Comparison of Three Meshes in Lichtenstein Hernia Repair
Lichtenstein
A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia
2 other identifiers
interventional
300
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Mar 2003
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedFebruary 14, 2011
February 1, 2011
1.8 years
February 11, 2011
February 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of chronic pain
Pain scores were measured by using a visual analoque scale.
5 years
Secondary Outcomes (1)
Presence of recurrences
5 years
Study Arms (3)
Vypro II mesh
ACTIVE COMPARATORA partly absorbable polypropylene-polyglactin mesh (50g/m2).
Premilene LP
ACTIVE COMPARATORA lightweight polypropylene mesh (55 g/m2)
Premilene mesh
PLACEBO COMPARATORA conventional polypropylene mesh (82 g/m2)
Interventions
A conventional polypropylene mesh (82 g/m2)
Eligibility Criteria
You may qualify if:
- uni-or bilateral primary or recurrent inguinal hernia
- patients age \>18yrs
You may not qualify if:
- previous mesh hernioplasty
- femoral hernia
- emergency operation
- allergy to polypropylene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- Mikkeli Central Hospitalcollaborator
Study Sites (1)
Hannu Paajanen
Kuopio, 70600, Finland
Related Publications (2)
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.
PMID: 17492341BACKGROUNDPaajanen 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.
PMID: 23246868DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hannu EK Paajanen, MD, PhD
University Hospital of Kuopio, Finland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 14, 2011
Study Start
March 1, 2003
Primary Completion
January 1, 2005
Study Completion
January 1, 2011
Last Updated
February 14, 2011
Record last verified: 2011-02