Inguinal Hernia Study Using Biodesign IHM

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: Biodesign IHM; Device: Polypropylene mesh

• 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

Study Timeline

• Study First Submitted: 2006-10-26
• Study First Submitted QC: 2006-10-27
• Study First Posted: 2006-10-29
• Study Start: 2007-03
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-07-29
• Results First Submitted QC: 2015-07-29
• Results First Posted: 2015-08-25
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-11-20

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

Arm && Interventions

Group	Intervention	Description
1	Biodesign IHM	Biodesign IHM Graft placement
2	Polypropylene mesh	Polypropylene mesh placement

Primary Outcome Measures

Name	Time	Method
Number of Patients With Inguinal Hernia Recurrence	1 year

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States