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ASMBS issues policy statement on gastric plication
The American Society for Metabolic and Bariatric Surgery (ASMBS) has issued a policy statement on gastric plication as a surgical treatment for obesity. Gastric plication (laparoscopic gastric plication or laparoscopic greater curvature plication) is a new bariatric procedure that involves folding and stitching the stomach to reduce food intake and enable weight loss.
Gastric plication does not involve any sectioning off, removing, or rerouting of the stomach or intestines, or placement of a gastric band system into the body. It is a minimally-invasive, reversible, low-risk, and low-cost alternative to other bariatric surgeries.
The potential benefits of gastric plication in regards to safety and cost make it an appealing surgical weight loss option. To address the interest and inquiries regarding this procedure, the ASMBS has made the following recommendations:
• Gastric plication procedures should be considered investigational at this time. This procedure should be performed under a study protocol with third party oversight (local or regional ethics committee, Institutional Review Board, data Monitoring and Safety Board, or equivalent authority) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.
• Reporting of short- and long-term safety and efficacy outcomes in the medical literature is strongly encouraged. Data for these procedures should also be reported to a program’s center of excellence database.
• Any marketing or advertisement for this procedure should include a statement to the effect that this is an investigational procedure.
The ASMBS states that their intent is not to impede innovation, as they encourage and support the development of new and innovative procedures that can benefit patients, rather to stress the importance of responsible conduct, appropriate supervision and appropriate training.
They will continue to monitor the results of gastric plication studies as they emerge and issue a formal evidence-based position statement at the appropriate time. At this time, however, they say there is not enough data to make any conclusions regarding the safety and effectiveness of this procedure.
They cite both the quantity (only four studies and less than 300 patients) and quality (prospective or retrospective case series) of the available information to date.
Several gastric plication clinical trials are ongoing, which will enable researchers to gather more data on this new bariatric surgery. Outside of clinical trials, only a few doctors in the US perform gastric plication surgery. If positive results continue to be realized, the procedure will most likely become more widely available in the next few years.