efficacy and complications of one-row Laparoscopic Gastric Plication versus two-row Laparoscopic Gastric Plication in the treatment of morbid obesity
Phase 2
- Conditions
- Morbid obesity.Morbid obesity
- Registration Number
- IRCT2013052312294N4
- Lead Sponsor
- Vice chancellor for research, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
morbid obesity ( BMI>40 kg/m2 or BMI>35kg/m2 with co-existing morbidities ); age 18 to 65; previous unsuccessful weight loss attempts Exclusion criteria: previous restrictive or malabsorptive procedure for obesity treatment; previous gastric surgery; history of anti-reflux surgery; pregnancy
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of excess weight loss. Timepoint: 3,6,12,18,24 months postoperatively. Method of measurement: (primary weight - weight at follow-up)*100/excess weight.;Percent of bmi loss. Timepoint: 3,6,12,18,24 months postoperatively. Method of measurement: ( Initial BMI - Follow-up BMI) x 100/(Initial BMI - 25).
- Secondary Outcome Measures
Name Time Method Efficacy of two procedures in improving obesity related comorbidities. Timepoint: 3,6, 12, 18, 24 months postoperatively. Method of measurement: history, physical examination, lab data.;Early and late complications of each procedure. Timepoint: from postoperative day to 24 months postoperatively. Method of measurement: history, physical examination, lab data.;Percent of weight loss. Timepoint: 3, 6, 12, 18, 24 months postoperatively. Method of measurement: (baseline weight - weight at follow-up)*100/weight.