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Clinical Trials/NCT00820131
NCT00820131
Completed
Phase 4

A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh

Medical University of Vienna7 sites in 1 country250 target enrollmentJanuary 2008

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Medical University of Vienna
Enrollment
250
Locations
7
Primary Endpoint
chronic pain
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.

A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.

Two techniques of inguinal hernia repair will be evaluated:

  1. open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
  2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)

Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • primary unilateral inguinal hernia
  • 18 years and older

Exclusion Criteria

  • bilateral hernia
  • recurrent hernia
  • incarcerated hernia
  • malignant disease within the last 5 years
  • not able to understand the questionaire

Outcomes

Primary Outcomes

chronic pain

Time Frame: 3 months, 15 months

Secondary Outcomes

  • morbidity(3 months, 15 months)
  • recurrence rate(3 months and 15 months)
  • quality of life(3 months and 15 months)

Study Sites (7)

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