Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hernia Incisional, Hernia, Abdominal

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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. |