Clinical Trials Directory

Trials / Completed

CompletedNCT06111287

Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

: Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia Repair: an Italian Multicenter Cohort Study

Status
Completed
Phase
Study type
Observational
Enrollment
432 (actual)
Sponsor
Azienda Sanitaria Locale Napoli 2 Nord · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2015-01-01
Primary completion
2020-05-01
Completion
2020-07-01
First posted
2023-11-01
Last updated
2023-11-01

Locations

2 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT06111287. Inclusion in this directory is not an endorsement.