Bariatric Surgery: Outcomes & Impact on Pathophysiology

减肥手术：结果

• 批准号: 8727908
• 负责人: PAUL David BERK
• 金额: $ 16.5万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8727908
• 关键词: Achievement; Address; Ancillary Study; Bariatrics; Blood; Body Weight decreased; Caring; Cessation of life; Characteristics; Clinical; Communities; Community Hospitals; Comorbidity; DNA; Data; Data Collection; Data Element; Databases; Disease; Enrollment; Epidemic; Functional disorder; Funding; Genetic Markers; Goals; Grant; Guidelines; Health; Heterogeneity; Hypoglycemia; Individual; Instruction; Life Expectancy; Longitudinal Studies; Medical; Metric; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Operative Surgical Procedures; Outcome; Paper; Participant; Pathogenesis; Patients; Peer Review; Persons; Procedures; Protocols documentation; Publications; Recruitment Activity; Research; Research Infrastructure; Safety; Sampling; Serological; Suicide; Surgeon; System; Time; Urine; bariatric surgery; base; care delivery; cohort; cost; design; economic outcome; follow-up; health economics; meetings; operation; patient population; psychosocial; repository

The Longitudinal Assessment of Bariatric Surgery (LABS) was conceived to address important issues in bariatric surgery and in disease pathogenesis and pathophysiology in the obese and morbidly obese. LABS explores relationships among patient characteristics, clinical conditions and co-morbidities, serologic and genetic markers, surgical procedures and other aspects of care, with clinical, psychosocial and health economic outcomes. LABS' primary achievements in its first 5 years have been to define the domains of exploration, identify appropriate metrics, and design and implement two major and several more restricted protocols. By 12/31/2007 LABS had completed enrollment and initial surgery in a cohort of 4,772 obese patients (median BMI 46.5) to study short-term safety of bariatric surgery (LABS-1), and as of October 13, 2008 had enrolled and completed surgery in 1,991 of the planned 2,400 person cohort in whom longer-term safety and efficacy will be studied (LABS-2). These studies employ the rigorous research infrastructure the LABS has built at 6 Clinical Centers representing diverse care delivery systems and patient populations. LABS patients are enrolled at 6 academic & 4 affiliated community hospitals, undergoing operations by 33 surgeons. The result is a unique LABS-2 cohort with heterogeneous patient characteristics undergoing a diversity of surgical procedures. LABS is now seeking funding for a 5 year extension to enable it to address scientifically important research questions from the LABS-2 study that cannot be addressed with the limited follow-up currently supported. This extension would permit LABS to evaluate the durability of weight loss and comorbidity improvement, as well increasingly recognized late-emerging effects of surgery such as hypoglycemia and suicide, and effects that change over time. The critical scientific advantages of the multi- center LABS consortium include heterogeneity of the participant base, the ability to recruit a large number of patients in important sub-groups, and an existing research infrastructure with rigorous data collection practices, high levels of data accuracy and completeness, rigorous follow-up, and a comprehensive database of cleariy defined data elements to address these important issues. RELEVANCE (See instructions): The obesity epidemic has profound health issues, e.g. -300,000 deaths/year, a reduction in life expectancy, and enormous costs. Bariatric surgery seems the most reliable means to major weight loss and correction of co-morbidities (e.g. type 2 diabetes). While its safety & long-term benefit remain uncertain, ~250,000 annual operations are expected. This proposal seeks to extend LABS studies that will answer many of these issues.

对减肥手术（实验室）的纵向评估是为了解决重要问题 肥胖和病态肥胖的减肥手术以及疾病发病机理和病理生理学。实验室 探索患者特征，临床状况和合并症之间的关系，血清学和 遗传标记，手术程序和护理的其他方面，以及临床，社会心理和健康 经济成果。实验室在头5年中的主要成就是定义的 探索，确定适当的指标，设计和实施两个主要和几个受限制的指标 协议。到2007年12月31日，实验室已经完成了4,772个肥胖的队列的入学和初次手术 患者（BMI 46.5）研究减肥手术的短期安全性（LABS-1），截至10月13日， 2008年在计划的2,400人群中，已经参加并完成了手术 将研究安全性和功效（LABS-2）。这些研究采用了严格的研究基础设施 实验室已建立了6个临床中心，代表了不同的护理输送系统和患者人群。 实验室患者已入学6个学术和4个附属社区医院，经营33次。 外科医生。结果是一个独特的Labs-2队列，具有非均匀患者特征 手术程序的多样性。实验室现在正在寻求5年延长的资金，以使其能够解决 实验室-2研究中的科学重要研究问题无法与有限有关 当前支持后续行动。此扩展将允许实验室评估减肥的耐用性 和合并症的改善，以及越来越多地认识到手术的晚期作用，例如 低血糖和自杀，以及随着时间的变化的影响。多数的关键科学优势 中心实验室财团包括参与者基础的异质性，招募大量的能力 重要的子组中的患者以及具有严格数据收集的现有研究基础设施 实践，高水平的数据准确性和完整性，严格的随访以及全面 清晰定义的数据元素的数据库，以解决这些重要问题。 相关性（请参阅说明）： 肥胖症流行有严重的健康问题，例如-300,000次死亡/年，预期寿命降低， 和巨大的成本。减肥手术似乎是重量减肥和纠正的最可靠手段 合并症（例如2型糖尿病）。虽然其安全性和长期利益仍然不确定，但每年约25万 期望运营。该建议旨在扩展实验室研究，以回答许多此类问题。