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

Abdominal Wall Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05278117
• Other study ID #: burst abdomen
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: February 1, 2022

Study information

• Verified date: September 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 1, 2022
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Wall Defect

Intervention

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

Locations

Country	Name	City	State
Egypt	Tamer Alsaied Alnaimy	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent burst abdomen	incidence of recurrent burst abdomen by %	3.5 years
Primary	incisional hernia	incidence of incisional hernia measured by clinical examination and computerized tomography by %	3.5 years
Secondary	incidence of surgical site infection	by %	30 days