Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia

Not Applicable

• Conditions: Hernia, Abdominal; Hernia, Ventral; Hernia Incisional
• Interventions: Procedure: Mesh-only repair; Procedure: Posterior Component Separation with Transversus Abdominis Muscle Release

• Registration Number: NCT04516031
• Lead Sponsor: Mansoura University

Brief Summary

This trial was designed as a prospective randomized, controlled, intervention, with two parallel groups, and a primary endpoint of recurrence during 12 months' follow-up after initial treatment, with the randomization, was performed by an online software a 1:1 allocation.

Detailed Description

Eligibility Criteria

* both sexes

* aged between 18 and 65 years old

* presented complex ventral wall hernia or incisional hernia

Exclusion

* pregnant

* patients on steroid therapy

* underwent their hernia repair on an emergency basis

Interventions

* Eligible patients were randomized in equal proportions between "Mesh Only Repair" and "Posterior Component Separation with Transversus Abdominis Muscle Release"

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-13
• Last Update Submitted: 2020-08-13
• Study First Posted: 2020-08-17
• Last Update Posted: 2020-08-17
• Primary Completion: 2020-09-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• patients with complex ventral-wall and incisional hernia

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Exclusion Criteria

• pregnant female
• steroid therapy
• emergency basis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesh-only repair	Mesh-only repair	-
Transversus Abdominis Muscl	Posterior Component Separation with Transversus Abdominis Muscle Release	-

Primary Outcome Measures

Name	Time	Method
Hernia recurrence	after 12 months	Reappearance of symptoms or swelling

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days postoperative	Postoperative mortality
Morbidity	30 days postoperative	postoperative morbidity

Trial Locations

Locations (1)

Faculty of Medicine Mansoura University; 🇪🇬 Mansoura, Egypt