Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.

Official Title
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Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial

Conditions
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Physical Function, Pain, Hernia, Wound Infection, Postoperative Complication, Recurrence

Intervention / Treatment
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* Device: polypropylene mesh
* Device: Infinit® PTFE mesh (WL Gore)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 <65 years of age Diagnosis of Unilateral inguinal hernia Able to provide written consent BMI < 35 ASA I-II patients Non-complicated primary inguinal hernia performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty Informed consent Exclusion Criteria: Recurrent hernias Incarcerated hernia BMI > 35 ASA III-IV patients Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted) Hypersensitivity to any drug in study Patients with an intra-operative findings of different pathology will be excluded from the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: PTFE mesh<br>A Lichtenstein tension-free hernioplasty is performed using PTFE mesh | Device: Infinit® PTFE mesh (WL Gore)<br>* A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.<br>|
| Active Comparator: polypropylene mesh<br>A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh | Device: polypropylene mesh<br>* A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-hernioplasty acute pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function | to measure the physical function score from the SF-36 questionnaire | 24 hours | 
| postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 24 hours | 
| wound infection | to rate the wound infection risk. | 7 days | 
| postoperative complication | to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period. | from 24 hours to 5 years | 
| recurrence | to measure the recurrence | from 1 months to 5 years | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 14 days | 
| post-hernioplasty acute pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 72 hours | 
| post-hernioplasty acute pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 7 days | 
| post-hernioplasty acute pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 14 days | 
| post-hernioplasty chronic pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 1 months | 
| post-hernioplasty chronic pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 3 months | 
| post-hernioplasty chronic pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 6 months | 
| post-hernioplasty chronic pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 1 year | 
| post-hernioplasty chronic pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 2 years | 
| post-hernioplasty chronic pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 3 years | 
| post-hernioplasty chronic pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 4 years | 
| post-hernioplasty chronic pain | to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups | 5 years | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 72 hours | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 7 days | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 14 days | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 1 months | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 3 months | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 6 months | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 1 year | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 2 years | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 3 years | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 4 years | 
| physical function | to measure the physical function score from the SF-36 questionnaire | 5 years | 
| postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 72 hours | 
| postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 14 days | 
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 1 months | 
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 3 months | 
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 6 months | 
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 1 year | 
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 2 years | 
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 3 years | 
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 4 years | 
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 5 years | 
| postoperative acute and chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 7 days | 
| wound infection | to rate the wound infection risk. | 14 days | 
| wound infection | to rate the wound infection risk. | 1 months | 
| wound infection | to rate the wound infection risk. | 3 months | 
| wound infection | to rate the wound infection risk. | 6 months | 
| wound infection | to rate the wound infection risk. | 1 year | 
| wound infection | to rate the wound infection risk. | 2 years | 
| wound infection | to rate the wound infection risk. | 3 years | 
| wound infection | to rate the wound infection risk. | 4 years | 
| wound infection | to rate the wound infection risk. | 5 years | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 1 months | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 3 months | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 6 months | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 1 years | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 2 years | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 3 years | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 4 years | 
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shrinkage, postoperative pain and discomfort