Rebound Hernia Repair Device Mesh Trial

Study Overview
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Brief Summary
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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.

Official Title
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Rebound Hernia Repair Device Trial

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: Rebound HRD
* Device: Standard hernia mesh (VitaMesh)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age Unilateral or bilateral inguinal hernia (moderate in size), primary in nature Exclusion Criteria: Unable to provide informed consent Assessed as ASA 3 or 4 Renal failure;creatinine greater than 2.0mg percent Ascites as determined by clinical suspicion/ultrasound confirmation Known pregnancy Femoral hernias Diabetes requiring injectable insulin Prior lower abdominal surgery through lower midline or Pfannenstiel incision TAPP approach Requiring anticoagulants during surgery Participation in another study involving another device or drug Emergent procedures for hernia incarceration and strangulation Recurrent inguinal hernias

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Rebound hernia repair device with no fixation<br>Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature. | Device: Rebound HRD<br>* Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation<br>|
| Active Comparator: Standard Hernia Mesh using fixation<br>Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature. | Device: Standard hernia mesh (VitaMesh)<br>* Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation<br>* Other names: VitaMesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of hernia recurrence |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort to patients using VAS |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, mesh, hernia repair device