Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair

Tanta University

Status: Enrolling

Conditions: Double Dartos Flap; Distal Hypospadias Repair; Single Dartos Flap; Microsurgical

Treatments: Procedure: Microsurgical Double Dartos Flap; Procedure: Microsurgical Single Dartos Flap

Study type: Interventional

Funder types: Other

Identifiers

NCT07676916

36265MS61/5/26

Details and patient eligibility

About

This study aims to compare the surgical and functional outcomes of microsurgical single dartos flap versus double dartos flap in distal hypospadias repair.

Full description

Hypospadias is recognized as a frequent congenital defect of the male urogenital system, with its prevalence exhibiting significant regional and ethnic disparities globally.

Despite continuous improvements in surgical methodology, the development of a urethrocutaneous fistula (UCF) remains a persistent and difficult postoperative challenge. Reported UCF rates fluctuate between 1% and over 20%, heavily influenced by factors such as the initial position of the meatus, the specific surgical approach, and the practitioner's level of expertise.

Expanding on the use of a single-layer dartos flap (SDF), recent research has focused on whether a double-layer dartos flap (DDF) provides enhanced protection against fistula formation.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients diagnosed with Distal Hypospadias.
• Age: From 6 months to 18 years.
• Primary cases.
• Uretheral Plate>8mm.
• Glanular width≥14mm.

Exclusion criteria

• Coronal and glanular hypospadias.
• Severe chordee.
• Associated disorders of sexual development.
• Un-controlled bleeding disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A

Experimental group

Description:

Patients will undergo Microsurgical Single Dartos Flap.

Treatment:

Procedure: Microsurgical Single Dartos Flap

Group B

Experimental group

Description:

Patients will undergo Microsurgical Double Dartos Flap.

Treatment:

Procedure: Microsurgical Double Dartos Flap