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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014