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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maraeh Angela Mancha | Contact | +974-40033333 | MMancha@sidra.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidra Medicine | Recruiting | Doha | Baladiyat ad Dawhah | 26999 | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23683961 | Background | 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. | |
| 38071112 | Background | 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. |
| Label | URL |
|---|---|
| Hypospadias Registry | View source |
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De-identified individual participant data, including anatomical measurements, surgical details, and postoperative outcomes, will be made available to qualified researchers upon reasonable request following publication of the primary study results. Data sharing will comply with all applicable privacy regulations and institutional policies to ensure participant confidentiality. Requests will be reviewed by the study steering committee, and data will be shared via a secure platform after completion of a data use agreement.
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| 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 |
| 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 |
| 37138577 | Background | 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. |
| 32830060 | Background | 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. |
| 35644790 | Background | 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. |
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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