IMPACT: Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

• Sponsor: Azienda Sanitaria Locale Napoli 2 Nord (Other)
• Overall Status: Completed
• CT.gov ID: NCT06111287
• Collaborator: (none)
• Enrollment: 432
• Locations: 2
• Actual Duration (Months): 66
• Patients Per Site: 216
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 432 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: : Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia Repair: an Italian Multicenter Cohort Study
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: Jul 1, 2020

Outcome Measures

Primary Outcome Measures

1. Hernia Recurrence [3 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.

2. Hernia Recurrence [6 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.

3. Hernia Recurrence [12 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.

4. Hernia Recurrence [24 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.

5. 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.

6. Mesh Bulging [3 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.

7. Mesh Bulging [12 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.

8. Mesh Bulging [24 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.

9. 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.

10. 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)

11. Number of patients affected by Superficial surgical site infection [1 months]

    Superficial infections according to Clavien-Dindo criteria

Secondary Outcome Measures

1. Number of patients affected by Superficial surgical site infections [Within 30 days postoperatively]

   Superficial infections according to Clavien-Dindo criteria

2. Number of patients affected by Deep surgical site infections [Within 30 days postoperatively]

   Deep surgical site infections according to Clavien-Dindo criteria

3. Number of patients affected by organ space infections [Within 30 days postoperatively]

   Organ space infections according to Clavien-Dindo criteria

4. 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

5. Postoperative pain [Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 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').

6. Postoperative pain [Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 3 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').

7. Postoperative pain [Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 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').

8. Postoperative pain [Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 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').

9. Postoperative pain [Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 24 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').

10. 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').

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Francdesco Pizza	Napoli	Naples	Italy	80035
2	Francesco Pizza	Naples		Italy	80131

Sponsors and Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Francesco Pizza, MD,PhD, Responsible for the Bariatric and Metabolic Surgery unit, Azienda Sanitaria Locale Napoli 2 Nord
• ClinicalTrials.gov Identifier: NCT06111287
• Other Study ID Numbers: 1988
• First Posted: Nov 1, 2023
• Last Update Posted: Nov 1, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hernia; Hernia, Abdominal; Hernia, Ventral; Internal Hernia; Incisional Hernia

Study Results

No Results Posted as of Nov 1, 2023