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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

February 11, 2011
February 11, 2011
March 2003
January 2005   (final data collection date for primary outcome measure)
Presence of chronic pain [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Pain scores were measured by using a visual analoque scale.
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Comparison of Three Meshes in Lichtenstein Hernia Repair
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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Pain
  • Recurrences
  • Device: Vypro II mesh
    partly absorbable mesh
    Other Name: polypropylene-polyglactin mesh
  • Device: Premilene LP
    lightweight mesh
    Other Name: lightweight polypropylene
  • Device: Premilene mesh
    A conventional polypropylene mesh (82 g/m2)
    Other Name: polypropylene mesh
  • Active Comparator: Vypro II mesh
    A partly absorbable polypropylene-polyglactin mesh (50g/m2).
    Intervention: Device: Vypro II mesh
  • Active Comparator: Premilene LP
    A lightweight polypropylene mesh (55 g/m2)
    Intervention: Device: Premilene LP
  • Placebo Comparator: Premilene mesh
    A conventional polypropylene mesh (82 g/m2)
    Intervention: Device: Premilene mesh

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
January 2011
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01295437
Lichtenstein hernia repair, Lichtenstein
Yes
Hannu Paajanen, Department of Surgery, Kuopio University Hospital, Kuopio, Finland
Kuopio University Hospital
Mikkeli Central Hospital, Mikkeli, Finland
Principal Investigator: Hannu EK Paajanen, MD, PhD University Hospital of Kuopio, Finland
Kuopio University Hospital
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP