Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fibrin-Enhanced TIP Urethroplasty, Grafted TIP Urethroplasty.
- Who it may be relevant to
- Registry conditions: Distal Hypospadias, Hypospadias. Basic parameters: 6 months — 84 months · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia, Uzbekistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Randomized Controlled Trial Comparing Fibrin-Enhanced Tubularized Incised Plate (F-TIP) and Grafted Tubularized Incised Plate (G-TIP) Urethroplasty in Distal Hypospadias With Unfavorable Urethral Plates
Overview
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.
Detailed description
This is a prospective, multicenter, single-blinded randomized controlled trial designed to compare fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty using autologous platelet-rich fibrin (PRF) with grafted tubularized incised plate (G-TIP) urethroplasty in children with distal hypospadias and an unfavorable urethral plate.
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.
Interventions
- Procedure Fibrin-Enhanced TIP Urethroplasty
Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization. - Procedure Grafted TIP Urethroplasty
Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.
Primary outcome measures
- Incidence of postoperative urethral complications [Time frame: 6 months postoperatively]
Secondary outcome measures (3)
- Incidence of urethral stricture [Time frame: 6 months postoperatively]
- Cosmetic outcome assessed by HOSE score [Time frame: 6 months postoperatively]
- Maximum urinary flow rate (Qmax) [Time frame: 6 months postoperatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- Dr. Cipto Mangunkusumo Hospital — Jakarta
Uzbekistan · 1 center
- National Children's Medical Center — Tashkent
Publications
- 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. PMID 38071112
- 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. PMID 35031224
- 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. PMID 35644790
Identifiers
NCT: NCT07319780 · 102025-11