Adhesiolysis in Repeat Caesarean Delivery Common, Costly

Adhesiolysis in Repeat Caesarean Delivery Common, Costly
Alice Goodman

May 20, 2011 (Washington, DC) — Adhesions from previous Caesarean deliveries severe enough to require adhesiolysis during repeat Caesarean delivery have clinical and economic implications, according to a retrospective review of a large database with discharge data from 60 hospitals in the United States. The data were reported here at the American Congress of Obstetricians and Gynecologists 59th Annual Clinical Meeting.

The matched cohort study found that for patients who required adhesiolysis, the cost per patient was $300 more, operative length was longer, hospital stay was longer, and postoperative complications were more frequent.

"Adhesions are a significant complication of surgery. C-sections are increasingly common in the United States, and anywhere from 30% to 50% of patients have adhesions," explained Michael Broder, MD, from the University of California at Los Angeles School of Medicine. He estimated that treating complications of adhesions related to Caesarean deliveries that are severe enough for adhesiolysis costs $25 million to $30 million per year.
Read The Rest

SprayShield EU Post Market Study Terminated

Sorry everyone...

SprayShield EU Post Market Study

This study has been terminated.

http://clinicaltrials.gov/ct2/show/NCT01002287



First Received on October 26, 2009. Last Updated on May 4, 2010 History of Changes



Sponsor: Confluent Surgical



Information provided by: Confluent Surgical



ClinicalTrials.gov Identifier: NCT01002287



Purpose



This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.




Condition Intervention Phase



Ulcerative Colitis



Familial Polyposis



Device: SprayShield Adhesion Barrier System



Procedure: Good Surgical Technique Alone



Phase IV





Study Type: Interventional



Study Design: Allocation: Randomized



Intervention Model: Parallel Assignment



Masking: Single Blind (Subject)



Primary Purpose: Prevention



Official Title: An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery




Resource links provided by NLM:





Genetics Home Reference related topics: Crohn disease familial adenomatous polyposis Help Me Understand Genetics



MedlinePlus related topics: Adhesions Ulcerative Colitis



U.S. FDA Resources




Further study details as provided by Confluent Surgical:




Primary Outcome Measures:



•To evaluate the incidence of adhesions, defined as the proportion of subjects presenting at the follow-up surgery (10-12 weeks) with one or more adhesions to the midline incision, regardless of extent and/or severity. [ Time Frame: 10-12 Weeks post Initial Surgery for J-Pouch ] [ Designated as safety issue: No ]





Estimated Enrollment: 30



Study Start Date: October 2009



Estimated Study Completion Date: May 2011



Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)



Arms Assigned Interventions



SprayShield Adhesion Barrier: Experimental



SprayShield Adhesion Barrier + Good Surgical Technique



Intervention: Device: SprayShield Adhesion Barrier System Device: SprayShield Adhesion Barrier System



Adhesion Barrier Device Plus Good Surgical Technique



Control: No Intervention



Good Surgical Technique Alone



Intervention: Procedure: Good Surgical Technique Alone Procedure: Good Surgical Technique Alone



Good Surgical Technique Alone



Eligibility

Ages Eligible for Study: 18 Years and older



Genders Eligible for Study: Both



Accepts Healthy Volunteers: No




Criteria



Inclusion Criteria:




•Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible



Contacts and Locations




Please refer to this study by its ClinicalTrials.gov identifier: NCT01002287




Locations



United States, Massachusetts



Confluent Surgical



Waltham, Massachusetts, United States, 02451



Sponsors and Collaborators



Confluent Surgical



More Information




No publications provided




Responsible Party: Confluent Surgical ( Jennifer Doyle/Director, Clinical Affairs )



ClinicalTrials.gov Identifier: NCT01002287 History of Changes



Other Study ID Numbers: ABD-08-001



Study First Received: October 26, 2009



Last Updated: May 4, 2010



Health Authority: Czech Republic: Ethics Committee; Poland: Ministry of Health







Additional relevant MeSH terms:



Colitis



Colitis, Ulcerative



Adenomatous Polyposis Coli



Ulcer



Gastroenteritis



Gastrointestinal Diseases



Digestive System Diseases



Colonic Diseases



Intestinal Diseases



Inflammatory Bowel Diseases



Adenomatous Polyps



Adenoma



Neoplasms, Glandular and Epithelial



Neoplasms by Histologic Type



Neoplasms



Colorectal Neoplasms



Intestinal Neoplasms



Gastrointestinal Neoplasms



Digestive System Neoplasms



Neoplasms by Site



Colonic Neoplasms



Neoplastic Syndromes, Hereditary



Intestinal Polyposis



Genetic Diseases, Inborn



Pathologic Processes




ClinicalTrials.gov processed this record on May 12, 2011

Pity

Intraperitoneal adhesions-an ongoing challenge between biomedical engineering and the life sciences.

J Biomed Mater Res A. 2011 May 4. doi: 10.1002/jbm.a.33083. [Epub ahead of print]


Intraperitoneal adhesions-an ongoing challenge between biomedical engineering and the life sciences.

Brochhausen C, Schmitt VH, Rajab TK, Planck CN, Krämer B, Wallwiener M, Hierlemann H, Kirkpatrick CJ.

SourceREPAIR-Lab, Institute of Pathology, University Medical Centre of the Johannes Gutenberg-University, Mainz, Germany. brochhausen@pathologie.klinik.uni-mainz.de.



Abstract

Peritoneal adhesions remain a relevant clinical problem despite the currently available prophylactic barrier materials. So far, the physical separation of traumatized serosa areas using barriers represents the most important clinical strategy for adhesion prevention. However, the optimal material has not yet been found. Further optimization or pharmacological functionalization of these barriers could give an innovative input for peritoneal adhesion prevention. Therefore, a more complete understanding of pathogenesis is required. On the basis of the pathophysiology of adhesion formation the main barriers currently in clinical practice as well as new innovations are discussed in the present review. Physiologically, mesothelial cells play a decisive role in providing a frictionless gliding surface on the serosa. Adhesion formation results from a cascade of events and is regulated by a variety of cellular and humoral factors. The main clinically applied strategy for adhesion prevention is based on the use of liquid or solid adhesion barriers to separate physically any denuded tissue. Both animal and human trials have not yet been able to identify the optimal barrier to prevent adhesion formation in a sustainable way. Therefore, further developments are required for effective prevention of postoperative adhesion formation. To reach this goal the combination of structural modification and pharmacological functionalization of barrier materials should be addressed. Achieving this aim requires the interaction between basic research, materials science and clinical expertise. © 2011 Wiley Periodicals, Inc. J Biomed Mater Res Part A: , 2011.


http://www.ncbi.nlm.nih.gov/pubmed/21548063

ENDURING Endometriosis

Painful disorder may increase risk of infertility

EILEEN CIPRIANI Times Leader Correspondent


It is among the top three causes of infertility and pelvic pain in women. There is a research center and a foundation in the United States, as well as an international society and yellow ribbon devoted to the disorder. According to the U.S. Department of Health and Human Services more than 5 million women in America alone have been diagnosed. Oscar Award-winning actress Susan Sarandon and “Top Chef” host Padma Lakshmi are among them. In March at the 3rd annual Blossom Ball fundraiser for research in New York, Sarandon and Lakshmi shared their first-hand experiences with the malady -- endometriosis.

Endometriosis is when endometrial cells that normally line the interior of the uterus relocate in other areas of the body. The cells usually become displaced in the pelvic area, but in extremely rare cases they can be found in other parts of the body, says Dr. Jennifer Sue Gell of Geisinger Health System’s Women’s Health Center. Gell is obstetrics-gynecology certified with a practicing specialty in reproductive endocrinology and fertility.



In endometriosis the displaced tissues acts as it normally would during the menstrual cycle. It thickens and bleeds, but because it is unable to exit the body it irritates surrounding tissue causing pain and eventually develops scar tissue and adhesions.

Click link to read the rest
http://www.timesleader.com/features/ENDURING_Endometriosis_05-02-2011.html

Marilyn Monroe suffered with Adhesions!

Marilyn's Autopsy


Coroner Thomas Noguchi conducted the operation. He was assisted by Eddy Day. Noguchi's findings were as follows.



External examination: The unembalmed body is that of a 36-year-old well-developed, well-nourished Caucasian female weighing 117 pounds and measuring 65-1/2 inches in length. The scalp is covered with bleached blond hair. The eyes are blue. The fixed lividitv is noted in the face, neck, chest, upper portions of arms and the right side of the abdomen. The faint lividity which disappears upon pressure is noted in the back and posterior aspect of the arms and legs. A slight ecchymotic area is noted in the left hip and left side of lower back. The breast shows no significant lesion. There is a horizontal 3-inch long surgical scar in the right upper quadrant of the abdomen. A suprapubic surgical scar measuring 5 inches in length is noted. The conjunctivae are markedly congested; however, no ecehymosis or petechiae are noted. The nose shows no evidence of fracture. The external auditory canals are not remarkable:. No evidence of trauma is noted in the scalp, forehead, cheeks, lips or chin. The neck shows no evidence of trauma. Examination of the hands and nails shows no defects. The lower extremities show no evidence of trauma.



Body cavity: The usual Y-shaped incision is made to open the thoracic and abdominal cavities. The pleural and abdominal cavities contain no excess of fluid or blood. The mediastinum shows no shifting or widening. The diaphragm is within normal limits. The lower edge of the liver is within the costal margin. The organs are in normal position and relationship.



Cardiovascular system: The heart weighs 300 grams. The pericardial cavity contains no excess of fluid. The epicardium and pericardium are smooth and glistening. The left ventricular wall measures 1.1 cm. and the right 0.2 cm. The papillary muscles are not hypertrophic. The chordae tendineac are not thickened or shortened. The valves have the usual number of leaflets which are thin and pliable. The tricuspid valve measures 10 cm., the pulmonary valve 6.5 cm., mitral valve 9.5 cm. and aortic valve 7 cm in circumference. There is no septal defect. The foramen ovale is closed. The coronary arteries arise from their usual location and are distributed in normal fashion. Multiple sections of the anterior descending branch of the left coronary artery with a 5 mm. interial demonstrate a patent lumen throughout. The circumflex branch and the right coronary artery also demonstrate a patent lumen. The pulmonary artery contains no thrombus. The aorta has a bright yellow smooth intima.



Respiratory system: The right lung weighs 465 grams and the left 420 grams. Both lungs are moderately congested with some edema. The surface is dark and red with mottling. The posterior portion of the lungs show severe congestion. The tracheobronchial tree contains no aspirated material or blood. Multiple sections of the lungs show congestion and edematous fluid exuding from the cut surface. No consolidation or suppuration is noted. The mucosa of the larynx is grayish white.



Liver and biliary system: The liver weighs 1890 grams. The surface is dark brown and smooth. There are marked adhesions through the omentum and abdominal wall in the lower portion of the liver as the gallbladder has been removed. The common duct is widely patent. No calculus or obstructive material is found. Multiple sections of the liver show slight accentuation of the lobular pattern; however, no hemorrhage or tumor is found.



Hemic and lymphatic system: The spleen weighs 190 grams. The surface is dark red and smooth. Section shows dark red homogeneous firm cut surface. The Malpighian bodies are not clearly identified. There is no evidence of lymphadenopathy. The bone marrow is dark red in color. Endocrine system: The adrenal glands have the usual architectural cortex and medulla. The thyroid glands are of normal size, color and consistency. Urinary system: The kidneys together weigh 350 grams. Their capsules can be stripped without difficulty. Dissection shows a moderately congested parenchyma. The cortical surface is smooth. The pelves and ureters are not dilated or stenosed. The urinary bladder contains approximately 150 cc. of clear straw-colored fluid. The mucosa is not altered.



Genital system: The external genitalia shows no gross abnormality. Distribution of the pubic hair is of female pattern. The uterus is of the usual size. Multiple sections of the uterus show the usual thickness of the uterine wall without tumor nodules. The endometrium is grayish yellow, measuring up to 0.2 cm in thickness. No polyp or tumor is found. The cervix is clear, showing no nabothian cysts. The tubes are intact. The right ovary demonstrates recent corpus luteum haemorrhagicum. The left ovary shows corpora lutea and albicantia. A vaginal smear is taken. Digestive system: The esophagus has a longitudinal folding mucosa. The stomach is almost completely empty. The contents is brownish mucoid fluid. The volume is estimated to be no more than 20 cc. No residue of the pills is noted. A smear made from the gastric contents and examined under the polarized microscope shows no refractile crystals. The mucosa shows marked congestion and submucosal petechial hemorrhage diffusely. The duodenum shows no ulcer. The contents of the duodenum is also examined under polarized microscope and shows no refractile crystals. The remainder of the small intestine shows no gross abnormality. The appendix is absent. The colon shows marked congestion and purplish discoloration. The pancreas has a tan lobular architecture. Multiple sections shows a patent duct.



Skeletomuscular system: The clavicle, ribs, vertebrae and pelvic bones show fracture lines. All bones of the extremities are examined by palpation showing no evidence of fracture.



Head and central nervous system: The brain weighs 1440 grams. Upon reflection of the scalp there is no evidence of contusion or hemorrhage. The temporal muscles are intact. Upon removal of the dura mater the cerebrospinal fluid is clear. The superficial vessels are slightly congested. The convolutions of the brain are not flattened. the contour of the brain is not distorted. No blood is found in the epidural, subdural or subarachnoid spaces. Multiple sections of the brain show the usual symmetrical ventricles and basal ganglia. Examination of the cerebellum and brain stem shows no gross abnormality. Following removal of the dura mater from the base of the skull and calvarium no skull fracture is demonstrated.



Liver temperature taken at 10:30 A.M. registered 89 F



Specimen: Unembalmed blood is taken for alcohol and barbiturate examination. Liver, kidney, stomach and contents, urine and intestine are saved for further toxicological study. A vaginal smear is made.



T NOGUCHI, M.D. DEPUTY MEDICAL EXAMINER 8-13-62
http://marilynmonroepages.com/autopsy.html

A reliable way to predict intraabdominal adhesions at repeat cesarean delivery: scar characteristics

NASUH U. DOGAN1, SEVAL A. HAKTANKACMAZ1, SELEN DOGAN2, OZLENEN OZKAN3, HATICE CELIK1, OZLEM G. ERYILMAZ1, MELIKE DOGANAY1, CAVIDAN GULERMAN1Article first published online: 16 MAR 2011Keywords: Intraabdominal adhesion; repeat cesarean delivery; hypertrophic scar



DOI: 10.1111/j.1600-0412.2011.01080.x
© 2011 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2011 Nordic Federation of Societies of Obstetrics and Gynecology





Abstract


Objective. To evaluate association between scar characteristics and intraabdominal adhesions at repeat cesarean delivery. Design. A prospective, cross-sectional study. Setting. Tertiary Government Maternity Training Hospital in Ankara, Turkey. Population. 295 pregnant women with at least one prior cesarean delivery. Methods. All women were at least 36 weeks pregnant. Appearance of previous cesarean delivery scars was categorized into three groups – flat, depressed and elevated. Pigmentation status was also noted (non-pigmented or pigmented). Main Outcome Measures. Intraoperatively detected adhesions, evaluated and classified into three groups (no adhesion, filmy adhesion and dense adhesion groups) by a modified Nair's classification. Results. Elevated scars had significantly more dense adhesion formation than depressed ones (31.4 vs. 12.7%, p=0.02). No difference was found for dense adhesions when depressed and flat scars were compared (12.7 vs. 6.8%, p=0.124). Of flat scars, 93.2% were free of dense adhesions. Pigmented scars had more dense adhesions than non-pigmented (26.6 vs. 9.3%, p<0.01). Using logistic regression analysis scar length, scar width and appearance of scar (flat or non-flat) were directly related to adhesion formation. Conclusion. There is an association between scar type and adhesions, particularly for hypertrophic scars and dense adhesions.

FDA Acts to Reduce Harm from Opioid Drugs

FDA Acts to Reduce Harm from Opioid Drugs


On This Page:

•FDA Opioid Strategy

•Widespread Problem

The White House on Tuesday unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the U.S.—including an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.



Gil Kerlikowske, director of the White House Office of National Drug Control Policy, says the plan—a collaborative effort involving agencies of the departments of Justice, Health and Human Services, Veterans Affairs, Defense, and others—provides a national framework for reducing prescription drug abuse and the diversion of prescription drugs for recreational use.



“The toll our nation’s prescription drug abuse epidemic has taken in communities nationwide is devastating,” says Kerlikowske. “We share a responsibility to protect our communities from the damage done by prescription drug abuse.”



Key elements of the plan—called Epidemic: Responding to America’s Prescription Drug Abuse Crisis—include:



•expansion of state-based prescription drug monitoring programs

•recommending convenient and environmentally responsible ways to remove unused medications from homes

•supporting education for patients and health care providers

•reducing the number of “pill mills” and doctor-shopping through law enforcement

back to top



FDA Opioid Strategy

In concert with the White House plan, the Food and Drug Administration (FDA) is announcing a new risk reduction program—called a Risk Evaluation and Mitigation Strategy—for all extended-release and long-acting opioid medications.



Opioids are synthetic versions of opium that are used to treat moderate and severe pain.



FDA experts say extended-release and long-acting opioids—including OxyContin, Avinza, Dolophine, Duragesic, and eight other brand names—are extensively misprescribed, misused, and abused, leading to overdoses, addiction, and even deaths across the United States. FDA says a 2007 survey revealed that more than half of opioid abusers got the drug from a friend or relative.



Opioids—such as morphine and oxycodone—are used to treat moderate and severe pain. Over the past few decades, drug makers have developed extended-release opioid formulas to treat people in pain over a long period.



The new REMS plan focuses primarily on: educating doctors about proper pain management, patient selection, and other requirements and improving patient awareness about how to use these drugs safely. As part of the plan, FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.



FDA wants drug makers to work together to develop a single system for implementing the REMS strategies. Toward that goal, FDA is now notifying opioid makers that they must propose a REMS plan within 120 days.



Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, says this risk management strategy is designed to improve pain management, while preserving patient access to these needed medications.



“This will be an important step toward addressing what has become a critical public health problem,” she says.



Doctor training, patient counseling, and other risk reduction measures developed by opioid makers as part of the REMS are expected to become effective by early 2012. They will be required for various brand name products known under the generic names:



•hydromorphone

•oxycodone

•morphine

•oxymorphone

•methadone

•transdermal fentanyl

•transdermal buprenorphine

back to top



Widespread Problem

FDA estimates that more than 33 million Americans age 12 and older misused extended-release and long-acting opioids during 2007—up from 29 million just five years earlier. And in 2006, nearly 50,000 emergency room visits were related to opioids.



"Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients, but we know that they pose serious risks when used improperly—with serious negative consequences for individuals, families, and communities," says FDA Commissioner Margaret A. Hamburg, M.D. “The prescriber education component of this Opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks."



Although doctor training is not mandatory under the REMS plan, other federal agencies are working to get Congress to link mandatory physician training to the already required Drug Enforcement Administration registration number that doctors must have to prescribe controlled substances.



FDA will also require the risk management plan to include a way to determine if the education programs are helping to reduce problems associated with long-acting and extended-release opioids, as well as allowing patients who need opioids to get them.



FDA has had the power to request companies to develop REMS since 2007. The plans may also include medication guides and patient package inserts.



This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.



April 19, 2011
http://www.drugs.com/fda-consumer/fda-acts-to-reduce-harm-from-opioid-drugs-178.html

What is adhesions related disorder (ARD)?

What is adhesions related disorder (ARD)?


Adhesion related disorder is a complex 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 to the gynecologic orders in women as this disorder frequently affects women.



Changes in the menstrual cycle, infertility, and pain with sexual intercourse can be encountered.



Other symptoms, not directly related to the adhesions, can also be encountered.



Since ARD generally results in chronic problems, anxiety and depression can result.



Strained relationships can occur especially when the disorder affects sexual function.



Difficulty with conception can result.



This further adds to the anxiety and problems with self esteem experienced by women who suffer with this disorder.



Difficulty eating can result in poor nutrition, weakening suffers overall medical condition and can also lead to a decrease in immune function leading to many other illnesses.



Since many of the symptoms related to ARD are vague and wide spread and often include emotional factors, they are often difficult to diagnose.



Symptoms of ARD will often be attributed to other abnormalities.



Patient will often carry multiple diagnoses including chronic fatigue syndrome, endometriosis, irritable bowel syndrome, fibromyalgia, depression, anxiety, along with a whole host of other possible syndromes.



While multiple disorders can certainly exist in one patient, the confusion over which abnormality is truly causing the symptoms adds to the frustration of ARD. This, unfortunately, adds to the discomfort experienced by those who suffer with adhesions.



Undiagnosed chronic pain causes so much physical and emotional pain for victims of adhesion related disorder – and fills their lives with so much indecision.



In time the effects of ARD will begin to affect the lives of their families, their relationships and their jobs. This inordinate control by ARD has the power to erode and change our lives – and not necessarily for the better!