Hernia, VentralNCT04516031
Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia
A study testing Posterior Component Separation with Transversus Abdominis Muscle Release and Mesh-only repair in people with Hernia, Ventral and Hernia Incisional, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hernia, Ventral, Hernia Incisional, Hernia, Abdominal
- What is being tested?
- Posterior Component Separation with Transversus Abdominis Muscle Release and Mesh-only repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with complex ventral-wall and incisional hernia
Who cannot join
- pregnant female
- steroid therapy
- emergency basis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Mansoura University
Al Mansurah, 35516
Mostafa Shalaby, MD, MSc, PhD
About this study
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
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.
Read the 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
- Hernia, Ventral, Hernia Incisional, Hernia, Abdominal
- Being tested
- Posterior Component Separation with Transversus Abdominis Muscle Release, Mesh-only repair
- Medical subject headings
- Hernia, Ventral, Incisional Hernia, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Component Separation with Transversus Abdominis Muscle ReleaseProcedure or surgery
Also called 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 repairProcedure or surgery
The prosthetic mesh only repair was done as described by Wantz in 1991.
| Study group | Role | What they receive |
|---|---|---|
| Mesh-only repair | Active comparator | Not described Receives: Procedure: Mesh-only repair |
| Transversus Abdominis Muscl | Active comparator | Not described Receives: Procedure: Posterior Component Separation with Transversus Abdominis Muscle Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
Reappearance of symptoms or swelling
Measured: after 12 months
Secondary outcomes (2)
Morbidity
postoperative morbidity
Measured: 30 days postoperative
Mortality
Postoperative mortality
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Aug 2018
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa shalaby, MD, MSc, PhD, Mansoura University
- Investigators
- Mostafa Shalaby, MD, MSc, PhD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516031
- Sponsor's protocol ID
- Transversus Abdominis Release
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36127722
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04516031
- Acronym / sponsor ID
- Transversus Abdominis Release
- Conditions
- Hernia, Ventral, Hernia Incisional, Hernia, Abdominal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh-only repair | Active comparator | Procedure: Mesh-only repair |
| Transversus Abdominis Muscl | Active comparator | Procedure: Posterior Component Separation with Transversus Abdominis Muscle Release |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with complex ventral-wall and incisional hernia
Key exclusion criteria (3 listed)
- pregnant female
- steroid therapy
- emergency basis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior Component Separation with Transversus Abdominis Muscle ReleaseAlso: Transversus Abdominis Muscle ReleaseThe posterior component separation technique with transversus abdominis muscle release was done as prescribed in Novitsky et al in 2012. | Procedure or surgery | Transversus Abdominis Muscl |
| Mesh-only repairThe prosthetic mesh only repair was done as described by Wantz in 1991. | Procedure or surgery | Mesh-only repair |
Primary outcome
Hernia recurrence
Time frame: after 12 months
Reappearance of symptoms or swelling
2 secondary outcomes
Morbidity
Time frame: 30 days postoperative
Mortality
Time frame: 30 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Derived from this study: PubMed 36127722Rabie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Shalaby, MD, MSc, PhD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Component Separation with Transversus Abdominis Muscle Release and Mesh-only repair in people with Hernia, Ventral and Hernia Incisional, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa shalaby, MD, MSc, PhD (00201001645917, mostafashalaby@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence (time frame: after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.