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
Results First Received: December 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Pain
Interventions: Procedure: Open mesh inguinal hernia repair
Device: Prolene Hernia System
Procedure: Lichtenstein technique

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Included were 300 adult patients (282 men, 18 women) referred for elective repair having unilateral or bilateral inguinal hernias. Study period: September 2001 - January 2004, outpatient unit of Jorvi Hospital (Helsinki University Central Hospital, Espoo, Finland).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Prolene Hernia System Device Inguinal hernia repair either with a bilayer mesh (PHS)
Lichtenstein Inguinal hernia repair with the Lichtenstein technique

Participant Flow:   Overall Study
    Prolene Hernia System Device     Lichtenstein  
STARTED     150     149  
COMPLETED     122     110  
NOT COMPLETED     28     39  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Prolene Hernia System Device Inguinal hernia repair either with a bilayer mesh (PHS)
Lichtenstein Inguinal hernia repair with the Lichtenstein technique
Total Total of all reporting groups

Baseline Measures
    Prolene Hernia System Device     Lichtenstein     Total  
Number of Participants  
[units: participants]
  150     149     299  
Age  
[units: years]
Median ( Full Range )
  46  
  ( 19 to 72 )  
  47  
  ( 20 to 70 )  
  46  
  ( 19 to 72 )  
Gender  
[units: participants]
     
Female     10     8     18  
Male     140     141     281  
Region of Enrollment  
[units: participants]
     
Finland     150     149     299  



  Outcome Measures

1.  Primary:   Long-term Sequelae   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Georgios Pierides
Organization: Helsinki University Central Hospital
phone: +358 9 4711
e-mail: georgios.pierides@hus.fi


No publications provided


Responsible Party: Jaana Vironen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01070693     History of Changes
Other Study ID Numbers: TYH1333
Study First Received: February 17, 2010
Results First Received: December 2, 2013
Last Updated: December 2, 2013
Health Authority: Finland: Data Protection Board
Finland: Ethics Committee
Finland: Finnish Medicines Agency
Finland: Ministry of Social Affairs and Health
Finland: National Advisory Board on Health Care Ethics