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.