Gastric Bypass Surgery News Links

St. Louis, MO

A Granite City, Illinois woman has become the first patient in the country to undergo a new obesity procedure that can restrict the size of the stomach without an incision.

Inserting instruments through Carrie Williamson's mouth and down her throat, doctors at Barnes-Jewish Hospital on Wednesday created a small pouch in her stomach that will make her feel full after eating only a small amount of food.

The procedure was performed as part of the TOGA (transoral gastroplasty) Pivotal Trial, a multicenter national study that is evaluating the investigational, nonsurgical procedure.

"This is a shift in the way we approach the surgical treatment of obesity," said Dr. J. Christopher Eagon, a Washington University bariatric surgeon. "If this technique provides results close to those achieved with more traditional surgery, it may be an option for people who need to lose a great deal of weight but don't want to have surgery."

In the TOGA procedure, doctors insert a set of flexible stapling devices through the mouth and into the stomach. Then, watching through a scope, they use the staplers to create a restrictive pouch to help limit food intake. In the traditional surgery, surgeons work through incisions in the abdomen.

Between February 2006 and July 2007, 47 patients who were an average of 120 pounds overweight had the TOGA procedure in a pilot study at medical centers in Mexico and Belgium. After a year, they had lost an average of 40 percent of their excess weight.

"That's not as great a loss as we see with gastric bypass surgery, which is still the gold standard for weight-loss procedures," said Dr. Sreenivasa Jonnalagadda, the co-principal investigator at Washington University.

"The key benefits ... are quicker recovery period, shortened hospital stay, decreased risk of complications and an incision-free procedure. And if the restrictive pouch becomes bigger over time, as has been the experience with some obesity surgery patients, it may be possible in the future to further decrease the size of pouch with this new generation of devices."

Williamson's procedure was done under general anesthesia and required an overnight stay at Barnes-Jewish Hospital for observation. Eventually, Eagon and Jonnalagadda expect it could be done on an outpatient basis under sedation, depending on the results of the study.

The current study will involve at least 275 patients at centers across the country. Washington University will enroll at least 27 volunteers. Those eligible must be 18 to 60 years old, at least 100 pounds overweight and have no history of heart attack, stroke, chest pain or severe reflux disease. Lighter patients may be considered if they have type 2 diabetes or high blood pressure.

Because she was the first, Williamson knew she was getting the actual treatment, but during the study, one of every three volunteers will receive only anesthesia and an examination of the stomach, not the procedure itself.

However, these "control" patients will be offered the TOGA procedure after 12 months if it proves effective. Doctors will evaluate weight loss along with related health problems such as diabetes, cholesterol and blood pressure.

"In patients undergoing gastric bypass surgery, it's common to see blood lipids and blood glucose levels normalize in the days after surgery, even before they lose any weight," Eagon said. "We may see similar benefits from this procedure, but we need to test that hypothesis."