Rebound Hernia Repair Device Mesh Trial
Recruitment status was: Active, not recruiting
This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference.
The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.
|Inguinal Hernia||Device: Rebound HRD Device: Standard hernia mesh (VitaMesh)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Rebound Hernia Repair Device Trial|
- Presence of hernia recurrence [ Time Frame: 2 years ]
- Pain and discomfort to patients using VAS [ Time Frame: 2 years ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: The Rebound hernia repair device with no fixation
Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.
Device: Rebound HRD
Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation
Active Comparator: Standard Hernia Mesh using fixation
Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.
Device: Standard hernia mesh (VitaMesh)
Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation
Other Name: VitaMesh
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968773
|United States, Kentucky|
|University of Kentucky Dept. Of Surgery|
|Lexington, Kentucky, United States, 40536-0293|
|United States, Ohio|
|The Ohio State Medical Center, Dept. of Surgery|
|Columbus, Ohio, United States, 43210-1228|
|Principal Investigator:||John S Roth, MD||University of Kentucky|
|Principal Investigator:||Jeffrey W Hazey, MD||Ohio State University|