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Glubran Mesh Fixation in Lichtenstein Hernioplasty

Phase 2
Completed
Conditions
Inguinal Hernia
Interventions
Procedure: cyanoacrylate glue
Registration Number
NCT00659542
Lead Sponsor
Kuopio University Hospital
Brief Summary

The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.

Detailed Description

Repair of inguinal hernia in one of the most frequently performed surgical operation in western world. The technique of choice is currently to support inguinal tissues by using polypropylene mesh. Chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. Pain might be related to mesh fixation by sutures. This randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. The patients are followed 1 year postoperatively. Pain, quality of life, operative parameters (time, cost) and recurrences are reported.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
Inclusion Criteria
  • inguinal hernia
  • adult patient
Exclusion Criteria
  • patient not willing
  • multiple recurrences
  • inguinal pain without evidence of hernia
  • femoral hernia
  • large scrotal hernia

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2cyanoacrylate gluemesh fixation by cyanoacrylate glue
Primary Outcome Measures
NameTimeMethod
postoperative pain1 year
Secondary Outcome Measures
NameTimeMethod
hernia recurrence, quality of life1 year

Trial Locations

Locations (1)

Hannu Paajanen

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Kuopio, Finland

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