Back to resultsLichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Open mesh inguinal hernia repair
Prolene Hernia System
Lichtenstein technique
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Inguinal hernia, Open mesh repair, Long term outcome, Recurrence, Discomfort
Eligibility Criteria
Inclusion Criteria:
- Uni- or bilateral
- Primary or recurrent
Exclusion Criteria:
- body-mass index over 40kg/m2, severe co-morbidities
Sites / Locations
- Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prolene Hernia System device
Lichtenstein
Arm Description
Inguinal hernia repair either with a bilayer mesh (PHS)
Inguinal hernia repair with the Lichtenstein technique
Outcomes
Primary Outcome Measures
Long-term Sequelae
Any pain at five years
Secondary Outcome Measures
Full Information
NCT ID
NCT01070693
First Posted
February 17, 2010
Last Updated
December 2, 2013
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01070693
Brief Title
Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair
Official Title
Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Inguinal hernia, Open mesh repair, Long term outcome, Recurrence, Discomfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prolene Hernia System device
Arm Type
Experimental
Arm Description
Inguinal hernia repair either with a bilayer mesh (PHS)
Arm Title
Lichtenstein
Arm Type
Experimental
Arm Description
Inguinal hernia repair with the Lichtenstein technique
Intervention Type
Procedure
Intervention Name(s)
Open mesh inguinal hernia repair
Intervention Description
Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Intervention Type
Device
Intervention Name(s)
Prolene Hernia System
Intervention Description
Prolene Hernia System
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein technique
Intervention Description
Lichtenstein technique
Primary Outcome Measure Information:
Title
Long-term Sequelae
Description
Any pain at five years
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uni- or bilateral
Primary or recurrent
Exclusion Criteria:
body-mass index over 40kg/m2, severe co-morbidities
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Espoo
ZIP/Postal Code
07430
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair
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