作者: Louis F. Martin , Gerard J. Smits , Robert J. Greenstein
DOI: 10.1016/J.AMJSURG.2007.03.002
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摘要: 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) trial B (1 year)—with ongoing safety follow-up. These trials were conducted United States community university hospitals (trial = 8 sites 12 sites). Trial comprised 292 subjects (mean ± SD preoperative weight: 133 kg 24.4), 193 (129 20.8). Intervention included placement constrictive, band around upper stomach to limit food intake induce weight loss. Main outcome measures primary efficacy end point Secondary end-points change quality-of-life, parameters, complications, including slippage, reoperation, device explantation. Results In trials, 485 devices implanted (92% laparoscopically), no deaths occurred. Of patients A, 206 (70.5%) completed 3-year follow-up, 142 (73.6%) 1-year Weight-loss results, using last value carried forward, for all demonstrated mean body mass index (kg/m2) from 47.4 7.0 39.0 7.3 46.7 7.8 38.4 7.6 at 1 year (P < .001 both B), with minimal further 3 years (39.0 8.5) subjects. percentage initial lost was 17.7% 9.4% 18.2% 8.9% subjects, whereas total 18.3% 13.1%. At year, 76% 66% had mostly related gastrointestinal symptoms. By 9 after surgery, 33% (96 292) their explanted because complications or inadequate loss. Conclusions These first-generation suggest this viable bariatric therapeutic option treatment obesity.