NCT01543789

The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	Intraperitoneal mesh placement	Mesh placement inside the peritoneal cavity.
PROCEDURE	Preperitoneal mesh placement	Mesh placement between peritoneum and muscle layer.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-12-01
• Completion: 2023-12-31
• First posted: 2012-03-05
• Last updated: 2024-07-03

Locations

3 sites across 1 country: Belgium