Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Procedure: Open mesh inguinal hernia repair; Procedure: Lichtenstein technique; Device: Prolene Hernia System

• Registration Number: NCT01070693
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2005-01
• Study Completion: 2009-12
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Status Verified: 2013-12
• Results First Submitted: 2013-12-02
• Results First Submitted QC: 2013-12-02
• Last Update Submitted: 2013-12-02
• Results First Posted: 2014-01-16
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

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

Inclusion Criteria

• Uni- or bilateral
• Primary or recurrent

Exclusion Criteria

• body-mass index over 40kg/m2, severe co-morbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lichtenstein	Open mesh inguinal hernia repair	Inguinal hernia repair with the Lichtenstein technique
Lichtenstein	Lichtenstein technique	Inguinal hernia repair with the Lichtenstein technique
Prolene Hernia System device	Prolene Hernia System	Inguinal hernia repair either with a bilayer mesh (PHS)
Prolene Hernia System device	Open mesh inguinal hernia repair	Inguinal hernia repair either with a bilayer mesh (PHS)

Primary Outcome Measures

Name	Time	Method
Long-term Sequelae	5 years	Any pain at five years

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Espoo, Finland