- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295437
Comparison of Three Meshes in Lichtenstein Hernia Repair (Lichtenstein)
February 11, 2011 updated by: Kuopio University Hospital
A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia
Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty.
The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique.
The patients were randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias), a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven polypropylene mesh (Premilene, 100 hernias).
Pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kuopio, Finland, 70600
- Hannu Paajanen
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- uni-or bilateral primary or recurrent inguinal hernia
- patients age >18yrs
Exclusion Criteria:
- previous mesh hernioplasty
- femoral hernia
- emergency operation
- allergy to polypropylene
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vypro II mesh
A partly absorbable polypropylene-polyglactin mesh (50g/m2).
|
partly absorbable mesh
Other Names:
|
Active Comparator: Premilene LP
A lightweight polypropylene mesh (55 g/m2)
|
lightweight mesh
Other Names:
|
Placebo Comparator: Premilene mesh
A conventional polypropylene mesh (82 g/m2)
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A conventional polypropylene mesh (82 g/m2)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of chronic pain
Time Frame: 5 years
|
Pain scores were measured by using a visual analoque scale.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of recurrences
Time Frame: 5 years
|
Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hannu EK Paajanen, MD, PhD, University Hospital of Kuopio, Finland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Paajanen H. A single-surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia. Hernia. 2007 Aug;11(4):335-9. doi: 10.1007/s10029-007-0236-1. Epub 2007 May 10.
- Paajanen H, Ronka K, Laurema A. A single-surgeon randomized trial comparing three meshes in lichtenstein hernia repair: 2- and 5-year outcome of recurrences and chronic pain. Int J Surg. 2013;11(1):81-4. doi: 10.1016/j.ijsu.2012.11.020. Epub 2012 Dec 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
February 11, 2011
First Submitted That Met QC Criteria
February 11, 2011
First Posted (Estimate)
February 14, 2011
Study Record Updates
Last Update Posted (Estimate)
February 14, 2011
Last Update Submitted That Met QC Criteria
February 11, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lichtenstein hernia repair
- Lichtenstein (Other Identifier: Etelä-Savon Eettinen tmk ETMK§11)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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