Morbid Obesity
Conditions
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
Interventions
COMBINATION_PRODUCTsleeve + preoperative PPI
sleeve + preoperative PPI
COMBINATION_PRODUCTsleeve + preoperative Placebo
sleeve + preoperative Placebo
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed