Authors' objectives:

The aim of this report was to review the available evidence on whether laparoscopic gastric bypass (LGBY) results in similar improvements in health outcomes as does open gastric bypass (GBY).

Authors' results and conclusions: Weight loss at 1 year was very similar for laparoscopic and open procedures. The data on longer term weight loss were less rigorous, but it appears that long-term weight loss is similar as well between the two approaches. Summary estimates were made for perioperative and long-term complications. The estimated mortality rate was low for both procedures, but somewhat lower for laparoscopic surgery (0.3% vs. 1.1%). The laparoscopic procedures had a higher rate of postoperative anastomotic leaks than open procedures (3.7% vs. 1.9%) and a somewhat higher rate of bleeding (4.1% vs. 2.4%). On the other hand, open surgery had higher rates of cardiopulmonary complications (2.6% vs. 1.0%) and wound infections (11.0% vs. 4.7%). Long-term adverse event rates were reported by a smaller number of studies, lending less precision to these data. For the laparoscopic group, the rates of reoperation (9.9%) and anastomotic problems (8.0%) may be higher than for the open group (6.0% and 2.0%, respectively), while the rate of incisional hernia is higher for the open group (9.0% vs. 0%). The evidence did not allow a rigorous examination of the impact of programmatic elements or hospital setting on outcomes. Documentation of a thorough preoperative assessment was used as a proxy for a comprehensive, multidisciplinary program, but sensitivity analysis on this variable did not reveal any clear patterns.

Authors' recommendations: The evidence is sufficient to conclude that weight loss is similar between the two procedures. In a previous TEC Assessment performed in 2003, evidence on the comparative rates of adverse events was not sufficient to form conclusions. A number of new studies available since the previous report provide additional evidence on adverse events, thus addressing the primary deficiency in the evidence reviewed at that time. The profile of adverse events differs between the two approaches, with each having its advantages and disadvantages. LGBY offers a less-invasive procedure that is associated with decreased hospital stay and earlier return to usual activities. The mortality may be lower with the laparoscopic approach, although both procedures have mortality rates less than 1%. Postoperative wound infections and incisional hernias are also less common with LGBY. On the other hand, anastomotic problems, GI bleeding, and bowel obstruction appear to be higher with the laparoscopic approach, but not markedly higher. Given these data, it is not possible to say that one procedure is superior to the other, and overall the benefit/risk ratio for these two approaches appears to be more similar than different. Concern remains about the generalizability of published results, which largely represent high-volume, academic programs, to other settings. While evidence exists to support a positive correlation between volume and outcomes for bariatric surgery in general, the evidence is not sufficient to determine the impact of other programmatic elements and/or hospital setting on outcomes of LGBY. Based on the available evidence, the Blue Cross and Blue Shield Medical Advisory Panel made the following judgments about whether laparoscopic gastric bypass meets 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. The intervention under consideration is a surgical procedure and is not subject to U.S. Food and Drug Administration (FDA) regulations. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The available evidence is sufficient to form conclusions on the benefits and risks of laparoscopic gastric bypass compared with open gastric bypass. Weight loss at 1 year is similar for laparoscopic gastric bypass compared to open gastric bypass. The profile of short-term adverse events differs between the two approaches, with each having its advantages and disadvantages. Given these data, the overall outcomes of laparoscopic gastric bypass appear to be similar to open gastric bypass. 3. The technology must improve the net health outcome. The evidence is sufficient to conclude that laparoscopic gastric bypass improves the net health outcome. Data from non-randomized comparative trials are sufficient to establish that health outcomes are improved following bariatric surgery in general. Among available bariatric surgical procedures, gastric bypass with Roux-en-Y anastomosis appears to have the most favorable benefit/risk ratio. The current Assessment establishes that the overall benefit/risk ratio of laparoscopic gastric bypass is similar to that of open gastric bypass. Therefore, it can be determined that laparoscopic gastric bypass, as well as open gastric bypass, improves the net health outcome. 4. The technology must be as beneficial as any established alternatives. The main established alternative to laparoscopic gastric bypass is open gastric bypass, and this Assessment concludes that the benefits and risks of laparoscopic gastric bypass compared with open gastric bypass are similar. Therefore, laparoscopic gastric bypass is as beneficial as established alternatives. 5. The improvement must be attainable outside the investigational settings. The improvement in health outcomes for laparoscopic gastric bypass can be attained outside the investigational setting, if the training of surgeons and the programmatic elements are similar to programs in the published literature, and if performed at a hospital with sufficient surgical volume. However, there may be considerable variation in capabilities and resources among different bariatric surgery programs. To address this concern, Blue Cross and Blue Shield Association and the American College of Surgeons have developed criteria for credentialing and tracking outcomes from bariatric surgery programs. Based on the above, laparoscopic gastric bypass meets the TEC criteria, when performed in appropriately selected patients, by surgeons who are adequately trained and experienced in the specific techniques used, and in institutions that support a comprehensive bariatric surgery program, including long-term monitoring and follow-up post-surgery.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)