Back to resultsA Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lichtenstein's operation
Prolene Hernia System
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Surgery, Lichtenstein, Prolene Hernia System, Postoperative pain, Recurrence
Eligibility Criteria
Inclusion Criteria: Primary unilateral groin hernia in adult Exclusion Criteria: recurrence warfarin treatment bilateral groin hernia
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lichtenstein's operation
Prolene Hernia System
Arm Description
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia
Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia
Outcomes
Primary Outcome Measures
pain postoperative
Secondary Outcome Measures
Recurrences after groin hernia repair
Full Information
NCT ID
NCT00184483
First Posted
September 15, 2005
Last Updated
September 9, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
Sorlandet Hospital HF, Voss Sykehus, Haraldsplass Deaconess Hospital, Sykehuset Ostfold
1. Study Identification
Unique Protocol Identification Number
NCT00184483
Brief Title
A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair
Official Title
Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Sorlandet Hospital HF, Voss Sykehus, Haraldsplass Deaconess Hospital, Sykehuset Ostfold
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Surgery, Lichtenstein, Prolene Hernia System, Postoperative pain, Recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lichtenstein's operation
Arm Type
Experimental
Arm Description
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia
Arm Title
Prolene Hernia System
Arm Type
Active Comparator
Arm Description
Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein's operation
Intervention Description
Lichtenstein's operation to repair primary unilateral inguinal hernia
Intervention Type
Procedure
Intervention Name(s)
Prolene Hernia System
Intervention Description
Prolene Hernia System to repair primary unilateral inguinal hernia
Primary Outcome Measure Information:
Title
pain postoperative
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Recurrences after groin hernia repair
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary unilateral groin hernia in adult
Exclusion Criteria:
recurrence warfarin treatment bilateral groin hernia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helge E Myrvold, MD PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair
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