Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled 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
- Percentage total body weight loss (%TBWL)
研究概览
简要总结
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
详细描述
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
The Study design is a prospective, randomized, single center study.
Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.
Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who are eligible for a primary RYGB
排除标准
- •Bariatric surgery in history
- •Patients with a language barrier which may affect the compliance with medical advice
- •Any kind of genetic disorders which can be of influence on the monitoring of medical advice
- •Patients with a disease not related to morbid obesity, such as Cushing or drug related.
- •Chronic bowel disease for example Crohn's disease or colitis Colitis.
- •Renal impairment (MDRD <30) or hepatic dysfunction (liver function twice the normal values)
- •Pregnancy
- •Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
结局指标
主要结局
Percentage total body weight loss (%TBWL)
时间窗: 3 years
weight loss is measured in kilogram.
次要结局
- Decrease in dyslipidaemia(3 years)
- Decrease in type 2 diabetes mellitus(3 years)
- percentage total body weight regain (%TBWR)(3 years)
- Percentage excess weight loss (%EWL)(3 years)
- Quality of life(3 years)
- Decrease in hypertension(3 years)