Clinical trial NCT06111287: Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia
Official title: : Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia Repair: an Italian Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Abdominal
Hernia Incisional
Lead sponsor: Azienda Sanitaria Locale Napoli 2 Nord
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 432
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2015 and May 2020, all the patients affected by primary or recurrent complex abdominal hernias undergoing open component posterior separation with trasversus abdomen release referring to 6 centres, were considered for enrollment in the study.

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

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

Primary outcomes:
measure: Hernia Recurrence
timeFrame: 3 months
measure: Hernia Recurrence
timeFrame: 6 months
measure: Hernia Recurrence
timeFrame: 12 months
measure: Hernia Recurrence
timeFrame: 24 months
measure: Hernia Recurrence
timeFrame: 36 months
measure: Mesh Bulging
timeFrame: 3 months
measure: Mesh Bulging
timeFrame: 12 months
measure: Mesh Bulging
timeFrame: 24 months
measure: Mesh Bulging
timeFrame: 36 months
measure: surgical site events
timeFrame: 1 months
measure: Number of patients affected by Superficial surgical site infection
timeFrame: 1 months
Secondary outcomes:
measure: Number of patients affected by Superficial surgical site infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by Deep surgical site infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by organ space infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by Surgical Site Occurence
timeFrame: Within 30 days postoperatively
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 3 month.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 24 month.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 36 month.
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Francdesco Pizza
state: Naples
city: Naples
country: Italy
facility: Francesco Pizza
Study officials:
References: