Actively Recruiting
Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Urethroplasty for Management of Proximal Hypospadias A Randomized Clinical Trial
Led by Tanta University · Updated on 2024-09-19
43
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Proximal hypospadias is a serious condition affecting infants and their caregivers, involving an abnormality of the urethra. Researchers are comparing two surgical methods to repair this condition: the hybrid Duckett urethroplasty, a staged procedure, and the modified Duckett urethroplasty, which is completed in a single surgery. This randomized clinical trial aims to evaluate which technique better restores urethral continuity and improves cosmetic appearance. Infants and children diagnosed with proximal hypospadias will be randomly assigned to one of two groups. Group A will undergo the hybrid Duckett procedure, involving initial placement of a double-face Duckett tube on the ventral penis, with the final connection to the urethra scheduled six months later. Group B will receive the modified Duckett procedure, where the tube is placed and connected to the proximal urethral opening in a single operation. Participants will be followed for at least six months after surgery to assess the success of the repair, focusing on absence of fistula and restoration of urethral continuity as the main outcome. Researchers will also evaluate the cosmetic appearance after surgery. The study includes assessments during the operative period and follow-up visits to monitor healing and surgical results. The total participation period varies depending on individual treatment schedules and recovery.
CONDITIONS
Brief Title
Hybrid Duckett vs Modified Duckett Urethroplasty for Proximal Hypospadias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All infants and children with proximal hypospadias
- Male gender
- Age between 6 months and 18 years
You will not qualify if you...
- Disorders of sex development
- Previous penile surgery
- Circumcised children
- Crippled penis
- Refusal of the management plan by caregivers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single session for initial surgery with group-specific procedures
Participants undergo either hybrid Duckett urethroplasty or modified Duckett urethroplasty to repair proximal hypospadias.
1 surgical visit (in-person)
Duration - Days to weeks immediately after surgery
Participants receive post-operative care immediately following surgery to support recovery and monitor for complications.
Approximately 1 to 2 post-operative visits
Duration - Second surgery scheduled approximately six months after initial surgery
Group A participants have a scheduled second surgery for proximal anastomosis to complete the urethral repair.
1 surgical visit (in-person) for second procedure
Duration - Up to six months after surgery
Participants are monitored after surgery to assess healing, functional outcomes, and cosmetic appearance.
Several follow-up visits over six months
Trial Site Locations
Total: 1 location
1
Tanta University Hospitals
Tanta, Elgharbeya, Egypt, 31111
Actively Recruiting
Research Team
M
mohammad khirallah, professor
N
Nagi Eldessouki, professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here