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

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Ghent
Sponsor:
Collaborator:
Medri
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01543789
First received: February 10, 2012
Last updated: October 29, 2012
Last verified: October 2012
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Recurrence Rate [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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: March 2014 (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
Genders Eligible for Study:   Both
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
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 Ghent University Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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: October 29, 2012
Health Authority: Belgium: Ethics Committee

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 May 21, 2013