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| Name | Class |
|---|---|
| University of Kentucky | OTHER |
| Ohio State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Rebound hernia repair device with no fixation | Experimental | Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature. |
|
| Standard Hernia Mesh using fixation | Active Comparator | Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebound HRD | Device | Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of hernia recurrence | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and discomfort to patients using VAS | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John S Roth, MD | University of Kentucky | Principal Investigator |
| Jeffrey W Hazey, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Dept. Of Surgery | Lexington | Kentucky | 40536-0293 | United States | ||
| The Ohio State Medical Center, Dept. of Surgery |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard hernia mesh (VitaMesh) | Device | Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation |
|
|
| Columbus |
| Ohio |
| 43210-1228 |
| United States |