N/A N=299 Randomized Quadruple-blind Treatment

Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT01070693 ↗

Enrolled (actual)

299

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcome: Primary: Long-term Sequelae — 10; 13 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Open mesh inguinal hernia repair (Procedure); Prolene Hernia System (Device); Lichtenstein technique (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Helsinki University Central Hospital
Primary completion: Jan 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Long-term Sequelae	10; 13	—

Summary

This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.

Eligibility Criteria

Inclusion Criteria

Uni- or bilateral
Primary or recurrent

Exclusion Criteria

body-mass index over 40kg/m2, severe co-morbidities

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Data sourced from ClinicalTrials.gov (NCT01070693). 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.