Safety and efficacy of bariatric surgery: Longitudinal Assessment of Bariatric Surgery
Safety and efficacy of bariatric surgery: Longitudinal Assessment of Bariatric Surgery
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DOI：
10.1016/j.soard.2007.01.006
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发表时间：
2007-03-01
影响因子：
3.1
通讯作者：
Yanovski, Susan Z.
中科院分区：
文献类型：
--
作者：
Belle, Steven H.;Berk, Paul D.;Yanovski, Susan Z.
背景：肥胖是美国主要的健康问题。由于传统的减肥治疗方法在长期内通常是不成功的，因此越来越多地进行减肥外科手术来治疗极度肥胖。为了促进这一领域的研究，国家糖尿病、消化和肾脏疾病研究所通过建立减肥手术纵向评估（LABS）联盟来应对这一知识缺口。一个竞争激烈的国家糖尿病、消化和肾脏疾病研究所的拨款过程导致了一组具有减肥手术、内科、内分泌学、行为科学、成果研究、流行病学、生物统计学和其他相关领域。这些研究者密切合作，计划、开发和开展LABS研究。LABS联盟方案是一项前瞻性、多中心观察性队列研究，在6家临床中心接受减肥手术的连续患者中进行。LABS包括一个广泛的数据库的信息系统收集术前，在手术中，围手术期在术后30天期间，和long-term。结果：LABS研究已被组织成3个阶段。LABS-1将包括所有≥ 18岁的患者，这些患者接受了由LABS认证的外科医生进行的减肥手术，目的是评估减肥手术的短期安全性。LABS-2是约2400例LABS-1患者的子集，将评价患者和手术特征与减肥手术长期安全性和有效性的关系。LABS-3将涉及LABS-2受试者的一个子集，这些受试者将接受有关体重变化机制的详细研究。本报告详细介绍了减肥手术研究的基本原理、目标和方法，沿着描述了LABS-1和LABS-2中使用的结局、测量方法和假设。结论：LABS联盟的目标是通过评估减肥手术的风险和益处来加速对极端肥胖及其并发症的临床研究和理解。实验室研究人员使用标准化的定义，高保真的数据收集和验证的工具，以提高临床医生的能力，为患者评估，手术选择和随访护理提供有意义的循证建议。(Surg Obes Relat Dis 2007;3：116-126.）(C)2007年美国肥胖外科学会。All rights reserved.
Background: Obesity is a leading health concern in the United States. Because traditional treatment approaches for weight loss are generally unsuccessful in the long term, 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 National Institute of Diabetes and Digestive and Kidney Diseases 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. These investigators have worked closely to plan, develop, and conduct the LABS study. The LABS consortium protocol is a prospective, multicenter observational cohort study of consecutive patients undergoing bariatric surgery at 6 clinical centers. LABS includes an extensive database of information systematically collected preoperatively, at surgery, perioperatively during the 30-day postoperative period, and longer term.Results: The LABS study has been organized into 3 phases. LABS-1 will include all patients >= 18 years of age who have undergone 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, will evaluate the relationship of patient and surgical characteristics to the longer term safety and efficacy of bariatric surgery. LABS-3 will involve a subset of LABS-2 subjects who will 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 used in LABS-1 and -2.Conclusion: 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 evidence-based recommendations for patient evaluation, selection for surgery, and follow-up care. (Surg Obes Relat Dis 2007;3:116-126.) (C) 2007 American Society for Bariatric Surgery. All rights reserved.