The GMS hypospadias score: assessment of inter-observer reliability and correlation with post-operative complications.
Laura S Merriman, Angela M Arlen, Bruce H Broecker...
https://pubmed.ncbi.nlm.nih.gov/23683961Actively Recruiting
Age: 1Year - 12Years
MALE
ID07017842
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
Led by Sidra Medicine · Updated on 2025-06-12
1300
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypospadias is a common birth condition affecting the anatomy of the penis, which can influence surgical results. Researchers are conducting a large, prospective multicenter study to systematically assess key anatomical features like urethral plate size, glans size, chordee severity, and meatal position. The goal is to create and validate a tool to predict the risk of complications after surgery, helping tailor surgical plans and improve counseling for patients and families. This observational study enrolls male children aged 1 to 12 years who are undergoing their first surgical repair for hypospadias at specialized pediatric urology centers. There are no experimental treatments; patients receive the usual surgical care determined by their doctors. Detailed assessments of anatomy are done before surgery, and surgical details are recorded. The study will analyze outcomes based on the severity of hypospadias and the surgical methods used. Participants will be followed for at least six months after surgery to monitor complications, with additional optional assessments at one month, three months, 12 months, and at the last clinic visit. Researchers will evaluate complication rates, cosmetic and functional results, and how preoperative anatomy relates to specific postoperative issues. This will help improve prediction and management of surgical outcomes over the study period, which runs until early 2028.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 1Year - 12Years
MALE
Eligibility Criteria
You may qualify if you...
- Male patients aged 1 to 12 years
- Diagnosed with hypospadias (distal, midpenile, proximal)
- Undergoing primary surgical repair
- Parent or legal guardian consent obtained
You will not qualify if you...
- Prior hypospadias or penile surgery (revision cases)
- Major associated genital anomalies such as ambiguous genitalia or severe differences of sex development
- Refusal of consent or inability to complete follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Day of surgery and immediate recovery period
Participants undergo primary surgical repair for hypospadias using standard surgical techniques determined by their surgeons. Detailed preoperative and surgical procedure information is collected.
1 visit (in-person)
Post-operative Follow-up
Duration - At least 6 months post-surgery, with optional follow-up up to 12 months or last clinic visit
Participants are monitored for complications and recovery progress after surgery. Assessments include cosmetic and functional outcomes as well as complication rates.
Visits at 1 month, 3 months, and minimum 6 months post-surgery; optional visits at 12 months or last clinic visit
Trial Site Locations
Total: 1 location
1
Sidra Medicine
Doha, Baladiyat ad Dawhah, Qatar, 26999
Actively Recruiting
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Research Team
M
Maraeh Angela Mancha
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Plate Objective Scoring Tool (POST) in distal hypospadias: Correlation with post-repair complications.
Tariq O Abbas, Ibrahim A Khalil, Mohamed Hatem...
https://pubmed.ncbi.nlm.nih.gov/38071112Automated measurement of penile curvature using deep learning-based novel quantification method.
Sriman Bidhan Baray, Mohamed Abdelmoniem, Sakib Mahmud...
https://pubmed.ncbi.nlm.nih.gov/37138577Plate Objective Scoring Tool (POST); An objective methodology for the assessment of urethral plate in distal hypospadias.
Tariq O Abbas, Santiago Vallasciani, Abubakr Elawad...
https://pubmed.ncbi.nlm.nih.gov/32830060An objective hypospadias classification system.
Tariq O Abbas
https://pubmed.ncbi.nlm.nih.gov/35644790