Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

NCT06111287 | Completed

• 1 other identifier: 1988
• Study Type: observational
• Target: 432
• Locations: 1 country
• Sites: 2

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.

Conditions

Hernia, Abdominal; Hernia Incisional

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (10)

• Number of patients affected by Superficial surgical site infections

  Within 30 days postoperatively

• Number of patients affected by Deep surgical site infections

  Within 30 days postoperatively

• Number of patients affected by organ space infections

  Within 30 days postoperatively

• Number of patients affected by Surgical Site Occurence

  Within 30 days postoperatively

• Postoperative pain

  Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age ≥16 years,
• primary or recurrent complex abdominal hernias with more than \>10 cm midline defects

You may not qualify if:

• follow-up data lower than 36-months, patients with a stoma for whom closure was not planned during the abdominal hernia repair

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (2)

Francdesco Pizza

Napoli, Naples, 80035, Italy

Location

Francesco Pizza

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Hernia, Abdominal; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD, Responsible for the Bariatric and Metabolic Surgery unit

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: January 1, 2015
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: july 2024

Locations

IT (2)