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

Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01070693
Enrollment
300
Registered
2010-02-18
Start date
2001-09-30
Completion date
2009-12-31
Last updated
2014-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Inguinal hernia, Open mesh repair, Long term outcome, Recurrence, Discomfort

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.

Interventions

PROCEDUREOpen mesh inguinal hernia repair

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

DEVICEProlene Hernia System

Prolene Hernia System

PROCEDURELichtenstein technique

Lichtenstein technique

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Uni- or bilateral * Primary or recurrent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Long-term Sequelae5 yearsAny pain at five years

Countries

Finland

Participant flow

Recruitment details

Included were 300 adult patients (282 men, 18 women) referred for elective repair having unilateral or bilateral inguinal hernias. Study period: September 2001 - January 2004, outpatient unit of Jorvi Hospital (Helsinki University Central Hospital, Espoo, Finland).

Participants by arm

ArmCount
Prolene Hernia System Device
Inguinal hernia repair either with a bilayer mesh (PHS)
150
Lichtenstein
Inguinal hernia repair with the Lichtenstein technique
149
Total299

Baseline characteristics

CharacteristicProlene Hernia System DeviceLichtensteinTotal
Age, Continuous46 years47 years46 years
Region of Enrollment
Finland
150 participants149 participants299 participants
Sex: Female, Male
Female
10 Participants8 Participants18 Participants
Sex: Female, Male
Male
140 Participants141 Participants281 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1500 / 149
serious
Total, serious adverse events
0 / 1500 / 149

Outcome results

Primary

Long-term Sequelae

Any pain at five years

Time frame: 5 years

ArmMeasureValue (NUMBER)
Prolene Hernia System DeviceLong-term Sequelae10 percentage of participants
LichtensteinLong-term Sequelae13 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026