Hypospadias
Conditions
Brief 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.
Interventions
None listed
Sponsors
Sidra Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
\* Inclusion Criteria: Male patients aged 1 to 12 years Diagnosed with hypospadias (distal, midpenile, proximal) Undergoing primary surgical repair Parent/legal guardian consent obtained \*
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome: | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months or last clinic visit | 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 | Based on data collected during a minimum 6 months after surgery | 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. |
Countries
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Contacts
Primary ContactMaraeh Angela Mancha
Outcome results
None listed