Incision-Free Weight Loss Surgery in Experimental Phase

Obesity is proliferating in the United States. Research statistics show that between 1962 and 2000, the number of obese Americans grew from 13 percent to 31 percent of the population. Obesity surgery has been shown to be the only long-term effective means of weight loss for morbidly obese patients, typically working far better than diet, exercise or drugs. Over the years, these operations have become less painful and invasive. The most common bariatric operation, which once required a large incision, is now performed through several small incisions in the abdomen. A new weight loss surgery currently being evaluated in a U.S. study also allows doctors to reduce the size of the stomach, but with one big difference—no surgical incisions.

In the procedure, named Toga, for transoral gastroplasy, surgeons pass a stapler down the throat and staple the stomach from the inside, forming a thumb-sized tube that holds only a small amount of food. This gives patients a feeling of fullness after a small meal. The procedure is intended to be safer and easier for patients to tolerate than conventional obesity surgery. However, the procedure isn’t quite as simple as it sounds.

First, the patient is given general anesthesia and put on a respirator. Then the surgeons thread a dilator, a tube about three-quarters of an inch wide, down the patients’ throat to stretch the esophagus. The stomach is inflated with carbon dioxide to create a space to work. Next another wide tube, this one about two feet long, which contains the stapler, is inserted.

After the stapler is properly positioned, it is activated and a sail and curving wire emerges to help push aside the folds of the stomach. Then a vacuum pump is used to draw parts of the front and back walls of the stomach into the device to be stapled together. Three rows of staples are needed, but the stapler only holds one row. Consequently, the device has to be withdrawn, rinsed, reloaded, inserted back down the throat and repositioned for each row. The surgery takes about three hours.

After the surgery, the patient is placed on a liquid diet for several weeks and warned that eating too much or too fast could cause vomiting. Nutritionists say the best time to lose weight is in the 6 to 12 months following the surgery, because the body will try to fight the surgery by absorbing more nutrients. 

Over the past several years, 98 patients in Mexico and Europe have had the new weight-loss surgery. Those who have passed the one-year mark have lost about 40 percent of their excess weight, on average. But in the U.S., the procedure is strictly experimental and has been used on only a few patients as part of a study paid for by the device maker, Satiety Inc.

Satiety, Inc. was founded in 2001 through a collaboration of medical device incubators Thomas Fogarty Engineering and The Foundry, and is headquartered in Palo Alto, California. Other companies are also developing new devices and minimally invasive operations, but Satiety is among the first to start testing its products in people.

Karleen Perez, a 25-year-old graduate student in social work, was the second patient at New York-Presbyterian Hospital/Columbia to enter the study. Dr. Marc Bessler and Dr. Daniel Davis performed the procedure Ms. Perez, while Satiety employees advised. “It (the procedure) has a lot of promise,” Dr. Bessler said. “I deal with a lot of new technologies. This, I’m really excited about.” Dr. Bessler said that he and Dr. Davis had no financial interest in Satiety other than the company paying for their work on the study.

Dr. Philip Schauer, director of bariatric surgery at the Cleveland Clinic, called the new operation very promising and said that so far it seemed to offer “a drastic reduction in side effects and risk.” Dr. Schauer was not involved in the Toga study.