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

ConditionHypospadias
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age1-12
SponsorSidra Medicine

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,300 Participants
are grouped into 1 trial group
Group A: Hypospadias (Age 1-12 years old)

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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