Inguinal Hernia Study Using Biodesign IHM

Completed · Not applicable

Conditions studied: Inguinal Hernia

In brief

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.

Key facts

Study ID

NCT00393887

Run by

Cook Group Incorporated

People needed

100

Starts

2007-03-01

Expected to finish

2014-06-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age
• Diagnosis of Unilateral inguinal hernia repair
• Able to provide written consent

You may not qualify if…

• 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

Where it is running

• University of Maryland — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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