Cedars-Sinai Tries Endoscopic Obesity Procedure

LOS ANGELES — Doctors at Cedars-Sinai Medical Center in Los Angeles this week performed the first two non-surgical procedures in the Western United States that restrict the size of the stomach to treat obesity.

The medical staff used direct endoscopic visualization with specialized instruments passed into the stomach through the mouth. The patients were both women, age 34 and 40.

The experimental procedures were part of the TOGA Pivotal Trial, a Phase III, multi-center study that evaluates an incision-free procedure using the TOGA® System (transoral gastroplasty).

Like conventional “open” surgery or laparoscopic band procedures to treat obesity, the TOGA procedure is designed to alter a patient's anatomy to give a sense of fullness after a small meal. The difference is that the investigational technique delivers the treatment through the mouth, without incisions.

The first procedure took almost two hours and the second procedure took 90 minutes, according to Edward Phillips, MD, and Gregg Kai Nishi, MD, surgeons in the hospital’s Center for Weight Loss Surgery.

“Everything went exactly as planned,” Phillips said.

This investigational procedure represents a potential new approach to weight loss surgery.

“If this non-surgical procedure provides results that are comparable to those of conventional weight loss surgeries, it may provide a good option for patients who need to lose a significant amount of weight but do not wish to have surgery,” said Phillips, who is executive vice-chairman of the department of surgery and chief of general surgery at Cedars-Sinai.

In the TOGA procedure, a set of flexible stapling devices are delivered through the mouth into the stomach, and the staples create a restrictive pouch for food.

In a pilot study being conducted at medical centers in Belgium, Mexico and Italy, 93 subjects have had the procedure since February 2006.

During this year’s Digestive Disease Week, data on 29 of these patients were presented and showed that before the procedure, patients weighed an average of almost 130 pounds over their ideal body weight. The 27 subjects who reached the six-month interval had lost almost 40 percent of their excess body weight, and the nine patients who reached the 12-month interval had lost almost 50 percent of their excess weight.

"That's less than we typically see with gastric bypass surgery," said Nishi. “However, when compared to laparoscopic or open surgeries, endoscopic procedures generally result in quicker recoveries, shorter hospital stays, and fewer complications.”

Both of the Cedars-Sinai patients were given general anesthesia when receiving the TOGA procedure and stayed overnight for observation. However, Phillips anticipates that the procedure will eventually be performed on an outpatient basis with sedation rather than general anesthesia, depending on the study's results.

The TOGA study will investigate the technique in at least 275 patients at centers across the United States.

For more information about the TOGA study, call (866) 678-8399 or click here.  

Source: Cedars-Sinai Medical Center