Umbilical HerniaFUNNCT01543789
The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial
A study testing Intraperitoneal mesh placement and Preperitoneal mesh placement in people with Umbilical Hernia, run by University Hospital, Ghent at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- Intraperitoneal mesh placement and Preperitoneal mesh placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesBelgium
- Study dates
- Mar 2012to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent from the patient or his/her legal representative
- primary umbilical hernia requiring elective surgical repair
- diameter between 0 and 3 cm
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
ASZ Aalst
Aalst, 9300
Ghent University Hospital
Ghent, 9000
UZ Leuven
Leuven, 3000
About this study
Official title: 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.
- Conditions
- Umbilical Hernia
- Being tested
- Intraperitoneal mesh placement, Preperitoneal mesh placement
- Keywords
- Umbilical Hernia
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal mesh placementProcedure or surgery
Mesh placement inside the peritoneal cavity.
Preperitoneal mesh placementProcedure or surgery
Mesh placement between peritoneum and muscle layer.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal mesh placement | Experimental | Mesh placement inside the peritoneal cavity Receives: Procedure: Intraperitoneal mesh placement |
| Preperitoneal mesh placement | Active comparator | Mesh placement between peritoneum and muscle layer. Receives: Procedure: Preperitoneal mesh placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Total duration of the operation with an expected average of approximately 45 minutes.
Secondary outcomes (4)
Surgical wound morbidity complication rate.
Measured: Up to 1 year.
Recurrence Rate
Clinical examination will be performed. No ultrasound, unless doubt about recurrence.
Measured: up to 2 years
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.
Measured: within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years
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.
Measured: Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical HerniaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medri
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543789
- Sponsor's protocol ID
- EC/2012/072
- Acronym
- FUN
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2012
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01543789
- Acronym / sponsor ID
- FUN / EC/2012/072
- Conditions
- Umbilical Hernia
- Keywords
- Umbilical Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medri
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal mesh placement | Experimental | Procedure: Intraperitoneal mesh placementMesh placement inside the peritoneal cavity |
| Preperitoneal mesh placement | Active comparator | Procedure: Preperitoneal mesh placementMesh placement between peritoneum and muscle layer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent from the patient or his/her legal representative
- primary umbilical hernia requiring elective surgical repair
- diameter between 0 and 3 cm
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraperitoneal mesh placementMesh placement inside the peritoneal cavity. | Procedure or surgery | Intraperitoneal mesh placement |
| Preperitoneal mesh placementMesh placement between peritoneum and muscle layer. | Procedure or surgery | Preperitoneal mesh placement |
Primary outcome
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.
4 secondary outcomes
Surgical wound morbidity complication rate.
Time frame: Up to 1 year.
Recurrence Rate
Time frame: up to 2 years
Pain evaluation
Time frame: within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years
Discomfort evaluation.
Time frame: Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Berrevoet, MD, PhD principal investigator
University Hospital, Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraperitoneal mesh placement and Preperitoneal mesh placement in people with Umbilical Hernia, run by University Hospital, Ghent at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.