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NCT05123833 Clinical Trial

The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial

Urologic Diseases Clinical Trial

Official title:
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05123833
Other study ID # Hypospadias-UC
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date August 1, 2022

Study information
Verified date November 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 88
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 6 Months to 12 Years
Eligibility Inclusion Criteria: - Age = 6 months. - Distal, mid-shaft penile hypospadias. Exclusion Criteria: - Glanular hypospadias. - Penoscrotal, Scrotal & Perineal hypospadias. - Recurrent cases.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hypospadias repair
surgical repair of hypospadias

Locations
Country Name City State
Egypt Urology and Nephrology Center, Mansoura University Mansoura Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fistula Fistula prevalence will be recorded as a complication after surgery Within the first three months after surgery.
Secondary Cosmetic outcome Patients' parents reported cosmetic outcomes will be evaluated using The Pediatric Penile Perception Score (PPPS). Within the first three months after surgery.
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