The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial (FUN)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Collaborator:
Medri
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01543789
First received: February 10, 2012
Last updated: December 4, 2014
Last verified: December 2014
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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:
Genetics Home Reference related topics:
abdominal wall defect
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 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 |
| 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
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
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:
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: | December 4, 2014 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Hospital, Ghent:
|
Umbilical Hernia |
Additional relevant MeSH terms:
|
Hernia, Umbilical Hernia Hernia, Abdominal |
Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on March 01, 2015