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
Sidra Medicine
1,300 participants
Jun 4, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Male patients aged 1 to 12 years
- Diagnosed with hypospadias (distal, midpenile, proximal)
- Undergoing primary surgical repair
- Parent/legal guardian consent obtained
Exclusion Criteria3
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07017842