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Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair

Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair: A Prospective Randomized Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07676916
Enrollment
100
Registered
2026-06-30
Start date
2026-05-16
Completion date
2027-04-01
Last updated
2026-06-30

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

Conditions

Distal Hypospadias Repair, Double Dartos Flap, Microsurgical, Single Dartos Flap

Brief summary

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

Detailed 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.

Interventions

PROCEDUREMicrosurgical Single Dartos Flap

Patients will undergo Microsurgical Single Dartos Flap.

PROCEDUREMicrosurgical Double Dartos Flap

Patients will undergo Microsurgical Double Dartos Flap.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of the Uethrocutaneous fistula6 months after surgeryIncidence of the Uethrocutaneous fistula will be recorded.

Secondary

MeasureTime frameDescription
Incidence of the meatal stenosis6 months after surgeryIncidence of the meatal stenosis will be recorded.
Wound infection rate6 months after surgeryWound infection rate will be recorded.
Cosmetic appearance6 months after surgeryCosmetic appearance will be recorded.
Overall complication rate6 months after surgeryOverall complication rate will be recorded.

Countries

Egypt

Contacts

CONTACTAhmed M Goda, MBBCH
mamo.goda20@gmail.com00201146341100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026