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
  Purpose

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 Intervention
Chronic Pain
Procedure: Open mesh inguinal hernia repair
Device: Prolene Hernia System
Procedure: Lichtenstein technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Long-term Sequelae [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Any pain at five years


Enrollment: 300
Study Start Date: September 2001
Study Completion Date: December 2009
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uni- or bilateral
  • Primary or recurrent

Exclusion Criteria:

  • body-mass index over 40kg/m2, severe co-morbidities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070693

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

No publications provided

Responsible Party: Jaana Vironen, Consultant, 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

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

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 16, 2014