The Safety and Efficacy of Bariatric Surgery: The Longitudinal Assessment of Bariatric Surgery (LABS)

Background—Obesity is a leading health concern in the United States. Since traditional treatment approaches for weight loss are generally unsuccessful long-term 1, bariatric surgical procedures are increasingly being performed to treat extreme obesity. To facilitate research in this field, the National Institute of Diabetes and Digestive and Kidney Diseases responded to this knowledge gap by establishing the Longitudinal Assessment of Bariatric Surgery (LABS) consortium. Methods—A competitive NIDDK grant process resulted in the creation of a group of investigators with expertise in bariatric surgery, internal medicine, endocrinology, behavioral science, outcomes research, epidemiology, biostatistics and other relevant fields who have worked closely to plan, develop, and conduct the LABS study. The LABS consortium protocol is a prospective, multi-center observational cohort study of consecutive patients undergoing bariatric surgery at six clinical centers. LABS includes an extensive database of information systematically collected pre-operatively, at surgery, and perioperatively during the 30 day post-operative period, and longer term. Results—The LABS study is organized into three phases. LABS-1 includes all patients at least 18 years of age who undergo bariatric surgery by LABS-certified surgeons with the goal to evaluate the short-term safety of bariatric surgery. LABS-2, a subset of approximately 2400 LABS-1 patients, evaluates the relationship of patient and surgical characteristics to longer-term safety and efficacy of bariatric surgery. LABS-3 involves a subset of LABS-2 subjects who undergo detailed studies of mechanisms involved in weight change. The rationale, goals, and approach to study bariatric surgery are detailed in this report along with a description of the outcomes, measures, and hypotheses utilized in LABS-1 and -2. Conclusions—The goal of the LABS consortium is to accelerate clinical research and understanding of extreme obesity and its complications by evaluating the risks and benefits of bariatric surgery. LABS investigators use standardized definitions, high fidelity data collection, and validated instruments to enhance the ability of clinicians to provide meaningful evidencebased recommendations for patient evaluation, selection for surgery, and follow-up care.

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