Unilateral Inguinal HerniaREBOUNDNCT01622712
Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device
A study testing Rebound HRD Mesh in people with Unilateral Inguinal Hernia, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Unilateral Inguinal Hernia
- What is being tested?
- Rebound HRD Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Feb 2013to 2 Sep 2014
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective repair for a primary unilateral inguinal hernia OR
- elective repair for a recurrent unilateral inguinal hernia after non-mesh repair
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.
The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.
Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.
- Conditions
- Unilateral Inguinal Hernia
- Being tested
- Rebound HRD Mesh
- Keywords
- inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebound HRD MeshDevice
Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral inguinal hernia | Experimental | A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia. Receives: Device: Rebound HRD Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.
A CT scan is performed.
Measured: 12 months post-surgery
Secondary outcomes (5)
Pain assessment.
Measured: after 1 year
Discomfort assessment.
Measured: after 1 year
Use of oral analgetics.
Measured: after 1 year
Wound morbidity.
Measured: after 4 weeks
Recurrence of hernia.
Measured: after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study start1 Feb 2013
- Primary completion2 Sep 2014
- Study completion2 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Inguinal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 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
- NCT01622712
- Sponsor's protocol ID
- 2011/823
- Acronym
- REBOUND
- Status last verified
- Dec 2022
- First submitted
- 15 Jun 2012
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.
- ClinicalTrials.gov ID
- NCT01622712
- Acronym / sponsor ID
- REBOUND / 2011/823
- Conditions
- Unilateral Inguinal Hernia
- Keywords
- inguinal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medri
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 2 Sep 2014 (actual)
- Study completion
- 2 Sep 2014 (actual)
- First posted
- 19 Jun 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 aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.
Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral inguinal hernia | Experimental | Device: Rebound HRD MeshA Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective repair for a primary unilateral inguinal hernia OR
- elective repair for a recurrent unilateral inguinal hernia after non-mesh repair
Key exclusion criteria (0 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 |
|---|---|---|
| Rebound HRD MeshPatients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh. | Device | Unilateral inguinal hernia |
Primary outcome
Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.
Time frame: 12 months post-surgery
A CT scan is performed.
5 secondary outcomes
Pain assessment.
Time frame: after 1 year
Discomfort assessment.
Time frame: after 1 year
Use of oral analgetics.
Time frame: after 1 year
Wound morbidity.
Time frame: after 4 weeks
Recurrence of hernia.
Time frame: after 1 year
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 29 Dec 2022.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebound HRD Mesh in people with Unilateral Inguinal Hernia, run by University Hospital, Ghent at 2 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 2 inclusion and 0 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 29 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 2 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?
Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation. (time frame: 12 months post-surgery). 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 29 Dec 2022.