Back to resultsThe Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
Primary Purpose
Pediatric Disorder, Hypospadias, Congenital Hypospadia
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hypospadias repair
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Disorder focused on measuring Hypospadias repair, Tunica Vaginalis Flap, Dartos Fascia, Fistula
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 6 months.
- Distal, mid-shaft penile hypospadias.
Exclusion Criteria:
- Glanular hypospadias.
- Penoscrotal, Scrotal & Perineal hypospadias.
- Recurrent cases.
Sites / Locations
- Urology and Nephrology Center, Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dartos Fascia
Tunica Vaginalis
Arm Description
Dartos flap is used as a covering layer for urethra during repair of hypospadias
Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias
Outcomes
Primary Outcome Measures
Fistula
Fistula prevalence will be recorded as a complication after surgery
Secondary Outcome Measures
Cosmetic outcome
Patients' parents reported cosmetic outcomes will be evaluated using The Pediatric Penile Perception Score (PPPS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05123833
Brief Title
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
Official Title
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Disorder, Hypospadias, Congenital Hypospadia, Urologic Diseases
Keywords
Hypospadias repair, Tunica Vaginalis Flap, Dartos Fascia, Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dartos Fascia
Arm Type
Active Comparator
Arm Description
Dartos flap is used as a covering layer for urethra during repair of hypospadias
Arm Title
Tunica Vaginalis
Arm Type
Active Comparator
Arm Description
Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias
Intervention Type
Procedure
Intervention Name(s)
Hypospadias repair
Intervention Description
surgical repair of hypospadias
Primary Outcome Measure Information:
Title
Fistula
Description
Fistula prevalence will be recorded as a complication after surgery
Time Frame
Within the first three months after surgery.
Secondary Outcome Measure Information:
Title
Cosmetic outcome
Description
Patients' parents reported cosmetic outcomes will be evaluated using The Pediatric Penile Perception Score (PPPS).
Time Frame
Within the first three months after surgery.
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
males less than 12 years
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 6 months.
Distal, mid-shaft penile hypospadias.
Exclusion Criteria:
Glanular hypospadias.
Penoscrotal, Scrotal & Perineal hypospadias.
Recurrent cases.
Facility Information:
Facility Name
Urology and Nephrology Center, Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
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