NCT07319780 Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
| NCT ID | NCT07319780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Children's Medical Center, Uzbekistan |
| Condition | Distal Hypospadias |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-05 |
| Primary Completion | 2028-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-01-05 with a primary completion date of 2028-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hypospadias is a common congenital condition in boys in which the opening of the urethra is located on the underside of the penis. Distal hypospadias is the most common form and is usually treated surgically using tubularized incised plate (TIP) urethroplasty. In boys with an unfavorable urethral plate, graft-augmented techniques (G-TIP) are often used; however, postoperative complications such as urethrocutaneous fistula and narrowing of the urethral opening (meatal stenosis) may still occur. Platelet-rich fibrin (PRF) is a biological material obtained from the patient's own blood that contains natural growth factors and may help improve tissue healing. This study aims to evaluate whether the use of PRF during surgery can reduce postoperative complications and improve surgical outcomes in children undergoing hypospadias repair.
Eligibility Criteria
Inclusion Criteria: * Male children aged 6 months to 84 months * Primary or redo distal hypospadias * Unfavorable urethral plate * Penile curvature less than 45 degrees after degloving * Eligibility for tubularized incised plate urethroplasty Exclusion Criteria: * Disorders of sex development or ambiguous genitalia * Severe penile curvature requiring urethral plate transection * Previous graft-based urethroplasty * Active local or systemic infection at the time of surgery * Known bleeding or platelet disorders * Inability to comply with postoperative follow-up
Contact & Investigator
Zafar Abdullaev, MD, PhD
PRINCIPAL INVESTIGATOR
National Children's Medical Center, Tashkent, Uzbekistan
Frequently Asked Questions
Who can join the NCT07319780 clinical trial?
This trial is open to male participants only, aged 6 Months or older, up to 84 Months, studying Distal Hypospadias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07319780 currently recruiting?
Yes, NCT07319780 is actively recruiting participants. Contact the research team at Abdullaev.med@gmail.com for enrollment information.
Where is the NCT07319780 trial being conducted?
This trial is being conducted at Jakarta, Indonesia, Tashkent, Uzbekistan.
Who is sponsoring the NCT07319780 clinical trial?
NCT07319780 is sponsored by National Children's Medical Center, Uzbekistan. The principal investigator is Zafar Abdullaev, MD, PhD at National Children's Medical Center, Tashkent, Uzbekistan. The trial plans to enroll 100 participants.