Hernia, UmbilicalNCT00323141
Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis
A study testing Ventralex versus Leight Weight Vypro II prothesis in people with Hernia, Umbilical, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Umbilical
- What is being tested?
- Ventralex versus Leight Weight Vypro II prothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Mar 2016to 31 Aug 2017
- 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
- Symptomatic hernia umbilicalis
- > 18 years old
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial to Study the Effectiveness of an Intraperitoneal Mesh With an Overlap of 3cm Versus a Rives-Stoppa Repair With an Overlap of 6cm With Patients With a Hernia Umbilicalis
To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.
- Conditions
- Hernia, Umbilical
- Being tested
- Ventralex versus Leight Weight Vypro II prothesis
- Keywords
- Hernia umbilicalis
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventralex versus Leight Weight Vypro II prothesisDevice
Ventralex and Leight Weight Vypro II prothesis are compared.
| Study group | Role | What they receive |
|---|---|---|
| Ventralex | Active comparator | Not described Receives: Device: Ventralex versus Leight Weight Vypro II prothesis |
| Leight Weight Vypro II prothesis | Active comparator | Not described Receives: Device: Ventralex versus Leight Weight Vypro II prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of relapses after 1 and 3 years
Measured: after 1 and 3 years
Secondary outcomes (4)
Duration of surgery
Measured: Depends from type of surgery.
Duration of hospitalisation
Measured: Depends from type of surgery.
Frequency of complications
Measured: After 1 and 3 years.
Pain assessment
Measured: After 1 and 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study start11 Mar 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, UmbilicalStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323141
- Sponsor's protocol ID
- 2006/079
- Status last verified
- Dec 2022
- First submitted
- 7 May 2006
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial to Study the Effectiveness of an Intraperitoneal Mesh With an Overlap of 3cm Versus a Rives-Stoppa Repair With an Overlap of 6cm With Patients With a Hernia Umbilicalis
- ClinicalTrials.gov ID
- NCT00323141
- Acronym / sponsor ID
- 2006/079
- Conditions
- Hernia, Umbilical
- Keywords
- Hernia umbilicalis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 9 May 2006 (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.
To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventralex | Active comparator | Device: Ventralex versus Leight Weight Vypro II prothesis |
| Leight Weight Vypro II prothesis | Active comparator | Device: Ventralex versus Leight Weight Vypro II prothesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic hernia umbilicalis
- > 18 years old
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Ventralex versus Leight Weight Vypro II prothesisVentralex and Leight Weight Vypro II prothesis are compared. | Device | Leight Weight Vypro II prothesis, Ventralex |
Primary outcome
Number of relapses after 1 and 3 years
Time frame: after 1 and 3 years
4 secondary outcomes
Duration of surgery
Time frame: Depends from type of surgery.
Duration of hospitalisation
Time frame: Depends from type of surgery.
Frequency of complications
Time frame: After 1 and 3 years.
Pain assessment
Time frame: After 1 and 3 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 7 Dec 2022.
- Website of the University Hospital GhentLink provided by the sponsor.
Related trials for Hernia, Umbilical
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Not yet recruiting
Topical Tranexamic Acid Spray Versus No Spray on Postoperative Outcomes Following Mesh Repair of Umbilical Hernia
Umbilical Hernia Repair
Recruiting
Robotic Single Port Combined Umbilical and Inguinal Hernia Repair
Inguinal Hernia Repair, Umbilical Hernia Repair
Not yet recruiting
Taping for Umbilical Hernia
Umbilical Hernia
Enrolling by invitationObservational study
Patient Reported Outcome Measures in Umbilical Hernia Surgery
Umbilical Hernia Repair
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventralex versus Leight Weight Vypro II prothesis in people with Hernia, Umbilical, run by University Hospital, Ghent at 1 site 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 2 inclusion and 1 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of relapses after 1 and 3 years (time frame: after 1 and 3 years). 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 7 Dec 2022.