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

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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

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.

Condition or disease Intervention/treatment
Chronic Pain Procedure: Open mesh inguinal hernia repair Device: Prolene Hernia System Procedure: Lichtenstein technique

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair
Study Start Date : September 2001
Primary Completion Date : January 2005
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prolene Hernia System device
Inguinal hernia repair either with a bilayer mesh (PHS)
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
Experimental: Lichtenstein
Inguinal hernia repair with the Lichtenstein technique
Procedure: Open mesh inguinal hernia repair
Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Procedure: Lichtenstein technique
Lichtenstein technique



Primary Outcome Measures :
  1. Long-term Sequelae [ Time Frame: 5 years ]
    Any pain at five years



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uni- or bilateral
  • Primary or recurrent

Exclusion Criteria:

  • body-mass index over 40kg/m2, severe co-morbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070693


Locations
Finland
Helsinki University Central Hospital
Espoo, Finland, 07430
Sponsors and Collaborators
Helsinki University Central Hospital

Responsible Party: Jaana Vironen, Consultant, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01070693     History of Changes
Other Study ID Numbers: TYH1333
First Posted: February 18, 2010    Key Record Dates
Results First Posted: January 16, 2014
Last Update Posted: January 16, 2014
Last Verified: December 2013

Keywords provided by Jaana Vironen, Helsinki University Central Hospital:
Inguinal hernia
Open mesh repair
Long term outcome
Recurrence
Discomfort

Additional relevant MeSH terms:
Hernia
Chronic Pain
Hernia, Inguinal
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hernia, Abdominal