Physicians at The University of Texas Medical School at Houston's Minimally Invasive Surgeons of Texas have enrolled the first patient in Texas in a clinical trial that will examine the safety and effectiveness of an incision-free procedure to treat obesity.
The investigational procedure is part of the multi-center TOGA Pivotal Trial. On Monday, Erik B. Wilson, MD, associate professor and director of the Division of Minimally Invasive and Elective General Surgery; and Brad Snyder, MD, assistant professor and director of clinical research for Minimally Invasive Surgeons of Texas, performed the first transoral gastroplasty (TOGA) procedure at Memorial Hermann-Texas Medical Center (TMC). Like other obesity procedures, such as gastric bypass, lap band and gastric sleeve surgeries, TOGA is designed to alter the patient's stomach anatomy to give a feeling of fullness after a small meal. The difference is that the procedure is performed without any cuts on the abdomen.
"This promising procedure allows us to do the entire surgery through the mouth, eliminating the need for even the smallest incision," said Wilson, principal investigator of the study's Houston site and also head of bariatric surgery at Memorial Hermann-TMC. "If the study results demonstrate that this is safe and effective, TOGA will be another tool bariatric surgeons can offer patients to help them be healthier and successful with long-term weight loss. It could be ideal for patients who need to lose a significant amount of weight to get healthy but don't like the idea of a more invasive surgery."
Surgeons performing the TOGA procedure put a set of flexible stapling devices into the stomach through the mouth and use them to create a restrictive pouch. The pouch is intended to catch food as it enters the stomach so that patients feel full faster and eat smaller portions. The TOGA Pivotal Trial will evaluate the safety and effectiveness of this new procedure for the treatment of morbid obesity. Patients whose body mass index, a weight-to-height ratio, is at least 40, or patients with a BMI between 35 and 40 who suffer from one or more obesity-related diseases, meet the clinical definition for morbid obesity.
Two out of three patients enrolled in the clinical trial will receive the TOGA procedure, while one out of three will receive a control procedure, which is similar to the TOGA procedure except no pouch is created. After one year, patients will be told which procedure they received, and patients who received the control procedure will be offered the TOGA procedure if they continue to meet the treatment criteria.
The UT Medical School at Houston is currently recruiting patients for the TOGA Pivotal Trial. Patients will be followed for a minimum of 12 months. Patients' healthcare insurance should cover the initial visit. Once they are approved, the pre-hospital testing, procedure and study-related medical care, including medically-supervised nutritional counseling, will be free of charge. The procedures will be performed at Memorial Hermann-TMC, and Wilson, Snyder and other specialists, including nurses and nutritionists on the bariatrics team, will provide follow-up care at the UT Specialty Surgery Center, 6700 W. Loop S.
"Obesity is an epidemic in the United States and throughout the world. Nearly one-third of adults in America are obese, and their excess weight contributes to heart disease, Type 2 diabetes, hypertension, stroke and other medical conditions, even cancer," Snyder said. "We offer surgical solutions - including gastric bypass, lap band and gastric sleeve procedures - that help morbidly obese patients lose excess weight, eliminate existing medical problems and reduce their risk of future weight-related health complications. We are excited to be a part of the TOGA trial so that we can test whether this is another viable choice for our patients who are considering weight-loss surgery."
Between February 2006 and July 2007, 47 patients had the TOGA procedure in a pilot study at medical centers in Mexico and Belgium. They weighed an average of almost 120 pounds over their ideal body weight. Six months after the procedure, patients had lost more than a third of their excess body weight, and at 12 months, their excess weight loss averaged almost 40 percent.
"People who have gastric bypass surgery tend to lose more weight more rapidly than what we saw in the TOGA pilot study, but gastric bypass is not for everyone," Wilson said. According to the American Society for Metabolic and Bariatric Surgery, approximately 200,000 patients had weight-loss surgery in 2007. That number is estimated to be less than 2 percent of the eligible patient population.
"This endoscopic procedure may be an option for severely obese patients who are considered too high risk for laparoscopic or open surgery," Wilson said. "We expect the incision-free procedure may also result in a faster recovery period, shortened hospital stay and decreased risk of complications. One concern we do have is that the procedure may not have long-term durability. The stomach may eventually stretch, and patients who have initial success with weight loss may begin to regain weight. That's one of the things we hope to determine with this study."
The TOGA study will investigate the technique in at least 275 patients at centers across the United States. Wilson and Snyder will enroll at least 30 volunteers for the trial. Patients who are between 18 and 60 years of age, approximately 100 or more pounds overweight, and have been unsuccessful with non-surgical weight loss methods may qualify to participate in this study. Patients with a recent heart attack, stroke, chest pain or severe reflux disease are not eligible.