Back to resultsComparison of Three Meshes in Lichtenstein Hernia Repair (Lichtenstein)
Primary Purpose
Chronic Pain, Recurrences
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Vypro II mesh
Premilene LP
Premilene mesh
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring inguinal hernia, Lichtenstein hernioplasty, chronic pain
Eligibility Criteria
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
Sites / Locations
- Hannu Paajanen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Vypro II mesh
Premilene LP
Premilene mesh
Arm Description
A partly absorbable polypropylene-polyglactin mesh (50g/m2).
A lightweight polypropylene mesh (55 g/m2)
A conventional polypropylene mesh (82 g/m2)
Outcomes
Primary Outcome Measures
Presence of chronic pain
Pain scores were measured by using a visual analoque scale.
Secondary Outcome Measures
Presence of recurrences
Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination
Full Information
NCT ID
NCT01295437
First Posted
February 11, 2011
Last Updated
February 11, 2011
Sponsor
Kuopio University Hospital
Collaborators
Mikkeli Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01295437
Brief Title
Comparison of Three Meshes in Lichtenstein Hernia Repair
Acronym
Lichtenstein
Official Title
A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kuopio University Hospital
Collaborators
Mikkeli Central Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Recurrences
Keywords
inguinal hernia, Lichtenstein hernioplasty, chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vypro II mesh
Arm Type
Active Comparator
Arm Description
A partly absorbable polypropylene-polyglactin mesh (50g/m2).
Arm Title
Premilene LP
Arm Type
Active Comparator
Arm Description
A lightweight polypropylene mesh (55 g/m2)
Arm Title
Premilene mesh
Arm Type
Placebo Comparator
Arm Description
A conventional polypropylene mesh (82 g/m2)
Intervention Type
Device
Intervention Name(s)
Vypro II mesh
Other Intervention Name(s)
polypropylene-polyglactin mesh
Intervention Description
partly absorbable mesh
Intervention Type
Device
Intervention Name(s)
Premilene LP
Other Intervention Name(s)
lightweight polypropylene
Intervention Description
lightweight mesh
Intervention Type
Device
Intervention Name(s)
Premilene mesh
Other Intervention Name(s)
polypropylene mesh
Intervention Description
A conventional polypropylene mesh (82 g/m2)
Primary Outcome Measure Information:
Title
Presence of chronic pain
Description
Pain scores were measured by using a visual analoque scale.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Presence of recurrences
Description
Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD
Organizational Affiliation
University Hospital of Kuopio, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannu Paajanen
City
Kuopio
ZIP/Postal Code
70600
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
17492341
Citation
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.
Results Reference
background
PubMed Identifier
23246868
Citation
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.
Results Reference
derived
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Comparison of Three Meshes in Lichtenstein Hernia Repair
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