Rebound Hernia Repair Device Mesh Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | September 2013 |
Rebound Hernia Repair Device Trial
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.
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.
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
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