Omentopexy After Sleeve Gastrectomy in Children and Adolescences.

NCT ID: NCT06811623

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2025-01-01

Brief Summary

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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

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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.

Conditions

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Morbid Obesity Pediatric Obesity LAP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group with Omentopexy

Laparoscopic Sleeve Gastrectomy with omentopexy

Group Type ACTIVE_COMPARATOR

Laparoscopic Sleeve Gastrectomy with omentopexy

Intervention Type PROCEDURE

Laparoscopic Sleeve Gastrectomy with omental fixation to the gastric tube

Group without Omentopexy

Laparoscopic Sleeve Gastrectomy without omentopexy

Group Type ACTIVE_COMPARATOR

Laparoscopic Sleeve Gastrectomy without omentopexy

Intervention Type PROCEDURE

Laparoscopic Sleeve Gastrectomy without omental fixation to the gastric tube

Interventions

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Laparoscopic Sleeve Gastrectomy with omentopexy

Laparoscopic Sleeve Gastrectomy with omental fixation to the gastric tube

Intervention Type PROCEDURE

Laparoscopic Sleeve Gastrectomy without omentopexy

Laparoscopic Sleeve Gastrectomy without omental fixation to the gastric tube

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohammad Daboos

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Daboos

Professor at Pediatric Surgery Department, Al-Azhar University.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohammad Daboos

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Other Identifiers

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2/2015OBSGN63

Identifier Type: -

Identifier Source: org_study_id

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