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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01070693
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : January 16, 2014
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
Jaana Vironen, Helsinki University Central Hospital

Tracking Information
First Submitted Date  ICMJE February 17, 2010
First Posted Date  ICMJE February 18, 2010
Results First Submitted Date  ICMJE December 2, 2013
Results First Posted Date  ICMJE January 16, 2014
Last Update Posted Date January 16, 2014
Study Start Date  ICMJE September 2001
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Long-term Sequelae [ Time Frame: 5 years ]
Any pain at five years
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
Convalescence Long-term sequelae [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair
Official Title  ICMJE Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2010)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Uni- or bilateral
  • Primary or recurrent

Exclusion Criteria:

  • body-mass index over 40kg/m2, severe co-morbidities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01070693
Other Study ID Numbers  ICMJE TYH1333
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaana Vironen, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Helsinki University Central Hospital
Verification Date December 2013

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