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

Mansoura University

Status: Unknown

Conditions: Pediatric Disorder; Hypospadias; Congenital Hypospadia; Urologic Diseases

Treatments: Procedure: Hypospadias repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05123833

Hypospadias-UC

Details and patient eligibility

About

To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.

Enrollment: 88 estimated patients

Sex: Male

Ages: 6 months to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Dartos Fascia

Active Comparator group

Description:

Dartos flap is used as a covering layer for urethra during repair of hypospadias

Treatment:

Procedure: Hypospadias repair

Tunica Vaginalis

Active Comparator group

Description:

Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias

Treatment:

Procedure: Hypospadias repair