Experimental Oral Obesity Surgery
Bariatric surgery is any surgery performed to modify the gastrointestinal system of individuals who are obese for the purpose of helping them lose weight. For many years, these types of procedures been performed with minimally invasive laparoscopic surgery, or through the use of several small incisions rather than one long incision. Laparoscopic procedures tend to require shorter hospital stays and recovery periods and threaten less risk of infection for the patient. New advancements in technology could reduce the recovery and risk of bariatric surgery even further. These experimental procedures involve accessing the patient's gastrointestinal system through the mouth, or transorally.
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Transoral Gastroplasty
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One of these experimental procedures is called Transoral Gastroplasty, or TOGA. With TOGA, the patient is placed under general anesthesia. The surgeon then inserts a stapler device through the mouth and into the stomach. An instrument called an endoscope is also inserted. An endoscope is a long, flexible device that allows the doctor to see inside the body. The stapling device uses suction to gather a fold of the stomach into a sleeve shape, which is then stapled. A second device is inserted to narrow the bottom of the sleeve. This creates a pouch that collects food, making patients feel full after eating smaller quantities of food.
Clinical Trials
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Clinical trials for TOGA involve a group of participants selected to participate in a randomized, sham-controlled study. A sham-controlled study means that some participants receive the surgery, and up to a third of the participants receive what is known as a sham surgery. In a sham surgery, the patient is anesthetized and the TOGA device is inserted, but no pouch is formed. Patients are not told if they received the actual surgery or the sham surgery. Both groups of patients are then monitored to determine effectiveness and safety of the procedure, and its effects on quality of life and obesity-related conditions. Those patients receiving the sham surgery may be eligible to receive the actual procedure after 12 months. Nine hospitals in the US are participating in the trial, which involves 275 patients.
Eligibility
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To be eligible for the study, patients must be between the ages of 18 and 60, with a body mass index (BMI) greater than 40, or greater than 35 with one or more significant co-morbidities. Co-morbidities are conditions that are commonly associated with morbid obesity, such as diabetes, high blood pressure, or heart disease. The patients must have a history of obesity for at least two and a half years, and a proven history of an inability to lose weight through non-surgical methods. They must also have had a stable weight that has not fluctuated more than ten percent for at least one year prior to the study.
Exclusion Criteria
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Some patients who meet the above requirements may not be eligible for the study if they have other disqualifying conditions. These include a genetic cause for the obesity, a history of cancer, or a history of gastrointestinal inflammatory disease such as Crohn's disease. Patients with neck and jaw problems, such as an inability to fully open the mouth or a risk of developing temporomandibular joint (TMJ) syndrome are also not eligible. Pregnant or nursing women may not participate.
Results
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Because there are no incisions that require healing or are at risk of infection, the recovery period for transoral procedures is expected to be significantly shorter than for traditional bariatric surgery. Since transoral procedures are in the investigational state, there is no information available about long-term results. Patients are expected to lose up to sixty percent of excess body weight.
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