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

NCT ID: NCT01070693

Last Updated: 2014-01-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prolene Hernia System device

Inguinal hernia repair either with a bilayer mesh (PHS)

Group Type EXPERIMENTAL

Open mesh inguinal hernia repair

Intervention Type PROCEDURE

Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique

Prolene Hernia System

Intervention Type DEVICE

Prolene Hernia System

Lichtenstein

Inguinal hernia repair with the Lichtenstein technique

Group Type EXPERIMENTAL

Open mesh inguinal hernia repair

Intervention Type PROCEDURE

Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique

Lichtenstein technique

Intervention Type PROCEDURE

Lichtenstein technique

Interventions

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Open mesh inguinal hernia repair

Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique

Intervention Type PROCEDURE

Prolene Hernia System

Prolene Hernia System

Intervention Type DEVICE

Lichtenstein technique

Lichtenstein technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Uni- or bilateral
* Primary or recurrent

Exclusion Criteria

* body-mass index over 40kg/m2, severe co-morbidities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jaana Vironen

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Central Hospital

Espoo, , Finland

Site Status

Countries

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Finland

Other Identifiers

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TYH1333

Identifier Type: -

Identifier Source: org_study_id

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