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Selective Criteria and a Modified Technique of Applying "URAGPI" Technique for More Proximal Degree of Hypospadias

Primary Purpose

Hypospadias

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
URAGPI technique
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypospadias

Eligibility Criteria

1 Year - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al

Exclusion Criteria:

  • circumcised patients
  • sever degrees of chordae
  • previous surgical repair
  • meatal stenosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hypospadias in children

    Arm Description

    Distal shaft hypospadias at age of 12 years or less

    Outcomes

    Primary Outcome Measures

    Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks
    evaluation according to "Hypospadias Objective Penile Evaluation Score"

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2019
    Last Updated
    January 7, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03911635
    Brief Title
    Selective Criteria and a Modified Technique of Applying "URAGPI" Technique for More Proximal Degree of Hypospadias
    Official Title
    Applying of Urethral Advancement, Glanuloplasty and Preputioplasty Technique for More Proximal Degrees of Hypospadias. Selective Criteria and a Modified Technique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    January 1, 2021 (Anticipated)
    Study Completion Date
    March 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis. Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations [1]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias [2]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty " URAGPI" versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion. B) Normal appearance of the penis. C) Good functional results.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Hypospadias in children
    Arm Type
    Experimental
    Arm Description
    Distal shaft hypospadias at age of 12 years or less
    Intervention Type
    Procedure
    Intervention Name(s)
    URAGPI technique
    Intervention Description
    the Urethral Advancement, Glanuloplasty and Preputioplasty
    Primary Outcome Measure Information:
    Title
    Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks
    Description
    evaluation according to "Hypospadias Objective Penile Evaluation Score"
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al Exclusion Criteria: circumcised patients sever degrees of chordae previous surgical repair meatal stenosis

    12. IPD Sharing Statement

    Learn more about this trial

    Selective Criteria and a Modified Technique of Applying "URAGPI" Technique for More Proximal Degree of Hypospadias

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