Randomized Single Blinded Trial of Gastric Imbrication versus Sleeve Gastrectomy for WeighT Loss
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome is Excess Weight Loss: Depending upon the type of surgery,36 % to 90 % of excess body weight will be lost over a period of 6 months to two years. Patients may lose 30 to 50 % of their excess weight in the first 6 months and ~ 77 % as early as 12 months after surgery.
研究概览
简要总结
This is a randomized Single Blinded Trial of the Gastric Imbrications surgery versus Sleeve Gastrectomy Surgery for weight loss. The main objective of this study is to provide a surgery for weight loss which is reversible and having minimum complications. Total numbers of patients for this study are 60 either male or female and having their BMI 35 or more than that. The site for this study is Asian surgicentre, Ahmedabad and study duration is of 18 months. Study visits for this trial are Screening,7 day follow up,1 month follow up,3 month follow up,6 month follow up , 9 month follow up and 1 year follow up. The tests done at these study visits are Blood investigations, X-ray, USG, Body analysis and diet chart adherence along with routine tests. The outcome measurement is Excess weight loss up to 70 % in 12 months.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
入选标准
- •Body Mass Index (BMI) > 35 Male or female subjects with Age > 18 and < 65 years.
- •Able to read and understand the ICF (English/Hindi/Gujarati) and willing to give voluntary ConsentWilling to comply with protocol requirements.
排除标准
- •Associated fatal diseasesCancerLiver failure Kidney failure.Women who are pregnant.
结局指标
主要结局
Primary outcome is Excess Weight Loss: Depending upon the type of surgery,36 % to 90 % of excess body weight will be lost over a period of 6 months to two years. Patients may lose 30 to 50 % of their excess weight in the first 6 months and ~ 77 % as early as 12 months after surgery.
时间窗: 12 months
次要结局
未报告次要终点