N/A
N=100
Inguinal Hernia Study Using Biodesign IHM
Inguinal Hernia
Bottom Line
View on ClinicalTrials.gov: NCT00393887 ↗Enrolled (actual)
100
Serious AEs
12.6%
Results posted
Aug 2015
Primary outcome: Primary: Number of Patients With Inguinal Hernia Recurrence — 3; 0 participants — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biodesign IHM (Device); Polypropylene mesh (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Inguinal Hernia Recurrence |
3; 0 | 0.11 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00393887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.