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

Not Applicable

• Conditions: Congenital Hypospadia; Pediatric Disorder; Hypospadias; Urologic Diseases
• Interventions: Procedure: Hypospadias repair

• Registration Number: NCT05123833
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Last Update Submitted: 2021-11-05
• Study First Posted: 2021-11-17
• Last Update Posted: 2021-11-17
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 88

Inclusion Criteria

• Age ≥ 6 months.
• Distal, mid-shaft penile hypospadias.

Read More

Exclusion Criteria

• Glanular hypospadias.
• Penoscrotal, Scrotal & Perineal hypospadias.
• Recurrent cases.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dartos Fascia	Hypospadias repair	Dartos flap is used as a covering layer for urethra during repair of hypospadias
Tunica Vaginalis	Hypospadias repair	Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias

Primary Outcome Measures

Name	Time	Method
Fistula	Within the first three months after surgery.	Fistula prevalence will be recorded as a complication after surgery

Secondary Outcome Measures

Name	Time	Method
Cosmetic outcome	Within the first three months after surgery.	Patients' parents reported cosmetic outcomes will be evaluated using The Pediatric Penile Perception Score (PPPS).

Trial Locations

Locations (1)

Urology and Nephrology Center, Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt