Back to resultsModified Second Layer Repair for Distal Penile Hypospadias
Primary Purpose
Hypospadias
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Derma -Dartos Flap for second layer closure
Sponsored by
About this trial
This is an interventional treatment trial for Hypospadias
Eligibility Criteria
Inclusion Criteria:
- All male patient with distal penile hypospadias aged less than 18
Exclusion Criteria:
- Patients with penile rotation or hypoplastic urethral plate were excluded from the study
Sites / Locations
- Ahmed Maher
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention group
Arm Description
patients underwent our newly modified technique for hypospadias repair
Outcomes
Primary Outcome Measures
urethro-cutaneous fistula
presence of urethro-cutaneous fistula after closure of hypospadias as assess by inspection for the presence of urinary fistula
Secondary Outcome Measures
Full Information
NCT ID
NCT05253456
First Posted
February 14, 2022
Last Updated
February 14, 2022
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05253456
Brief Title
Modified Second Layer Repair for Distal Penile Hypospadias
Official Title
Modified Tubularized Incised Plate Urethroplasty (Snodgrass) For Distal Hypospadias Repair in a Circumcised Patient With the Use of a Derma -Dartos Flap for Second Layer Closure: Our Initial Experience
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams 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
to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias
Detailed Description
In our study, we applied a new modification by using an intervening layer of a de-epithelialized ventral derma-dartos flap for neourethral covering. we present our newly applied technique and its impact on the success rate.
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
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
patients underwent our newly modified technique for hypospadias repair
Intervention Type
Procedure
Intervention Name(s)
Derma -Dartos Flap for second layer closure
Intervention Description
usage of Derma -Dartos Flap for second layer closure of a distal penile hypospadias in circumcised patients
Primary Outcome Measure Information:
Title
urethro-cutaneous fistula
Description
presence of urethro-cutaneous fistula after closure of hypospadias as assess by inspection for the presence of urinary fistula
Time Frame
1 year follow up
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Hypospadias is congenital urethra defect in male urethra only
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All male patient with distal penile hypospadias aged less than 18
Exclusion Criteria:
Patients with penile rotation or hypoplastic urethral plate were excluded from the study
Facility Information:
Facility Name
Ahmed Maher
City
Cairo
State/Province
القاهرة
ZIP/Postal Code
11757
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified Second Layer Repair for Distal Penile Hypospadias
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