Overview

This trial is active, not recruiting.

Condition chronic pain
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(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.
ultrapro® meshes
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
detecting the mode of admission to hospital
Ordinary admission or day surgery
duration of surgery
Time operating room
anesthesia volume and type used
Anesthesias used: infiltration, followed by spinal, general, epidural.
(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.
"prolene®" meshes
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
detecting the mode of admission to hospital
Ordinary admission or day surgery
duration of surgery
Time operating room
anesthesia volume and type used
Anesthesias used: infiltration, followed by spinal, general, epidural.

Primary Outcomes

Measure
Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)
time frame: 6 months after the operation

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Istituto Clinico Humanitas.