Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Wall Defect
Keywords: Abdomen burst, Incisional hernia, mesh
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-03-14
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: recurrent burst abdomen
timeFrame: 3.5 years
measure: incisional hernia
timeFrame: 3.5 years
Secondary outcomes:
measure: incidence of surgical site infection
timeFrame: 30 days
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Tamer Alsaied Alnaimy
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Alnaimy alnaimy, Phd
role: PRINCIPAL_INVESTIGATOR
References: