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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Incidence of postoperative urethral complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 84 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
G-TIP Urethroplasty
Participants will undergo grafted tubularized incised plate (G-TIP) urethroplasty using standard graft augmentation techniques for unfavorable urethral plates.
干预措施: Grafted TIP Urethroplasty (Procedure)
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.
干预措施: Fibrin-Enhanced TIP Urethroplasty (Procedure)
结局指标
主要结局
Incidence of postoperative urethral complications
时间窗: 6 months postoperatively
Incidence of postoperative urethral complications, defined as the occurrence of meatal stenosis requiring dilation or surgical intervention and/or urethrocutaneous fistula identified on clinical examination.
次要结局
- Incidence of urethral stricture(6 months postoperatively)
- Cosmetic outcome assessed by HOSE score(6 months postoperatively)
- Maximum urinary flow rate (Qmax)(6 months postoperatively)
研究者
Zafar Abdullaev
Head of the Pediatric Urology Department
National Children's Medical Center, Uzbekistan