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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-04

Study Completion Date

2028-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypospadias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypospadias (Age 1-12 years old)

This study includes a single prospective observational cohort of male pediatric patients aged 1 to 12 years undergoing primary surgical repair for hypospadias at participating tertiary pediatric urology centers. No experimental interventions are assigned by the study; instead, patients receive standard-of-care surgical techniques as determined by their treating surgeons. Detailed preoperative anatomical assessments and surgical procedure documentation are collected to evaluate the impact of anatomical variables and surgical approaches on postoperative complication rates. Subgroup analyses will be performed based on hypospadias severity (distal, midpenile, proximal) and the surgical technique utilized.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No