An observational study in Hernia, Abdominal and Hernia Incisional, sponsored by Azienda Sanitaria Locale Napoli 2 Nord. Completed at 2 sites in Italy. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Azienda Sanitaria Locale Napoli 2 Nord · Observational
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.
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
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's enrollment of 432 is above the median of 115 across 29 observational studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Azienda Sanitaria Locale Napoli 2 Nord is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 1 months
Number of patients affected by Superficial surgical site infection
Superficial infections according to Clavien-Dindo criteria
Time frame: 1 months
Number of patients affected by Superficial surgical site infections
Superficial infections according to Clavien-Dindo criteria
Time frame: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Deep surgical site infections according to Clavien-Dindo criteria
Time frame: Within 30 days postoperatively
Number of patients affected by organ space infections
Organ space infections according to Clavien-Dindo criteria
Time frame: 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
Time frame: 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').
Time frame: 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').
Time frame: 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').
Time frame: 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').
Time frame: 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').
Time frame: 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').
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 36 month.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: july 2024
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in May 2020, 64 months.
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Azienda Sanitaria Locale Napoli 2 Nord