Comparison of Three Meshes in Lichtenstein Hernia Repair (Lichtenstein)

February 11, 2011 updated by: Kuopio University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70600
        • Hannu Paajanen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vypro II mesh
A partly absorbable polypropylene-polyglactin mesh (50g/m2).
Device: Vypro II mesh
partly absorbable mesh
Other Names:
  • polypropylene-polyglactin mesh
Active Comparator: Premilene LP
A lightweight polypropylene mesh (55 g/m2)
Device: Premilene LP
lightweight mesh
Other Names:
  • lightweight polypropylene
Placebo Comparator: Premilene mesh
A conventional polypropylene mesh (82 g/m2)
Device: Premilene mesh
A conventional polypropylene mesh (82 g/m2)
Other Names:
  • polypropylene mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of chronic pain
Time Frame: 5 years
Pain scores were measured by using a visual analoque scale.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of recurrences
Time Frame: 5 years
Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Mikkeli Central Hospital

Investigators

  • Principal Investigator: Hannu EK Paajanen, MD, PhD, University Hospital of Kuopio, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (Estimate)

February 14, 2011

Study Record Updates

Last Update Posted (Estimate)

February 14, 2011

Last Update Submitted That Met QC Criteria

February 11, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lichtenstein hernia repair
  • Lichtenstein (Other Identifier: Etelä-Savon Eettinen tmk ETMK§11)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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