The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Umbilical Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intraperitoneal mesh placement

Mesh placement inside the peritoneal cavity

Group Type EXPERIMENTAL

Intraperitoneal mesh placement

Intervention Type PROCEDURE

Mesh placement inside the peritoneal cavity.

Preperitoneal mesh placement

Mesh placement between peritoneum and muscle layer.

Group Type ACTIVE_COMPARATOR

Preperitoneal mesh placement

Intervention Type PROCEDURE

Mesh placement between peritoneum and muscle layer.

Interventions

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Intraperitoneal mesh placement

Mesh placement inside the peritoneal cavity.

Intervention Type PROCEDURE

Preperitoneal mesh placement

Mesh placement between peritoneum and muscle layer.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No