Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microsurgical Single Dartos Flap, Microsurgical Double Dartos Flap.
- Who it may be relevant to
- Registry conditions: Microsurgical, Single Dartos Flap, Double Dartos Flap, Distal Hypospadias Repair. Basic parameters: 6 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair: A Prospective Randomized Trial
Overview
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
- Procedure Microsurgical Single Dartos Flap
Patients will undergo Microsurgical Single Dartos Flap. - Procedure Microsurgical Double Dartos Flap
Patients will undergo Microsurgical Double Dartos Flap.
Primary outcome measures
- Incidence of the Uethrocutaneous fistula [Time frame: 6 months after surgery]
Secondary outcome measures (4)
- Incidence of the meatal stenosis [Time frame: 6 months after surgery]
- Wound infection rate [Time frame: 6 months after surgery]
- Cosmetic appearance [Time frame: 6 months after surgery]
- Overall complication rate [Time frame: 6 months after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07676916 · 36265MS61/5/26