Clinical Trials Directory

Trials / Unknown

UnknownNCT04516031

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
59 (estimated)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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"

Conditions

Interventions

TypeNameDescription
PROCEDUREPosterior Component Separation with Transversus Abdominis Muscle ReleaseThe posterior component separation technique with transversus abdominis muscle release was done as prescribed in Novitsky et al in 2012.
PROCEDUREMesh-only repairThe prosthetic mesh only repair was done as described by Wantz in 1991.

Timeline

Start date
2018-08-01
Primary completion
2020-09-01
Completion
2021-01-01
First posted
2020-08-17
Last updated
2020-08-17

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04516031. Inclusion in this directory is not an endorsement.