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| Name | Class |
|---|---|
| Zeta Research Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U - ULTRAPRO | Experimental | 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. |
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| P - Prolene | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ULTRAPRO® meshes | Device | The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Montorsi, Prof. | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
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| "Prolene®" meshes | Device | The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug. |
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| Detecting the mode of admission to hospital | Procedure | Ordinary admission or day surgery |
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| Duration of surgery | Procedure | Time operating room |
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| Anesthesia volume and type used | Procedure | Anesthesias used: infiltration, followed by spinal, general, epidural. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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