#7 Endoscopic Weight-Loss Procedure Transoral Gastroplasty (TOGA)

Overview

Rates of overweight and obesity, higher than ever in the United States, are both linked with an increased risk of
life-threatening conditions, including heart disease, stroke, type 2 diabetes, and cancer. Moreover, obesity can lead to psychological distress as a result of poor self image, social isolation, and job discrimination.

Obesity is a life-threatening disease affecting 34% of adults in the U.S. However, bariatric surgery to promote
weight loss by restricting oral intake and changing absorption of food is a viable option. Most procedures are done laparoscopically, in which instruments are inserted through a tiny incision in the abdominal wall.

More than 225,000 Americans who are 100 pounds overweight and unable to lose weight through diet, exercise,
and weight-loss medication are expected to undergo bariatric surgery this year. The surgery doesn’t remove excess tissue but instead reduces size of the stomach and the body’s ability to absorb nutrients from food. In the two years following a bariatric procedure, many people are able to lose more than 60% of their excess weight, a majority experience resolution of their diabetes and high blood pressure and a reduction in their cholesterol.

Bariatric surgery is safe, but as with any surgical procedure there is still a risk of complications. In an effort to
reduce or eliminate complications and offer a “scar-less” procedure, there is now a new weight-loss option for
obese patients who want to lose weight and improve their health but without undergoing major surgery.
The Transoral Gastroplasty, or TOGA, represents a significant improvement in minimally-invasive bariatric surgery.
 
Instead of making incisions in the abdominal wall, this incision-less option combines two flexible endoscopic
staplers passed through the mouth that are used to create a small restrictive pouch in the stomach. After eating
a small meal, patients are left with a feeling of satiety, thereby decreasing caloric intake, and eventually shedding excess pounds.

During a one-to two-hour TOGA procedure, the patient is first given general anesthesia and then a specialized flexible device is placed in the mouth and guided down the esophagus into the stomach. Using a tiny camera at the end of a thin endoscope, the doctor is able to visualize the stomach anatomy. Once the TOGA device is moved into place, it is opened and creates a vacuum, which brings the folds of the stomach together. The cylindrical TOGA device forms a little tube, which is then finally held together with a series of strategically-placed titanium staples and a ring at the new stomach outlet.

What remains after the surgery is a gastric sleeve, so small that when even little amounts of food enter the sleeve and push against its wall, there is a sensation of fullness that will encourage the patient to stop eating.
While traditional laparoscopic bypass surgery requires a recovery time of several days and a clear liquid diet that is moved up to soft solids and then a normal diet over time, TOGA patients are typically discharged a few hours after surgery and resume eating normal foods sooner than their laparoscopic counterparts.

Weight loss in early placebo-controlled TOGA clinical trials has ranged from 12 to 28 pounds in the month following surgery. Losses approaching 40% of excess body weight can be expected within a year.
Final Phase III results of a pivotal multi-center TOGA study are anticipated in late 2010, with FDA approval to follow soon after. Since there are no incisions and minimal anesthesia is used, it’s likely that the TOGA procedure will eventually be performed on an outpatient basis.

Where Are They Now

More than 10% of American men and 18% of women are severely obese, a chronic condition that is extremely difficult to treat. A viable option to promote weight loss by restricting food intake is bariatric surgery. Most procedures are done laparoscopically, in which instruments are inserted through a tiny incision in the abdominal wall. TOGA is a weight-loss option for obese patients who want to lose weight and improve their health without undergoing major surgery. This endoscopic method eliminates complications and offers a "scar-less" procedure. TOGA represents a significant improvement in minimally-invasive bariatric surgery and losses approaching 40% of excess body weight can be expected within a year.

Due to a poor response in clinical trials from lack of efficacy, the company behind the procedure went out of business in late 2010. However, bariatric surgery is becoming more accessible, and a myriad of innovative products are being developed in hopes of circumventing the need for surgery.

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