Clinical Trial: Inguinal Hernia Study Using Biodesign IHM

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Inguinal Hernia Study: A Double Blinded Randomized Prospective Study

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 Summary:
Sponsor: Cook

Current Primary Outcome: Number of Patients With Inguinal Hernia Recurrence [ Time Frame: 1 year ]

Original Primary Outcome: Recurrence rate

Current Secondary Outcome:

Original Secondary Outcome: Time back to baseline and complications

Information By: Cook

Dates:
Date Received: October 26, 2006
Date Started: March 2007
Date Completion:
Last Updated: October 16, 2015
Last Verified: October 2015