Omentopexy After Sleeve Gastrectomy in Children and Adolescences.

NCT06811623 | Completed DMC

• 1 other identifier: 2/2015OBSGN63
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Morbid Obesity; Pediatric Obesity; LAP

Outcome Measures

Primary Outcomes (1)

• post-operative complications

  post operative nausea, vomiting and leakage

  6 months

Secondary Outcomes (1)

• operative time and hospital stay

  6 months

Study Arms (2)

Group with Omentopexy

ACTIVE COMPARATOR

Laparoscopic Sleeve Gastrectomy with omentopexy

Procedure: Laparoscopic Sleeve Gastrectomy with omentopexy

Group without Omentopexy

ACTIVE COMPARATOR

Laparoscopic Sleeve Gastrectomy without omentopexy

Procedure: Laparoscopic Sleeve Gastrectomy without omentopexy

Interventions

Laparoscopic Sleeve Gastrectomy with omentopexy PROCEDURE

Laparoscopic Sleeve Gastrectomy with omental fixation to the gastric tube

Group with Omentopexy

Laparoscopic Sleeve Gastrectomy without omentopexy PROCEDURE

Laparoscopic Sleeve Gastrectomy without omental fixation to the gastric tube

Group without Omentopexy

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• body mass index (BMI) of 40 kg/m2 or
• BMI of 35 kg/m2 due to at least 1 comorbid condition

You may not qualify if:

• secondary obesity
• more than 18 years
• previous operation

Sponsors & Collaborators

• Mohammad Daboos: lead

MeSH Terms

Conditions

Obesity, Morbid; Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Daboos

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor at Pediatric Surgery Department, Al-Azhar University.

Model Details: group 1: included 24 patients managed with Laparoscopic Sleeve Gastrectomy with omentopexy and group 2: included 24 patients managed with Laparoscopic Sleeve Gastrectomy without omentopexy.

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2015
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share