Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

NCT ID: NCT06111287

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 432 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-07-31

Brief Summary

This multicenter retrospective study analyzed data from 308 patients who underwent open Posterior Component separation with Trasversus release for primary or recurrent complex abdominal hernias between 2015 and 2020. The primary endpoint was the rate of Hernia Recurrence and Mesh Bulging at 3, 6, 12, 24, and 36 months. Secondary outcomes included surgical site events and were assessed using the Pain scale.

Detailed Description

Study design This study is reported according to the STROBE statement for cohort studies A retrospective multicentric study was conducted to analyze the surgical outcomes of patients undergoing open with Posterior Component separation with Trasversus release for inisional hernia. It was conducted according to the ethical principles stated in the Declaration of Helsinki. Written informed consent was obtained from all subjects.

Study setting and study population From January 2015 and May 2020, all the patients affected by primary or recurrent complex abdominal hernias undergoing open Posterior Component separation with Trasversus release referring to 6 centers, were considered for enrollment in the study. Inclusion criteria were age ≥16 years, primary or recurrent complex abdominal hernias with more than >10 cm midline defects Exclusion criteria were follow-up data lower than 36 months, patients with a stoma for whom closure was not planned during the abdominal hernia repair

Conditions

Hernia, Abdominal; Hernia Incisional

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• age ≥16 years,
• primary or recurrent complex abdominal hernias with more than >10 cm midline defects

Exclusion Criteria

• follow-up data lower than 36-months, patients with a stoma for whom closure was not planned during the abdominal hernia repair

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria Locale Napoli 2 Nord

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pizza

MD,PhD, Responsible for the Bariatric and Metabolic Surgery unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Francdesco Pizza

Napoli, Naples, Italy

Francesco Pizza

Naples, , Italy

Countries

Italy

Other Identifiers

1988

Identifier Type: -

Identifier Source: org_study_id