PREDICT-H Protocol: A Multicenter Prospective Cohort Study on Preoperative Anatomical Determinants and Postoperative...

Background: Hypospadias is a common congenital anomaly in boys, marked by ectopic urethral meatus and a wide range of anatomical variants such as chordee and atypical glans morphology. Despite advancements in surgical techniques, complication rates remain high and unpredictable due to heterogeneity in anatomy and a lack of standardized preoperative assessments. Retrospective studies suggest associations between specific anatomical features and postoperative complications; however, high-quality prospective, multicenter evidence is currently lacking. Methods: The PREDICT-H (Prospective Research on Essential Determinants Influencing Complication Trends in Hypospadias) study is a multicenter, prospective cohort study aiming to enroll approximately 1450 boys aged 1-12 years undergoing primary hypospadias repair at ten or more tertiary pediatric urology centers. A standardized preoperative assessment protocol will document detailed anatomical parameters, including urethral plate width and length, glans size, meatal location, chordee severity, and GMS score. Intraoperative variables and surgical techniques will be recorded. Postoperative outcomes, including urethrocutaneous fistula, meatal stenosis, and recurrent chordee, will be assessed at ≥6 months follow-up. Statistical analyses will include multivariate logistic regression and advanced modeling to identify independent predictors and develop a validated risk prediction nomogram. Interobserver reliability of anatomical assessments will also be evaluated. Results: As this is a study protocol, results are not yet available. Data collection is ongoing and will be analyzed upon completion of the planned follow-up period. The primary outcome will be the incidence of postoperative complications and the development of a predictive nomogram for individualized risk estimation. Conclusions: The PREDICT-H study is designed to provide robust, prospective evidence on the anatomical determinants of postoperative complications in hypospadias surgery. The development of a validated, clinically applicable risk prediction tool could standardize preoperative assessment and enhance individualized surgical planning. Findings from this study are expected to support evidence-based practice and inform future clinical guidelines.