Inguinal Hernia Study Using Biodesign IHM
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2007 |
| End Date: | June 2014 |
Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard
Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and
patient will be blinded), randomized, prospective comparative study with polypropylene mesh.
Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound
or CT scan.
Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and
patient will be blinded), randomized, prospective comparative study with polypropylene mesh.
Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound
or CT scan.
Inclusion Criteria:
- 18 years of age
- Diagnosis of Unilateral inguinal hernia repair
- Able to provide written consent
Exclusion Criteria:
- Incarcerated hernia
- Allergic or religious beliefs that disallow porcine material
- Previous hernia repair on the designated hernia site
- Class IV or V anesthesia requirements
- Bowel obstruction
- Peritonitis
- Life expectancy < 3 years
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