Rebound Hernia Repair Device Mesh Trial

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2009
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.
Epistemonikos ID: 7241906fccbcd584fe47833f206258b8c6885d89
First added on: May 05, 2024