Parietex Progrip Study

Study Overview
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Brief Summary
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The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.

Detailed Description
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Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures. Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study. 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.

Official Title
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ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Device: Parietex Progrip
* Device: Low weight polypropylene mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All male patients at participating centers with a primary, uncomplicated inguinal hernia. Collar of the defect ≤ 4 cm Signed informed consent Exclusion Criteria: 30 years ≥ Age ≥ 75 years Emergency procedure Inclusion in other trials Bilateral inguinal hernia Recurrence

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Male

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: 1<br>Parietex ProGrip | Device: Parietex Progrip<br>* Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.<br>|
| Active Comparator: 2<br>Low weight polypropylene mesh | Device: Low weight polypropylene mesh<br>* Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) | Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home. | M3, M12 after surgery | 
| Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) | Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known). | M3, M12 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foreign Body Sensation | Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. | M1, M3, M12 months after surgery | 
| Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score | Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home. | 3 months after surgery | 
| Wound Complications and Hernia Recurrences |  | M12 after surgery | 
| Return to Work and to Normal Daily Activities |  | Effective date | 
| Other Post-operative Complications |  | M12 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncomplicated primary inguinal hernias