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

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

Study Overview

• Status: Completed
• Conditions: Umbilical Hernia
• Intervention / Treatment: Procedure: Intraperitoneal mesh placement; Procedure: Preperitoneal mesh placement

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • ASZ Aalst
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraperitoneal mesh placement; Mesh placement inside the peritoneal cavity	Procedure: Intraperitoneal mesh placement; Mesh placement inside the peritoneal cavity.
Active Comparator: Preperitoneal mesh placement; Mesh placement between peritoneum and muscle layer.	Procedure: Preperitoneal mesh placement; Mesh placement between peritoneum and muscle layer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.	Time registration of the operating time will be extracted from the hospital electronic patient files.	Total duration of the operation with an expected average of approximately 45 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical wound morbidity complication rate.		Up to 1 year.
Recurrence Rate	Clinical examination will be performed. No ultrasound, unless doubt about recurrence.	up to 2 years
Pain evaluation	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.	within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years
Discomfort evaluation.	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.	Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Medri
• Investigators: Principal Investigator: Frederik Berrevoet, MD, PhD, University Hospital, Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimated): March 5, 2012

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Umbilical Hernia
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia, Ventral; Hernia; Hernia, Umbilical
• Other Study ID Numbers: EC/2012/072