Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- body weight reduction
研究概览
简要总结
Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.
The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice.
Endpoints are quality of life, gastrointestinal function, and weight development.
详细描述
Two variations of gastric bypass are compared:
Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable.
Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.
FU time is set at 5 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
- Double (Investigator, Outcomes Assessor)
盲法说明
Randomisation in the OR, (closed envelopes, blocks of six) no further info to ward or follow-up unit. No specific info as to randomisation outcome given to patients, all patients follow same protocol.
Code number in operative charts.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 50-65
- •Age 18-55
- •Conservative attempts at weight reduction failed
排除标准
- •Inability to speak and understand the Swedish language
- •Residence outside the county of Skåne
- •Psychotic disease
- •Inflammatory bowel disease
结局指标
主要结局
body weight reduction
时间窗: 5 years
absolute BW reduction, percentage of patients reaching BMI below 30,
次要结局
- gastrointestinal function(5 years)