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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Prolene Hernia System; Procedure: Lichtenstein technique; Procedure: Open mesh inguinal hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01070693

TYH1333

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uni- or bilateral
• Primary or recurrent

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

Prolene Hernia System device

Experimental group

Description:

Inguinal hernia repair either with a bilayer mesh (PHS)

Treatment:

Procedure: Open mesh inguinal hernia repair

Device: Prolene Hernia System

Lichtenstein

Experimental group

Description:

Inguinal hernia repair with the Lichtenstein technique

Treatment:

Procedure: Lichtenstein technique

Procedure: Open mesh inguinal hernia repair