Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia

Study Overview
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Brief Summary
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With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to investigate the benefits in terms of incidence of pain and discomfort, improvement in the quality of life for the patient after the use of the newly introduced semi-absorbable prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material (conventional meshes in polypropylene Prolene®), and in terms of the costs for the hospital, the National Health System (NHS), and the society of associates for the use of the ULTRAPRO® in inguinal hernia surgeries.

Official Title
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A Multicenter Prospective Randomized Study Of Comparison Between Semi-Absorbable Prosthesis And Totally Nonabsorbable Prosthesis In Inguinal Hernia Surgery

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: ULTRAPRO® meshes
* Device: Prolene® meshes
* Procedure: Detecting the mode of admission to hospital
* Procedure: Duration of surgery
* Procedure: Anesthesia volume and type used


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgery Males and females Adults over 18 All primitive inguinal hernia Exclusion Criteria: Emergency surgery Impossibility to complete the follow-up Patients with acquired immunodeficiency symptoms Patients with relapsed inguinal hernia

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: U - ULTRAPRO<br>Inguinal Hernia Surgery with ULTRAPRO® meshes, a new ULTRAPRO® mesh will be implanted in patients in the group (AG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment. | Device: ULTRAPRO® meshes<br>* The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.<br>Procedure: Detecting the mode of admission to hospital<br>* Ordinary admission or day surgery<br>Procedure: Duration of surgery<br>* Time operating room<br>Procedure: Anesthesia volume and type used<br>* Anesthesias used: infiltration, followed by spinal, general, epidural.<br>|
| Active Comparator: P - Prolene<br>Inguinal Hernia Surgery with Prolene® meshes, the conventional mesh in polypropylene Prolene® will be implanted in patients in the control group (CG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment. | Device: Prolene® meshes<br>* The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.<br>Procedure: Detecting the mode of admission to hospital<br>* Ordinary admission or day surgery<br>Procedure: Duration of surgery<br>* Time operating room<br>Procedure: Anesthesia volume and type used<br>* Anesthesias used: infiltration, followed by spinal, general, epidural.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS) | VAS is a horizontal line, 100 mm in length, anchored by word descriptors (no pain, very severe pain) at each end. | 6 months after the operation |