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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Abdominal Wall Defect

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent burst abdomen | incidence of recurrent burst abdomen by % | 3.5 years | 
| incisional hernia | 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 | by % | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdomen burst, Incisional hernia, mesh