Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
NCT ID: NCT07319780
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2026-01-05
2028-12-25
Brief Summary
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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.
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Detailed Description
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Male children aged 6 months to 84 months with primary or redo distal hypospadias and mild penile curvature will be eligible for inclusion. Participants will be randomized in a 1:1 ratio to undergo either F-TIP urethroplasty with intraoperative application of autologous PRF or standard G-TIP urethroplasty without PRF.
Autologous PRF will be prepared intraoperatively from the patient's peripheral blood using a standardized centrifugation protocol and applied to the incised urethral plate prior to tubularization.
Participants will be followed postoperatively for the assessment of surgical complications, functional outcomes, and cosmetic results according to predefined outcome measures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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F-TIP Urethroplasty
Participants will undergo fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty. Autologous platelet-rich fibrin will be prepared intraoperatively and applied to the incised urethral plate and fixed with PDS 6/0-7/0 suture prior to tubularization.
Fibrin-Enhanced TIP Urethroplasty
Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.
G-TIP Urethroplasty
Participants will undergo grafted tubularized incised plate (G-TIP) urethroplasty using standard graft augmentation techniques for unfavorable urethral plates.
Grafted TIP Urethroplasty
Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.
Interventions
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Fibrin-Enhanced TIP Urethroplasty
Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.
Grafted TIP Urethroplasty
Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.
Eligibility Criteria
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Inclusion Criteria
* Primary or redo distal hypospadias
* Unfavorable urethral plate
* Penile curvature less than 45 degrees after degloving
* Eligibility for tubularized incised plate urethroplasty
Exclusion Criteria
* 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
6 Months
84 Months
MALE
No
Sponsors
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Dr Cipto Mangunkusumo General Hospital
OTHER
National Children's Medical Center, Uzbekistan
OTHER
Responsible Party
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Zafar Abdullaev
Head of the Pediatric Urology Department
Principal Investigators
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Zafar Abdullaev, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Children's Medical Center, Tashkent, Uzbekistan
Locations
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Dr. Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, Indonesia
National Children's Medical Center
Tashkent, Tashkent, Uzbekistan
Countries
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Central Contacts
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Facility Contacts
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Dr. Cipto Mangunkusumo General Hospital Jakarta, Indonesia Pediatric Urology Department
Role: primary
National Children's Medical Center Pediatric Urology department
Role: primary
References
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Abbas TO, Khalil IA, Hatem M, Boyko A, Zorkin S. Plate Objective Scoring Tool (POST) in distal hypospadias: Correlation with post-repair complications. J Pediatr Urol. 2024 Apr;20(2):238.e1-238.e6. doi: 10.1016/j.jpurol.2023.11.022. Epub 2023 Nov 25.
Abbas TO. Evaluation of penile curvature in patients with hypospadias; gaps in the current practice and future perspectives. J Pediatr Urol. 2022 Apr;18(2):151-159. doi: 10.1016/j.jpurol.2021.12.015. Epub 2021 Dec 31.
Abbas TO. An objective hypospadias classification system. J Pediatr Urol. 2022 Aug;18(4):481.e1-481.e8. doi: 10.1016/j.jpurol.2022.05.001. Epub 2022 May 11.
Other Identifiers
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102025-11
Identifier Type: -
Identifier Source: org_study_id
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