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Completed

NCT Number: NCT01295437

Comparison of Three Meshes in Lichtenstein Hernia Repair

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).

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Key information

Conditions

Chronic Pain Disease Attributes Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence Recurrences Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannu Paajanen

Kuopio, 70600, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vypro II mesh

Device

partly absorbable mesh

Other names: polypropylene-polyglactin mesh

Premilene LP

Device

lightweight mesh

Other names: lightweight polypropylene

Premilene mesh

Device

A conventional polypropylene mesh (82 g/m2)

Other names: polypropylene mesh

Primary outcomes

  1. Presence of chronic pain

    Time frame: 5 years

    Pain scores were measured by using a visual analoque scale.

Secondary outcomes

  1. Presence of recurrences

    Time frame: 5 years

    Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • Mikkeli Central Hospital

Registry information

Official study title

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

Acronym: Lichtenstein

Important dates

Study start
2003
Primary completion
2005
Study completion
2011
First posted
Feb 14, 2011
Registry last updated
Feb 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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