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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Umbilical Hernia	Procedure: Intraperitoneal mesh placement; Procedure: Preperitoneal mesh placement	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.
Study Start Date :	March 2012
Estimated Primary Completion Date :	December 2015
Estimated Study Completion Date :	March 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Frederik Berrevoet, MD, PhD		Frederik.Berrevoet@ugent.be
Contact: Aude Vanlander, MD		Aude.Vanlander@ugent.be

Locations

Belgium
ASZ Aalst	Recruiting
Aalst, Belgium, 9300
Contact: Tijl Vierendeels, MD Tijl.Vierendeels@asz.be
Principal Investigator: Tijl Vierendeels, MD
Ghent University Hospital	Recruiting
Ghent, Belgium, 9000
Contact: Frederik Berrevoet, MD, PhD Frederik.Berrevoet@ugent.be
Principal Investigator: Frederik Berrevoet, MD, PhD
UZ Leuven	Recruiting
Leuven, Belgium, 3000
Contact: Marc Miserez, MD, PhD marc.miserez@uz.kuleuven.ac.be
Principal Investigator: Marc Miserez, MD, PhD

Sponsors and Collaborators

University Hospital, Ghent

Medri

Investigators

Principal Investigator:	Frederik Berrevoet, MD, PhD	University Hospital, Ghent

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT01543789 History of Changes
Other Study ID Numbers:	EC/2012/072
First Posted:	March 5, 2012
Last Update Posted:	June 3, 2015
Last Verified:	June 2015

Keywords provided by University Hospital, Ghent:

Umbilical Hernia

Additional relevant MeSH terms:

Hernia; Hernia, Umbilical; Pathological Conditions, Anatomical	Infant, Newborn, Diseases; Hernia, Ventral; Hernia, Abdominal