Hybrid Mathieu Urethroplasty
Primary Purpose
Distal Penile Hypospadias (Disorder)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hyebrid Mathieu Urethroplasty
Sponsored by
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
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
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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