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

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ULTRAPRO® meshes
"Prolene®" meshes
Detecting the mode of admission to hospital
Duration of surgery
Anesthesia volume and type used
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    U - ULTRAPRO

    P - Prolene

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2016
    Last Updated
    January 25, 2016
    Sponsor
    Istituto Clinico Humanitas
    Collaborators
    Zeta Research Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02666040
    Brief Title
    Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia
    Acronym
    SUPERMESH
    Official Title
    A Multicenter Prospective Randomized Study Of Comparison Between Semi-Absorbable Prosthesis And Totally Nonabsorbable Prosthesis In Inguinal Hernia Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    March 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istituto Clinico Humanitas
    Collaborators
    Zeta Research Ltd

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    U - ULTRAPRO
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    P - Prolene
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    ULTRAPRO® meshes
    Intervention Description
    The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
    Intervention Type
    Device
    Intervention Name(s)
    "Prolene®" meshes
    Intervention Description
    The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
    Intervention Type
    Procedure
    Intervention Name(s)
    Detecting the mode of admission to hospital
    Intervention Description
    Ordinary admission or day surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Duration of surgery
    Intervention Description
    Time operating room
    Intervention Type
    Procedure
    Intervention Name(s)
    Anesthesia volume and type used
    Intervention Description
    Anesthesias used: infiltration, followed by spinal, general, epidural.
    Primary Outcome Measure Information:
    Title
    Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)
    Description
    VAS is a horizontal line, 100 mm in length, anchored by word descriptors (no pain, very severe pain) at each end.
    Time Frame
    6 months after the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marco Montorsi, Prof.
    Organizational Affiliation
    Humanitas Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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