N/A Completed N=100 Randomized Quadruple-blind Treatment

Inguinal Hernia Study Using Biodesign IHM

Inguinal Hernia

Source: ClinicalTrials.gov NCT00393887 ↗

Enrolled (actual)

100

Serious AEs

12.6%

Results posted

Aug 2015

Primary outcomePrimary: Number of Patients With Inguinal Hernia Recurrence — 3; 0 participants — p=0.11

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Inguinal Hernia Recurrence	3; 0	0.11

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00393887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.