Omentopexy After Sleeve Gastrectomy in Children and Adolescences.

January 31, 2025 updated by: Mohammad Daboos

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
post operative nausea, vomiting and leakage
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammad Daboos

Investigators

  • Principal Investigator: Mohammad Daboos, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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