[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594315":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":30,"armGroups":31,"interventions":26,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":60,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":76,"studyType":77,"phases":26,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Sidra Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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.","minimum 6 months post-surgery",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"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.","At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months and last clinic visit",{"measure":19,"description":20,"timeFrame":21},"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.","At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months or last clinic visit",{"measure":23,"description":24,"timeFrame":25},"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.","Based on data collected during a minimum 6 months after surgery",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","PROSPECTIVE","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.",[32],{"label":33,"type":26,"description":34,"interventionNames":26},"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.",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Maraeh Angela Mancha","CONTACT","+974-40033333","MMancha@sidra.org",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Doha","Baladiyat ad Dawhah","26999","Qatar","QA",{"type":50,"coordinates":51},"Point",[52,53],51.53096,25.28545,{"lat":53,"lon":52},[56,57],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Tariq O Abbas, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Tariq Abbas","Consultant Pediatric Urologist","100594315","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-100594315",false,"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","PREDICT-H","\\* Inclusion Criteria:\n\nMale patients aged 1 to 12 years\n\nDiagnosed with hypospadias (distal, midpenile, proximal)\n\nUndergoing primary surgical repair\n\nParent\u002Flegal guardian consent obtained\n\n\\* Exclusion Criteria:\n\nPrior hypospadias or penile surgery (revision cases)\n\nMajor associated genital anomalies (e.g., ambiguous genitalia, severe DSD)\n\nRefusal of consent or inability to complete follow-up","MALE","1 Year","12 Years",{"count":74,"type":75},1300,"ESTIMATED","6 Months","OBSERVATIONAL","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.",[80],"Hypospadias","2025-06-04",{"date":83,"type":84},"2025-06-12","ACTUAL",{"date":81,"type":84},{"date":87,"type":75},"2028-02-28",{"name":5,"class":6},1]