Longitudinal Assessment of Bariatric Surgery (LABS-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,458
- 试验地点
- 9
研究概览
简要总结
The primary objective of LABS-2 is to use standardized techniques and measures to assess the longer-term safety and efficacy of bariatric surgery by:
- comparing post-surgical outcomes to pre-operative status
- examining risks and benefits of surgery.
LABS-2 will determine the associations between clinical/demographic patient characteristics, components of the surgical procedure, and peri-operative and post-operative care with post-operative risks and changes in patient status.
Funds are not available to pay for the surgery for patients, only to address research questions.
详细描述
The primary goal of LABS-2 is to evaluate the efficacy and safety of bariatric surgery over a longer term than LABS-1, i.e., more than 30 days. Using a sample of the LABS-1 cohort, approximately 2,400 patients, will be recruited over 3 years. LABS-2 will include clinical assessments and detailed interviews and questionnaires pre-operatively and at several post-operative time points (30 days, 6 months, 12 months following surgery, and annually thereafter) to assess risks of surgery, and changes in clinical, metabolic, and psychosocial characteristics in patients, and health care utilization following bariatric surgery. Detailed data about the surgical procedure and peri- and post-operative care will also be collected to determine if components of the surgical procedure, and peri-operative and post-operative care as well as clinical/demographic patient characteristics are associated with post-operative risks and changes in patient status. Patients enrolled in LABS-2 will provide blood specimens pre-operatively and post-operatively to address LABS-2 hypotheses and additional samples will be stored at the NIDDK tissue repository for serologic, pathologic and genomic testing of other hypotheses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon
- •Previous enrollment in LABS-1
- •Selected by algorithm to be included in LABS-2
排除标准
- •Informed consent not obtained
- •Prior bariatric surgery
- •Unlikely to comply with follow-up protocol
- •Unable to communicate with local study staff
研究者
Steven Belle
Professor
University of Pittsburgh
