Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

Hernia, Abdominal Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06111287
• Other study ID #: 1988
• Status: Completed
• Start date: January 2015
• Est. completion date: July 2020

Study information

• Verified date: October 2023
• Source: Azienda Sanitaria Locale Napoli 2 Nord
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia Incisional
• Hernia, Abdominal
• Hernia, Ventral
• Incisional Hernia
• Internal Hernia

Locations

Country	Name	City	State
Italy	Francesco Pizza	Naples
Italy	Francdesco Pizza	Napoli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale Napoli 2 Nord

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of patients affected by Superficial surgical site infection	Superficial infections according to Clavien-Dindo criteria	1 months
Secondary	Number of patients affected by Superficial surgical site infections	Superficial infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Secondary	Number of patients affected by Deep surgical site infections	Deep surgical site infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Secondary	Number of patients affected by organ space infections	Organ space infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.