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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05123833

Enrollment

Registered

2021-11-17

Start date

2021-08-01

Completion date

2022-08-01

Last updated

2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Hypospadia, Hypospadias, Pediatric Disorder, Urologic Diseases

Keywords

Hypospadias repair, Tunica Vaginalis Flap, Dartos Fascia, Fistula

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.

Interventions

PROCEDUREHypospadias repair

surgical repair of hypospadias

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

6 Months to 12 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Fistula	Within the first three months after surgery.	Fistula prevalence will be recorded as a complication after surgery

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026