Plicated Laparoscopic Adjustable Gastric Banding Study

Prospective Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.

This is a prospective clinical trial comparing experimental plicated adjustable gastric banding versus standard adjustable gastric banding. All enrolled patients will choose to either standard (control group) banding or plication (study group) banding. Each patient will complete a standardized survey rating their satisfaction from surgery, their satiety levels and Green Zone Patient Questionnaire at each visit.

Inclusion Criteria:

• Age older than 18 years
• Morbidly Obese
• BMI >40 or
• BMI >35 plus co-morbid obesity related disease conditions
• Without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease
• Without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, Prader-Willi

Exclusion Criteria:

• Any patient not meeting the inclusion criteria
• Patients with any major medical problems contraindicating surgery
• Patients with a medically treatable cause of obesity
• Patients who elect to undergo a surgery other than Plication adjustable gastric banding or standard adjustable gastric banding
• Alcohol or drug addiction
• Established infection anywhere in the body at the time of surgery
• Previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis
• Family or patient history of autoimmune disease