Omentopexy After Sleeve Gastrectomy in Children and Adole... | NCT06811623

Studies
Omentopexy After Sleeve Gastrectomy in Children and Adolescences.

NCT06811623

Sponsor

Mohammad Daboos

Status

Completed

Last Update Posted

Feb 6, 2025Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Morbid Obesity
Pediatric Obesity
LAP

Interventions

Laparoscopic Sleeve Gastrectomy with omentopexy
Laparoscopic Sleeve Gastrectomy without omentopexy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Oct 1, 2024Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Jan 26, 2025

First Submission Date that Met QC Criteria

Jan 31, 2025

First Posted Date

Feb 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2025

Last Update Posted Date

Feb 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammad Daboos, Professor at Pediatric Surgery Department, Al-Azhar University., Al-Azhar UniversitySponsor-Investigator

Lead Sponsor

Mohammad DaboosOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic Sleeve Gastrectomy with omentopexy	Procedure	Laparoscopic Sleeve Gastrectomy with omental fixation to the gastric tube	Group with Omentopexy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mohammad Daboos	Al-Azhar University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided