Pathogenesis:
• Normal luminal flow of intestinal contents is interrupted
• Bowel proximal to obstruction dilates as intestinal secretions are prevented from
passing distally
• Nausea and emesis
• Swallowed air and gas from bacterial fermentation accumulates, adding to dilatation
• Bacterial overgrowth occurs in the proximal SB
• Emesis can become feculent due to bacterial overgrowth
• Bowel wall becomes edematous and intestine's normal absorptive function is lost -
more fluid is sequestered in bowel lumen
• Secretion of fluid into lumen of proximal dilated bowel increases. - transudative loss
of fluid into peritoneal cavity
• Tachycardia, oliguria, azotemia, and hypotension can result from progressive
dehydration
• Strangulation complicates approximately 10% of bowel obstructions, and occurs
when bowel wall edema and increasing intraluminal pressure compromise perfusion
to a segment of intestine
• Necrosis with concomitant fever and leukocytosis, which will eventually lead to
perforation unless the process is interrupted
Causes:
• Postop or primary
• Extrinsic: Post-operative adhesions (75%), hernias, volvulus
• Intrinsic: Tumors, inflammatory stricture (Crohn’s), radiation enteritis
• Normal lumen: Intussusception, gallstones, feces, bezoar, traumatic intramural
hematoma
Symptoms:
• Obstipation, nausea, vomiting, abdominal pain, and bloating
• No reliable sign or symptom differentiating patients with strangulation or impending
strangulation from those in whom surgery will not be necessary
Incidence:
• >300,000 hospitalizations for adhesiolysis, resulting in >800,000 days of inpatient
care and $1.3 billion in expenditures
• Postoperative adhesions/SBO occur in 5-15% of patients
Types:
• Complete
• Partial
Physical examination:
• Fever and tachycardia - associated with strangulation
• Hypotension, oliguria, and dry mucous membranes indicate dehydration
• Inspect the abdomen for surgical scars and the degree of distention
• Auscultate - high-pitched or hypoactive bowel sounds
Wednesday, May 28, 2008
Adhesion Headlines ARDvark Blog
Health Care Coalition Pushes For E-Prescribing Legislation, Citing Existing Standards For ImplementationThe technical standards necessary to establish a national electronic prescribing system already have been adopted by physicians and pharmacy software companies, according to a letter to lawmakers from a coalition of health...[read article]
Op-Eds Address Presidential Candidates' Health Care Proposals
Antibiotics Accompanying Surgery Prevent Some Infections But Increasingly Cause Another
Abbott Presents Long-term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA® (adalimumab) Maintained Remission
AMITIZA(R) (lubiprostone) 8 Mcg Now Available To Treat Irritable Bowel Syndrome With Constipation In Adult Women
Senate Passes War Funding Package, Including Provisions On Medicaid, Birth Control Discounts
Ovarian Cancer Vaccine Clinical Trial Begins At Cancer Treatment Centers Of America
Fibroids Common, But Women Have Options
Kroger Matches Discounts Of Other Retailers On Prescription Women's Health Medications
C-Sections A Critical Factor In Preterm Birth Increase
Is Fertility Affected By Chemicals In The Environment?
Fertility Warning To Female Veterinarians
NovaBay (NBY) Announces Positive Results From Phase IIA Study Of AgaNase(TM) For Nasal Decolonization Of Staph Including MRSA
Risks For Painkiller Abuse Do Not Outweigh Benefits In Chronic Pain
Structure Of Receptor For Hot Chili Pepper And Pain Revealed
Untreated Depressed People Have Fewer Serotonin & Opioid Receptors, And Variation Is Linked To Symptoms And Treatment Response
New Study Suggests Tapentadol IR For Acute Pain Is Associated With Improved Gastrointestinal Tolerability Compared To Oxycodone IR
Infections/Inflammation Of The Genitourinary Tract: Interstitial Cystitis
The Effect Of Urologic Disorders And Treatments On Fertility
Op-Eds Address Presidential Candidates' Health Care Proposals
Antibiotics Accompanying Surgery Prevent Some Infections But Increasingly Cause Another
Abbott Presents Long-term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA® (adalimumab) Maintained Remission
AMITIZA(R) (lubiprostone) 8 Mcg Now Available To Treat Irritable Bowel Syndrome With Constipation In Adult Women
Senate Passes War Funding Package, Including Provisions On Medicaid, Birth Control Discounts
Ovarian Cancer Vaccine Clinical Trial Begins At Cancer Treatment Centers Of America
Fibroids Common, But Women Have Options
Kroger Matches Discounts Of Other Retailers On Prescription Women's Health Medications
C-Sections A Critical Factor In Preterm Birth Increase
Is Fertility Affected By Chemicals In The Environment?
Fertility Warning To Female Veterinarians
NovaBay (NBY) Announces Positive Results From Phase IIA Study Of AgaNase(TM) For Nasal Decolonization Of Staph Including MRSA
Risks For Painkiller Abuse Do Not Outweigh Benefits In Chronic Pain
Structure Of Receptor For Hot Chili Pepper And Pain Revealed
Untreated Depressed People Have Fewer Serotonin & Opioid Receptors, And Variation Is Linked To Symptoms And Treatment Response
New Study Suggests Tapentadol IR For Acute Pain Is Associated With Improved Gastrointestinal Tolerability Compared To Oxycodone IR
Infections/Inflammation Of The Genitourinary Tract: Interstitial Cystitis
The Effect Of Urologic Disorders And Treatments On Fertility
FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
TIRAT CARMEL, Israel, May 28 /PRNewswire/ --
- Study Will Compare Birth Rates of Women who Underwent Non-Invasive MRgFUS to Those who had Invasive Fibroid Surgery
InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) cleared the company to conduct a clinical trial to evaluate the efficacy and safety of the ExAblate(R) 2000 system utilizing MR-guided Focused Ultrasound Surgery (MRgFUS) for the enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility.
Twenty U.S. and international sites will enroll a total of 650 women with uterine fibroids who are diagnosed with unexplained infertility. Half the women will undergo treatment with the ExAblate system, while the other half will have their fibroids surgically removed.
The study will measure the safety of each procedure, including pregnancy and delivery-related complications. The main efficacy goal of the trial will be to measure which procedure leads to a higher percentage of healthy live births resulting from pregnancies three to 15 months after treatment. Researchers will also examine the cost of treatment and any additional clinically required medical encounters and/or medications outside the study visits.
Read More
- Study Will Compare Birth Rates of Women who Underwent Non-Invasive MRgFUS to Those who had Invasive Fibroid Surgery
InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) cleared the company to conduct a clinical trial to evaluate the efficacy and safety of the ExAblate(R) 2000 system utilizing MR-guided Focused Ultrasound Surgery (MRgFUS) for the enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility.
Twenty U.S. and international sites will enroll a total of 650 women with uterine fibroids who are diagnosed with unexplained infertility. Half the women will undergo treatment with the ExAblate system, while the other half will have their fibroids surgically removed.
The study will measure the safety of each procedure, including pregnancy and delivery-related complications. The main efficacy goal of the trial will be to measure which procedure leads to a higher percentage of healthy live births resulting from pregnancies three to 15 months after treatment. Researchers will also examine the cost of treatment and any additional clinically required medical encounters and/or medications outside the study visits.
Read More
Monday, May 26, 2008
Memorial Day 2008
We would like to pay tribute to those who went before us.
We remember these women, who died from complications related to their Adhesions Related Disorder, may they also represent the many who die without ever knowing what caused their deaths:
We remember these women, who died from complications related to their Adhesions Related Disorder, may they also represent the many who die without ever knowing what caused their deaths:
Ms Carol J Howland
Rochelle “Shellie” S. Sabowski
died July 13, 2003
(10 years of suffering with ARD) age 38
Friday, May 23, 2008
FDA Approves Entereg to Help Restore Bowel Function Following Surgery
FDA News
FOR IMMEDIATE RELEASEMay 20, 2008
Media Inquiries: Rita Chappelle, 301-827-6242Consumer Inquiries: 888-INFO-FDA
FDA Approves Entereg to Help Restore Bowel Function Following Surgery
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.
"Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste," said Joyce Korvick, M.D., deputy director, Division of Gastroenterology Products. "Entereg will help accelerate their recovery, improve bowel function, and get these patients back on a normal diet. As with all FDA-approved products, the agency will monitor Entereg throughout its life cycle."
FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.
In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.
Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.
The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.
The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo. Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies. The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia (heartburn) and flatulence (excess bowel gas).
FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients. This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days. A causal relationship with Entereg and myocardial infarction has not been established.
Consumers and health care professionals are encouraged to report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.
Adolor Corporation, the manufacturer of Entereg
FOR IMMEDIATE RELEASEMay 20, 2008
Media Inquiries: Rita Chappelle, 301-827-6242Consumer Inquiries: 888-INFO-FDA
FDA Approves Entereg to Help Restore Bowel Function Following Surgery
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.
"Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste," said Joyce Korvick, M.D., deputy director, Division of Gastroenterology Products. "Entereg will help accelerate their recovery, improve bowel function, and get these patients back on a normal diet. As with all FDA-approved products, the agency will monitor Entereg throughout its life cycle."
FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.
In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.
Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.
The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.
The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo. Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies. The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia (heartburn) and flatulence (excess bowel gas).
FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients. This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days. A causal relationship with Entereg and myocardial infarction has not been established.
Consumers and health care professionals are encouraged to report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.
Adolor Corporation, the manufacturer of Entereg
Thursday, May 22, 2008
Is The Future Of Surgery Painless And Scarless?
Main Category: GastroIntestinal / GastroenterologyArticle Date: 21 May 2008 - 1:00 PDT
A sophisticated new surgical technology holds promise for future painless and scarless surgery with shorter recovery times than laparoscopic surgery. New research supporting the safety and efficacy of natural orifice translumenal endoscopic surgery (NOTESTM) and detailing the outcomes associated with new tools and robotic applications will be presented at Digestive Disease Week® 2008 (DDW®).
DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. "The research developments presented today are continuing to demonstrate the great potential of this exciting new surgical procedure," said Pankaj J. Pasricha, MD, FASGE, professor of medicine, gastroenterology and hepatology, Stanford University School of Medicine. "Surgical advances like NOTES may lead the way toward the adoption of even more minimally invasive techniques than laparoscopy and allow patients to return to their home, family and work more quickly."
NOTES is performed by passing an endoscope through a natural orifice then through an internal incision in the stomach, vagina, bladder or colon, thus avoiding any external incisions or scars.
A Prospective Randomized Controlled Trial of NOTES versus Laparoscopic Distal Pancreatectomy, Preliminary Results (Abstract #881) Investigators have conducted the largest and most rigorously controlled study of natural orifice surgery to date. The study showed that while NOTESTM is more time-consuming than traditional (laparoscopic) surgery, it is equally successful. The study also demonstrated that complex surgery with a high rate of complications could be performed via the mouth using a flexible endoscope. "NOTES is an area of promise in active development," said Field Willingham, MD, MPH, senior fellow in the gastrointestinal unit at Massachusetts General Hospital. "The opportunities with NOTES are significant and should some day provide patients with a viable scarless and painless option for certain medical procedures." Previous NOTES research has involved small sample sizes and no control groups. This prospective, randomized controlled trial compared the efficacy of endoscopic transgastric distal pancreatectomy (ETDP) to laproscopic distal pancreatectomy (LDP). Investigators randomized twenty-eight 45kg swine to EDTP or LDP and then compared the results based on an extensive post-operative analysis. The procedure time for EDTP was significantly greater versus LDP (1:52 versus 0:32 hour), but investigators found no clinical or survival difference between the NOTES and laparoscopic approaches. Dr. Willingham noted that the tools used to dissect or retract during NOTES procedures may pose some limitations. "It can be challenging to perform complex procedures such as holding traction while simultaneously dissecting tissue through a single NOTES endoscope." However, this study does demonstrate the non-inferiority of NOTES in solid organ resection compared to standard laparoscopic surgery.
Successful Diagnostic and Therapeutic Intrauterine Fetal Interventions by NOTES (Abstract #871) Investigators using NOTESTM have found for the first time that it can look at the entire uterus and reach areas that had not previously been accessible. The findings are important because the morbidity and mortality of fetal surgery is substantial. If the fetus requires lifesaving surgery, the only way to operate previously was through traditional laparoscopy or laparotomy. But this method is limiting because the uterus and the fetus can only be accessed from the front; unless a doctor is aiming to intervene right beneath the abdominal wall, it would be difficult to access the desired organ. However, using flexible endoscopy, doctors can reach almost any part of the uterus, regardless of the direction the fetus is facing. Furthermore, the procedure could be particularly helpful since it provides a minimally invasive approach to performing fetal surgery. Researchers performed transgastric peritonoscopy on one ewe and transvaginal peritonoscopy on another following standard needle-knife entry into the abdominal cavity. Access to the uterus was assessed with both a forward-viewing endoscope and a linear-array echoendoscope. Visibility of the fetal areas via endoscopic ultrasound (EUS) was directly compared to transabdominal ultrasound. EUS-guided, transuterine injection of saline into the fetal cardiac ventricle was attempted in both sheep using a 22-gauge fine needle aspiration needle. Investigators found that access to and complete visualization of the uterus were successful with both endoscopes using an anterior, posterior and lateral approach once inside the abdominal cavity. Also, visualization of the fetal parts by EUS was impressive and superior to transabdominal ultrasound. "Our findings suggest that NOTES may provide an avenue through which one can ultimately stage even more complicated operations in pregnant women and the fetus," said Samuel A. Giday, MD, assistant professor of medicine at Johns Hopkins University School of Medicine division of gastroenterology and hepatology. Randomized Multicenter Controlled Study of Endoscopic and Surgical Closure of A Gastric NOTES Access
Perforation in a Porcine Model (Abstract #876) Researchers studying endoscopically sutured closure of a gastric access perforation using a T-tag tissue apposition system (TAS) compared to conventional surgical closure found that gastric NOTESTM access perforations can be safely and reliably closed using TAS. TAS is designed to suture via flexible endoscopes. It places a tilt T-tag attached to a thread into tissue using a small diameter flexible needle. Two or more threads can then be locked together using a thread locking device. All the components can be passed through a conventional (2.8 mm) accessory channel of a flexible gastroscope without requiring withdrawal of the endoscope. Unlike other suturing devices, it does not require loading onto the endoscope before use, it is much smaller in diameter, and it does not interfere with endoscope flexibility or function. The needle can be placed under direct vision with great accuracy and is intuitively easy to use. In a randomized, multi-center study of 30 pigs, investigators measured procedure time, recovery time and weight gain at days seven and 14. The study found that closure time using the endoscopic NOTES technique was significantly longer than with open surgery. However, researchers found that at necropsy on day 14, there were significantly more intra-abdominal adhesions (internal scarring sticking internal organs together) in the surgical group, mainly between the stomach, liver and abdominal wall. Concerns about efficacy and consequent safety of closure, especially of the stomach approach, are important if the potential benefits of a NOTES approach are to be realized. If the method can be as safe as a surgical closure and reduce adhesion formation then this will encourage further research in this field. Adhesions can cause abdominal pain and obstruction, very occasionally requiring surgery. Transgastric surgery as a NOTES access approach is in general more attractive than transvaginal or transrectal approaches, provided closure can be shown to be safe and effective. Recovery time following the procedure was the same in both groups, and there was no difference in post-operative weight gain between the groups. Also, a gastric NOTES access perforation can be safely closed endoscopically using TAS sutures and clips. Lastly, researchers found that animals in the endoscopic group had significantly fewer lesions at autopsy, and recovered more quickly post-operatively, compared with open surgery. "Because the TAS system allows access to small and remote areas, and results in less scarring than open surgery closures, it may be the key to expanding the use of the NOTES procedure," said Paul Swain, MD, of the department of technology and medicine at the Imperial College of Science in London.
Robotics and NOTES: A Good Marriage or Just Hype? (Abstract #Sp535) Incisionless surgery using robotic technology, in which surgeons work exclusively through the mouth or other openings, showed excellent results in a recent study. The approach is important for three reasons: first, it allows patients to undergo procedures without pain and scarring; second, the procedure is performed on an outpatient basis; and third, the robotic technology enables doctors to perform procedures in ways they would not otherwise be able to do. Researchers used a small robotic device to perform more than 25 procedures in five animals - including abdominal exploration, bowel manipulation, cholecystectomy, and intracorporeal suturing, partial splenectomy and liver resection - without making cuts to the abdomen. The devices, which are the size of two lipstick tubes, have a central body, two working arms and a built-in light source. Researchers obtained standard transgastric access, and then passed a 22-millimeter overtube past the gastrotomy. They then inserted several miniature robots to perform the operations. Each procedure was accomplished with at least two robots and endoscopic assistance. Researchers found that visualization of the operative field was superior to endoscopic manipulation alone because it offered more opportunities for use. "Currently there are a number of endoscopic tools for taking out polyps" said Dmitry Oleynikov, MD, director of minimally invasive surgery at the University of Nebraska Medical Center. "But this technology can do much more, and it can do it more efficiently." For example, the robotic device could be used to remove portions of the colon that had cancer, it could remove the spleen, or it could repair a hernia. Dr. Oleynikov said that while the device showed promising results in this study, it has limitations. For example, while its small size allows it to reach areas that other devices cannot, the device is not large enough to move around larger organs, so more research will have to be done to make it more robust, especially for human use. He said it is possible that with successful FDA trials, the technology could be available for human use any time from 18 months to three years from today.
Digestive Disease Week® 2008 (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 17-22, 2008 in San Diego, Calif. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. Massachusetts General Hospital
http://www.medicalnewstoday.com/articles/108095.php
A sophisticated new surgical technology holds promise for future painless and scarless surgery with shorter recovery times than laparoscopic surgery. New research supporting the safety and efficacy of natural orifice translumenal endoscopic surgery (NOTESTM) and detailing the outcomes associated with new tools and robotic applications will be presented at Digestive Disease Week® 2008 (DDW®).
DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. "The research developments presented today are continuing to demonstrate the great potential of this exciting new surgical procedure," said Pankaj J. Pasricha, MD, FASGE, professor of medicine, gastroenterology and hepatology, Stanford University School of Medicine. "Surgical advances like NOTES may lead the way toward the adoption of even more minimally invasive techniques than laparoscopy and allow patients to return to their home, family and work more quickly."
NOTES is performed by passing an endoscope through a natural orifice then through an internal incision in the stomach, vagina, bladder or colon, thus avoiding any external incisions or scars.
A Prospective Randomized Controlled Trial of NOTES versus Laparoscopic Distal Pancreatectomy, Preliminary Results (Abstract #881) Investigators have conducted the largest and most rigorously controlled study of natural orifice surgery to date. The study showed that while NOTESTM is more time-consuming than traditional (laparoscopic) surgery, it is equally successful. The study also demonstrated that complex surgery with a high rate of complications could be performed via the mouth using a flexible endoscope. "NOTES is an area of promise in active development," said Field Willingham, MD, MPH, senior fellow in the gastrointestinal unit at Massachusetts General Hospital. "The opportunities with NOTES are significant and should some day provide patients with a viable scarless and painless option for certain medical procedures." Previous NOTES research has involved small sample sizes and no control groups. This prospective, randomized controlled trial compared the efficacy of endoscopic transgastric distal pancreatectomy (ETDP) to laproscopic distal pancreatectomy (LDP). Investigators randomized twenty-eight 45kg swine to EDTP or LDP and then compared the results based on an extensive post-operative analysis. The procedure time for EDTP was significantly greater versus LDP (1:52 versus 0:32 hour), but investigators found no clinical or survival difference between the NOTES and laparoscopic approaches. Dr. Willingham noted that the tools used to dissect or retract during NOTES procedures may pose some limitations. "It can be challenging to perform complex procedures such as holding traction while simultaneously dissecting tissue through a single NOTES endoscope." However, this study does demonstrate the non-inferiority of NOTES in solid organ resection compared to standard laparoscopic surgery.
Successful Diagnostic and Therapeutic Intrauterine Fetal Interventions by NOTES (Abstract #871) Investigators using NOTESTM have found for the first time that it can look at the entire uterus and reach areas that had not previously been accessible. The findings are important because the morbidity and mortality of fetal surgery is substantial. If the fetus requires lifesaving surgery, the only way to operate previously was through traditional laparoscopy or laparotomy. But this method is limiting because the uterus and the fetus can only be accessed from the front; unless a doctor is aiming to intervene right beneath the abdominal wall, it would be difficult to access the desired organ. However, using flexible endoscopy, doctors can reach almost any part of the uterus, regardless of the direction the fetus is facing. Furthermore, the procedure could be particularly helpful since it provides a minimally invasive approach to performing fetal surgery. Researchers performed transgastric peritonoscopy on one ewe and transvaginal peritonoscopy on another following standard needle-knife entry into the abdominal cavity. Access to the uterus was assessed with both a forward-viewing endoscope and a linear-array echoendoscope. Visibility of the fetal areas via endoscopic ultrasound (EUS) was directly compared to transabdominal ultrasound. EUS-guided, transuterine injection of saline into the fetal cardiac ventricle was attempted in both sheep using a 22-gauge fine needle aspiration needle. Investigators found that access to and complete visualization of the uterus were successful with both endoscopes using an anterior, posterior and lateral approach once inside the abdominal cavity. Also, visualization of the fetal parts by EUS was impressive and superior to transabdominal ultrasound. "Our findings suggest that NOTES may provide an avenue through which one can ultimately stage even more complicated operations in pregnant women and the fetus," said Samuel A. Giday, MD, assistant professor of medicine at Johns Hopkins University School of Medicine division of gastroenterology and hepatology. Randomized Multicenter Controlled Study of Endoscopic and Surgical Closure of A Gastric NOTES Access
Perforation in a Porcine Model (Abstract #876) Researchers studying endoscopically sutured closure of a gastric access perforation using a T-tag tissue apposition system (TAS) compared to conventional surgical closure found that gastric NOTESTM access perforations can be safely and reliably closed using TAS. TAS is designed to suture via flexible endoscopes. It places a tilt T-tag attached to a thread into tissue using a small diameter flexible needle. Two or more threads can then be locked together using a thread locking device. All the components can be passed through a conventional (2.8 mm) accessory channel of a flexible gastroscope without requiring withdrawal of the endoscope. Unlike other suturing devices, it does not require loading onto the endoscope before use, it is much smaller in diameter, and it does not interfere with endoscope flexibility or function. The needle can be placed under direct vision with great accuracy and is intuitively easy to use. In a randomized, multi-center study of 30 pigs, investigators measured procedure time, recovery time and weight gain at days seven and 14. The study found that closure time using the endoscopic NOTES technique was significantly longer than with open surgery. However, researchers found that at necropsy on day 14, there were significantly more intra-abdominal adhesions (internal scarring sticking internal organs together) in the surgical group, mainly between the stomach, liver and abdominal wall. Concerns about efficacy and consequent safety of closure, especially of the stomach approach, are important if the potential benefits of a NOTES approach are to be realized. If the method can be as safe as a surgical closure and reduce adhesion formation then this will encourage further research in this field. Adhesions can cause abdominal pain and obstruction, very occasionally requiring surgery. Transgastric surgery as a NOTES access approach is in general more attractive than transvaginal or transrectal approaches, provided closure can be shown to be safe and effective. Recovery time following the procedure was the same in both groups, and there was no difference in post-operative weight gain between the groups. Also, a gastric NOTES access perforation can be safely closed endoscopically using TAS sutures and clips. Lastly, researchers found that animals in the endoscopic group had significantly fewer lesions at autopsy, and recovered more quickly post-operatively, compared with open surgery. "Because the TAS system allows access to small and remote areas, and results in less scarring than open surgery closures, it may be the key to expanding the use of the NOTES procedure," said Paul Swain, MD, of the department of technology and medicine at the Imperial College of Science in London.
Robotics and NOTES: A Good Marriage or Just Hype? (Abstract #Sp535) Incisionless surgery using robotic technology, in which surgeons work exclusively through the mouth or other openings, showed excellent results in a recent study. The approach is important for three reasons: first, it allows patients to undergo procedures without pain and scarring; second, the procedure is performed on an outpatient basis; and third, the robotic technology enables doctors to perform procedures in ways they would not otherwise be able to do. Researchers used a small robotic device to perform more than 25 procedures in five animals - including abdominal exploration, bowel manipulation, cholecystectomy, and intracorporeal suturing, partial splenectomy and liver resection - without making cuts to the abdomen. The devices, which are the size of two lipstick tubes, have a central body, two working arms and a built-in light source. Researchers obtained standard transgastric access, and then passed a 22-millimeter overtube past the gastrotomy. They then inserted several miniature robots to perform the operations. Each procedure was accomplished with at least two robots and endoscopic assistance. Researchers found that visualization of the operative field was superior to endoscopic manipulation alone because it offered more opportunities for use. "Currently there are a number of endoscopic tools for taking out polyps" said Dmitry Oleynikov, MD, director of minimally invasive surgery at the University of Nebraska Medical Center. "But this technology can do much more, and it can do it more efficiently." For example, the robotic device could be used to remove portions of the colon that had cancer, it could remove the spleen, or it could repair a hernia. Dr. Oleynikov said that while the device showed promising results in this study, it has limitations. For example, while its small size allows it to reach areas that other devices cannot, the device is not large enough to move around larger organs, so more research will have to be done to make it more robust, especially for human use. He said it is possible that with successful FDA trials, the technology could be available for human use any time from 18 months to three years from today.
Digestive Disease Week® 2008 (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 17-22, 2008 in San Diego, Calif. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. Massachusetts General Hospital
http://www.medicalnewstoday.com/articles/108095.php
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