Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study

NCT06166069 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 272

Last updated 2023-12-18

No results posted yet for this study

Summary

Background: Ventral hernia repair poses challenges for surgeons due to controversies in approach, patient selection, and mesh selection. The GORE® SYNECOR Intraperitoneal (IP) Biomaterial, a hybrid mesh, aims to balance durability and infection risk.

Objective: To analyze extended-term outcomes of using the Intaperitoneal device for ventral and incisional hernia repair.

Methods: Retrospective analysis of patients undergoing surgery in eight Italian Surgery Centers, evaluating pIPOM and sIPOM techniques with GORE® SYNECOR IP Biomaterial. Preoperative evaluations included anthropometric measurements, comorbidities, CT scans, and GIQLI assessments. Surgical procedures and interventions were recorded. Postoperative complications, GIQLI changes, cosmesis, hernia recurrence, and mesh bulging were assessed.

Conditions

  • Hernia
  • Incisional Hernia
  • Laparoscopic

Sponsors & Collaborators

  • Azienda Sanitaria Locale Napoli 2 Nord

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-10-30
Completion
2023-11-18

Countries

  • Italy

Study Locations

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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 NCT06166069 on ClinicalTrials.gov