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

NCT02666040 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2016-01-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Zeta Research Ltd

    collaborator INDUSTRY

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Marco Montorsi, Prof. · Humanitas Research Hospital IRCCS, Rozzano-Milan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2016-01-31
Completion
2016-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666040 on ClinicalTrials.gov