The first patient in the New York City area received incision free surgery for obesity as part of the ongoing multicenter TOGA Pivotal Trial at NewYork-Presbyterian Hospital/Columbia University Medical Center.
Drs. Marc Bessler and Daniel Davis performed the TOGA Procedure (for "transoral gastroplasty"), which, like other obesity procedures, is designed to alter the patient's stomach anatomy to give them a feeling of fullness after a small meal. The difference is that TOGA was performed under direct endoscopic visualization with specialized instruments passed into the stomach through the mouth without any incisions.
"This new surgery is an exciting option for severely overweight patients who do not respond to diet, exercise and drug therapy. We hope to show that, like other weight-loss operations, the TOGA procedure will help them to lose weight and improve their health," says Dr. Bessler, principal investigator and director of laparoscopic surgery and director of the Center for Obesity Surgery at NewYork-Presbyterian/Columbia. He is also an assistant professor of surgery at Columbia University College of Physicians and Surgeons.
In the new procedure, the surgeon introduces a set of flexible stapling devices through the mouth into the stomach, and uses them to create a restrictive pouch that is intended to catch food as it enters the stomach, giving patients a feeling of fullness after a small meal.
"The benefits of an endoscopic approach are less pain, quicker recovery, shortened hospital stay and decreased complications, as well as a lack of scarring," says study co-investigator Dr. Davis, a surgeon at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of surgery at Columbia University College of Physicians and Surgeons. "Eventually, TOGA may also be an option for patients who are unable or unwilling to undergo more invasive surgery."
A 2006 - 2007 pilot study at medical centers in Mexico and Belgium found that patients receiving the TOGA procedure lost more than a third of their excess body weight. By 12 months, their excess weight loss averaged almost 40 percent.
In the current study, two out of three patients 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.
Patients enrolled in the clinical trial will be followed for a minimum of 12 months. All study-related medical care will be provided at no charge to the patient, and patients will receive medically supervised nutritional counseling.
The purpose of the TOGA Pivotal Trial is to evaluate the safety and effectiveness of the TOGA procedure. Investigators will be evaluating weight loss and changes in obesity-related health problems such as Type 2 diabetes, cholesterol levels and hypertension. If successful, it's hoped that this study will result in FDA approval of the TOGA System, which will allow patients to be treated outside of clinical trials. Currently, the TOGA System is an "investigational device" and can only be used in clinical studies.
NewYork-Presbyterian/Columbia plans to enroll at least 15 patients out of a total 275 patients to be enrolled at centers nationwide. Volunteers must be 18 to 60 years old and 100 pounds or more overweight, and must have been unsuccessful with non-surgical weight-loss methods.
Obesity is a global disease affecting over 300 million people, according to the World Health Organization. Obesity causes or contributes to numerous serious medical conditions, including Type 2 diabetes, hypertension, cardiovascular disease, arthritis, sleep apnea and certain types of cancer.
Source: Medical News Today
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