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

Istituto Clinico Humanitas

Status: Unknown

Conditions: Chronic Pain

Treatments: Procedure: Anesthesia volume and type used; Device: ULTRAPRO® meshes; Procedure: Detecting the mode of admission to hospital; Device: "Prolene®" meshes; Procedure: Duration of surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02666040

10-v035

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

U - ULTRAPRO

Experimental group

Description:

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.

Treatment:

Procedure: Duration of surgery

Procedure: Detecting the mode of admission to hospital

Device: ULTRAPRO® meshes

Procedure: Anesthesia volume and type used

P - Prolene

Active Comparator group

Description:

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.

Treatment:

Procedure: Duration of surgery

Device: "Prolene®" meshes

Procedure: Detecting the mode of admission to hospital

Procedure: Anesthesia volume and type used