A Prospective Multicentre Study Evaluating the Outcomes of the Abdominal Wall Dehiscence Repair Using Posterior Component Separation With Transversus Abdominis Muscle Release Reinforced by a Retro-muscular Mesh - Filling a Step

September 5, 2022 updated by: Tamer Alsaied Alnaimy, Zagazig University

Purpose: This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.

Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.

Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 055
        • Tamer Alsaied Alnaimy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BA Grade IA according to Björck's initial classification following midline laparotomy from various departments,
  • ≥ 18 years
  • both sex
  • emergency or elective surgery

Exclusion Criteria:

  • BA grade 1B,2,3, and 4 according to Björck's initial classification,
  • < 18 years,
  • primary laparotomy performed through a non-midline incision, open abdomen,
  • if another laparotomy had been performed between the surgery for BA and the end of the follow-up period,
  • concomitant intra-abdominal surgery, abdominal complications during BA surgery,
  • adherent bowel to the defect edge that cannot be separated,
  • patients lost during follow up,
  • presence of intra-abdominal contamination that cannot be controlled radiologically,
  • history of previous BA repair,
  • stoma exteriorized from the midline primary wound,
  • temporarily wound closure techniques,
  • prior abdominal surgeries other than operation resulted in BA,
  • prior abdominal wall hernia repair with or without mesh,
  • history of collagen diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: complete burst abdomen repair
Procedure: outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh
outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent burst abdomen
Time Frame: 3.5 years
incidence of recurrent burst abdomen by %
3.5 years
incisional hernia
Time Frame: 3.5 years
incidence of incisional hernia measured by clinical examination and computerized tomography by %
3.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of surgical site infection
Time Frame: 30 days
by %
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Alnaimy alnaimy, Phd, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • burst abdomen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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