Hernia, Abdominal, Hernia Incisional, Hernia, Ventral
Conditions
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
Interventions
PROCEDUREPosterior 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.
PROCEDUREMesh-only repair
The prosthetic mesh only repair was done as described by Wantz in 1991.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients with complex ventral-wall and incisional hernia
Exclusion criteria
* pregnant female * steroid therapy * emergency basis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | after 12 months | Reappearance of symptoms or swelling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 30 days postoperative | postoperative morbidity |
| Mortality | 30 days postoperative | Postoperative mortality |
Countries
Egypt
Contacts
Primary ContactMostafa shalaby, MD, MSc, PhD
Outcome results
None listed