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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 1
Maximum Age: 12
Healthy Volunteers: f
View:

• Male patients aged 1 to 12 years

• Diagnosed with hypospadias (distal, midpenile, proximal)

• Undergoing primary surgical repair

• Parent/legal guardian consent obtained

Locations
Other Locations
Qatar
Sidra Medicine
RECRUITING
Doha
Contact Information
Primary
Maraeh Angela Mancha
MMancha@sidra.org
+974-40033333
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 1300
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Sidra Medicine

This content was sourced from clinicaltrials.gov