Treating morbid obesity with laparoscopic adjustable gastric banding

• Published in: The American journal of surgery Vol. 194; no. 3; pp. 333 - 343
• Main Authors: Martin, Louis F., Smits, Gerard J., Greenstein, Robert J.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2007; Elsevier Limited
• Subjects: Adjustable gastric banding; Adult; Body mass index; Clinical trials; Comorbidity; Female; Gastrointestinal surgery; Gastroplasty - methods; Humans; Indigent care; LAP-BAND; Laparoscopy; Male; Morbid (severe) obesity; Mortality; Obesity; Obesity, Morbid - surgery; Ostomy; Prospective Studies; Quality of life; Restrictive bariatric surgery; Safety; Surgery; Surgical techniques; Weight loss; Restrictive bariatric surgery; Morbid (severe) obesity; Weight loss; Clinical trials; Laparoscopy; Safety; Adjustable gastric banding; LAP-BAND; Quality of life
• ISSN: 0002-9610; 1879-1883; 1879-1883
• DOI: 10.1016/j.amjsurg.2007.03.002

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. 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. 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/m 2) ± 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. These first-generation implantable adjustable gastric band results suggest that this is a viable bariatric surgery therapeutic option for the treatment of obesity.