Skip to main content
OpenTrials
Completed

NCT Number: NCT05278117

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tamer Alsaied Alnaimy

Zagazig, Sharqia Province, 055, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh

Procedure

outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh

Primary outcomes

  1. recurrent burst abdomen

    Time frame: 3.5 years

    incidence of recurrent burst abdomen by %

  2. incisional hernia

    Time frame: 3.5 years

    incidence of incisional hernia measured by clinical examination and computerized tomography by %

Secondary outcomes

  1. incidence of surgical site infection

    Time frame: 30 days

    by %

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.