Skip to main content
OpenTrials
Completed

NCT Number: NCT01543789

The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASZ Aalst, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraperitoneal mesh placement

Procedure

Mesh placement inside the peritoneal cavity.

Preperitoneal mesh placement

Procedure

Mesh placement between peritoneum and muscle layer.

Primary outcomes

  1. Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.

    Time frame: Total duration of the operation with an expected average of approximately 45 minutes.

    Time registration of the operating time will be extracted from the hospital electronic patient files.

Secondary outcomes

  1. Surgical wound morbidity complication rate.

    Time frame: Up to 1 year.

  2. Recurrence Rate

    Time frame: up to 2 years

    Clinical examination will be performed. No ultrasound, unless doubt about recurrence.

  3. Pain evaluation

    Time frame: within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years

    A questionnaire and Visual Analog Scale (VAS) will be filled out. The patient is asked whether he or she has pain. Answer NO: VAS = 0, Yes: patient will determine the exact VAS score.

  4. Discomfort evaluation.

    Time frame: Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.

    A questionnaire and Visual Analog Scale (VAS) will be filled out. The patient is asked whether he or she has discomfort. Answer NO: VAS = 0, Yes: patient will determine the exact VAS score.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Medri

Registry information

Official study title

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

Acronym: FUN

Important dates

Study start
2012
Primary completion
2015
Study completion
2023
First posted
Mar 5, 2012
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.