Inguinal Hernia Study Using Biodesign IHM
Not Applicable
Completed
- Conditions
- Inguinal Hernia
- Registration Number
- NCT00393887
- Lead Sponsor
- Cook Group Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Patients With Inguinal Hernia Recurrence 1 year
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Biodesign IHM in inguinal hernia repair compared to polypropylene mesh?
How does Biodesign IHM compare to standard Lichtenstein repair with polypropylene mesh in recurrence rates and patient outcomes?
Are there specific biomarkers that predict better outcomes with Biodesign IHM versus polypropylene mesh in inguinal hernia repair?
What are the known adverse events associated with Biodesign IHM and how do they compare to polypropylene mesh in hernia repair?
What are the current trends in hernia repair devices, and how does Cook Group's Biodesign IHM fit into the therapeutic landscape compared to other hernia repair meshes?
Trial Locations
- Locations (1)
University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Maryland🇺🇸Baltimore, Maryland, United States