The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial (FUN)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Umbilical Hernia

Treatments: Procedure: Intraperitoneal mesh placement; Procedure: Preperitoneal mesh placement

Study type: Interventional

Funder types: Other

Identifiers

NCT01543789

EC/2012/072

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written informed consent from the patient or his/her legal representative
• primary umbilical hernia requiring elective surgical repair
• diameter between 0 and 3 cm

Exclusion criteria

• no written informed consent
• incisional hernia at the level of the umbilicus
• recurrent umbilical hernia, as they have to be considered an incisional hernia
• emergency surgery (incarcerated hernia)
• pregnancy
• non-compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Intraperitoneal mesh placement

Experimental group

Description:

Mesh placement inside the peritoneal cavity

Treatment:

Procedure: Intraperitoneal mesh placement

Preperitoneal mesh placement

Active Comparator group

Description:

Mesh placement between peritoneum and muscle layer.

Treatment:

Procedure: Preperitoneal mesh placement