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ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials

NCT05632952 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-03-08

No results posted yet for this 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.

Conditions

  • Uncomplicated Ventral Incisional Hernia
  • Obesity

Interventions

DEVICE

Intraperitoneal Onlay Mesh positioning Plus

Intraperitoneal Onlay Mesh (IPOM) Plus with closure of the hernia defect will be performed according to the common recommendations. The closure of the wall defect will be decided according to the surgeon evaluations: hernia size and choice of technique will be recorded in the database. The mesh will have an overlap of at least 5 cm on all sides of the defect. Dimension of the mesh will be sized to overlap the hernia orifice by at least five centimetres and placed in the intraperitoneal position. Using non-articulating laparoscopic fixation devices, 5.1-mm non-absorbable or absorbable tacks will be then positioned around the circumference of the prosthesis in a 3-row manner or 2-row manner based on the intraoperative findings, the patient's specific situation and the operating surgeon's decision.

Sponsors & Collaborators

  • Azienda Sanitaria Locale Napoli 2 Nord

    lead OTHER

Principal Investigators

  • Francesco Pizza, MD, PhD · Azienda Sanitaria Locale Napoli 2 Nord

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-12-31
Completion
2024-01-31
FDA Device
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05632952 on ClinicalTrials.gov