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

Tartu University Hospital

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: Ultrapro mesh; Device: Optilene LP mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT02500056

10100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

OM group

Active Comparator group

Description:

Optilene LP mesh

Treatment:

Device: Optilene LP mesh

UM group

Active Comparator group

Description:

Ultrapro mesh

Treatment:

Device: Ultrapro mesh