The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia

Study Overview
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Brief Summary
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For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.

Official Title
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The Effect of Mesh Type on Pain After Surgery for Inguinal Hernia. Randomized Clinical Trial of Lichtenstein Operation With Sutured Polypropylene Patch or Self-adhesive ProGrip Patch.

Conditions
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Inguinal Hernia, Primary, Unilateral

Intervention / Treatment
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* Device: Open inguinal hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary unilateral inguinal hernia Exclusion Criteria: not willing to participate not capable to understand or fill in the questionnaires

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sutured mesh<br>200 patients are randomized to inguinal hernia repair with sutured light weight (38g/m2) polypropylene mesh (Lichtenstein repair) | Device: Open inguinal hernia repair<br>* Altogether 400 patients are randomized to receive an open mesh repair with either sutured light weight mesh (38g/m2) or with a non-sutured light weight polypropylene mesh that adheres to tissues with polylactic micro hooks<br>* Other names: Parietene ProGrip;|
| Experimental: non-sutured mesh<br>200 patients are randomized to receive a light weight mesh that adheres to tissues with polylactic micro hooks without sutures | Device: Open inguinal hernia repair<br>* Altogether 400 patients are randomized to receive an open mesh repair with either sutured light weight mesh (38g/m2) or with a non-sutured light weight polypropylene mesh that adheres to tissues with polylactic micro hooks<br>* Other names: Parietene ProGrip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complaints |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open mesh repair, sutured, non-sutured, pro-grip, postoperative pain