Clinical Trial: Study of Surgical Mesh for Inguinal Hernia Repair

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique

Brief Summary: The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.

Detailed Summary:
Sponsor: Biomerix

Current Primary Outcome: Technical success with no complications through 6 weeks. [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hernia recurrence [ Time Frame: 1 year ]
  • Pain and functional status [ Time Frame: 10 day, 6 weeks, 6 months 1 year ]
  • Incidence of complications [ Time Frame: 10 days, 6 weeks, 6 months, 1 year ]


Original Secondary Outcome: Same as current

Information By: Biomerix

Dates:
Date Received: June 17, 2009
Date Started: June 2009
Date Completion: November 2010
Last Updated: October 1, 2010
Last Verified: October 2010