Microsurgical Single vs Double Dartos Flap in Distal Hypospadias Repair
Official title: Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair: A Prospective Randomized Trial
Run by Tanta University · NCT07676916 · Data updated 2026-11-12
This trial tests whether using a single or double dartos flap during distal hypospadias repair helps patients see better surgical and functional results.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 18 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Status | Recruiting |
| Started | May 16, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07676916 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are male patients aged 6 months to 18 years with distal hypospadias undergoing primary repair, with urethral plate greater than 8 mm and glanular width at least 14 mm.
✕Probably not a fit
Patients with coronal or glanular hypospadias, severe chordee, associated disorders of sexual development, or uncontrolled bleeding disorders may not benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two microsurgical techniques—single dartos flap and double dartos flap—in distal hypospadias repair. It enrolls male patients aged 6 months to 18 years undergoing primary (first-time) surgery with specific urethral plate and glanular measurements. Outcomes focus on surgical success and functional results, including the rate of complications such as fistula formation. Urethrocutaneous fistula remains a common challenge, and this study investigates whether a double flap provides superior protection. The trial is conducted at Tanta University in Egypt, led by the lead sponsor, with no listed collaborators.
Why it matters
Potential benefit: If successful, the double dartos flap technique could reduce postoperative fistula rates and improve overall surgical outcomes for distal hypospadias.
How similar studies have gone: Previous research has explored dartos flap techniques, but evidence on the superiority of double over single flaps remains mixed and not definitive.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Tanta University
Tanta, El-Gharbia, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed M Goda, MBBCH
- Email: mamo.goda20@gmail.com
- Phone: 00201146341100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.