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

Not Applicable

Completed

• Conditions: Abdominal Wall Defect
• Interventions: Procedure: outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh

• Registration Number: NCT05278117
• Lead Sponsor: Zagazig University

Brief Summary

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.

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 Timeline

• Study Start: 2014-06-01
• Primary Completion: 2018-04-01
• Study Completion: 2022-02-01
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-14
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
incisional hernia	3.5 years	incidence of incisional hernia measured by clinical examination and computerized tomography by %
recurrent burst abdomen	3.5 years	incidence of recurrent burst abdomen by %

Secondary Outcome Measures

Name	Time	Method
incidence of surgical site infection	30 days	by %

Trial Locations

Locations (1)

Tamer Alsaied Alnaimy; 🇪🇬 Zagazig, Sharkia, Egypt