Surgery News - September 2007 - (Page 8) GENERAL SURGERY SURGERY NEWS • S E P T E M B E R 2 0 0 7 Morbidity, Mortality Risks May Drop Weight Loss • from page 1 consisting of a sleeve gastrectomy fol- hormones that may switch the diabetes to lowed by a Roux-en-Y gastric bypass reverse itself,” Dr. Gagner said in an inter(RYGB) or a duodenal switch (Obes. Surg. view. “I think we will see more and more of that technology being developed, and 2003;13:861-4). “The rationale is that the first-stage op- we’ll see variants like different materials, eration, sleeve gastrectomy, is compara- different lengths [of sleeves], et cetera.” He tively simple (requiring no anastomosis), was not affiliated with the study. In other studies of presurgical endoluneeds less operative time (1-2 hours), and results in a predictable 40- to 50-kg weight minal therapy, the intragastric balloon deloss,” Dr. Schauer and his associates wrote veloped by BioEnterics Corp. has been in their review. “Such weight loss reduces used successfully as a first-stage procedure the operative risk for the second-stage to reduce presurgical weight and perioperative risk in superobese paprocedure, which presumably tients, but clinical results are results in more weight loss and limited. greater durability.” In the arena of postsurgical Dr. Gagner, professor of endoluminal revision procesurgery and chief of bariatric dures, small studies of C.R. surgery at Cornell University, Bard Inc.’s EndoCinch suturing New York, and his associates system and endoscopic suturwere also the first to publish ing device have demonstrated results of an approach using promising results. the placement of endoluminal Dr. Christopher C. Thompduodenojejunal tube or plastic ‘People think it’s son and his associates used the sleeve to the first part of the going to happen EndoCinch suturing system in duodenum proximal to the overnight. I think eight patients who had underampulla of Vater in pigs as a it’s going to take gone RYGB but had regained weight-loss strategy (Obes. much longer than an average of 24 kg from baseSurg. 2006;16:620-6). This what we think.’ line (Surgery for Obesity and study, which demonstrated DR. GAGNER Related Diseases 2005;1:223). good weight loss in pigs, was the basis for the first human trial report- They placed plications at the rim of the ed by Dr. Leonardo Rodriguez and his as- anastomosis, thereby reducing the anassociates at the annual meeting of the tomotic aperture. At 4 months after unAmerican Society for Metabolic and dergoing the procedure, six of the eight Bariatric Surgery (formerly the American patients had lost an average of 10 kg, and Society for Bariatric Surgery) in June 2007. four reported significant improvements In the human trial, 12 patients from in satiety. In another study, Dr. Michael Chile and Brazil, including four with diabetes, underwent placement of a 61-cm Schweitzer and his associates used the enendoluminal duodenojejunal tube or plas- doscopic suturing device in four patients tic sleeve that was anchored endoscopi- who regained weight after RYGB surgery cally in the duodenum and removed after ( J. Laparoendosc. Adv. Surg. Tech. A. 2004;14:223-6). The study did not include 12 weeks. All patients achieved an estimated long-term results, but noted that all four weight loss of at least 10%, and 10 of the patients reported improvements in early 12 patients lost an estimated 24% of their weight loss and satiety. At the annual meeting of the Society of weight. All of the diabetic patients completed the study without the need for hy- American Gastrointestinal Endoscopic Surgeons in April 2007, Dr. Roberto Fogel poglycemic medications. “By diverting the flow of food from the of Caracas, Venezuela, reported that an duodenum and the proximal jejunum, we endoluminal vertical gastroplasty procemight be able to change some of the GI dure produced an average excess weight The EndoCinch suturing system nears the dilated gastrojejunostomy. The gastrojejunostomy has been reduced in size by two suture clips. loss of 46% in patients 3 months after surgery. In this procedure, an interrupted suture pattern was used in 31 patients with a mean body mass index (kg/m2) of 38.1. In addition to the weight loss, reductions were achieved in glucose intolerance or type 2 diabetes (from 14 patients to 2), hypertension (from 26 to 11), and dyslipidemia (from 27 to 11). Such suturing procedures hold particular promise, Dr. Schauer said, because “they emulate gastric restriction, a concept that has been proven over several decades in bariatric surgery.” Dr. Schauer is one of the clinicians participating in the phase III RESTORe (Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction) trial for patients with inadequate weight loss following RYGB. The purpose of the trial, which is supported by Bard and Davol Inc., is to evaluate weight loss and other clinical outcomes following application of transoral reduction of a dilated gastrojejunostomy anastomosis in 220 patients who have inadequate weight loss following RYGB. The expected completion date of the trial is July 2008. The use of endoluminal techniques for the primary treatment of obesity is in its infancy, Dr. Schauer said. One investigational device that has been studied in small trials of patients outside the United States is the transoral gastroplasty (TOGa) system, developed by Satiety Inc. In this procedure, an endoscopic stapling device is inserted through the mouth to the stomach to create a small restrictive pouch. Dr. Gagner said that he is optimistic about such developments, but cautioned that much more study is required before they are embraced by gastrointestinal endoscopic surgeons. “It’s great that we have this research effort going on, that there’s a lot of enthusiasm,” he said. “People think it’s going to happen overnight. I think it’s going to take much longer than what we think.” Dr. Schauer called the development of endoluminal techniques for obesity “another potential great leap forward in reducing the risk of these procedures. We already know that going from open procedures to laparoscopic procedures was one of the major factors that propelled bariatric surgery from a very low niche field [15,000 cases per year] across the United States, to 200,000 procedures per year. What really drove that was the reduction in complications and recovery.” Similar success with endoluminal techniques will take time, and will require the ability to overcome technical hurdles and challenges associated with reimbursement. “These procedures will require new CPT codes and applications to insurance carriers to get reimbursed,” he said. Dr. Schauer disclosed that he is a paid consultant for Bard, Davol, Ethicon EndoSurgery Inc., Stryker Endoscopy, Baxter International Inc., W.L. Gore & Associates Inc., and Barosense Inc. Dr. Gagner disclosed that he is a scientific advisor for GI Dynamics Inc., and he has received research grants from Covidien AG, Olympus America Inc., and Bard. ■ Major Reoperation Needed in 13% of Gastric Banding Patients BY DOUG BRUNK Else vier Global Medical Ne ws S A N D I E G O — Thirteen percent of patients who underwent laparoscopic adjustable gastric banding required a major reoperation, results from a long-term single-center study showed. “We see complications, even many years after surgery,” Dr. Vincenzo Bacci said at the annual meeting of the American Society for Bariatric Surgery. “This information should really be conveyed to our surgical candidates,” Dr. Bacci advised. “Lifelong management and surveillance are necessary for these patients.” Dr. Bacci and his associates studied the rate and causes of reoperation in 448 patients who underwent laparoscopic ad- justable gastric banding in the surgery department at La Sapienza University in Rome, between 1996 and 2006. In 2002 the perigastric technique was replaced by the pars flaccida approach. Of the 448 patients, 83% were women and their average body mass index was 43 kg/m2. The average follow-up was 3.2 years, and 84 patients (19%) were followed for more than 5 years. Dr. Bacci reported that 59 patients (13%) required a major reoperation for band repositioning/removal or revision, and 29 patients (6%) required a minor reoperation for port complications. The rate of major reoperation was 4.1 per 100 person-years, while the rate of minor reoperation was 2.1 per 100 personyears. Patients with a BMI of greater than 50 kg/m2 were 3.9 times as likely to require a major or minor reoperation as were patients with a lower BMI. The main reasons for major reoperation were dilatation, erosion of the band, lack of weight loss, psychological problems, and slippage. Minor reoperations were necessitated by infections of the port site, a twist of the port, or breakage. The rate of major reoperation in a subset of patients followed for longer than 5 years was 24%, chiefly because they had undergone gastric banding with the perigastric technique. Overall, the pars flaccida technique appeared to have a protective effect over the perigastric technique (a risk ratio for reoperation of 0.7), but this did not reach statistical significance. ■ Gastric Banding Patients Requiring Reoperation 13% 6% ELSEVIER GLOBAL MEDICAL NEWS Major reoperation Minor reoperation Note: Based on a study of 448 patients with an average 3.2-year follow-up. Source: Dr. Bacci IMAGES COURTESY C. R. BARD, INC.
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