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Comparison of Three Meshes in Lichtenstein Hernia Repair (Lichtenstein)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295437
First Posted: February 14, 2011
Last Update Posted: February 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mikkeli Central Hospital, Mikkeli, Finland
Information provided by:
Kuopio University Hospital
  Purpose
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).

Condition Intervention
Chronic Pain Recurrences Device: Vypro II mesh Device: Premilene LP Device: Premilene mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Presence of chronic pain [ Time Frame: 5 years ]
    Pain scores were measured by using a visual analoque scale.


Secondary Outcome Measures:
  • Presence of recurrences [ Time Frame: 5 years ]
    Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination


Enrollment: 300
Study Start Date: March 2003
Study Completion Date: January 2011
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vypro II mesh
A partly absorbable polypropylene-polyglactin mesh (50g/m2).
Device: Vypro II mesh
partly absorbable mesh
Other Name: polypropylene-polyglactin mesh
Active Comparator: Premilene LP
A lightweight polypropylene mesh (55 g/m2)
Device: Premilene LP
lightweight mesh
Other Name: lightweight polypropylene
Placebo Comparator: Premilene mesh
A conventional polypropylene mesh (82 g/m2)
Device: Premilene mesh
A conventional polypropylene mesh (82 g/m2)
Other Name: 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.
  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295437


Locations
Finland
Hannu Paajanen
Kuopio, Finland, 70600
Sponsors and Collaborators
Kuopio University Hospital
Mikkeli Central Hospital, Mikkeli, Finland
Investigators
Principal Investigator: Hannu EK Paajanen, MD, PhD University Hospital of Kuopio, Finland
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hannu Paajanen, Department of Surgery, Kuopio University Hospital, Kuopio, Finland
ClinicalTrials.gov Identifier: NCT01295437     History of Changes
Other Study ID Numbers: Lichtenstein hernia repair
Lichtenstein ( Other Identifier: Etelä-Savon Eettinen tmk ETMK§11 )
First Submitted: February 11, 2011
First Posted: February 14, 2011
Last Update Posted: February 14, 2011
Last Verified: February 2011

Keywords provided by Kuopio University Hospital:
inguinal hernia, Lichtenstein hernioplasty, chronic pain

Additional relevant MeSH terms:
Hernia
Chronic Pain
Recurrence
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes