Comparison of Three Meshes in Lichtenstein Hernia Repair

Study Overview
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Brief Summary
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Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).

Detailed Description
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Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique. The patients were randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias), a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven polypropylene mesh (Premilene, 100 hernias). Pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.

Official Title
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A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia

Conditions
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Chronic Pain, Recurrences

Intervention / Treatment
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* Device: Vypro II mesh
* Device: Premilene LP
* Device: Premilene mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: uni-or bilateral primary or recurrent inguinal hernia patients age >18yrs Exclusion Criteria: previous mesh hernioplasty femoral hernia emergency operation allergy to polypropylene

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vypro II mesh<br>A partly absorbable polypropylene-polyglactin mesh (50g/m2). | Device: Vypro II mesh<br>* partly absorbable mesh<br>* Other names: polypropylene-polyglactin mesh;|
| Active Comparator: Premilene LP<br>A lightweight polypropylene mesh (55 g/m2) | Device: Premilene LP<br>* lightweight mesh<br>* Other names: lightweight polypropylene;|
| Placebo Comparator: Premilene mesh<br>A conventional polypropylene mesh (82 g/m2) | Device: Premilene mesh<br>* A conventional polypropylene mesh (82 g/m2)<br>* Other names: polypropylene mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of chronic pain | Pain scores were measured by using a visual analoque scale. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of recurrences | Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, Lichtenstein hernioplasty, chronic pain