Endoluminal Surgery - Revising Weight Loss Surgery

The field of bariatric surgery is constantly evolving as new technologies are developed. The first major shift was changing from open surgery to laparoscopic surgery, which is surgery using a camera and very tiny incisions. The next step will be endolumenal surgery, which is done completely through the mouth with no incisions.

Studies have shown that up to 20 percent of gastric bypass patients regain a significant amount of the weight they originally lost after surgery. This may be due to stretching of the stomach pouch or the connection between the pouch and the small intestine. Until recently, the only treatment for these two problems was revisional surgery, performed either laparoscopically or open. These procedures have an extremely high risk of complications, and most bariatric surgeons have felt that the risks were too high for the potential benefits.

With the introduction of endolumenal surgical devices, the potential risks have decreased considerably. The new devices specifically for bariatric surgery include the StomaphyX?, which is manufactured by Endogastric Solutions, Inc.; the Endocinch?, manufactured by Bard; and the EndoSurgical Operating System? (EOS), manufactured by USGI Medical, Inc. These devices can be used to tighten the connection between the gastric pouch and the small intestine and to decrease the size of the pouch.

As with all procedures, it is very important to choose your doctor appropriately for endolumenal surgery. You should choose a surgeon with a lot of endoscopic and bariatric surgery experience; these procedures are technically challenging and very different from traditional open or laparoscopic procedures.
Stomaphyx
The StomaphyX first received approval from the FDA in May of 2007. It is presently the only device being used for gastric bypass revision without being part of a research study. The main use of this device is to dramatically shrink the gastric pouch and indirectly narrow the connection to the small intestine. The StomaphyX is placed through the mouth into the gastric pouch while the surgeon watches on a television screen. The wall of the gastric pouch is then suctioned into the device, and an H-shaped plastic fastener, similar to the fasteners you might see on clothing price tags, is fired across the tissue, creating a pleat in the stomach wall and decreasing the size of the pouch. Usually between 15 and 20 fasteners or pleats are placed during this procedure, and it decreases the pouch to about 20 percent of the starting size.

My colleagues and I recently submitted one of the first research papers on the StomaphyX procedure to a surgery meeting. Our early data has been promising: patients experienced a dramatic decrease in hunger and significant weight loss. Most patients have the procedure on an ambulatory basis and return to work the following day, and the most common complaint afterwards is a sore throat for a day or two. The serious complications we always worry about when doing an endoscopic procedure are perforation and bleeding, but, to date, these complications have not been reported, although the long-term results of the procedure are unknown.

The nice thing about the StomaphyX procedure is that you do not burn any bridges: you can still have future procedures if needed, and you can even have this procedure done repeatedly. Most insurance companies currently cover the procedure, but some still consider it experimental and deny coverage.

The Endocinch was first approved by the FDA as an endoscopic suturing device for gastroesophageal reflux disease (GERD) or heartburn. A multi-center research study is currently being done on using the Endocinch to reduce the size of the connection between the stomach pouch and the small intestine after gastric bypass. However, the data on using the Endocinch for GERD has been poor: the device doesn?t take deep bites of the tissue, and only 19 percent of stitches are still present one year after the procedure. Most likely, the results will be similar for gastric bypass revision, but the jury is still out on this product until the multi-center study is complete.

The USGI EndoSurgical Operating System is introduced through the mouth and then creates tissue folds to shrink the stomach pouch and the connection to the small intestine. The folds are held by specially designed suture anchors. The EOS device is currently the subject of another multi-center research study; it is very complex and requires extensive training to learn, so it will likely need further refinement before it becomes available to the public.

Industry is working hard to develop new endoscopic bariatric procedures. Wouldn?t it be nice to have a completely endoscopic weight loss procedure done through the mouth with no incisions, if your BMI is between 30 and 35? It could happen. Medicine is constantly evolving, and the new era of endolumenal surgery has begun.

Shawn Garber, MD, FACS, is a pioneer in endolumenal surgery and teaches the StomaphyX procedure. Practicing in New York, he is widely featured on television.

March 2008

 

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