ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials (PSICHE-EROS)

Azienda Sanitaria Locale Napoli 2 Nord

Status: Enrolling

Conditions: Uncomplicated Ventral Incisional Hernia; Obesity

Treatments: Device: Intraperitoneal Onlay Mesh positioning Plus

Study type: Observational

Funder types: Other

Identifiers

NCT05632952

419N.Reg 26-2022oss

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

120 participants in 1 patient group

A

Description:

120 patients affected by Incisional Hernia with size between 3 to 10 cm, undergoing Intraperitoneal Onlay Mesh with the closure of defect

Treatment:

Device: Intraperitoneal Onlay Mesh positioning Plus