Tanta University
Tanta, El-Gharbia, 31527, Egypt
Location status: Recruiting
Location contact
Ahmed M Goda, MBBCH
CONTACT
Mohamed I El-Maadawy, MD
SUB_INVESTIGATOR
Mohamed R Taha, MD
SUB_INVESTIGATOR
Osama M El-Gamal, MD
SUB_INVESTIGATOR
Recruiting
NCT Number: NCT07676916
Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair
This study aims to compare the surgical and functional outcomes of microsurgical single dartos flap versus double dartos flap in distal hypospadias repair.
Recruiting
Interested in participating?
Request InfoKey information
Age range
6 month–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Microsurgical Single Dartos Flap
ProcedurePatients will undergo Microsurgical Single Dartos Flap.
Microsurgical Double Dartos Flap
ProcedurePatients will undergo Microsurgical Double Dartos Flap.
Primary outcomes
-
Incidence of the Uethrocutaneous fistula
Time frame: 6 months after surgery
Incidence of the Uethrocutaneous fistula will be recorded.
Secondary outcomes
-
Incidence of the meatal stenosis
Time frame: 6 months after surgery
Incidence of the meatal stenosis will be recorded.
-
Wound infection rate
Time frame: 6 months after surgery
Wound infection rate will be recorded.
-
Cosmetic appearance
Time frame: 6 months after surgery
Cosmetic appearance will be recorded.
-
Overall complication rate
Time frame: 6 months after surgery
Overall complication rate will be recorded.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Tanta University
Other
Registry information
Official study title
Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair: A Prospective Randomized Trial
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 30, 2026
- Registry last updated
- Jun 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.