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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Pain
Interventions Procedure: Open mesh inguinal hernia repair
Device: Prolene Hernia System
Procedure: Lichtenstein technique
Enrollment 300
Recruitment Details 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  
Arm/Group Title Prolene Hernia System Device Lichtenstein
Hide Arm/Group Description Inguinal hernia repair either with a bilayer mesh (PHS) Inguinal hernia repair with the Lichtenstein technique
Period Title: Overall Study
Started 150 149
Completed 122 110
Not Completed 28 39
Arm/Group Title Prolene Hernia System Device Lichtenstein Total
Hide Arm/Group Description Inguinal hernia repair either with a bilayer mesh (PHS) Inguinal hernia repair with the Lichtenstein technique Total of all reporting groups
Overall Number of Baseline Participants 150 149 299
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 150 participants 149 participants 299 participants
46
(19 to 72)
47
(20 to 70)
46
(19 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 149 participants 299 participants
Female
10
   6.7%
8
   5.4%
18
   6.0%
Male
140
  93.3%
141
  94.6%
281
  94.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Finland Number Analyzed 150 participants 149 participants 299 participants
150 149 299
1.Primary Outcome
Title Long-term Sequelae
Hide Description Any pain at five years
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolene Hernia System Device Lichtenstein
Hide Arm/Group Description:

Inguinal hernia repair either with a bilayer mesh (PHS)

Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique

Prolene Hernia System: Prolene Hernia System

Inguinal hernia repair with the Lichtenstein technique

Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique

Lichtenstein technique: Lichtenstein technique

Overall Number of Participants Analyzed 122 110
Measure Type: Number
Unit of Measure: percentage of participants
10 13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prolene Hernia System Device Lichtenstein
Hide Arm/Group Description

Inguinal hernia repair either with a bilayer mesh (PHS)

Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique

Prolene Hernia System: Prolene Hernia System

Inguinal hernia repair with the Lichtenstein technique

Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique

Lichtenstein technique: Lichtenstein technique

All-Cause Mortality
Prolene Hernia System Device Lichtenstein
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Prolene Hernia System Device Lichtenstein
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/149 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prolene Hernia System Device Lichtenstein
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/149 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Georgios Pierides
Organization: Helsinki University Central Hospital
Phone: +358 9 4711
EMail: georgios.pierides@hus.fi
Layout table for additonal information
Responsible Party: Jaana Vironen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01070693    
Other Study ID Numbers: TYH1333
First Submitted: February 17, 2010
First Posted: February 18, 2010
Results First Submitted: December 2, 2013
Results First Posted: January 16, 2014
Last Update Posted: January 16, 2014