Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device (REBOUND)
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:
NCT01622712
First received: June 15, 2012
Last updated: December 4, 2014
Last verified: December 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Unilateral Inguinal Hernia |
Device: Rebound HRD Mesh |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation. [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]A CT scan is performed.
Secondary Outcome Measures:
- Pain assessment. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
- Discomfort assessment. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
- Use of oral analgetics. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
- Wound morbidity. [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
- Recurrence of hernia. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Unilateral inguinal hernia
A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia.
|
Device: Rebound HRD Mesh
Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- elective repair for a primary unilateral inguinal hernia OR
- elective repair for a recurrent unilateral inguinal hernia after non-mesh repair
Exclusion Criteria:
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: NCT01622712
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622712
Contacts
| Contact: Frederik Berrevoet, MD, PhD | +32(0)93324892 | Frederik.Berrevoet@ugent.be |
Locations
| Belgium | |
| ASZ Aalst | Recruiting |
| Aalst, Belgium, 9300 | |
| Contact: Tijl Vierendeels, MD | |
| Principal Investigator: Tijl Vierendeels, MD | |
| Ghent University Hospital | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Frederik Berrevoet, MD, PhD +32(0)93324892 Frederik.Berrevoet@ugent.be | |
| Principal Investigator: Frederik Berrevoet, 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: | NCT01622712 History of Changes |
| Other Study ID Numbers: | 2011/823 |
| Study First Received: | June 15, 2012 |
| Last Updated: | December 4, 2014 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Hospital, Ghent:
|
inguinal hernia |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Hernia, Abdominal Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on March 03, 2015