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

Norwegian University of Science and Technology405 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

405

Conditions

Inguinal Hernia

Interventions

Lichtenstein's operationPROCEDURE

Lichtenstein's operation to repair primary unilateral inguinal hernia

Prolene Hernia SystemPROCEDURE

Prolene Hernia System to repair primary unilateral inguinal hernia

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary unilateral groin hernia in adult Exclusion Criteria: * recurrence warfarin treatment bilateral groin hernia

Locations (1)

St Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

pain postoperative

Time frame: 3 years

Secondary Outcomes

Recurrences after groin hernia repair

Time frame: 3 years

Data from ClinicalTrials.gov

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