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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:
Collaborators:
Sorlandet Hospital HF
Voss Sykehus
Haraldsplass Deaconess Hospital
Sykehuset Ostfold
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184483
First received: September 15, 2005
Last updated: February 4, 2016
Last verified: February 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrences after groin hernia repair [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

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

Inclusion Criteria:

  • Primary unilateral groin hernia in adult

Exclusion Criteria:

  • recurrence warfarin treatment bilateral groin hernia
  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: 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 
Study First Received: September 15, 2005
Last Updated: February 4, 2016
Health Authority: Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on September 23, 2016