ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials
- Conditions
- Uncomplicated Ventral Incisional HerniaObesity
- Interventions
- Device: Intraperitoneal Onlay Mesh positioning Plus
- Registration Number
- NCT05632952
- Lead Sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Brief Summary
The aim of this study is to evaluate safety and effectiveness of a hybrid mesh (GORE® SYNECOR Intraperitoneal Biomaterial) in patients with a BMI of 30 kg/m2 or more undergoing laparoscopic ventral hernia repair (LVHR) with intraperitoneal position of the mesh.
- Detailed Description
A prospective Italian multicenter observational trial will be conducted in 8 different Italian centers to compare the effectiveness and feasibility of treatment of Incisional Hernia with GORE® SYNECOR Intraperitoneal Biomaterial mesh in patients with BMI \>30 kg/m2. This study was reviewed and approved by the local regional Ethics Committee. The study adhered to the CONSORT guidelines in reporting this trial's results
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- age > 18 years
- Clean wounds
- Informed consent
- Patients affected by Incisional and Ventral Hernia
- Elective surgery
- Hernia size between 3 e 7 cm
- BMI > 30 kg/m2
- age < 18 years;
- Life expectancy < 24 months (as estimated by the operating surgeon), -
- Pregnancy
- Immunosuppressant therapy within 2 weeks before surgery
- Clean-contaminated and contaminated, dirty wounds
- Cirrhosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A Intraperitoneal Onlay Mesh positioning Plus 120 patients affected by Incisional Hernia with size between 3 to 10 cm, undergoing Intraperitoneal Onlay Mesh with the closure of defect
- Primary Outcome Measures
Name Time Method Rate of Incisional Hernia at Clinical examination Patients are postoperatively examined at 36 months. Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Rate of Incisional Hernia at ultrasonographic examination Patients are postoperatively examined at 36 months. An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint.
- Secondary Outcome Measures
Name Time Method 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 Superficial surgical site infections Within 30 days postoperatively Superficial 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
Postoperative pain Postoperative pain will be recorded according to visual analogue scale at 24 months. 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').
Trial Locations
- Locations (1)
Francdesco Pizza
🇮🇹Napoli, Naples, Italy