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

Chronic Pain Clinical Trial

— SUPERMESH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02666040
• Other study ID #: 10-v035
• Status: Active, not recruiting
• Phase: N/A
• First received: January 14, 2016
• Last updated: January 25, 2016
• Start date: November 2009
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• ULTRAPRO® meshes
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
• "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
• Duration of surgery
Time operating room
• Anesthesia volume and type used
Anesthesias used: infiltration, followed by spinal, general, epidural.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Zeta Research Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)	VAS is a horizontal line, 100 mm in length, anchored by word descriptors (no pain, very severe pain) at each end.	6 months after the operation	No