Omentopexy After Sleeve Gastrectomy in Children and Adolescences.

Omentopexy After Sleeve Gastrectomy in Children and Adolescences, is it Effective in Reducing Post-operative Complications.

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity; Morbid Obesity; LAP
• Intervention / Treatment: Procedure: Laparoscopic Sleeve Gastrectomy with omentopexy; Procedure: Laparoscopic Sleeve Gastrectomy without omentopexy

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group with Omentopexy; Laparoscopic Sleeve Gastrectomy with omentopexy	Procedure: Laparoscopic Sleeve Gastrectomy with omentopexy; Laparoscopic Sleeve Gastrectomy with omental fixation to the gastric tube
Active Comparator: Group without Omentopexy; Laparoscopic Sleeve Gastrectomy without omentopexy	Procedure: Laparoscopic Sleeve Gastrectomy without omentopexy; Laparoscopic Sleeve Gastrectomy without omental fixation to the gastric tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative complications	post operative nausea, vomiting and leakage	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time and hospital stay	the length of operative procedure and post-operative hospital stay	6 months

Collaborators and Investigators

• Sponsor: Mohammad Daboos
• Investigators: Principal Investigator: Mohammad Daboos, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: January 26, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity; Obesity, Morbid
• Other Study ID Numbers: 2/2015OBSGN63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No