Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Weight reduction
研究概览
简要总结
Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.
The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.
The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.
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
- Single (Participant)
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
- •Patient eligible for bariatric surgery according Fried guidelines
- •Primary Gastric bypass
- •BMI 35 - 40 with a comorbidity
- •or BMI > 40
排除标准
- •Exclusion criteria for bariatric surgery (Fried Guidelines)
- •Patients with language problems that interveins to follow medical advises
- •Genetic diseases that intervens to follow medical advises
- •Chronic bowel diseases
- •Nephrologic (MDRD <30) of liver diseases (AST/ALT more than twice the norm)
- •Pregnancy
结局指标
主要结局
Weight reduction
时间窗: 2 years
Excess weight loss (%EWL)
次要结局
- Change in comorbidities(2 years)