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Recruiting NCT07017842

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

— Observational Hypospadias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hypospadias. Basic parameters: 1 year — 12 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Qatar
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Primary outcome measures

  • Primary Outcome: [Time frame: minimum 6 months post-surgery]
Secondary outcome measures (3)
  • Individual Complication Rates Following 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 [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 [Time frame: Based on data collected during a minimum 6 months after surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Qatar · 1 center
  • Sidra Medicine — Doha

Publications

  • Merriman LS, Arlen AM, Broecker BH, Smith EA, Kirsch AJ, Elmore JM. The GMS hypospadias score: assessment of inter-observer reliability and correlation with post-operative complications. J Pediatr Urol. 2013 Dec;9(6 Pt A):707-12. doi: 10.1016/j.jpurol.2013.04.006. Epub 2013 May 15. PMID 23683961
  • Abbas TO, Khalil IA, Hatem M, Boyko A, Zorkin S. Plate Objective Scoring Tool (POST) in distal hypospadias: Correlation with post-repair complications. J Pediatr Urol. 2024 Apr;20(2):238.e1-238.e6. doi: 10.1016/j.jpurol.2023.11.022. Epub 2023 Nov 25. PMID 38071112
  • Baray SB, Abdelmoniem M, Mahmud S, Kabir S, Faisal MAA, Chowdhury MEH, Abbas TO. Automated measurement of penile curvature using deep learning-based novel quantification method. Front Pediatr. 2023 Apr 17;11:1149318. doi: 10.3389/fped.2023.1149318. eCollection 2023. PMID 37138577
  • Abbas TO, Vallasciani S, Elawad A, Elifranji M, Leslie B, Elkadhi A, Pippi Salle JL. Plate Objective Scoring Tool (POST); An objective methodology for the assessment of urethral plate in distal hypospadias. J Pediatr Urol. 2020 Oct;16(5):675-682. doi: 10.1016/j.jpurol.2020.07.043. Epub 2020 Aug 5. PMID 32830060
  • Abbas TO. An objective hypospadias classification system. J Pediatr Urol. 2022 Aug;18(4):481.e1-481.e8. doi: 10.1016/j.jpurol.2022.05.001. Epub 2022 May 11. PMID 35644790

Identifiers

NCT: NCT07017842 · SDR600058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗