About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Male patients aged 1 to 12 years with diagnosed distal, midpenile, or proximal hypospadias scheduled for primary surgical repair will be enrolled. Exclusion criteria include prior hypospadias or penile surgery, major genital anomalies (e.g., ambiguous genitalia, severe DSD), inability or refusal to consent, or incomplete follow-up. Patients will be recruited from multiple tertiary pediatric urology centers. Informed consent will be obtained from parents or legal guardians. All participants will be followed for a minimum of 6 months postoperatively to assess surgical outcomes and complications.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Primary Outcome:
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.
Secondary outcomes
Individual Complication Rates Following Hypospadias Repair
The frequency of specific postoperative complications-including urethrocutaneous fistula, meatal stenosis, urethral stricture, recurrent chordee, wound infection, and need for surgical revision-will be assessed in patients undergoing primary hypospadias repair.
Cosmetic and Functional Outcomes After Hypospadias Surgery
Cosmetic appearance and functional urinary outcomes will be evaluated using validated scoring systems and satisfaction surveys completed by surgeons and parents at follow-up visits scheduled at 1, 3, and 6 months post-surgery. A minimum follow-up of 6 months is required for all patients, with an optional assessment at 12 months for long-term outcome validation.
Correlation Between Preoperative Anatomical Variables and Specific Postoperative Complications
Statistical analyses will evaluate associations between preoperative anatomical measurements and individual postoperative complications. Data collection and follow-up for these analyses require a minimum postoperative period of 6 months.
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