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

January 25, 2016 updated by: Michele Tedeschi, Istituto Clinico Humanitas

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: U - ULTRAPRO
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.
Device: ULTRAPRO® 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.
Active Comparator: P - Prolene
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.
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.
Device: "Prolene®" meshes
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)
Time Frame: 6 months after the operation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Collaborators

Zeta Research Ltd

Investigators

  • Principal Investigator: Marco Montorsi, Prof., Humanitas Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-v035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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