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BACKGROUND: In the United States, 60 million people are considered obese. Nine million of those individuals are morbidly obese, meaning they weight more than 100 pounds over their ideal body weight. Bariatric surgery has been a life-saving option for many people struggling with obesity. It works by changing the anatomy of a person's digestive system, limiting the amount of food that can be digested. Gastric bypass has been the most popular form of bariatric surgery in the United States, but in some cases the risks of the major invasive surgery outweigh the potential benefits. In gastric bypass, a surgeon creates a small pouch at the top of the stomach and adds a bypass around a segment of the stomach and small intestine. The surgeon staples the stomach across the top, sealing it off from the rest of the stomach. The resulting pouch is about the size of a walnut and can hold only about an ounce of food. Gastric bypass surgery has evolved from an open procedure, during which surgeons create one large, long incision in the abdomen, to a laparoscopic procedure that utilizes several small incisions, to now a surgery-free option.

BYPASS WITHOUT SURGERY: An investigational procedure that allows surgeons to restrict the size of the stomach without performing surgery is showing promise in study trials. The procedure is done under direct endoscopic visualization with a specialized set of instruments, called the TOGA System, that are passed into the stomach through the mouth. During the TOGA procedure, the surgeon feeds a set of flexible stapling devices down the mouth, into the stomach and then uses the staplers to create the restrictive pouch characteristic of gastric bypass surgery. Dr. Brent Miedema of the University of Missouri says the new pouch is about the size of a small hot dog. For comparison, before surgery a stomach can hold the contents of a one liter bottle. Dr. Miedema also believes this procedure is safer than both gastric bypass and the Lap-Band procedure because it doesn't require a foreign body be left behind, like in the Lap-Band surgery, and unlike gastric bypass does not come with as many concerns about nutritional deficiencies. Dr. Miedema says the major risks for this procedure are perforation of the esophagus or the stomach during the procedure. With all gastric procedures patients will have restrictions on how much they can eat after the pouch is created. Dr. Miedema says all of the procedures help patients fight diabetes, back, and joint problems.

THE TRIAL: The TOGA procedure underwent a pilot study between February 2007 and July 2007 at medical centers in Mexico and Belgium. The University of Missouri and Washington University in St. Louis are the only two centers in Missouri participating. During the study, 47 subjects who weighed an average of 120 pounds over their ideal body weight had the procedure. Six months after the procedure, the subjects had lost more than a third of their excess body weight, and by 12 months, their excess weight loss averaged nearly 40 percent. For comparison gastric bypass patients can expect a 60 percent loss of excess weight, according to Dr. Miedema. The United States TOGA Pivotal Study, which is currently underway, plans to test the procedure in at least 275 patients at centers across the nation. The study has been approved by the FDA (via an investigational device exemption) and results will be used to seek approval to market the TOGA system. To enroll in the trial, patients must be 18 to 60 years old and more than 100 pounds overweight. Lighter patients may be considered if they suffer from type 2 diabetes or high blood pressure. Depending on the study's results, researchers say the TOGA procedure could potentially be performed on an outpatient basis with sedation rather than general anesthesia. MU will enroll 30 people in it's trial. But not all patients who enter the trial at MU will get the procedure done right away. Dr. Miedema says it's a "blind" trial. That means for every two patients who get the TOGA procedure done, one does not. After one year the weight loss of the two groups will be compared and those who got the "sham" procedure will be offered TOGA for free.

AVAILABLE IN MID-MISSOURI: University of Missouri Health Care is recruiting approximately 22 more patients for the TOGA study. Dr. Miedema says for every 200 inquiries about 10 people are considered. He says many do not qualify or follow through with the process. Rosie Edwards of New Bloomfield was one of the first two patients in the trial. Only those two were guaranteed to get the procedure right away. Edwards says it's helped her stop eating so much. "I never had a shut off valve," Edwards remembers. "You know I could eat and eat and eats and never get full. With this, the way they've reshaped the stomach pouch you know and made it smaller, I get that sensation of full and so now I'm full and do not feel like I need to keep eating." Edwards has lost 23 pounds in the first six weeks. Edwards, and all study participants will have the procedure done for free. Dr. Miedema believes when it's FDA approved, TOGA will cost about $12,000-$13,000, half of the price of gastric bypass surgery.

For more information call 1-866-678-8399 or visit the following link to the TOGA study.