ProGrip Mesh Repair vs Lichtenstein Operation

Study Overview
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Brief Summary
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The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.

Detailed Description
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Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively. Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.

Official Title
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Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: Covidien Parietex ProGrip Self-Fixating Mesh
* Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with primary inguinal hernia Signed consent Exclusion Criteria: Recurrent hernia Emergency procedure Patient not willing to participate

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ProGrip Mesh Repair<br>80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation. | Device: Covidien Parietex ProGrip Self-Fixating Mesh<br> <br> |
| Active Comparator: Lichtenstein Operation<br>80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (<40 g/m2) with standard Lichtenstein technique. | Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption)<br>* Serag Wiessner SERAMESH® PA 15x10 cm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative pain and its intensity using VAS Scale | Assessment will be made using Visual Analogue Scale (VAS). | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of foreign body sensation - Subjective feeling of discomfort in the groin | Foreign body sensation is a patients' subjective feeling of discomfort in the groin. Assesment will be made by phone questionnaire. | 12 Months | 
| Hernia recurrence rate | Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination) | 12 Months | 
| Post-operative complications | Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain) | 12 Months | 
| Duration of surgery |  | Day of surgery | 
| Incidence of Treatment-Emergent Adverse Events [Safety] |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, mesh, lichtenstein, hernia repair, selfgripping mesh