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

Hernia, Ventral Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04516031
• Other study ID #: Transversus Abdominis Release
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2020
• Source: Mansoura University
• Contact: Mostafa shalaby, MD, MSc, PhD
• Phone: 00201001645917
• Email: mostafashalaby[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: January 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients with complex ventral-wall and incisional hernia

Exclusion Criteria:

• pregnant female

• steroid therapy

• emergency basis

Related Conditions & MeSH terms

• Hernia
• Hernia Incisional
• Hernia, Abdominal
• Hernia, Ventral
• Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence	Reappearance of symptoms or swelling	after 12 months
Secondary	Morbidity	postoperative morbidity	30 days postoperative
Secondary	Mortality	Postoperative mortality	30 days postoperative