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A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184483
First Posted: September 16, 2005
Last Update Posted: February 5, 2016
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.
Collaborators:
Sorlandet Hospital HF
Voss Sykehus
Haraldsplass Deaconess Hospital
Sykehuset Ostfold
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.

Condition Intervention
Inguinal Hernia Procedure: Lichtenstein's operation Procedure: Prolene Hernia System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • pain postoperative [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Recurrences after groin hernia repair [ Time Frame: 3 years ]

Enrollment: 405
Study Start Date: October 2001
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lichtenstein's operation
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia
Procedure: Lichtenstein's operation
Lichtenstein's operation to repair primary unilateral inguinal hernia
Active Comparator: Prolene Hernia System
Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia
Procedure: Prolene Hernia System
Prolene Hernia System to repair primary unilateral inguinal hernia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary unilateral groin hernia in adult

Exclusion Criteria:

  • recurrence warfarin treatment bilateral groin hernia
  Contacts and Locations
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): NCT00184483


Locations
Norway
St Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Sorlandet Hospital HF
Voss Sykehus
Haraldsplass Deaconess Hospital
Sykehuset Ostfold
Investigators
Study Director: Helge E Myrvold, MD PhD NTNU
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184483     History of Changes
Other Study ID Numbers: Norwegian Hernia Study
First Submitted: September 15, 2005
First Posted: September 16, 2005
Last Update Posted: February 5, 2016
Last Verified: February 2016

Keywords provided by Norwegian University of Science and Technology:
Surgery
Lichtenstein
Prolene Hernia System
Postoperative pain
Recurrence

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