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

Norwegian University of Science and Technology

Status: Completed

Conditions: Inguinal Hernia

Treatments: Procedure: Lichtenstein's operation; Procedure: Prolene Hernia System

Study type: Interventional

Funder types: Other

Identifiers

NCT00184483

Norwegian Hernia Study

Details and patient eligibility

About

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.

Enrollment: 405 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary unilateral groin hernia in adult

Exclusion criteria

• recurrence warfarin treatment bilateral groin hernia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 2 patient groups

Lichtenstein's operation

Experimental group

Description:

Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia

Treatment:

Procedure: Lichtenstein's operation

Prolene Hernia System

Active Comparator group

Description:

Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia

Treatment:

Procedure: Prolene Hernia System