Comparing two surgical techniques for treating proximal hypospadias in infants
Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Uteothroplasty for Management of Proximal Hypospadias: a Randomized Clinical Trial
This study is testing which of two surgical methods works better for fixing a condition called proximal hypospadias in infants, one that takes two surgeries and one that only needs one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | Male |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Elgharbeya) |
| Trial ID | NCT06598215 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of hybrid Duckett urethroplasty, a staged surgical procedure, against modified Duckett urethroplasty, a single-stage procedure, for infants diagnosed with proximal hypospadias. Infants will be randomly assigned to one of two groups: Group A will undergo the hybrid procedure, where the urethral connection is completed in a second surgery six months later, while Group B will have the connection completed in the same surgery. The primary outcome will be the successful completion of the procedure and restoration of urethral continuity, with secondary outcomes focusing on cosmetic appearance. Recruitment will be conducted using a sealed envelope method to ensure unbiased allocation.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and children diagnosed with proximal hypospadias.
Not a fit: Patients with disorders of sex development, previous penile surgery, circumcised children, or those whose caregivers refuse the management plan may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and cosmetic results for infants with proximal hypospadias.
How similar studies have performed: While various surgical techniques for hypospadias have been explored, this specific comparison of hybrid versus modified Duckett urethroplasty is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * all infants and children with proximal hypospadias Exclusion Criteria: * disorders of sex developments * previous penile surgery * circumcised children * crippled penis * refusal of the plan of the management by the care givers
Where this trial is running
Tanta, Elgharbeya
- Tanta University Hospitals — Tanta, Elgharbeya, Egypt (Recruiting)
Study contacts
- Study coordinator: mohammad khirallah, professor
- Email: mohamed.khirallah@med.tanta.edu.eg
- Phone: 00201118420783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.