Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia
This trial is active, not recruiting.
|Treatments||ultrapro® meshes, "prolene®" meshes, detecting the mode of admission to hospital, duration of surgery, anesthesia volume and type used|
|Sponsor||Istituto Clinico Humanitas|
|Collaborator||Zeta Research Ltd|
|Start date||November 2009|
|End date||January 2016|
|Trial size||1200 participants|
|Trial identifier||NCT02666040, 10-v035|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
|Primary purpose||supportive care|
Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)
time frame: 6 months after the operation
Male or female participants at least 18 years old.
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
|Official title||A Multicenter Prospective Randomized Study Of Comparison Between Semi-Absorbable Prosthesis And Totally Nonabsorbable Prosthesis In Inguinal Hernia Surgery|
|Principal investigator||Marco Montorsi, Prof.|
Call for more information