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

August 13, 2020 updated by: Mostafa shalaby, MD, MSc, PhD, Mansoura University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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"

Study Type

Interventional

Enrollment (Anticipated)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Recruiting
        • faculty of medicine Mansoura university
        • Contact:
          • Mostafa Shalaby, MD, MSc, PhD

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with complex ventral-wall and incisional hernia

Exclusion Criteria:

  • pregnant female
  • steroid therapy
  • emergency basis

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Mesh-only repair
Procedure: Mesh-only repair
The prosthetic mesh only repair was done as described by Wantz in 1991.
ACTIVE_COMPARATOR: Transversus Abdominis Muscl
Procedure: Posterior Component Separation with Transversus Abdominis Muscle Release
The posterior component separation technique with transversus abdominis muscle release was done as prescribed in Novitsky et al in 2012.
Other Names:
  • Transversus Abdominis Muscle Release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia recurrence
Time Frame: after 12 months
Reappearance of symptoms or swelling
after 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 30 days postoperative
postoperative morbidity
30 days postoperative
Mortality
Time Frame: 30 days postoperative
Postoperative mortality
30 days postoperative

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Director: Mostafa Shalaby, MD, MSc, PhD, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (ACTUAL)

August 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Transversus Abdominis Release

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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