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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2015 by University Hospital, Ghent.
Recruitment status was: Recruiting

Sponsor:

Collaborator:

Medri

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01543789

First received: February 10, 2012

Last updated: June 2, 2015

Last verified: June 2015

History of Changes

Purpose

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	Intervention
Umbilical Hernia	Procedure: Intraperitoneal mesh placement Procedure: Preperitoneal mesh placement


Study Type:	Interventional
Study Design:	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.

Resource links provided by NLM:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

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:

Surgical wound morbidity complication rate. [ Time Frame: Up to 1 year. ]
Recurrence Rate [ Time Frame: up to 2 years ]
Clinical examination will be performed. No ultrasound, unless doubt about recurrence.
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.
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.


Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543789

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT01543789 History of Changes
Other Study ID Numbers:	EC/2012/072
Study First Received:	February 10, 2012
Last Updated:	June 2, 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

ClinicalTrials.gov processed this record on August 17, 2017

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