Topography Guided Repair Versus Tubularized Incised Plate for Distal Hypospadias: A Randomized Pilot Trial of Early Adoption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Complication-Free Rate
研究概览
简要总结
This study compares two surgical techniques used to repair distal hypospadias in children: topography-guided repair (TGR), a newer approach, and tubularized incised plate (TIP) repair, a commonly used standard technique. Children with distal hypospadias were randomly assigned to receive one of the two procedures. Researchers assessed early surgical complications, need for additional surgery, and postoperative appearance and function during follow-up visits over 12 months. The study aims to determine whether TGR can be safely adopted by surgical teams other than its developer and to guide larger future studies.
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 16 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children younger than 16 years with previously untreated distal penile hypospadias.
- •Uncircumcised patients.
- •Parent or caregiver able to provide written informed consent.
排除标准
- •Previous hypospadias repair.
- •Previous circumcision.
- •Proximal hypospadias diagnosed before surgery.
- •Penile curvature of 30 degrees or greater.
研究组 & 干预措施
Tubularized Incised Plate Repair (TIP)
Distal Hypospadias Repair using the TiP technique
干预措施: Tubularized Incised Plate Repair (Procedure)
Topography-Guided Repair (TGR)
Distal Hypospadias Repair using the topographic anatomical repair technique
干预措施: Topography Guided Repair (Procedure)
结局指标
主要结局
Complication-Free Rate
时间窗: 3 months after primary hypospadias repair
The proportion of participants without postoperative complications, including urethrocutaneous fistula, meatal stenosis, glanular dehiscence, or other complications, at 3 months after the primary repair. Participants were classified according to their current complication status before any revision surgery.
次要结局
- Complication-Free Rate at 12 Months(12 months after primary hypospadias repair)
- Hypospadias Objective Scoring Evaluation (HOSE) Score(3 and 12 months after primary hypospadias repair)
研究者
Amr Salama
Prof.
Alexandria University