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NCT01070693 Clinical Trial

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

Chronic Pain Clinical Trial

Official title:
Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01070693
Other study ID # TYH1333
Secondary ID
Status Completed
Phase N/A
First received February 17, 2010
Last updated December 2, 2013
Start date September 2001
Est. completion date December 2009

Study information
Verified date December 2013
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Data Protection BoardFinland: Ethics CommitteeFinland: Finnish Medicines AgencyFinland: Ministry of Social Affairs and HealthFinland: National Advisory Board on Health Care Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 2009
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Uni- or bilateral

- Primary or recurrent

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Open mesh inguinal hernia repair
Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Device:
• Prolene Hernia System
Prolene Hernia System
Procedure:
• Lichtenstein technique
Lichtenstein technique

Locations
Country Name City State
Finland Helsinki University Central Hospital Espoo

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term Sequelae Any pain at five years 5 years No
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