Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial

Study Overview
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Brief Summary
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this study has the aim to analize the correlation between three different methods of mesh fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy

Detailed Description
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In the last decades the rate of recurrence in the anterior inguinal erniorraphy has been drastically lowered with the introduction of the mesh , on the other hand the rate of chronic pain is reported to be high in many papers. The chronic pain influences the quality of life and what's more causes an increase in the social costs. the classical Lichtenstein inguinal anterior erniorrhaphy , wich is the technique suggested by the international guidelines, expected to fix the mesh with non absorbable sutures . The investigators would analyze the possible correlation between the method of mesh fixation and chronic pain keeping a lower rate of recurrence. That said the primary endpoint in this study is the rate of recurrence and the secondary endpoint is the rate of chronic pain after lichtenstein anterior inguinal erniorrhaphy in the three different methods of fixation of the mesh

Official Title
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Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation
* Procedure: Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation
* Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primitive inguinal hernia age > 18 years old compliancy to the study Exclusion Criteria: reccurent inguinal hernia age < 18 years old refusal of the study

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: absorbable sutures<br>mesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy | Procedure: Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation<br> <br> |
| Active Comparator: non absorbable sutures<br>mesh fixation with non absorbable sutures in lichtenstein anterior inguinal herniorrhaphy. This is the method to be considered the standard of care thus far. | Procedure: Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation<br> <br> |
| Experimental: fibrin biological glue<br>mesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy | Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of recurrence |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of chronic pain |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Groin hernia, lichtenstein herniorrhaphy