The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial (FUN)
Primary Purpose
Umbilical Hernia
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Intraperitoneal mesh placement
Preperitoneal mesh placement
Sponsored by
About this trial
This is an interventional treatment trial for Umbilical Hernia focused on measuring Umbilical Hernia
Eligibility 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
Sites / Locations
- ASZ Aalst
- Ghent University Hospital
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intraperitoneal mesh placement
Preperitoneal mesh placement
Arm Description
Mesh placement inside the peritoneal cavity
Mesh placement between peritoneum and muscle layer.
Outcomes
Primary Outcome Measures
Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.
Time registration of the operating time will be extracted from the hospital electronic patient files.
Secondary Outcome Measures
Surgical wound morbidity complication rate.
Recurrence Rate
Clinical examination will be performed. No ultrasound, unless doubt about recurrence.
Pain evaluation
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.
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.
Full Information
NCT ID
NCT01543789
First Posted
February 10, 2012
Last Updated
August 31, 2023
Sponsor
University Hospital, Ghent
Collaborators
Medri
1. Study Identification
Unique Protocol Identification Number
NCT01543789
Brief Title
The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial
Acronym
FUN
Official Title
The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Medri
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernia
Keywords
Umbilical Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraperitoneal mesh placement
Arm Type
Experimental
Arm Description
Mesh placement inside the peritoneal cavity
Arm Title
Preperitoneal mesh placement
Arm Type
Active Comparator
Arm Description
Mesh placement between peritoneum and muscle layer.
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal mesh placement
Intervention Description
Mesh placement inside the peritoneal cavity.
Intervention Type
Procedure
Intervention Name(s)
Preperitoneal mesh placement
Intervention Description
Mesh placement between peritoneum and muscle layer.
Primary Outcome Measure Information:
Title
Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.
Description
Time registration of the operating time will be extracted from the hospital electronic patient files.
Time Frame
Total duration of the operation with an expected average of approximately 45 minutes.
Secondary Outcome Measure Information:
Title
Surgical wound morbidity complication rate.
Time Frame
Up to 1 year.
Title
Recurrence Rate
Description
Clinical examination will be performed. No ultrasound, unless doubt about recurrence.
Time Frame
up to 2 years
Title
Pain evaluation
Description
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.
Time Frame
within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years
Title
Discomfort evaluation.
Description
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.
Time Frame
Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASZ Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
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The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial
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