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

I

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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