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

NCT00184483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2020-09-10

No results posted yet for this study

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.

Conditions

  • Inguinal Hernia

Interventions

PROCEDURE

Lichtenstein's operation

Lichtenstein's operation to repair primary unilateral inguinal hernia

PROCEDURE

Prolene Hernia System

Prolene Hernia System to repair primary unilateral inguinal hernia

Sponsors & Collaborators

  • Sorlandet Hospital HF

    collaborator OTHER_GOV

  • Voss Sykehus

    collaborator UNKNOWN

  • Haraldsplass Deaconess Hospital

    collaborator OTHER

  • Sykehuset Ostfold

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Helge E Myrvold, MD PhD · Norwegian University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00184483 on ClinicalTrials.gov