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Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

Study acronym: FTIP-RCT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jul 2028 to Jul 5, 2028
    • Study completion date: Dec 2028 to Dec 25, 2028
    • Start date changed from estimate of Jan 2026 to Jan 5, 2026
    • Site details revised at 2 of 2 sites
  2. Secondary endpoints revised (3)v3
  3. Primary endpoints: 3 to 1v2 Show 5 more changesShow less
    • Eligibility criteria shortened, about 67 words
    • Secondary endpoints revised (3)
    • Study description shortened, about 193 words
    • Site contacts updated at 1 of 2 sites
    • Study title expanded, about 2 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07319780
Lead Sponsor National Children's Medical Center, Uzbekistan
Collaborators: Dr Cipto Mangunkusumo General Hospital
Conditions
(from sponsor)		 Distal Hypospadias, Hypospadias
Related terms Hypospadias
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov