BARIATRIC SURGERY - Health Plan of Nevada

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WOU001 Vertical Banded Gastroplasty (VBG) A Cochrane Database Systematic Review by Colquitt et al. (2009) found that while complication rates for vertical banded gastroplasty are relatively rare, revision rates requiring further surgical intervention are approximately 30%. The vertical banded gastroplasty (VBG) also restricts the size of the stomach using a stapling technique but there is no rearrangement of the intestinal anatomy. This also can be an open or laparoscopic procedure. The Magenstrasse and Mill (M&M) Operation is a type of vertical gastroplasty designed to maintain physiological flow of ingesta without the use of implants such as bands or reservoirs. Silastic ring vertical gastroplasty (SRVG) is similar to VBG, except that silastic tubing is used for the band and no "window" is created. The mechanism of weight loss is restrictive, since the size of the stomach is reduced. Transected silastic ring vertical gastric bypass (TSRVGB), or the "Fobi pouch" procedure, is based on the standard Roux-en-Y procedure, but it employs three modifications. First, the distal stomach is transected vertically from the upper gastric pouch. Second, a silastic ring is placed around the upper pouch to provide gastric restriction. Third, a gastrostomy tube is connected to the distal stomach to permit percutaneous access. Adverse events include staple-line disruption after VBG. Some patients require re-operation to correct problems with the original surgery, including stenosis around the anastomosis site, causing post-prandial abdominal pain and vomiting (Kellum, 1998). Natural Orifice Transluminal Endoscopic Surgery (NOTES) NOTES, also referred to as endoluminal surgery is an emerging experimental alternative to conventional surgery that eliminates abdominal incisions and incision-related complications by combining endoscopic and laparoscopic techniques to diagnose and treat abdominal pathology (McGee, 2006). The NOTES technique involves the use of natural orifice access (e.g., mouth, urinary tract, anus) to perform a surgical procedure which potentially reduces or eliminates common incision-related complications. StomaphyX is one type of devise used in this type of endoscopic surgery. StomaphyX is a new and innovative revision procedure for individuals who have had Roux-en-Y gastric bypass surgery and have regained weight due to a stretched stomach pouch or enlarged stomach outlet. The StomaphyX procedure reduces the stomach pouch and stomach outlet (stoma) to the original gastric bypass size without traditional surgery or incisions and with minimal recovery time. It is not performed as a primary method of weight loss surgery, but as a type of revisional bariatric surgery for gastric bypass patients (StomaphyX, 2008). Currently there is insufficient evidence in the peer-reviewed medical literature to support the use of transluminal endoscopic surgery using devices such as StomaphyX for the management of severe obesity. Laparoscopic Mini-Gastric Bypass Mini gastric bypass (MGB) is a relatively new procedure that is performed laparoscopically. A gastric tube is constructed by dividing the stomach vertically, down to the antrum. As in the RYGB, food does Bariatric Surgery Page 14 of 30
WOU001 not enter the distal stomach. At a point about 200 cm distal to the ligament of Treitz, the small intestine is looped back toward the gastric tube and attached. Some surgeons contend that this is similar to an out-ofdate procedure called "loop" gastric bypass and do not recommend its use. A small number of studies in the published literature relate to laparoscopic mini-gastric bypass. These studies were reported by two primary groups, one led by the original surgeon of the procedure and another group based in Taiwan. A total of four abstracts were retrieved including one randomized controlled trial (n=80). Three other descriptive and case series reports of clinical trials were found (n=423 to 2410), though two of these report initial and final results of the same large case series study (Hayes, 2006). The small randomized controlled trial showed that operative times with the mini gastric approach, was 57 minutes less than the laparoscopic Rouxen- Y gastric bypass procedure. The initial findings are promising, but the small sample size, limited two year follow up and lack of identification of patient selection criteria indicate that further study is needed to establish the safety and efficacy of the procedure (Lee, 2005). Gastric Electrical Stimulator The implantable gastric stimulator (IGS) is a small, battery-powered device similar to a cardiac pacemaker, in a small pocket, created beneath the skin of the abdomen, using laparoscopy (hollow surgical tube and instruments inserted through an abdominal incision). Electrodes from the IGS are then implanted into the wall of the stomach and imaging or endoscopy is used to check that no perforations of the stomach wall have resulted. After a 1-month wait for healing at the surgical site, the device is turned on to intermittently stimulate the stomach wall. The IGS is programmed externally using a controller that sends radiofrequency signals to the device. Evidence is limited regarding the use of implantable gastric stimulators (IGS) and currently there are no IGS systems approved by the Food and Drug Administration to date for obesity treatment. The evidence is limited to 1 small randomized controlled trial (RCT), 1 double-blind, placebo-controlled RCT, and 5 case series. Overall, there is insufficient evidence to support the efficacy and safety of IGS therapy for promoting weight loss among patients with morbid obesity. There are no data from controlled clinical trials that proves that IGS reliably leads to weight loss or that it is safe and effective compared with standard therapies including diet and exercise, pharmacotherapy, or with more invasive types of bariatric surgery. In fact, the only controlled trial involving a substantial number of patients demonstrated no effect on weight at 6 months after implantation of the device. Robotic-Assisted Gastric Bypass Surgery Mohr et al. conducted a retrospective case study comparing the first 10 patients who underwent a totally robotic laparoscopic Roux-en Y gastric bypass to a retrospective sample of 10 patients who had undergone laparoscopic Roux-en Y gastric bypass surgery (Mohr, 2005). The median surgical times were significantly lower for the robotic procedures. Researchers from the same institution also conducted a RCT to compare a single surgeon's results using the da Vinci system (n=25) with those using traditional laparoscopic Roux-en Y gastric bypass surgery (n=25) when the techniques were learned simultaneously. The mean operating time was again significantly shorter for the robotic procedures. The largest difference was in patients with a BMI >43 kg/m2 (Sanchez, 2005). The authors concluded that these studies demonstrated the feasibility, safety, and potential superiority of robotic laparoscopic Roux-en Y gastric bypass. In addition, the learning curve may be significantly shorter with the robotic procedure. Further Bariatric Surgery Page 15 of 30
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