Comparison of Three Meshes in Lichtenstein Hernia Repair

This study has been completed.
Sponsor:
Collaborator:
Mikkeli Central Hospital, Mikkeli, Finland
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01295437
First received: February 11, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    Pain scores were measured by using a visual analoque scale.


Secondary Outcome Measures:
  • Presence of recurrences [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: Finland: Kuopio University Hospital, Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 25, 2014