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NCT00184483 Clinical Trial

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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00184483
Other study ID # Norwegian Hernia Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2001
Est. completion date December 2015

Study information
Verified date September 2020
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 405
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Primary unilateral groin hernia in adult

Exclusion Criteria:

- recurrence warfarin treatment bilateral groin hernia

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Lichtenstein's operation
Lichtenstein's operation to repair primary unilateral inguinal hernia
• Prolene Hernia System
Prolene Hernia System to repair primary unilateral inguinal hernia

Locations
Country Name City State
Norway St Olavs Hospital Trondheim

Sponsors (5)
Lead Sponsor Collaborator
Norwegian University of Science and Technology Haraldsplass Deaconess Hospital, Sorlandet Hospital HF, Sykehuset Ostfold, Voss Sykehus

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain postoperative 3 years
Secondary Recurrences after groin hernia repair 3 years
See also
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Completed NCT02240550 - A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair N/A
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Recruiting NCT05058378 - Correlation Between Spinal Anesthesia and Perfusion Index
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Recruiting NCT05879770 - Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
Completed NCT05107986 - Laparoscopy in Complicated Groin Hernia
Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
Completed NCT04033055 - Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia. N/A