NCT01070693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 16, 2014

Completed
Last Updated

January 16, 2014

Status Verified

December 1, 2013

Enrollment Period

3.3 years

First QC Date

February 17, 2010

Results QC Date

December 2, 2013

Last Update Submit

December 2, 2013

Conditions

Chronic Pain

Keywords

Inguinal herniaOpen mesh repairLong term outcomeRecurrenceDiscomfort

Outcome Measures

Primary Outcomes (1)

  • Long-term Sequelae

    Any pain at five years

    5 years

Study Arms (2)

Prolene Hernia System device

EXPERIMENTAL

Inguinal hernia repair either with a bilayer mesh (PHS)

Procedure: Open mesh inguinal hernia repairDevice: Prolene Hernia System

Lichtenstein

EXPERIMENTAL

Inguinal hernia repair with the Lichtenstein technique

Procedure: Open mesh inguinal hernia repairProcedure: Lichtenstein technique

Interventions

Open mesh inguinal hernia repairPROCEDURE

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

LichtensteinProlene Hernia System device
Prolene Hernia SystemDEVICE

Prolene Hernia System

Prolene Hernia System device
Lichtenstein techniquePROCEDURE

Lichtenstein technique

Lichtenstein

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uni- or bilateral
  • Primary or recurrent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Espoo, 07430, Finland

Location

MeSH Terms

Conditions

Chronic PainHernia, InguinalRecurrence

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHernia, AbdominalHerniaPathological Conditions, AnatomicalDisease AttributesPathologic Processes

Results Point of Contact

Title
Dr. Georgios Pierides
Organization
Helsinki University Central Hospital
georgios.pierides@hus.fi
+358 9 4711

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 18, 2010

Study Start

September 1, 2001

Primary Completion

January 1, 2005

Study Completion

December 1, 2009

Last Updated

January 16, 2014

Results First Posted

January 16, 2014

Record last verified: 2013-12

Locations

FI(1)