PREDICT-H Study: Prospective Research on Essential Determinants Influencing Complication Trends in Hypospadias - a Landmark Prospective Multicenter Cohort Study Aimed at Improving Outcome Prediction in Hypospadias Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Primary Outcome:
研究概览
简要总结
Hypospadias is a common congenital anomaly with complex anatomy that influences surgical outcomes. Despite numerous surgical techniques, a lack of standardized preoperative assessment protocols and consensus on anatomical risk factors limits prediction of complications. This study aims to systematically evaluate key anatomical features identified in previous meta-analyses-such as urethral plate width and length, glans size, chordee severity, meatal position, and others-in a large, prospective multicenter cohort. The ultimate goal is to develop and validate an objective nomogram predicting the risk of postoperative complications, enabling individualized surgical planning and improved patient counseling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 1 to 12 years
- •Diagnosed with hypospadias (distal, midpenile, proximal)
- •Undergoing primary surgical repair
- •Parent/legal guardian consent obtained
排除标准
- •Prior hypospadias or penile surgery (revision cases)
- •Major associated genital anomalies (e.g., ambiguous genitalia, severe DSD)
- •Refusal of consent or inability to complete follow-up
结局指标
主要结局
Primary Outcome:
时间窗: minimum 6 months post-surgery
Composite rate of postoperative complications within 6 months, including: urethrocutaneous fistula, meatal stenosis, urethral stricture, recurrent chordee, wound infection requiring treatment, and need for surgical revision.
次要结局
- Individual Complication Rates Following Hypospadias Repair(At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months and last clinic visit)
- Cosmetic and Functional Outcomes After Hypospadias Surgery(At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months or last clinic visit)
- Correlation Between Preoperative Anatomical Variables and Specific Postoperative Complications(Based on data collected during a minimum 6 months after surgery)
研究者
Tariq Abbas
Consultant Pediatric Urologist
Sidra Medicine