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The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

NCT01543789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-07-03

No results posted yet for this study

Summary

The use of mesh in the repair of umbilical hernias is a gold standard. The best location of the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the surgery.

This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene for preperitoneal use), will be used in this multicentric trial, to evaluate the best procedure in terms of efficacy, safety and postoperative complications.

Conditions

  • Umbilical Hernia

Interventions

PROCEDURE

Intraperitoneal mesh placement

Mesh placement inside the peritoneal cavity.

PROCEDURE

Preperitoneal mesh placement

Mesh placement between peritoneum and muscle layer.

Sponsors & Collaborators

  • Medri

    collaborator UNKNOWN

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Frederik Berrevoet, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-12-31
Completion
2023-12-31

Countries

  • Belgium

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 NCT01543789 on ClinicalTrials.gov