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 Medicine1,300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,300

Conditions

Hypospadias

Eligibility

Sex: MALEMin age: 1 YearMax age: 12 Years

Medical Language ↔ Plain English

\* 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

Locations (1)

Sidra Medicine

Doha, Baladīyat ad Dawḩah, Qatar

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.

Time frame: minimum 6 months post-surgery

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.

Time frame: At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months and last clinic visit

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.

Time frame: At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months or last clinic visit

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.

Time frame: Based on data collected during a minimum 6 months after surgery