Hernia, Abdominal, Hernia Incisional
Conditions
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.
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
Interventions
None listed
Sponsors
Azienda Sanitaria Locale Napoli 2 Nord
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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. |
| Number of patients affected by Superficial surgical site infection | 1 months | Superficial infections according to Clavien-Dindo criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients affected by Superficial surgical site infections | Within 30 days postoperatively | Superficial infections according to Clavien-Dindo criteria |
| 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'). |
| Number of patients affected by Deep surgical site infections | Within 30 days postoperatively | Deep surgical site infections according to Clavien-Dindo criteria |
| Number of patients affected by organ space infections | Within 30 days postoperatively | Organ space infections according to Clavien-Dindo criteria |
| 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 |
Countries
Italy
Outcome results
None listed