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Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery (UHU)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inguinal mesh hernioplasty
Sponsored by
Hospital del Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Male patients, Age > 18 year, Primary hernia, glue

Eligibility Criteria

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

Inclusion Criteria:

  • Male patients
  • Aged more than 18 years
  • Primary inguinal hernia

Exclusion Criteria:

  • Inguinoscrotal hernia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Glue

    Suture

    Arm Description

    Mesh fixation with glue

    Mesh fixation with suture

    Outcomes

    Primary Outcome Measures

    Chronic pain after two years

    Secondary Outcome Measures

    Full Information

    First Posted
    July 21, 2014
    Last Updated
    July 21, 2014
    Sponsor
    Hospital del Mar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02197585
    Brief Title
    Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery
    Acronym
    UHU
    Official Title
    Cyanoacrylate vs Suture for Mesh Fixation in Inguinal Hernia Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2007 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital del Mar

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare fixation with glubran2 with suture during surgery por primary inguinal hernia. Hypothesis: Glue may induce less complications and chronic pain than suture

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    Male patients, Age > 18 year, Primary hernia, glue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glue
    Arm Type
    Experimental
    Arm Description
    Mesh fixation with glue
    Arm Title
    Suture
    Arm Type
    Active Comparator
    Arm Description
    Mesh fixation with suture
    Intervention Type
    Procedure
    Intervention Name(s)
    Inguinal mesh hernioplasty
    Primary Outcome Measure Information:
    Title
    Chronic pain after two years
    Time Frame
    24 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male patients Aged more than 18 years Primary inguinal hernia Exclusion Criteria: Inguinoscrotal hernia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JA Pereira, MD
    Organizational Affiliation
    Hospital del Mar
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery

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