ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials

Last updated: March 7, 2023
Sponsor: Azienda Sanitaria Locale Napoli 2 Nord
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT05632952
419N.Reg 26-2022oss
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 120
Study Start date:
November 01, 2022
Estimated Completion Date:
January 31, 2024

Study 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

Connect with a study center

  • Francdesco Pizza

    Napoli, Naples 80035
    Italy

    Active - Recruiting

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