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Hybrid Mathieu Urethroplasty

Primary Purpose

Distal Penile Hypospadias (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hyebrid Mathieu Urethroplasty
Sponsored by
Tanta University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Penile Hypospadias (Disorder) focused on measuring distal hypospadias, Mathieu urethroplasty, modified, urethral plate

Eligibility Criteria

6 Months - 4 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • distal penile hypospadias

Exclusion Criteria:

  • sever hypospadias
  • cases need redo

Sites / Locations

    Outcomes

    Primary Outcome Measures

    successful treatment of distal penile hypospadias
    use of HOSE as a measure o success o repair
    increase the scope of classic Mathieu urethroplasty
    cases with glanular width from 10 mm to 15 mm were included

    Secondary Outcome Measures

    Full Information

    First Posted
    June 16, 2021
    Last Updated
    June 22, 2021
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04946058
    Brief Title
    Hybrid Mathieu Urethroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 31, 2012 (Actual)
    Primary Completion Date
    December 31, 2020 (Actual)
    Study Completion Date
    January 15, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.
    Detailed Description
    background: Distal hypospadias repair is one of most frequent surgical interventions in pediatric age group. Successful hypospadias repair should provide a functional penis and good cosmesis. Mathieu urethroplasty is one of the most popular techniques used. Authors aimed at performing a modification that expanded the scope of indications and improved final cosmetic results of classic Mathieu urethroplasty. Methods: forty-three patients with distal hypospadias were operated by hybrid Mathieu urethroplasty (HMU) during the period from March 2012 to December 2020. Creation of the peri meatal based flap was performed as Mathieu disrobed. This was followed by developing of glanular wings. The additional step was deep incision of the urethral plate. Then, urethroplasty was performed. The catheter was left in place for one to three days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Penile Hypospadias (Disorder)
    Keywords
    distal hypospadias, Mathieu urethroplasty, modified, urethral plate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    hyebrid Mathieu Urethroplasty
    Intervention Description
    incision of the urethral plate during the procedure
    Primary Outcome Measure Information:
    Title
    successful treatment of distal penile hypospadias
    Description
    use of HOSE as a measure o success o repair
    Time Frame
    6 moths post operative
    Title
    increase the scope of classic Mathieu urethroplasty
    Description
    cases with glanular width from 10 mm to 15 mm were included
    Time Frame
    6 months post operative

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    all male infants and children suffering from distal penile hypospadias
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: distal penile hypospadias Exclusion Criteria: sever hypospadias cases need redo

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    publishing an article including the operative details and results

    Learn more about this trial

    Hybrid Mathieu Urethroplasty

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