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A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair

Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00184483
Enrollment
405
Registered
2005-09-16
Start date
2001-10-31
Completion date
2015-12-31
Last updated
2020-09-10

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

Conditions

Inguinal Hernia

Keywords

Surgery, Lichtenstein, Prolene Hernia System, Postoperative pain, Recurrence

Brief summary

Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.

Interventions

PROCEDURELichtenstein's operation

Lichtenstein's operation to repair primary unilateral inguinal hernia

PROCEDUREProlene Hernia System

Prolene Hernia System to repair primary unilateral inguinal hernia

Sponsors

Sorlandet Hospital HF
CollaboratorOTHER_GOV
Voss Sykehus
CollaboratorUNKNOWN
Haraldsplass Deaconess Hospital
CollaboratorOTHER
Sykehuset Ostfold
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Primary unilateral groin hernia in adult

Exclusion criteria

* recurrence warfarin treatment bilateral groin hernia

Design outcomes

Primary

MeasureTime frame
pain postoperative3 years

Secondary

MeasureTime frame
Recurrences after groin hernia repair3 years

Countries

Norway

Outcome results

None listed

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