Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device (REBOUND)
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|ClinicalTrials.gov Identifier: NCT01622712|
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was: Recruiting
First Posted : June 19, 2012
Last Update Posted : December 5, 2014
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 or disease||Intervention/treatment||Phase|
|Unilateral Inguinal Hernia||Device: Rebound HRD Mesh||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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.
- Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation. [ Time Frame: 12 months post-surgery ]A CT scan is performed.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622712
|Contact: Frederik Berrevoet, MD, PhD||+32(0)93324892||Frederik.Berrevoet@ugent.be|
|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|
|Principal Investigator:||Frederik Berrevoet, MD, PhD||University Hospital, Ghent|