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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaana Vironen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01070693
First received: February 17, 2010
Last updated: December 2, 2013
Last verified: December 2013

February 17, 2010
December 2, 2013
September 2001
January 2005   (final data collection date for primary outcome measure)
Long-term Sequelae [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Any pain at five years
Convalescence Long-term sequelae [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01070693 on ClinicalTrials.gov Archive Site
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Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair
Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Pain
  • 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
  • Experimental: Prolene Hernia System device
    Inguinal hernia repair either with a bilayer mesh (PHS)
    Interventions:
    • Procedure: Open mesh inguinal hernia repair
    • Device: Prolene Hernia System
  • Experimental: Lichtenstein
    Inguinal hernia repair with the Lichtenstein technique
    Interventions:
    • Procedure: Open mesh inguinal hernia repair
    • Procedure: Lichtenstein technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2009
January 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Uni- or bilateral
  • Primary or recurrent

Exclusion Criteria:

  • body-mass index over 40kg/m2, severe co-morbidities
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01070693
TYH1333
No
Jaana Vironen, Helsinki University Central Hospital
Helsinki University Central Hospital
Not Provided
Not Provided
Helsinki University Central Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP