ClinicalTrials.gg
Status unknownNCT04516031Updated Aug 17, 2020

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

An interventional study of Posterior Component Separation with Transversus Abdominis Muscle Release and Mesh-only repair in Hernia, Ventral, Hernia Incisional and Hernia, Abdominal, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-08-17.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Aug 2018, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Hernia, Ventral with a site in Egypt — 4 open to participants now, 4 under way, none of them phase 3. Hernia, Ventral · Egypt.

Planned enrollment
6th of 11
59 · median 59
Started
2018
the only one that year
No phase
12 of 13
3 open now
Registered
5th of 13
by date
Lead sponsor
3 of 13
Mansoura University

Among the 13 studies in Hernia, Ventral with a site in Egypt, this one is the 6th largest by planned enrollment of the 11 interventional ones, is the only one that started in 2018, is one of 12 with no phase, and was the 5th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 3 open
Observational1 · 1 open

By the year they started

First in 2003; this study’s year is marked. 1 started in 2018.

Size and results

Median enrollment 59 across the 11 interventional studies, 420 across the 1 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Hernia, Ventral with a site in Egypt, or all of them as a file.
02

Study 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 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"
03

Conditions studied

  • Hernia, Ventral
  • Hernia Incisional
  • Hernia, Abdominal
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with complex ventral-wall and incisional hernia

Exclusion criteria

Exclusion Criteria:

  • pregnant female
  • therapy
  • emergency basis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
59 participants (estimated)

Study arms

  • Active comparator
    Mesh-only repair

    Procedure: Mesh-only repair

  • Active comparator
    Transversus Abdominis Muscl

    Procedure: 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.

    Also known as: Transversus Abdominis Muscle Release

  • ProcedureMesh-only repair

    The prosthetic mesh only repair was done as described by Wantz in 1991.

06

What researchers measure

Primary outcomes

  1. Hernia recurrence

    Reappearance of symptoms or swelling

    Time frame: after 12 months

Secondary outcomes

  1. Morbidity

    postoperative morbidity

    Time frame: 30 days postoperative

  2. Mortality

    Postoperative mortality

    Time frame: 30 days postoperative

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine Mansoura University
    Mansoura, 35516, Egypt
    Recruiting
    • Mostafa Shalaby, MD, MSc, PhD · Contact
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2018 (actual). Primary completion is estimated for Sep 2020, 25 months after the start.

Of 75 non-industry interventional studies with no phase under Hernia, Ventral, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 25 months is below that.

Counting every sponsor, half of 88 studies reached it within 37 months; a quarter within 19 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2020
First posted
Aug 17, 2020
StartActual
Aug 1, 2018
Primary completionEst.
Sep 1, 2020
CompletionEst.
Jan 1, 2021
Last update
Aug 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04516031
Responsible party
Mostafa shalaby, MD, MSc, PhD (Co-supervisor, Mansoura University) — Principal investigator
First posted
Aug 17, 2020
Start date
Aug 1, 2018
Primary completion
Sep 1, 2020 (estimated)
Completion
Jan 1, 2021 (estimated)
Last update
Aug 17, 2020

Study contacts

Mostafa shalaby, MD, MSc, PhD
Contact
mostafashalaby@mans.edu.eg
00201001645917
Mostafa Shalaby, MD, MSc, PhD
study director · Mansoura University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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