Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tartu University Hospital
- Enrollment
- 143
- Primary Endpoint
- Chronic Pain
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Chronic Pain
Time Frame: 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 Outcomes
- Chronic Pain(3-year follow-up)
- Foreign Body Feeling(6-month follow-up)
Investigators
Ceith Nikkolo
Dr.
Tartu University Hospital