Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia (IMPACT)

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

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Abdominal; Hernia Incisional

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 Type: Observational
• Enrollment (Actual): 432

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • francesco Pizza
  • Naples
    • Napoli, Naples, Italy, 80035
      • Francdesco Pizza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia Recurrence	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.	3 months
Hernia Recurrence	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.	6 months
Hernia Recurrence	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.	12 months
Hernia Recurrence	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.	24 months
Hernia Recurrence	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.	36 months
Mesh Bulging	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.	3 months
Mesh Bulging	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.	12 months
Mesh Bulging	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.	24 months
Mesh Bulging	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.	36 months
surgical site events	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)	1 months
Number of patients affected by Superficial surgical site infection	Superficial infections according to Clavien-Dindo criteria	1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients affected by Superficial surgical site infections	Superficial infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Number of patients affected by Deep surgical site infections	Deep surgical site infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Number of patients affected by organ space infections	Organ space infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Number of patients affected by Surgical Site Occurence	Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions	Within 30 days postoperatively
Postoperative pain	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').	Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
Postoperative pain	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').	Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 3 month.
Postoperative pain	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').	Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.
Postoperative pain	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').	Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.
Postoperative pain	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').	Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 24 month.
Postoperative pain	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').	Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 36 month.

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia; Incisional Hernia
• Other Study ID Numbers: 1988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: july 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No