Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,146
- 试验地点
- 1
- 主要终点
- Patient-reported comorbidities
研究概览
简要总结
This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients. The data will be used in conjunction with clinical outcomes to determine quality, safety, and comparative effectiveness of various metabolic and bariatric procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All preoperative metabolic and bariatric surgery patients with a scheduled metabolic and bariatric surgery at a participating center are eligible for inclusion.
- •Postoperative metabolic and bariatric surgery patients must have had their surgery within the preceding year at a participating center.
排除标准
- •Metabolic and bariatric surgery patients without an already scheduled surgery date at a participating center.
- •Postoperative metabolic and bariatric surgery patients who are more than 1 year postop from a participating center.
研究组 & 干预措施
Preop Metabolic & Bariatric Patients
Attempted collection of patient-reported outcome measures preoperatively and annually postoperatively will occur with all metabolic and bariatric surgery patients scheduled for surgery at a participating center.
干预措施: Collection of patient-reported outcome measures (Other)
Postop Metabolic & Bariatric Patients
Attempted collection of patient-reported outcome measures annually postoperatively will occur with all metabolic and bariatric surgery patients who had surgery at a participating center within the preceding 12 months.
干预措施: Collection of patient-reported outcome measures (Other)
结局指标
主要结局
Patient-reported comorbidities
时间窗: annually postoperatively
patients will be asked to report their obesity-related comorbidities
Patient-reported Obesity-related Problems
时间窗: preoperatively and annually postoperatively
patients will be asked to complete the Obesity-related Problems Scale
Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10
时间窗: preoperatively and annually postoperatively
patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey
Patient-reported Obesity and Weight-loss Quality of Life
时间窗: preoperatively and annually postoperatively
patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument
次要结局
未报告次要终点
研究者
Matthew Hutter
Medical Director of the Codman Center
Massachusetts General Hospital