Laparoscopic Procedures - Position of Blue Cross & Blue Shield Association
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Weight Loss Surgery Operations - Research Into Gastric Reduction Surgery |
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Recommendations of Blue Cross and Blue Shield Association Medical
Advisory Panel on As to whether new bariatric procedures like laparoscopic gastric bypass or laparoscopic gastric banding improve patient outcomes as compared to open gastric bypass, and whether variations on gastric bypass improve outcomes for patients with super-obesity, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether newer approaches to bariatric surgery meet the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. 1. The technology must have final approval from the appropriate governmental regulatory bodies. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The evidence is not sufficient to form conclusions about the relative efficacy and morbidity of less-invasive approaches to bariatric surgery, specifically laparoscopic gastric bypass and laparoscopic gastric banding. The evidence allows crude comparisons of weight loss outcomes between procedures at 1 year, but is not sufficiently robust to make meaningful comparisons at longer time intervals. The evidence is also not adequate to determine comparative rates of adverse events. For laparoscopic gastric bypass, the available evidence suggests that weight loss outcomes are similar to open gastric bypass at 1 year. Because of the technical complexity of this operation, there is concern for short-term complications such as anastomotic leaks. Leakage of intestinal contents causes peritonitis, which can be life threatening and usually requires reoperation. The comparative rates of these serious adverse events cannot be determined from the data, leaving considerable uncertainty as to the relative safety of laparoscopic bypass. There are very little data on outcomes longer than 1 year for this procedure. For laparoscopic gastric banding, the available evidence suggests that weight loss at 1 year is less than that achieved with gastric bypass. More limited evidence on 3-year weight loss suggests that this difference in weight loss may lessen over time. Early adverse event rates are low following laparoscopic gastric banding, and are probably lower than gastric bypass. There is a higher rate of long-term adverse events, and there are a number of potentially serious long-term adverse events such as band slippage or erosion. The available data are not sufficient to determine the rates of these longer-term adverse events with confidence. There are limited data on outcomes of bilio-pancreatic diversion and/or long-limb gastric bypass for patients with super-obesity. There are no high-quality comparative trials and only limited clinical series data for these indications. These limited data do not establish that these or other variants (e.g., duodenal switch) have any additional benefit for patients with super-obesity, as compared to gastric bypass. 3. The technology must improve the net health outcome; 4. The technology must be as beneficial as any established alternatives. There is insufficient evidence to conclude whether these procedures (i.e., laparoscopic gastric bypass, laparoscopic gastric banding, bilio-pancreatic diversion, long-limb gastric bypass) either improve the net health outcome or whether they are as beneficial as current established surgery, open gastric bypass with Roux-en-Y anastomosis. 5. The improvement must be attainable outside the investigational settings. Whether these procedures (i.e., laparoscopic gastric bypass, laparoscopic gastric banding, bilio-pancreatic diversion, long-limb gastric bypass) improve health outcomes has not been demonstrated in the investigational setting. Conclusion Based on the above, laparoscopic gastric bypass, laparoscopic gastric banding, bilio-pancreatic diversion, or long-limb gastric bypass do not meet the TEC criteria. Source: Stomach Bypass Surgery Information |