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Clinical Trials/NCT01295437
NCT01295437
Completed
Not Applicable

A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia

Kuopio University Hospital1 site in 1 country300 target enrollmentMarch 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Kuopio University Hospital
Enrollment
300
Locations
1
Primary Endpoint
Presence of chronic pain
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
January 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kuopio University Hospital

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

Outcomes

Primary Outcomes

Presence of chronic pain

Time Frame: 5 years

Pain scores were measured by using a visual analoque scale.

Secondary Outcomes

  • Presence of recurrences(5 years)

Study Sites (1)

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