A clinical trial to study the effect of Gastric Imbrications versus Sleeve Gastectomy for weight loss.
Not Applicable
- Registration Number
- CTRI/2010/091/001356
- Lead Sponsor
- Dr.Mahendra Narwaria MS, FICSASIAN Surgicenter1st Floor, Silver Point,Stadium Circle, Navrangpura, Ahmedabad - 380 009 India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
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 Consent
Willing to comply with protocol requirements
Exclusion Criteria
Associated fatal diseases
Cancer
Liver failure
Kidney failure.
Women who are pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil