Source: Eye  |  Posted 5 years ago

By Paula Moyer

LAS VEGAS, NV -- October 25, 2006 -- A transoral route for performing endoscopic bariatric surgery is technically feasible and well tolerated, according to findings presented here at the American College of Gastroenterology Annual Scientific Meeting (ACG).

"This early study showed that the procedure is feasible for patients who need to undergo gastroplasty," said principal investigator Steven A. Edmundowicz, MD, professor of gastroenterology, Washington University of St. Louis, St. Louis, Missouri.

"We need next to do a larger study with longer follow-up in order to demonstrate that the procedure is an effective way to do the surgery," Dr. Edmundowicz said on October 23[^]rd[].

In this study, Dr. Edmundowicz and colleagues recruited 12 patients who were morbidly obese as defined by a body mass index (BMI) of 40 or more or 35 or more and weight-related comorbidities.

Participating surgeons used endoscopic guidance to insert the TransOral Gastroplasty version A (TOGa) device through the patient's mouth into the stomach. The surgeon then used the device to narrow and suture the stomach, as is conventionally done in bariatric surgery.

Patients were under general anesthesia and were hospitalized overnight after the procedure. They were followed at 1, 3, and 6 months. One component of the postsurgical care was a diet and an exercise program.

Dr. Edmundowicz reported on the 1-month data, which showed that all subjects had some weight loss, ranging from 12 to 28 lbs (5.4 to 12.7 kg).

Some patients experienced device-related events, with 1 case each of pharyngeal pain, vomiting, temporomandibular joint dysfunction, and postprandial fullness. The investigators documented no serious adverse events.

"The results are promising," Dr. Edmundowicz said. "We know now that the procedure is feasible and safe for patients. Now we need to do a larger study to see if it's efficacious. We want to have a more effective way to manage morbid obesity. We're encouraged, but we're not there yet."

The study was supported by Satiety Incorporated, which is developing the TOGa device.

[Presentation title: A Safety and Feasibility Study of Trans Oral Gastroplasty (TOGa(TM)) for the Treatment of Morbid Obesity: Initial Human Experience With Endoscopic Gastric Stapling. Abstract 10]