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

NCT ID: NCT04516031

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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

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Hernia, Ventral Hernia Incisional Hernia, Abdominal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mesh-only repair

Group Type ACTIVE_COMPARATOR

Mesh-only repair

Intervention Type PROCEDURE

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

Transversus Abdominis Muscl

Group Type ACTIVE_COMPARATOR

Posterior Component Separation with Transversus Abdominis Muscle Release

Intervention Type PROCEDURE

The posterior component separation technique with transversus abdominis muscle release was done as prescribed in Novitsky et al in 2012.

Interventions

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Posterior 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.

Intervention Type PROCEDURE

Mesh-only repair

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

Intervention Type PROCEDURE

Other Intervention Names

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Transversus Abdominis Muscle Release

Eligibility Criteria

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Inclusion Criteria

* patients with complex ventral-wall and incisional hernia

Exclusion Criteria

* pregnant female
* steroid therapy
* emergency basis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa shalaby, MD, MSc, PhD

Co-supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mostafa Shalaby, MD, MSc, PhD

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Faculty of Medicine Mansoura University

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mostafa shalaby, MD, MSc, PhD

Role: CONTACT

00201001645917

Facility Contacts

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Mostafa Shalaby, MD, MSc, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36127722 (View on PubMed)

Other Identifiers

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Transversus Abdominis Release

Identifier Type: -

Identifier Source: org_study_id

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