Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Fibrin-Enhanced TIP Urethroplasty, Grafted TIP Urethroplasty.
- Кому может быть актуально
- Состояния в реестре: Distal Hypospadias, Hypospadias. Базовые параметры: 6 мес. — 84 мес. · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Индонезия, Узбекистан
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура Fibrin-Enhanced TIP Urethroplasty
Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization. - Процедура Grafted TIP Urethroplasty
Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.
Первичные конечные точки
- Incidence of postoperative urethral complications [Срок оценки: 6 months postoperatively]
Вторичные конечные точки (3)
- Incidence of urethral stricture [Срок оценки: 6 months postoperatively]
- Cosmetic outcome assessed by HOSE score [Срок оценки: 6 months postoperatively]
- Maximum urinary flow rate (Qmax) [Срок оценки: 6 months postoperatively]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Индонезия · 1 центр
- Dr. Cipto Mangunkusumo Hospital — Jakarta
Узбекистан · 1 центр
- National Children's Medical Center — Tashkent
Публикации
- 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
Идентификаторы
NCT: NCT07319780 · 102025-11