Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

Completed

• Conditions: Hernia, Abdominal; Hernia Incisional

• Registration Number: NCT06111287
• Lead Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

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

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2020-05
• Study Completion: 2020-07
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-26
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hernia Recurrence	36 months	In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Mesh Bulging	36 months	In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
surgical site events	1 months	Regarding the surgical site events, the classification of wound events was assigned according to the likelihood and degree of wound contamination at the time of the operation, as stated in the Centre for Disease Control and Prevention wound classification (superficial, deep or organ space)
Number of patients affected by Superficial surgical site infection	1 months	Superficial infections according to Clavien-Dindo criteria

Secondary Outcome Measures

Name	Time	Method
Number of patients affected by Superficial surgical site infections	Within 30 days postoperatively	Superficial infections according to Clavien-Dindo criteria
Number of patients affected by organ space infections	Within 30 days postoperatively	Organ space infections according to Clavien-Dindo criteria
Number of patients affected by Surgical Site Occurence	Within 30 days postoperatively	Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions
Number of patients affected by Deep surgical site infections	Within 30 days postoperatively	Deep surgical site infections according to Clavien-Dindo criteria
Postoperative pain	Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 36 month.	Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Trial Locations

Locations (2)

Francesco Pizza; 🇮🇹 Naples, Italy

Francdesco Pizza; 🇮🇹 Napoli, Naples, Italy