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

M

Mansoura University

Status

Unknown

Conditions

Hernia Incisional
Hernia, Abdominal
Hernia, Ventral

Treatments

Procedure: Posterior Component Separation with Transversus Abdominis Muscle Release
Procedure: Mesh-only repair

Study type

Interventional

Funder types

Other

Identifiers

NCT04516031
Transversus Abdominis Release

Details and patient eligibility

About

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.

Full 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"

Enrollment

59 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with complex ventral-wall and incisional hernia

Exclusion criteria

  • pregnant female
  • steroid therapy
  • emergency basis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 2 patient groups

Mesh-only repair
Active Comparator group
Treatment:
Procedure: Mesh-only repair
Transversus Abdominis Muscl
Active Comparator group
Treatment:
Procedure: Posterior Component Separation with Transversus Abdominis Muscle Release

Trial contacts and locations

1

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Central trial contact

Mostafa shalaby, MD, MSc, PhD

Data sourced from clinicaltrials.gov

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