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

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Lichtenstein's operation; Procedure: Prolene Hernia System

• Registration Number: NCT00184483
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

• Primary unilateral groin hernia in adult

Exclusion Criteria

• recurrence warfarin treatment bilateral groin hernia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lichtenstein's operation	Lichtenstein's operation	Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia
Prolene Hernia System	Prolene Hernia System	Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia

Primary Outcome Measures

Name	Time	Method
pain postoperative	3 years

Secondary Outcome Measures

Name	Time	Method
Recurrences after groin hernia repair	3 years

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway