NCT02666040

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	ULTRAPRO® meshes	The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
DEVICE	"Prolene®" meshes	The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
PROCEDURE	Detecting the mode of admission to hospital	Ordinary admission or day surgery
PROCEDURE	Duration of surgery	Time operating room
PROCEDURE	Anesthesia volume and type used	Anesthesias used: infiltration, followed by spinal, general, epidural.

Timeline

• Start date: 2009-11-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2016-01-28
• Last updated: 2016-01-28