Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Primary endpoint
研究概览
简要总结
Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.
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, Outcomes Assessor)
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
- •informed consent as documented by signature
- •patients with BMI of 35 kg/m2 or higher who comply with the regulatory rules for bariatric surgery in Switzerland
排除标准
- •general contraindications to kind of surgery
- •known or suspected non-compliance, drug or alcohol abuse
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
- •participation in another study
- •age < 18 years or > 65 years
- •BMI > 60 kg/m2
- •height < 145 cm
- •CL length of < 180 cm as measured intraoperatively
- •ASA physical status classification > III
- •inflammatory bowel disease
结局指标
主要结局
Primary endpoint
时间窗: From baseline to 5 years after surgery.
Percent total weight loss (%TWL, superiority), while not leading to a larger nutritional de- ficiency rate (non-inferiority).
次要结局
- Secondary endpoints(From baseline to 5 years after surgery.)