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

NCT05278117 | Completed

• 1 other identifier: burst abdomen
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Wall Defect

Keywords

Abdomen burst, Incisional hernia, mesh

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• incidence of surgical site infection

  30 days

Study Arms (1)

complete burst abdomen repair

EXPERIMENTAL

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

Interventions

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

complete burst abdomen repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BA Grade IA according to Björck's initial classification following midline laparotomy from various departments,
• ≥ 18 years
• both sex
• emergency or elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Tamer Alsaied Alnaimy

Zagazig, Sharqia Province, 055, Egypt

Location

Related Publications (1)

• Habeeb TAAM, Hussain A, Shelat V, Chiaretti M, Bueno-Lledo J, Garcia Fadrique A, Kalmoush AE, Elnemr M, Safwat K, Raafat A, Wasefy T, Heggy IA, Osman G, Abdelhady WA, Mawla WA, Fiad AA, Elaidy MM, Amr W, Abdelhamid MI, Abdou AM, Ibrahim AIA, Baghdadi MA. 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. World J Emerg Surg. 2023 Mar 3;18(1):15. doi: 10.1186/s13017-023-00485-9.

  PMID: 36869364 DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Alnaimy alnaimy, Phd

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour of general and laparoscopic surgery

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: June 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: February 1, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)