Mesh Fixation in Lichtenstein Hernioplasty

Study Overview
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Brief Summary
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This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.

Detailed Description
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Some 650 patients with inguinal hernia are operated using Lichtenstein operation in local anaesthesia. Mesh fixation is performed using 3 methods: Optilene™ mesh + cyanoacrylate glue (n=200), self-fixing Parietex Progrip™ mesh (n=200) and non-absorbable sutures with Ultrapro™ mesh (n=200). Operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.

Official Title
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A Randomized Multi-center Study of Tissue Glue Fixation of Optilene™ Mesh With Histoacryl™ or Self-gripping Parietex ProGrip™ Compared to Conventional Non-absorbable Suture Fixation of Ultrapro™ Mesh

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: Histoacryl
* Device: Progrip
* Device: sutures (prolene 3-0)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary or recurrent inguinal hernia unilateral or bilateral Exclusion Criteria: femoral hernia massive scrotal hernia allergy to polypropylene patient's refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: glue fixation<br>Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros) | Device: Histoacryl<br>* cyanoacrylate glue fixation of mesh 1 ml<br>* Other names: Histoacryl glue;|
| Active Comparator: self-gripping<br>ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros) | Device: Progrip<br>* self-gripping mesh<br>* Other names: Parietex Progrip;|
| Active Comparator: suture fixation<br>Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures | Device: sutures (prolene 3-0)<br>* non-absorbable suture fixation 3-0<br>* Other names: prolene 3-0;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | pain scores (VAS 0-10) preoperatively and after surgery | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| costs | operative cost-effectiveness | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, mesh fixation, glue, Lichtenstein