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

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ClinicalTrials.gov Identifier: NCT01543789
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : March 5, 2012
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Medri
Information provided by (Responsible Party):
University Hospital, Ghent

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543789


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

Locations
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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
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Principal Investigator: Frederik Berrevoet, MD, PhD University Hospital, Ghent
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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

Keywords provided by University Hospital, Ghent:
Umbilical Hernia

Additional relevant MeSH terms:
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Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
 Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal