Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Body weight reduction
研究概览
简要总结
Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.
Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.
详细描述
Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.
Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 50
排除标准
- •Psychiatric disease
- •Inflammatory bowel disease
- •inability to understand Swedish
结局指标
主要结局
Body weight reduction
时间窗: 2 years from end of inclusion
Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.
次要结局
- Patient assessed quality of life(2 years from end of inclusion)
研究者
Jan Hedenbro
Senior scientist
Aleris Obesity