Omentopexy After Sleeve Gastrectomy in Children and Adolescences, is it Effective in Reducing Post-operative Complications.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Primary Endpoint
- post-operative complications
Study Overview
Brief Summary
Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric operation, has become one of the most commonly performed bariatric surgeries. Postoperative gastrointestinal complications are agonizing in patients underwent this procedure. Most of these complications can be prevented by omentopexy in association with sleeve gastrectomy. The Primary aim of this study to assess the effectiveness of omentopexy during laparoscopic sleeve gastrectomy in reducing post-operative complication.
Detailed Description
This study was a carried out as a prospective study of 48 patients with obesity between January 2015 and October 2024. The patients were divided into 2 groups; group 1: included 24 patients managed with LSG with omentopexy and group 2: included 24 patients managed with LSG without omentopexy. Pre- operation data and post operation outcomes were taken for all patients in each group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •body mass index (BMI) of 40 kg/m2 or
- •BMI of 35 kg/m2 due to at least 1 comorbid condition
Exclusion Criteria
- •secondary obesity
- •more than 18 years
- •previous operation
Arms & Interventions
Group with Omentopexy
Laparoscopic Sleeve Gastrectomy with omentopexy
Intervention: Laparoscopic Sleeve Gastrectomy with omentopexy (Procedure)
Group without Omentopexy
Laparoscopic Sleeve Gastrectomy without omentopexy
Intervention: Laparoscopic Sleeve Gastrectomy without omentopexy (Procedure)
Outcomes
Primary Outcomes
post-operative complications
Time Frame: 6 months
post operative nausea, vomiting and leakage
Secondary Outcomes
- operative time and hospital stay(6 months)
Investigators
Mohammad Daboos
Professor at Pediatric Surgery Department, Al-Azhar University.
Al-Azhar University