RecruitingNCT07017842

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


Sponsor

Sidra Medicine

Enrollment

1,300 participants

Start Date

Jun 4, 2025

Study Type

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

Sex: MALEMin Age: 1 YearMax Age: 12 Years

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)

Sidra Medicine

Doha, Baladiyat ad Dawhah, Qatar

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NCT07017842


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