Preoperative PPI in Sleeve Gastrectomy
Phase 2
Completed
- Conditions
- Morbid Obesity
- Interventions
- Combination Product: sleeve + preoperative PPICombination Product: sleeve + preoperative Placebo
- Registration Number
- NCT03305432
- Lead Sponsor
- Minia University
- Brief Summary
he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy
- Detailed Description
In this study 200 morbidly obese patients will be included and will be undergone sleeve gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive PPI preoperative for 10 day and group 2 will not
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Morbidly obese patient with BMI more than 40 with or without co-morbidity
- Morbidly obese patient with BMI more than 35 with co-morbidity
Exclusion Criteria
- Unfit patients for laparoscopic sleeve gastrectomy
- patients refuse to share in the study
- patients that already on PPI due to any indications
- revisional surgery for obesity
- previous upper abdominal surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PPI group sleeve + preoperative PPI take preoperative PPI for 10 days Control group sleeve + preoperative Placebo take placebo for for 10 days preoperative
- Primary Outcome Measures
Name Time Method early postoperative bleeding and leak 2 weeks early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line
- Secondary Outcome Measures
Name Time Method operative time 5 hours time taken from skin incision to closure
microscopic picture of the removed stomach 2 weeks histological examination to detect the presence of inflammation in of the removed part of the stomach
Trial Locations
- Locations (1)
Faculty of medicine
🇪🇬Minya, Egypt