Comparison of Three Meshes in Lichtenstein Hernia Repair

Not Applicable

Completed

• Conditions: Chronic Pain; Recurrences
• Interventions: Device: Vypro II mesh; Device: Premilene LP; Device: Premilene mesh

• Registration Number: NCT01295437
• Lead Sponsor: Kuopio University Hospital

Brief Summary

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).

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 Timeline

• Study Start: 2003-03
• Primary Completion: 2005-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Last Update Submitted: 2011-02-11
• Study First Posted: 2011-02-14
• Last Update Posted: 2011-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vypro II mesh	Vypro II mesh	A partly absorbable polypropylene-polyglactin mesh (50g/m2).
Premilene LP	Premilene LP	A lightweight polypropylene mesh (55 g/m2)
Premilene mesh	Premilene mesh	A conventional polypropylene mesh (82 g/m2)

Primary Outcome Measures

Name	Time	Method
Presence of chronic pain	5 years	Pain scores were measured by using a visual analoque scale.

Secondary Outcome Measures

Name	Time	Method
Presence of recurrences	5 years	Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination

Trial Locations

Locations (1)

Hannu Paajanen; 🇫🇮 Kuopio, Finland