Treating morbid obesity with laparoscopic adjustable gastric banding

Abstract Background Morbid obesity results in multiple comorbidities and an increased mortality rate. The National Institutes of Health has stated that surgery is the most effective long-term therapy; therefore, we evaluated a laparoscopically implantable adjustable gastric band. Methods We reviewed 2 multicenter prospective, open-label, single-arm surgical trials—trial A (3 years) and trial B (1 year)—with ongoing safety follow-up. These trials were conducted in United States community and university hospitals (trial A = 8 sites and trial B = 12 sites). Trial A comprised 292 subjects (mean ± SD preoperative weight: 133 kg ± 24.4), and trial B comprised 193 subjects (129 kg ± 20.8). Intervention included placement of a constrictive, adjustable band around the upper stomach to limit food intake and induce weight loss. Main outcome measures were the primary efficacy end point of weight loss. Secondary end-points were change in quality-of-life, safety parameters, and complications, including band slippage, reoperation, and device explantation. Results In the 2 trials, 485 devices were implanted (92% laparoscopically), and no deaths occurred. Of the patients in trial A, 206 (70.5%) completed the 3-year follow-up, and 142 (73.6%) of patients in trial B completed the 1-year follow-up. Weight-loss results, using the last value carried forward, for all 292 patients in trial A and all 193 patients in trial B demonstrated a change in mean body mass index (kg/m2 ) ± SD from 47.4 ± 7.0 to 39.0 ± 7.3 in trial A and from 46.7 ± 7.8 to 38.4 ± 7.6 in trial B subjects at 1 year ( P < .001 for both trials A and B), with minimal further change at 3 years (39.0 ± 8.5) in trial A subjects. The percentage of initial body weight lost at 1 year was 17.7% ± 9.4% for trial A subjects and 18.2% ± 8.9% for trial B subjects, whereas the 3-year total for trial A subjects was 18.3% ± 13.1%. At 1 year, 76% of patients in trial A and 66% of patients in trial B had complications, mostly related to upper gastrointestinal symptoms. By 9 years after surgery, 33% (96 of 292) of trial A subjects had their devices explanted because of complications or inadequate weight loss. Conclusions These first-generation implantable adjustable gastric band results suggest that this is a viable bariatric surgery therapeutic option for the treatment of obesity.