Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- BMI
研究概览
简要总结
The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index [BMI] > 50 kg/m2).
详细描述
Surgery is the only treatment of morbid obesity that has proven to result in efficient and long lasting weight loss. There are few studies comparing different surgical techniques, especially in a randomized setting.
Superobesity (BMI > 50 kg/m2) demands an efficient surgical approach to result in satisfying weight loss. Laparoscopic techniques have been established to perform Roux-en-Y Gastric bypass and Biliopancreatic Diversion with Duodenal Switch which both are good options for treating superobesity.
This study aims to compare the outcome after surgery in a broad perspective (weight loss, metabolic normalization, gastro-intestinal side effects, eating patterns, body composition, health economics). Patients will be randomized to either surgical procedure and will be followed for five years.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 50-60 kg/m2
排除标准
- •Prior obesity operation
- •Prior major abdominal surgical procedure
- •Severe disabling cardiopulmonary disease
- •Malignancy
- •Oral steroid treatment
- •Condition associated with poor compliance
结局指标
主要结局
BMI
时间窗: 5 y
Metabolic normalization
时间窗: 5y
Gastro-intestinal side effects
时间窗: 5y
次要结局
- Health economics(5y)
- Vitamin/mineral deficiencies(5y)
- Body composition(5y)
- Quality of life(5y)
- Eating pattern(5y)