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

Primary Purpose

Hernia, Ventral, Hernia Incisional, Hernia, Abdominal

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Posterior Component Separation with Transversus Abdominis Muscle Release

Mesh-only repair

About this trial

This is an interventional treatment trial for Hernia, Ventral

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with complex ventral-wall and incisional hernia

Exclusion Criteria:

pregnant female
steroid therapy
emergency basis

Sites / Locations

Faculty of Medicine Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Mesh-only repair

Transversus Abdominis Muscl

Arm Description

Outcomes

Primary Outcome Measures

Hernia recurrence

Reappearance of symptoms or swelling

Secondary Outcome Measures

Morbidity

postoperative morbidity

Mortality

Postoperative mortality

Full Information

NCT ID

NCT04516031

First Posted

August 12, 2020

Last Updated

August 13, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04516031

Brief Title

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

Official Title

Posterior Component Separation With Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Ventral, Hernia Incisional, Hernia, Abdominal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mesh-only repair

Arm Type

Active Comparator

Arm Title

Transversus Abdominis Muscl

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Posterior Component Separation with Transversus Abdominis Muscle Release

Other Intervention Name(s)

Transversus Abdominis Muscle Release

Intervention Description

The posterior component separation technique with transversus abdominis muscle release was done as prescribed in Novitsky et al in 2012.

Intervention Type

Procedure

Intervention Name(s)

Mesh-only repair

Intervention Description

The prosthetic mesh only repair was done as described by Wantz in 1991.

Primary Outcome Measure Information:

Title

Hernia recurrence

Description

Reappearance of symptoms or swelling

Time Frame

after 12 months

Secondary Outcome Measure Information:

Title

Morbidity

Description

postoperative morbidity

Time Frame

30 days postoperative

Title

Mortality

Description

Postoperative mortality

Time Frame

30 days postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with complex ventral-wall and incisional hernia Exclusion Criteria: pregnant female steroid therapy emergency basis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa shalaby, MD, MSc, PhD

Phone

00201001645917

mostafashalaby@mans.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mostafa Shalaby, MD, MSc, PhD

Organizational Affiliation

Mansoura University

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Medicine Mansoura University

City

Mansoura

ZIP/Postal Code

35516

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mostafa Shalaby, MD, MSc, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36127722

Citation

Rabie M, Abdelnaby M, Morshed M, Shalaby M. Posterior component separation with transversus abdominis muscle release versus mesh-only repair in the treatment of complex ventral-wall hernia: a randomized controlled trial. BMC Surg. 2022 Sep 20;22(1):346. doi: 10.1186/s12893-022-01794-7.

Results Reference

derived

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

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