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
About this trial
This is an interventional treatment trial for Hypospadias
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
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
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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