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
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 12, 2020
CompletedFirst Posted
Study publicly available on registry
August 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedAugust 17, 2020
August 1, 2020
2.1 years
August 12, 2020
August 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Hernia recurrence
Reappearance of symptoms or swelling
after 12 months
Secondary Outcomes (2)
Morbidity
30 days postoperative
Mortality
30 days postoperative
Study Arms (2)
Mesh-only repair
ACTIVE COMPARATORTransversus Abdominis Muscl
ACTIVE COMPARATORInterventions
The posterior component separation technique with transversus abdominis muscle release was done as prescribed in Novitsky et al in 2012.
The prosthetic mesh only repair was done as described by Wantz in 1991.
Eligibility Criteria
You may qualify if:
- patients with complex ventral-wall and incisional hernia
You may not qualify if:
- pregnant female
- steroid therapy
- emergency basis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Mansoura University
Al Mansurah, 35516, Egypt
Related Publications (1)
Rabie M, Abdelnaby M, Morshed M, Shalaby M. Posterior component separation with transversus abdominis muscle release versus mesh-only repair in the treatment of complex ventral-wall hernia: a randomized controlled trial. BMC Surg. 2022 Sep 20;22(1):346. doi: 10.1186/s12893-022-01794-7.
PMID: 36127722DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mostafa Shalaby, MD, MSc, PhD
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-supervisor
Study Record Dates
First Submitted
August 12, 2020
First Posted
August 17, 2020
Study Start
August 1, 2018
Primary Completion
September 1, 2020
Study Completion
January 1, 2021
Last Updated
August 17, 2020
Record last verified: 2020-08