Phase 4
Completed N=172
Strattice in Repair of Inguinal Hernias
Hernia, Inguinal
Source: ClinicalTrials.gov NCT00681291 ↗
Enrolled (actual)
172
Serious AEs
3.5%
Results posted
Mar 2016
Primary outcomePrimary: Change From Baseline in Activities Assessment Scale at 3 Months — -7.49; -6.12 units on a scale
◆ Published Evidence
Emerging
18citations · ~1 / year
The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair.
Summary
This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.
Linked Publications
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The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Activities Assessment Scale at 3 Months |
-7.49; -6.12 | — |
| PRIMARY Change From Baseline in Activities Assessment Scale at 6 Months |
-8.17; -7.20 | — |
| PRIMARY Change From Baseline in Activities Assessment Scale at 12 Months |
-8.78; -7.61 | — |
| PRIMARY Change From Baseline in Activities Assessment Scale at 24 Months |
-7.57; -7.53 | — |
Eligibility Criteria
Inclusion Criteria
- adult male
- symptomatic and palpable inguinal hernia
- open, elective, primary unilateral inguinal hernia repair
Exclusion Criteria
- bilateral inguinal hernia repair
- BMI >35
- chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes, severe liver disease or COPD
- chronic prostatitis, orchitis, testicular pain
- local or systemic infection at time of repair
- known collagen disorder
- chronic pain syndrome or under active pain management
Data sourced from ClinicalTrials.gov (NCT00681291) and the linked publication. 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.