United States.1 In 2005, an estimated 30.3 % of all births involved C-section procedures2, and preliminary estimates from the Centers for Disease Control and Prevention indicate that the incidence of C-sections will continue to rise in the coming decade.3

The increased use of C-section procedures presents some important health considerations for specialists in maternal fetal medicine. According to the results of a study published in the American Journal of Obstetrics & Gynecology in May 20071:

Among women who underwent a second C-section, 46% (100 out of 217), developed pelvic adhesions.
Among women treated with a third C-section, 75% (48 out of 64) developed adhesions.
Among women treated with a fourth C-section, five out of six (83%) developed pelvic adhesions.
The development of adhesions was also shown to have an impact on time-to-delivery. On average, infant delivery was delayed 5.6 minutes among women who had a second C-section as compared to an average primary C-section. The comparative delay increased to 8.5 minutes and 18.1 minutes, respectively, for third and fourth C-sections
The Rationale for Proactive Strategies to Prevent Adhesions in C-Sections

Time to infant delivery once anesthesia has been administered and risk of surgical complexity at repeat C-section are of critical concern, particularly in cases of emergent C-section. Based on these findings and continuing trends in the incidence and impact of C-sections, obstetrical practices are increasingly considering strategies to help reduce the risk of adhesions. In some practices, strategies focus on restrictions in the use of C-section procedures among patients. The availability of proven adhesion prevention strategies has also built support for a more proactive strategy to reduce risk, especially among patients treated with multiple C-section procedures. Following a comprehensive review of options, our division led a practice-wide initiative to incorporate adhesion prevention strategies to reduce the risk of adhesions in most C-section procedures.

In considering this plan, which was introduced in 2005, we identified several factors in support of a more proactive adhesion prevention strategy:

As a busy obstetrical practice performing several thousand C-section procedures each year, our department is clearly positioned to be affected by trends in surgery that might increase the risk of adhesions among our patients. Based on available data it became apparent that an increased risk of post-surgical adhesions among our patients could have a significant impact in terms of treatment complications and delayed delivery time.
The use of an adhesion barrier was already in place in formulary at the hospital and was widely used in gynecologic oncology procedures where the risk of post-operative adhesions is well-established.
Based on established familiarity with adhesion prevention strategies in gynecologic oncology, support for a preventative strategy in obstetrics was in place among labor and delivery management teams familiar with both the proven efficacy of adhesion prevention strategies and the potential impact of adhesion development on our patients.
The introduction of an adhesion prevention strategy would require only minimal additional staff training and monitoring.
Data related to the safety and efficacy of adhesion prevention barriers was widely available.
Importantly, to deliver maximum benefit we determined that a preventative strategy to reduce the risk of adhesions in C-sections must be positioned as a complement to superior surgical technique at every stage.
The availability of more conclusive data related to the risk of adhesions among C-section patients will help to shape even more effective prevention strategies in the years ahead. In this area, however, the rapid increase in C-section procedures challenges us to identify the optimal strategies to reduce patient risk as quickly as possible. While available data related to the morbidity associated with C-section adhesions are limited, we concluded that available data are sufficient at this stage to support a broad preventative intervention strategy as outlined. We are continuing to monitor results based on this strategy to draw more precise conclusions related to treatment experience.

1. Morales KJ, Gordon MC, Bates GW Jr. Post cesarean delivery adhesions associated with delayed delivery of infant. Am J Obstet Gynecol 2007;196:461.e1-461.e6.
2. Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S, Munson ML. Births: Final data for 2005. National vital statistics reports; vol 56 no 6. Hyattsville, MD: National Center for Health Statistics 2007.
3. Hamilton BE, Martin JA, Ventura SJ. Births Preliminary data for 2006. National vital statistics reports; vol 56 no 7. Hyattsville, MD: National Center for Health Statistics. 2007.

The inpatient burden of abdominal and gynecological adhesiolysis in the US

2011-10-24T05:12:00.000-04:00

BMC Surg. 2011; 11: 13.
Published online 2011 June 9. doi: 10.1186/1471-2482-11-13 PMCID: PMC3141363

Copyright ©2011 Sikirica et al; licensee BioMed Central Ltd.
The inpatient burden of abdominal and gynecological adhesiolysis in the US
Vanja Sikirica,1 Bela Bapat,2 Sean D Candrilli,2 Keith L Davis,2 Malcolm Wilson,3 and Alan Johns4
1Shire Pharmaceuticals, Wayne, PA 19087 USA
2RTI Health Solutions, 200 Park Offices, Research Triangle Park, NC 27709 USA
3The Christie NHS Foundation Trust, Manchester, M20 4BX, UK
4Texas Health Care, Fort Worth, TX 76109 USA
Corresponding author.
Vanja Sikirica: vsikirica@shire.com; Bela Bapat: bbapat@rti.org; Sean D Candrilli: scandrilli@rti.org; Keith L Davis: kldavis@rti.org; Malcolm Wilson: Malcolm.Wilson@christie.nhs.uk; Alan Johns: daj@womenssurgerygroup.com
Received January 5, 2011; Accepted June 9, 2011.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Other Sections▼
AbstractBackgroundMethodsResults and DiscussionConclusionsCompeting interestsAuthors' contributionsFundingPre-publication historyReferencesAbstractBackground
Adhesions are fibrous bands of scar tissue, often a result of surgery, that form between internal organs and tissues, joining them together abnormally. Postoperative adhesions frequently occur following abdominal surgery, and are associated with a large economic burden. This study examines the inpatient burden of adhesiolysis in the United States (i.e., number and rate of events, cost, length of stay [LOS]).Methods
Hospital discharge data for patients with primary and secondary adhesiolysis were analyzed using the 2005 Healthcare Cost and Utilization Project's Nationwide Inpatient Sample. Procedures were aggregated by body system.Results
We identified 351,777 adhesiolysis-related hospitalizations: 23.2% for primary and 76.8% for secondary adhesiolysis. The average LOS was 7.8 days for primary adhesiolysis. We found that 967,332 days of care were attributed to adhesiolysis-related procedures, with inpatient expenditures totaling $2.3 billion ($1.4 billion for primary adhesiolysis; $926 million for secondary adhesiolysis). Hospitalizations for adhesiolysis increased steadily by age and were higher for women. Of secondary adhesiolysis procedures, 46.3% involved the female reproductive tract, resulting in 57,005 additional days of care and $220 million in attributable costs.Conclusions
Adhesiolysis remain an important surgical problem in the United States. Hospitalization for this condition leads to high direct surgical costs, which should be of interest to providers and payers.Keywords: Adhesions, adhesiolysis, abdominal, gynecological, burden of illness, hospitalizations.
Read Full Abstract here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3141363/?tool=pmcentrez

Young carers ~ taking care of Parents

2011-10-24T04:46:00.000-04:00

Supporting the county’s young carers
Mark Shields
Friday, October 21, 2011
12:21 PM
CHILDHOOD is a time for having fun, making friends and gaining confidence. But for more than 1,300 young carers across the county, those years are filled with looking after sick or disabled parents or siblings – which is where Crossroads Care Cambridgeshire comes in.

WHEN Shannon O’Neill gets home from school, the first thing she does is check how her mum Michelle is.

Michelle, 39, suffers from fibromyalgia and adhesion-related disorder (ARD), a condition which causes her constant abdominal pain.

There are times when she is able to look after Shannon as she would like to but, on her bad days, the pain is so intense that 11-year-old Shannon must look after her.

That could mean flushing out the feeding peg that was used in the past to connect Michelle’s colostomy bag, or giving her a massage to soothe her aching muscles.

Then it’s on to the household chores: making dinner, cleaning, washing, drying, and locking the house up for the night – before she sits down to begin her homework.

Even when Michelle is having a good spell, the unpredictability of her condition means she is always in Shannon’s thoughts.

“I’m always thinking of coming back at the end of the day and seeing how my mum is,” said Shannon. “I don’t like going to groups or after school clubs any more, because I’m scared to see what’s going to happen.”

Young carers are often the victims of bullying as they struggle to handle school, homework and their caring duties. As adults, they are twice as likely not to be in education or training as their peers, because caring has affected their education or would mean leaving their parent or sibling without care.

Please click here to read the rest:
http://www.huntspost.co.uk/news/latest-news/supporting_the_county_s_young_carers_1_1105307

Prolonged (longer than 3 hours) laparoscopic cholecystectomy: reasons and results.

2011-10-22T08:57:00.000-04:00

Am Surg. 2011 Aug;77(8):981-4.

Subhas G, Gupta A, Bhullar J, Dubay L, Ferguson L, Goriel Y, Jacobs MJ, Kolachalam RB, Silapaswan S, Mittal VK.

Source

Department of Surgery, Providence Hospital and Medical Centers, Southfield, Michigan, USA.

Abstract

For the experienced surgeon, the average operative time for a laparoscopic cholecystectomy is less than 1 hour. There has been no study documenting the causes and results of prolonged (longer than 3 hours) surgery. A retrospective study was done of patients who underwent cholecystectomy between January 2003 and December 2007. A total of 3126 cholecystectomies were done. After excluding patients who had a planned open cholecystectomy and patients who had additional laparoscopic surgeries, we identified 70 patients who had a planned laparoscopic cholecystectomy with operative time exceeding 3 hours. Multivariate stepwise logistic regression was performed analyzing the various factors leading to prolonged surgery. Of the 70 patients, ranging in age from 21 to 92 years (mean, 57 years), most (n = 53) were female. Operative time ranged from 3 hours to 6 hours 40 minutes (mean, 3 hours 37 minutes). Emergency:elective admission ratio was 9:5 and acute cholecystitis (n = 40) was the most common indication. Common characteristics were obesity (n = 44, P = 0.031), intra-abdominal adhesions (n = 43, P = 0.004), and previous abdominal surgeries (n = 40, P = 0.002). Intraoperative complications included spillage of stones (n = 6), bile duct injury (n = 3), and bleeding (n = 3). The possibility of prolonged laparoscopic cholecystectomy should be anticipated in patients with obesity and previous abdominal operations. Prolonged surgery increases the risk of complications (bile duct injury, bleeding) and prolongs the postoperative hospital stay.

PMID:: 21944510; [PubMed - in process]

Internal Scar Tissue ARD: Surgical Video – Ovarian Torsion with Dense Adhesive Disease

2011-10-21T06:33:00.000-04:00

Internal Scar Tissue ARD: Surgical Video – Ovarian Torsion with Dense Adhesive Disease

Asherman's Syndrome

2011-10-20T05:50:00.000-04:00

Asherman's Syndrome
http://www.ashermans.org/home/
"It's no longer a question of WHAT IF, but with knowledge it's answering WHAT NOW"
Welcome to our Web Site
Welcome to our site. If you are looking for information and support for Asherman's Syndrome, intrauterine adhesions/scarring, or related problems, you've found the right place.

What is Asherman's Syndrome?
Asherman's Syndrome, or intrauterine adhesions or synechiae, is an acquired uterine condition, characterized by the formation of adhesions (scar tissue) inside the uterus. In many cases the front and back walls of the uterus stick to one another. In other cases, adhesions only occur in a small portion of the uterus. The extent of the adhesions defines whether the case is mild, moderate or severe. The adhesions can be thin or thick, can be spotty in location, or can be confluent. They are usually not vascular, an important attribute that helps in treatment. Click here for more on Asherman's Syndrome grades.

Symptoms
Most patients with Asherman's have scanty or absent periods (amenorrhea) but some have normal periods. Some patients have no periods but feel pain at the time each month that their period would normally arrive. This pain may indicate that menstruation is occurring but the blood cannot exit the uterus because the cervix is blocked by adhesions. Recurrent miscarriage and infertility could also be symptoms (1).

Causes
Asherman’s syndrome occurs when trauma to the endometrial lining triggers the normal wound-healing process, which causes the damaged areas to fuse together. Most commonly, intrauterine adhesions occur after a D&C(dilation and curettage) that was performed because of a missed or incomplete miscarriage, because of retained placenta with or without hemorrhage after a delivery, or elective abortion. Pregnancy-related D&Cs have been shown to account for 90% of Asherman’s cases (2). Adhesions sometimes also occur following other pelvic surgeries such as cesarean section, surgery to remove fibroids or polyps, or in the developing world, as a result of infections such as genital tuberculosis (3) and schistosomiasis (4).

The risk of developing Asherman’s from a D&C is 25% 2-4 weeks after delivery (5-8). D&Cs also lead to Asherman’s in 30.9% of procedures for missed miscarriages(17) and 6.4% for incomplete miscarriages (2). Asherman’s risk increases with the number of D&Cs performed; after a single termination the risk is 16% however after 3 or more D&Cs the risk jumps to 32% (9). Each case of Asherman's Syndrome is different, and cause must be determined on a case-by-case basis. In some cases, Asherman's may have been caused by an "overly-aggressive" D&C. However, this is not often considered to be the case. The placenta may have attached very deeply in the endometrium or fibrotic activity of retained products of conception could have occurred both of which make it difficult to remove retained tissue without causing injury to the basal endometrium. For the most comprehensive information about D&Cs and Asherman's Syndrome, please click here to visit DandCnow.info.

There is a variant of Asherman's Syndrome that is more difficult to treat. This is a so-called "unstuck Asherman's" or endometrial sclerosis. In this condition, which may coexist with the presence of adhesions, the uterine walls are not stuck together. Instead, the endometrium has been denuded. Although curettage can cause this condition, it is more likely after uterine surgery, such as myomectomy. In these cases the endometrium, or at least its basal layer, has been removed or destroyed.

Incidence
Asherman’s is thought to be under-diagnosed because it is usually undetectable by routine diagnostic procedures such as ultrasound scan. The condition is estimated to affect 1.5% of women undergoing HSG (10), between 5 and 39% of women with recurrent miscarriage (11-13), and up to 40% of patients who have undergone D&C for retained products of conception following childbirth or incomplete abortion (14) (see Causes above).

Diagnosis
Direct visualization of the uterus via Hysteroscopyis the most reliable method for diagnosis. Other methods are sonohysterography (SHG) and hysterosalpingogram (HSG).

Prevention
Ideally, prevention is the best solution. It was suggested as early as in 1993 (9) that the incidence of IUA might be lower following medical evacuation (eg. Misoprostol) of the uterus, thus avoiding any intra-uterine instrumentation. So far, one study supports this proposal, showing that women who were treated for missed miscarriage with misoprostol did not develop IUA, while 7.7% of those undergoing D&C did(15). The advantage of misoprostol is that is can be used for evacuation not only following miscarriage, but also following birth for retained placenta or hemorrhaging. Alternatively, D&C could be performed under ultrasound guidance rather than blindly. This would enable the surgeon to end scraping the lining when all retained tissue has been removed, avoiding injury. Early monitoring during pregnancy to identify miscarriage can prevent the development of, or as the case may be, the reoccurrence of Asherman’s as adhesions are more likely to occur after a D&C the longer the period after fetal death (2). Therefore immediate evacuation following fetal death may prevent IUA. There is no evidence to suggest that suction D&C is less likely to result in adhesions than sharp D&C. Cases of Asherman’s have been reported even following manual vacuum aspiration (16) and the rate of Asherman’s has not dropped since the introduction of suction D&C.

Treatment
Asherman’s must be treated by a very experienced surgeon via hysteroscopy (sometimes assisted by Laparoscopy) Those few surgeons experienced enough in treating severe Asherman’s Syndrome recommend the avoidance of energy sources inside the uterus (this means removing scars with scissors rather than with energy-generating instruments such as resectoscopes or lasers, although not all surgeons agree with this). Adhesions have a tendency to reform especially in more severe cases. There are different methods to prevent re-scarring after surgery for Asherman´s Syndrome. Many surgeons prescribe estrogen supplementation to stimulate uterine healing respectively the growth of endometrium and place a splint or balloon to prevent apposition of the walls during the immediate post-operative healing phase. Other surgeons recommend weekly in-office hysteroscopy after the main surgery to cut away any newly formed adhesions. As yet, studies have not confirmed which method of treatment is most likely to have a successful outcome, that is one where the uterus/cervix remain scar free and fertility is restored.

Mission
This site is for a growing community of women who suffer or have suffered with Asherman's Syndrome. This site will provide information about Asherman's Syndrome, as well as personal support and shared experiences. Here, we share our hopes and despairs and talk about other options available for building our families, such as surrogacy and adoption. We will share medical and legal information, including any valuable links to other sites on the World Wide Web. We will also share our own stories as means of providing encouragement and hope.

Visit our YouTube channel to view videos about the experiences of women who have Asherman's Syndrome and the specialized doctors who treat them. We are continuously adding more videos to this channel so check it out often.

Contact Us
If you would like to join us or have any questions answered please visit our Contacts page.

If you are a medical professional and are interested in getting in touch with us, please email us for further communication. Please include the following information in your email: Name, Profession, Country, and Area of Interest in our group.

References (please click here for a complete list)

Intra-abdominal adhesions: Cellular mechanisms and strategies for prevention.

2011-10-19T06:11:00.000-04:00

Int J Surg. 2011 Sep 23. [Epub ahead of print]
Intra-abdominal adhesions: Cellular mechanisms and strategies for prevention.
Maciver AH, McCall M, James Shapiro AM.
SourceDepartment of Surgery, University of Alberta Hospitals, 2000 College Plaza, 8215 112th Street, Edmonton, Alberta, Canada T6G 2C8.

Abstract
Postoperative intra-abdominal adhesions represent a serious clinical problem. In this review, we have focused on recent progress in the cellular and humoral mechanisms underpinning adhesion formation, and have reviewed strategies that interfere with these pathways as a means to prevent their occurrence. Current and previous English-language literature on the pathogenesis of adhesion formation was identified. As the burden of surgical disease in the world population increases, and the frequency of reoperation increases, prevention of adhesion formation has become a pressing goal in surgical research.

Copyright © 2011. Published by Elsevier Ltd.

http://www.ncbi.nlm.nih.gov/pubmed/21964216

Idiopathic encapsulating peritonitis: Report of two cases.

2011-10-19T06:09:00.000-04:00

Surg Today. 2011 Dec;41(12):1644-8. Epub 2011 Oct 4.
Idiopathic encapsulating peritonitis: Report of two cases.
Da Luz MM, Barral SM, Barral CM, Bechara Cde S, Lacerda-Filho A.
SourceDivision of Coloproctology and Small Bowel, Alfa Institute of Gastroenterology, Federal University of Minas Gerais Hospital, Av. Alfredo Balena 110 - 2° andar, Belo Horizonte, MG 30130-100, Brazil.

Abstract
This report presents two cases of young males who developed the rare idiopathic form of sclerosing encapsulating peritonitis (SEP) presented as partial bowel obstruction, both diagnosed during surgical treatment, with satisfactory outcomes. Sclerosing encapsulating peritonitis is a rare and enigmatic condition, characterized by intraperitoneal fibrosclerosis, which causes intestinal obstruction. It is a chronic entity with a poorly elucidated pathophysiology, leading to the constitution of a thick white nacreous fibrosis membrane that wraps the bowel in a concertina-like fashion with some adhesions configuring an intra-abdominal cocoon. Sclerosing encapsulating peritonitis is reported in a wide variety of patients, including those who have undergone peritoneal dialysis, young adolescent girls, cirrhotic patients after peritoneal-venous shunting, and patients treated with β-blockers. Nevertheless, the etiology of SEP remains obscure. This entity presents many difficulties in preoperative diagnosis because of its peculiar characteristics. Recognition of the SEP results in proper management and prevents unnecessary bowel resection. Regardless of cause, the treatment of the obstruction is surgical, with dissection of the encasing membrane from the intestine and separation of adherent loops of small bowel until they are laid free and returned to their normal configuration. The prognosis after appropriate surgical therapy is good, but depends on coexisting diseases.

PMID:21969199[PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/21969199

Functional Bowel Disorders

2011-10-17T05:28:00.000-04:00

Functional Bowel Disorders
Michael Snyder, MD
Clinical Instructor
Colon and Rectal Surgery
University of Texas at Houston Health Center
Clinical Associate Professor
Baylor College of Medicine
Houston, Texas
http://www.fascrs.org/physicians/education/core_subjects/2005/functional_bowel_disorders/

Functional bowel disorders are syndromes characterized by chronic gastrointestinal tract symptoms in patients without significant infectious, metabolic or anatomical abnormalities. Functional gastrointestinal disorders can affect the entire digestive tract from the mouth to the anus. The two most common functional disorders seen by the colon and rectal surgeon are irritable bowel syndrome (IBS) and functional constipation which affect the mid to lower gastrointestinal tract.

Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS), the most frequent condition diagnosed in most gastroenterology practices, is responsible for over three million office visits annually. Depending on the diagnostic inclusion criteria, the prevalence of IBS in the United States is between six and twenty percent (1). Female predominance is as high as 2:1 in some studies. While it is primarily a disorder of younger people in the third or fourth decade of life, up to 23% of patients with IBS have symptoms that persist into old age. A new diagnosis of IBS should be made cautiously in patients older than 60, however, because this age group has an increased incidence of other colonic disorders with similar symptoms. Since there has never been a well-designed study on the natural history of IBS, the reasons for the female predominance are unclear. Whether this represents a true difference or is secondary to health care seeking behavior is uncertain. IBS is a chronic disorder with at least 75% of patients having persistent symptoms five years or more after the diagnosis is first considered (2).

The understanding of the pathophysiology of IBS has evolved significantly over the past half century. Originally IBS was thought to represent a nervous disorder with augmented gastrointestinal motility occurring in patients under stress. Recent research has shown that IBS is a complex multifaceted disorder. Abnormalities in intestinal motility in conjunction with heightened visceral sensory input and processing are important aspects of the disease. In many patients with IBS, abdominal pain in the immediate postprandial period is associated with either rhythmic contractions or high amplitude prolonged contractions. These alterations in the migratory motor complex can either delay or accelerate intestinal transit (3). In addition, increased sensitivity to pain in the gastrointestinal tract has been demonstrated in patients with IBS. Several studies have suggested that patients with IBS may process sensory input from the gastrointestinal tract differently and have an exaggerated response to intestinal distention (4). Finally, two studies have demonstrated that infectious gastroenteritis may increase the possibility of developing IBS later in life (5,6), presumably by damaging the enteric nerves responsible for peristalsis.

IBS is defined by abdominal discomfort associated with altered bowel habits. As there are no biochemical or structural markers, IBS is diagnosed by the absence of organic disease and the presence of a constellation of symptoms. The Rome II diagnostic criteria divide IBS into three relatively equal groups depending on the presence of diarrhea, constipation, or alternating diarrhea and constipation. These criteria for IBS require at least twelve weeks duration of symptoms in one year that need not be consecutive. Symptoms defining IBS are abdominal pain or discomfort relieved with defecation or associated with a change in the frequency or appearance of the stool. Nine symptoms supporting the diagnosis of IBS include (a greater than 25% occurrence of): 1) Fewer than three bowel movements per week, 2) More than three bowel movements per day, 3) Hard or lumpy stools, 4) Loose (mushy) or watery stools. 5) Straining during bowel movement, 6) Urgency, 7) Passing mucous during bowel movement, 9) Abdominal fullness, bloating or swelling. IBS with diarrhea is associated with one or more of the supportive symptoms numbered 2,4 or 6 and none of 1, 3 or 5. IBS with constipation is associated with one or more of the supportive symptoms numbered1,3 or 5 and none of 2, 4 or 6 (7). An individual patient may change from one diagnostic group to the other during the treatment of this, so symptom based management is currently recommended.

Patients prone to diarrhea find that the first stool in the morning is usually normal in consistency. Subsequent bowel movements, however, become more watery and mucoid, and are associated with intestinal cramps, rectal urgency and bloating. Symptoms are relieved with the passage of stool but often quickly return. Patients prone to constipation also note mucous either in the stool or separately. The stool consistency is often hard, and/or rocky. Many patients strain to complete defecation or experience incomplete evacuation. Fecal incontinence occurs in up to 20% of patients with IBS, primarily in those with concomitant diarrhea. This is possibly due to repetitive reflex relaxation of the sphincter mechanism associated with colonic spasms.

The evaluation of patients who fall into one of the Rome II criteria is limited as long as no "alarm" symptoms or signs are noted. These "alarm" symptoms or signs include hematochezia, weight loss greater than ten pounds, family history of colon cancer, recurring fever, anemia, and severe chronic diarrhea. Routine colonoscopy for colon cancer screening is no different than the general population. Based on the best current data, the probability of colorectal cancer, inflammatory bowel disease and infectious diarrhea is less than 1% among IBS patients without "alarm" symptoms or signs (8). As this is similar to that of healthy patients undergoing screening, the routine use of endoscopy, radiologic tests, or microbiological evaluation is unnecessary. The only exception occurs in those patients with IBS and diarrhea. The incidence of celiac sprue in these patients is 5% and routine testing of these patients should certainly be considered (9).

Because the precise etiology of IBS is unknown, and there is a lack of objective biochemical markers, treatment of IBS has focused upon the relief of symptoms. Treatment of IBS is indicated when the symptoms of IBS significantly decrease the quality of life. It should result in improvement of global IBS symptoms such as abdominal pain, bloating and altered bowel habits.

For patients with IBS and constipation initial treatment involves increasing both the amount of daily fiber to 25-30gms and water intake to 64oz a day. For many patients with mild symptoms this may be all that is required. If dietary changes are insufficient, fiber supplements such as methylcellulose or psyllium are added. While these products act as hydrophilic agents to bind water and prevent excessive dehydration, they do not relieve abdominal pain and may accentuate bloating. Other laxatives such as polyethylene glycol solutions have been used with some success, but also do not address the abdominal discomfort. Tegaserod, a selective serotonin type 4 receptor agonist, binds to the enteric receptors initiating the peristaltic reflex. Four randomized controlled trials have compared tegaserod 6mg b.i.d. to placebo and found significant global symptom relief in women with IBS and constipation. The use of tegaserod in men or in patients with alternating diarrhea and constipation is not established (10).

For patients with IBS and diarrhea, loperamide has been studied in randomized control trials and found to decrease stool frequency, improve stool consistency, but have no effect on abdominal pain or bloating. Low doses of tricyclic antidepressants may also decrease the frequency of diarrhea. In those women who fail to respond to this conservative therapy and who have severe diarrhea predominant IBS, the serotonin type 3-receptor antagonist alosetron may be used. Five randomized controlled studies have demonstrated efficacy. Side effects include constipation (25%) and ischemic colitis (84 cases in the literature)(10).

Therapy for the abdominal discomfort associated with IBS has been disappointing until recently. Traditionally, antispasmodic agents have been prescribed. Dicyclomine and hyoscyamine are the two agents available in the United States. The only trial to demonstrate efficacy of either medication was associated with a 70% rate of anticholinergic side effects (10). Since these side effects include constipation, the two antispasmodic medications should be used cautiously in IBS patients with constipation. Antispasmodic medications should be taken 30-60 minutes prior to a meal to prevent postprandial abdominal pain and bloating. Currently, however, the most effective and preferred medication for abdominal pain and bloating is the previously mentioned serotonin type 4 receptor agonist, tegaserod.

Other therapies for IBS include behavioral modification and investigational drugs. Anxiety and depression are noted in up to 20% of IBS patients. Behavioral therapy for IBS has been evaluated in sixteen randomized controlled studies. While none of these examined global IBS improvement, most studies demonstrated that attenuation of individual IBS symptoms correlated with a reduction in anxiety and depression. In patients with sleep disorders, the administration of melatonin significantly diminished abdominal pain and rectal urgency (11). Other medications with visceral analgesic properties are being investigated to include the kappa opioid agonist fedotozine and neurokinin receptor antagonists. Probiotics are also being evaluated because of promising results controlling flatulence in a controlled trial.

Constipation

Constipation, a common disorder seen by both primary care and specialty physicians, is responsible for more than 2.5 million annual office visits. Many people do not seek medical care and instead self medicate with a multitude of over the counter and alternative medications. Constipation is a symptom of many diseases and the medications used to treat them. It is interchangeably used to describe patients with stool that is difficult to pass, passes infrequently, or has a hard consistency. Because of a lack of consensus defining constipation in the literature, the International Congress of Gastroenterology formulated the Rome II criteria. They defined constipation as abdominal discomfort of at least twelve weeks duration in the previous twelve months (need not be consecutive) having two or more of the following symptoms; 1) Straining more than 25% of the time, 2) Lumpy or hard stools more than 25% of the time, 3) Anorectal blockage, 4) Incomplete evacuation, 5) Need for manual maneuvers, and 6) Less than three stools per week. In these patients loose stools may not be present and there should not be sufficient criteria for the diagnosis of irritable bowel syndrome (12).

The physiology of constipation primarily encompasses the transit of stool through the colon, rectum and anus. Stool enters the colon as a liquid and becomes solid during passage to the rectosigmoid. Segmental and high amplitude propagating contractions are the two major contractile activities in the colon. The propagating contractions are responsible for the movement of stool to the anal sphincter, which regulates eventual stool evacuation. These propagating contractions originate from pacemakers found in the muscle layer of the colon called the interstial cells of Cajal (13). The loss or inactivity of these cells may play a role in patients with slow transit constipation.

Defecation is the evacuation of stool from the rectum and is determined by the propulsive force of the stool and the resistance of the anus. It is triggered by distention of the rectum by stool. Propulsive force consists of voluntary increases in intra-abdominal pressure and involuntary high amplitude contractions of the rectum. Resistance to defecation decreases with voluntary straightening of the anorectal angle in conjunction with relaxation of the external sphincter and involuntary relaxation of the internal anal sphincter.

The etiology of constipation may be primary or secondary. The more common secondary causes of constipation are listed in Table 1. Many patients have multiple factors that may contribute to their constipation. Notably, medications, including over-the-counter and herbal preparations, are a factor in up to 40% of patients (14).

The evaluation of constipated patients begins with a thorough history and physical exam to identify one of the numerous secondary causes of constipation. A colonoscopy or combined sigmoidoscopy and barium enema should be considered to identify malignant or anatomical abnormalities in the colon and rectum. A careful examination of the perineum and anus will help exclude anatomical outlet obstruction, the presence of a rectocele and abnormal perineal descent. Laboratory testing includes thyroid functions and electrolytes to help diagnose metabolic and endocrine abnormalities contributing to the constipation.

If the initial evaluation does not reveal a secondary cause for the constipation, a transit study is recommended to objectively measure the severity, and helps establish the primary cause of the constipation. The initial study called a SitzMark test is performed with radio-opaque markers that are swallowed. Abdominal radiographs are obtained on days 3 and 5. The radiograph on day 3 confirms the patient ingesting the markers. The presence of more than 25% of the markers in the colon at day 5 is indicative of a positive test. Markers evenly spread throughout the colon are consistent with slow transit constipation, while those that congregate in the rectosigmoid are indicative of an outlet obstruction. A negative SitzMark test with fewer than 25% of the markers on day 5 is suggestive of normal transit constipation or a patient who is not compliant with the instructions regarding no laxative use during the testing.

Further evaluation of outlet obstruction consists of anal manometry and defecography. Anal manometry permits documentation of the anorectal inhibitory reflex to rule out a short segment Hirschrprung’s disease. In addition, normal manometric sphincter pressures during simulated defecation are useful in excluding outlet obstruction. Defecography is particularly useful in the diagnosis of intra-anal prolapse, rectoceles, and other pelvic floor abnormalities. Barium paste is placed into the rectum and the act of defecation is visualized. Anorectal angle visualization, perineal descent and the nonemptying of rectoceles can be objectively measured.

There are three types of primary constipation that are important to recognize. The first type, colonic inertia, is associated with a lack of urgency and intractability resulting in many patients having several days to weeks between bowel movements. Daily use of stimulant laxatives is typical and evacuation is uncommon without medication. While the etiology is idiopathic in nature, the patients are overwhelmingly young women. Increasing dietary fiber or fiber supplements may make symptoms of bloating and abdominal cramps worse. SitzMark studies are often markedly positive demonstrating a characteristic pattern of markers relatively evenly spaced throughout the colon. It is important to rule out coexisting outlet obstruction with defecography and/or anal manometry. The second type, normal transit constipation, is characterized by evacuation frequency and stool consistency that is within the normal range, but the patients feel constipated. Bowel management regimens and reassurance are often all that is necessary to treat these patients. The third type, anismus or obstructed defecation, is characterized by the sensation of incomplete evacuation and the need to strain to produce a stool. SitzMark studies may be positive with most markers present in the rectosigmoid. Physical examination along with defecography and/or anal manometry is critical in determining both the exact etiology and response to therapy.

Treatment of functional constipation begins with dietary manipulation consisting of a high fiber diet (25-30gm/day) and augmented water intake (64oz/day). Most patients can be effectively managed with dietary measures alone or in conjunction with occasional laxative or enema use. For those patients who fail dietary measures, treatment with mild stimulating or osmotic laxatives can be safely done. Polyethylene glycol (PEG) is a poorly absorbed large polymer with substantial osmotic activity. When used in a solution that does not contain any salt, PEG can be ingested in large amounts without any harmful effect. PEG also binds water to the stool improving the consistency in many constipated patients. Other osmotic agents include non-absorbed carbohydrates such as lactulose. These agents also bind water and soften the stool. Complications include fermentation with consequent bloating, flatus and abdominal cramping.

Additional therapies for refractory constipation have attempted to address the lack of normal high amplitude contractions in the colon found in patients with slow transit constipation. The selective serotonin type 4 receptor agonist, tegaserod, is currently recommended for women with IBS and constipation. It acts by stimulating the serotonin type 4 receptors with a pronounced enterokinetic effect. Constipation was improved in 5-19% of women compared to placebo (15). Previous serotonin type 4 agonists such as cisipride and prucalopride also induced strong contractions of the proximal colon, but because of cardiac arrhythmias and carcinogenesis respectively, they have been withdrawn from the market. Another way to recreate the high amplitude contractions appears to be colonic pacing. In a small study pacing induced rectal evacuation in two-thirds of patients with total colonic inertia (16). Further studies will determine if it will become a replacement for extirpative surgical intervention.

Other medical approaches to stimulating the enteric neural plexuses include serotonin reuptake inhibitors, cholecystokinnin antagonists, antimuscarinic agents and serotonin type 1-receptor agonists. All these agents are currently being investigated and are not yet commercially available.

The surgical approach to constipation is one of last resort. Obstructive defecation is initially treated with biofeedback that improves symptoms in up to 70% of patients, although a rare patient may benefit from internal sphincterotomy. In patients with slow transit constipation refractory to medical therapy, attempt at segmental resection of the colon is unsuccessful. Total abdominal colectomy with ileorectal anastomosis is the preferred operation. Relief of abdominal pain and return to normal bowel function occur in up to 90% of patients with total abdominal colectomy. Risks of the surgery include ileus in approximately one-third of patients, small bowel obstruction, diarrhea, and possible incontinence (17).

Conclusion

Functional bowel diseases such as IBS and constipation are common disorders. The Rome II criteria permit more objective diagnosis and patient stratification. Therapy is determined by the major symptom or symptom complex. Therapy is often simply dietary modification, but may require medications, biofeedback and rarely surgery. As more knowledge about the enteric neural pathways and the influence of various neurotransmitters on bowel motility is discovered, focused treatment regimens with fewer side effects should be possible.

Table 1. Common Causes of Constipation

Dietary
Low fiber diet, inadequate fluid intake, ingestion of stool hardening foods.

Functional
Inadequate toilet facilities, depression, psychosis, ignoring need for bowel movement, immobility.

Endocrine, Metabolic
Diabetes mellitus, hypothyroidism, hypoparathyroidism, pregnancy, hypopituitarism, hypokalemia, hypercalcemia.

Neuropathy
Cerebrovascular accident, Parkinson’s disease, multiple sclerosis, trauma, cerebral or spinal tumors, colonic inertia, Ogilvie’s syndrome, Hirschprung’s disease, Chagas’ disease.

Medication
Analgesics, anticonvulsants, antihistamines, antihypertensives, diuretics, chemotherapeutics, anticholinergics, metal ions and minerals.

Structural
Neoplasm, diverticular disease, inflammatory bowel disease, volvulus, ischemic colitis, endometriosis, anastomotic stricture.

Anal Outlet
Thrombosed hemorrhoids, anal fissure, rectal prolapse, proctitis, rectocele, nonrelaxing puborectalis, hypertrophic internal anal sphincter.

Bibliography

1.Olden, KW. Diagnosis of irritable bowel syndrome. Gastroenterology. 2002;122:1701-14.
2.Harvey RF, Mauad EC, Brown AM. Prognosis in the irritable bowel syndrome: a five year prospective study. Lancet. 1987;1:963-5.
3.Kellow JE, Phillips SF, Miller IJ, et al. Dysmotility of the small intestine in irritable bowel syndrome. Gut. 1988;29:1236-43.
4.Mertz H, Morgan V, Tanner G, et al. Regional cerebral activation in irritable bowel syndrome and control subjects with painful and non-painful rectal distention. Gastroenterology. 200;118:842-8.
5.Gwee KA, Leong YL, Graham C, et al. Psychometric scores and the persistence of irritable bowel after infectious diarrhoea. Lancet. 1996;347:150-3.
6.Rodriguez LA, Ruigomez A. Increased risk of irritable bowel syndrome after bacterial gastroenteritis. BMJ. 1999;318:565-6.
7.Thompson WG, Longstreth GF, Drossman DA, et al. Functional bowel disorders and functional abdominal pain. Gut.1999;45(suppl II):1143-7.
8.American College of Gastroenterology Functional Gastrointestinal Disorders Task Force. Evidence-based position statement on the management of irritable bowel syndrome in North America. Am J Gastroenterol. 2002;97:11(suppl):S1-5.
9.Sanders DS, Carter MJ, Hurlstone DP, et al. Association of adult celiac disease with irritable bowel syndrome: a case control study in patients fulfilling ROME II criteria referred to secondary care. Lancet. 2001;358:1604-8.
10.Brandt LJ, Bjorkman D, Fennerty MB, et al. Systematic review on the management of irritable bowel syndrome in North America. Am J Gastroenterol. 2002;97:11(suppl):S7-26.
11.Bowser A. Melatonin relieves IBS symptoms in patients with sleep disorders. Gastroenterology & Endoscopy News. 2005;56:12.
12.Thompson WG, Longstreth GF, Drossman DA, Heaton KW, et al. Functional bowel disorders and functional abdominal pain. Gut. 1999;45(suppl 2):1143-7.
13.Ward SM. Interstial cells of Cajal in enteric neurotransmission. Gut. 2000;47(suppl 4):iv40-3.
14.Adeniji OA, DiPalma JA. Prevalence of medication-associated constipation. Am J Gastroenterol. 2001;96:SI40.
15.American Gastroenterological Association Clinical Practice Committee. AGA technical review on irritable bowel syndrome. Gastroenterology 2002;123:2108-31.
16.Shafik A, Shafik AA, El-Sibai O, Ahmed I. Colonic pacing; a therapeutic option for the treatment of constipation due to total colonic inertia.
17.Lubowski DZ, Chen FC, Kennedy ML, King DW. Results of colectomy for slow transit constipation. Dis Colon Rectum. 1999;39:23-9.

ADHESIOGENESIS MODELLING IN A CASE OF SURGICAL CAUSED HORMONAL INSUFFICIENCY

2011-10-14T05:01:00.001-04:00

Zasyadkina N.E., Vorobyov A.A., Dvoretskaya J.A. ADHESIOGENESIS MODELLING IN A CASE OF SURGICAL CAUSED HORMONAL INSUFFICIENCY // EUROPEAN JOURNAL OF NATURAL HISTORY. – 2010. – № 1 – С. 18-19
URL: www.rae.ru/euro/137-20904 (дата обращения: 14.10.2011).
№ 1 for 2010 year

Medical and Biological sciences

ADHESIOGENESIS MODELLING IN A CASE OF SURGICAL CAUSED HORMONAL INSUFFICIENCY

Zasyadkina N.E., Vorobyov A.A., Dvoretskaya J.A.

PDF (128 K)
стр. 18-19

Last years , the quantity of surgically treated gynaecological diseases, used to be progressively increased. The most frequent surgical intervention is the total or subtotal hysterectomy with or without adnexa ( in occasion of myoma and adenomyosis).

The percent of this operations is about 38% in Russia, 25% in Great Britain, 36% in USA, 35% in Sweden. The middle age of such a surgically treated women is about 40.5 years old. Its about 76.8% of hysterectomy with ovariectomy were realized to a women of 40-45 years old in Great Britain. In USA the quantity of hysterectomy is about 60000 per year, in 60% of cases accompanied with bilateral ovariectomy.

In fact, the problem of adhesiogenesis is especially actual in operative gynaecology, because in the most cases, gynaecological surgery may attend a high risk of peritoneal adhesions forming, expanding beyond the bounds of pelvis. The rate of morphogenesis pelvic and peritoneal adhesions after obstetrical and gynaecological surgery is about 60-100%. For example, 92.6% - after supravaginal amputation of uterus, 95% - after uterine extirpation.

Postoperative adhesions has a great negative influence on a patients health condition , causes an intestinal obstruction, chronic pelvic pain syndrome, different surgical complications as an injuring of viscera and etc.

Main aim: An assessment of adhesiogenesis level under condition of hormonal insufficiency in the dynamics of a postoperative injury in the experiment.

Materials and Methods

The new experimental method of Adhesiogenesis modelling in a case of hormonal insufficiency was designed to determine the level of adhesive process.This model is reproducible on different kind of experimental animals. It were 30 nubilous female rats (Wistar Line)used in experiment. Their middle age was about 3 month, the weight was near 200 -350 grams. The method was realized by comparison of results of simultaneously provided experiments(a standard operational injury, uterine amputation without ovaries, uterine amputation with ovaries )were assessed under the experiment.

The level of adhesiogenesis in absolute numbers (TVA -total volume of adhesions) was assessed by us on the grounds of received macromorphometric data ( length, diameter, thickness, area of adhesions) and devised formula. It is possible to determine and objectively compare the process of adhesiogenesis in different groups.

In accord of earliest classification, all adhesions that were founded were devided on chordal, filiform, arachnoidal, scarious or planar morphological types. Each adhesion was described with a special parameters : diameter and length of a chordal and filiform adhesions, thickness and the area of scarious and planar adhesions.

Taking into account of the chordal and filiform adhesions middle diameter is about 5 and 1.5mm and scarious adhesion thickness is near 1mm, it is enough to define its length( for chordal and filiform adhesions) or area ( for scarious adhesions ) to identify their volume.

The formula for calculating of the TVA (Total Volume of Adhesions) was:

Vadh = Slchord.p(dchord/2)2 + Slfilif.p(dfilif./2)2 + + Slarachn.p(darachn./2)2 + SSscar.hscar. + SSплоск.hplanar.,

V - volume, l - adhesive length, d - diameter of adhesive transversal section, S - area of adhesion, h - thickness of adhesion, p = 3,14.

Results

The data was processed by statistical calculation of arithmetical mean.

In the first group ( with a standard operational injury ) TVA was 0.45 cm3. In the second group (amputation of the uterus without ovaries) TVA was 0.73 cm3. In the third group (amputation of the uterus with ovaries ) TVA was 0,92 сm 3.

Resume

TVA depends of the operational injury, so the widening of operational injury volume in a condition of attendant postoperational hormonal insufficiency activates the elevation the TVA.

The data was obtained by experiment allows to suppose the possible importance of such a clinical researches, including the reasonability of substitutive hormonal treatment of the patients with surgical menopause.

References

Surgical anatomy of abdomen after operative intervension and laparoscopic surgery of adhesions. A.A. Vorobjov, A.G.Beburishvili Volgograd "Izdatel" 2001

Postoperational adhesions V.I.Kulakov , L.V.Adamyan, O.A.Minbaev Moscow 1998

Hysterectomy and the female health V.I.Kulakov , L.V.Adamyan, S.I.Ascolskaya Moscow "Medicina" 1999

Gynaecology. National guidance. Ed.st. V.I.Kulakov, I.B.Manukhin, G.M.Savelieva Moscow "Geotar-Media´ 2009

Prophylaxis of postoperational adhesions in abdominal cavity. Surgical and morphological aspects. S.V.Poroyskiy diss.сand. of medicine. Volgograd 2004.

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Bibliographic reference

Zasyadkina N.E., Vorobyov A.A., Dvoretskaya J.A. ADHESIOGENESIS MODELLING IN A CASE OF SURGICAL CAUSED HORMONAL INSUFFICIENCY // EUROPEAN JOURNAL OF NATURAL HISTORY. – 2010. – № 1 – С. 18-19

URL: www.world-science.ru/euro/137-20904 (дата обращения: 14.10.2011).

Adhesion Related Disorder International Human Rights Team IHRT: So you want to go to Germany and have surgery with Kruschinski based on false hopes offered by Karen Steward??

2011-10-13T05:42:00.000-04:00

Intestinal ischemia and infarction

2011-10-13T03:51:00.000-04:00

Intestinal ischemia and infarction http://www.nlm.nih.gov/medlineplus/ency/article/001151.htm

Intestinal ischemia and infarction is damage to (ischemia) or death of (infarction) part of the intestine due to a decrease in its blood supply.

Causes There are several possible causes of intestinal ischemia and infarction.

Hernia: If the intestine moves into the wrong place or becomes tangled, this can lead to intestinal ischemia.

Adhesions: The intestine may become trapped in scar tissue from past surgery (adhesions). This can lead to ischemia if left untreated.

Embolus: A blood clot from the heart or main blood vessels may travel through the bloodstream and block one of the arteries supplying the intestine. Patients with previous heart attacks or with arrhythmias, such as atrial fibrillation, are at risk for this problem.

Arterial thrombosis: The arteries that supply blood to the intestine may become so narrowed from atherosclerotic disease (cholesterol buildup) that they become blocked. When this happens in the arteries to the heart, it causes a heart attack. When it happens in the arteries to the intestine, it causes intestinal ischemia.

Venous thrombosis: The veins carrying blood away from the intestines may become blocked by blood clots. This blocks blood flow into the intestines. This is more common in people with liver disease, cancer, or blood clotting disorders.

Low blood pressure: Very low blood pressure in patients who already have narrowing of the intestinal arteries may also cause intestinal ischemia. This typically occurs in patients who are very ill for other reasons. It can be compared to losing water pressure in a hose with a partial blockage.

SymptomsThe hallmark of intestinal ischemia is abdominal pain. Other symptoms include:

•Diarrhea
•Fever
•Vomiting
Exams and TestsLaboratory tests may show a high white blood cell (WBC) count (a marker of infection) and increased acid in the bloodstream.

Other tests include:

•Angiogram
•CT scan of the abdomen
None of these tests are foolproof, however. Sometimes the only sure way to diagnose intestinal ischemia is with a surgical procedure.

TreatmentTreatment usually requires surgery. The section of intestine that has died is removed, and the healthy remaining ends of bowel reconnected.

In some cases, a colostomy or ileostomy is necessary. A blockage of arteries supplying the intestine is corrected if possible.

Outlook (Prognosis)Intestinal ischemia is a serious condition that can result in death if not treated promptly. The outlook depends on the cause. A good outcome may be achieved with prompt treatment.

Possible Complications Intestinal infarction may require a colostomy or ileostomy, either temporary or permanent. Peritonitis is common in such cases.

Severe illness with fever and bloodstream infection (sepsis) can result.

When to Contact a Medical ProfessionalCall your health care provider if you have any severe abdominal pain.

PreventionPreventive measures include:

•Control risk factors, such as heart arrhythmias, high blood pressure, and high cholesterol
•Do not smoke
•Eat a nutritious diet
•Quickly treat hernias
Alternative NamesIntestinal necrosis; Ischemic bowel; Dead bowel; Dead gut

ReferencesFry RD, Mahmoud N, Maron DJ, Ross HM, Rombeau J. Colon and rectum. In: Townsend CM Jr, Beauchamp RD, Evers MB, Mattox KL, eds. Sabiston Textbook of Surgery. 18th ed. Philadelphia, Pa: Saunders Elsevier; 2007:chap 50.

Hauser SC. Vascular diseases of the gastrointestinal tract. In: Goldman L, Ausiello D, eds. Cecil Medicine. 23rd ed. Philadelphia, Pa: Saunders Elsevier; 2007:chap 146.

Update Date: 1/20/2010Updated by: David C. Dugdale, III, MD, Professor of Medicine, Division of General Medicine, Department of Medicine, University of Washington School of Medicine; and George F. Longstreth, MD, Department of Gastroenterology, Kaiser Permanente Medical Care Program, San Diego, California. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.

http://www.nlm.nih.gov/medlineplus/ency/article/001151.htm