LAS VEGAS -- A dozen patients have undergone safe and effective transoral stomach stapling, researchers reported here.
LAS VEGAS, Oct. 26 -- A dozen patients have undergone safe and effective transoral stomach stapling, researchers reported here.
The transoral approach involves a stapling device that is guided into the stomach endoscopically, reported Steven Edmundowciz, M.D., of Washington University in St. Louis, and colleagues, at the American College of Gastroenterology meeting.
In a pilot study of 12 patients, the device appeared safe and effective, resulting in significant weight loss with no serious adverse events, Dr. Edmundowciz said.
The study included adults with a history of morbid obesity for at least two and a half years and for whom non-surgical attempts at weight loss, such as diet and exercise, had failed. All participants were eligible for bariatric surgery according to the NIH guidelines (?40 BMI or ?35 BMI with one or more comorbidities).
Of the 12 participants, 10 were female. Their average age was 43 (range 22 to 57), and their average BMI was 44 (range 37 to 52).
After undergoing the procedure under general anesthesia, patients were put on a liquid diet and asked to begin an exercise program. No serious adverse events were reported during or after the procedure. However, minor adverse events included vomiting, posterior pharyngeal pain, temporomandibular joint dysfunction, and post prandial fullness. Each of these was experienced by one participant. All the events were transient.
All patients had significant weight loss at one month of follow up. The groups' average weight loss was about 20 pounds. The patient who lost the most shed about 28 pounds, while the patient who slimmed the least lost nearly 13 pounds, the investigators reported.
The study demonstrated the feasibility of this novel technique, but, the researchers cautioned, "Carefully designed long term randomized controlled studies will be required to demonstrate the efficacy of this device for the treatment of morbid obesity."
Although the technique is certainly less invasive than other forms of bariatric surgery, it is not clear that it would be less expensive, Dr. Edmundowciz said. "We hope that it will be, but we have no idea where the prices will go."
The next step will be to take this preliminary data to the FDA so the agency can determine what type of larger study it would like to see to consider the device for approval.
The study was supported by Satiety Incorporated of Redwood City, California, maker of the TOGa transoral stapling device.