Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: Optilene LP mesh; Device: Ultrapro mesh

• Registration Number: NCT02500056
• Lead Sponsor: Tartu University Hospital

Brief Summary

The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.

Detailed Description

The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-04
• Study Completion: 2015-04
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Results First Submitted: 2016-04-20
• Results First Submitted QC: 2017-04-25
• Status Verified: 2017-06
• Results First Posted: 2017-06-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• age ≥18 years
• unilateral primary reducible inguinal hernia
• elective operation
• consent to participate in the study.

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Exclusion Criteria

• age <18 years
• irreducible
• strangulated
• recurrent hernia
• inability to understand the questionnaire
• unwillingness to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OM group	Optilene LP mesh	Optilene LP mesh
UM group	Ultrapro mesh	Ultrapro mesh

Primary Outcome Measures

Name	Time	Method
Chronic Pain	6-month follow-up	On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise

Secondary Outcome Measures

Name	Time	Method
Chronic Pain	3-year follow-up	On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
Foreign Body Feeling	6-month follow-up	The question about foreign body feeling was a yes-or-no question