Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device (REBOUND)
Recruitment status was: Recruiting
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:||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.|
- 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.
- 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 ]
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622712
|Aalst, Belgium, 9300|
|Ghent University Hospital|
|Ghent, Belgium, 9000|
|Principal Investigator:||Frederik Berrevoet, MD, PhD||University Hospital, Ghent|