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

This study is currently recruiting participants. (see Contacts and Locations)
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

February 10, 2012
October 29, 2012
March 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01543789 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Umbilical Hernia
  • Procedure: Intraperitoneal mesh placement
    Mesh placement inside the peritoneal cavity.
  • Procedure: Preperitoneal mesh placement
    Mesh placement between peritoneum and muscle layer.
  • Experimental: Intraperitoneal mesh placement
    Mesh placement inside the peritoneal cavity
    Intervention: Procedure: Intraperitoneal mesh placement
  • Active Comparator: Preperitoneal mesh placement
    Mesh placement between peritoneum and muscle layer.
    Intervention: Procedure: Preperitoneal mesh placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2016
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Frederik Berrevoet, MD, PhD Frederik.Berrevoet@ugent.be
Contact: Aude Vanlander, MD Aude.Vanlander@ugent.be
Belgium
 
NCT01543789
EC/2012/072
No
University Hospital, Ghent
University Hospital, Ghent
Medri
Principal Investigator: Frederik Berrevoet, MD, PhD Ghent University Hospital
University Hospital, Ghent
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP