NCT03838276Unknown3 期
Ponderal Outcomes After Roux-en-Y Gastric Bypass With Alimentary Limb (AL) of 150cm and Biliopancreatic Limb (BPL) of 100cm vs AL 100cm and BPL 150cm
Hospital General Universitario Elche0 个研究点目标入组 200 人开始时间: 2019年2月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 主要终点
- Weight loss
研究概览
简要总结
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:
- Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm
- Group 2: AL 100cm and BPL 150cm
Weight loss will be evaluated 1 year after surgery
详细描述
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:
- Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm
- Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm
Weight loss will be evaluated 1 year after surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 40 Kg/m2
- •BMI > 35 Kg/m2, associated with obesity-related comorbidities
- •Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
排除标准
- •Patients undergoing Roux-en-Y gastric bypass as revisional procedure
- •Patients lost to follow-up
研究组 & 干预措施
AL150 BPL100
Active Comparator
Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
干预措施: AL 150 BPL100 (Procedure)
AL100 BPL150
Experimental
Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb
干预措施: AL 100 BPL 150 (Procedure)
结局指标
主要结局
Weight loss
时间窗: 1 year after surgery
Weight loss will be assessed 1 year after surgery
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche
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