Status:
ACTIVE_NOT_RECRUITING
Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents with Hypospadias
Lead Sponsor:
Xing Liu
Conditions:
Hypospadias
Eligibility:
MALE
9-18 years
Phase:
NA
Brief Summary
This prospective, cluster-randomized, crossover, two-arm controlled clinical trial aims to determine whether urethral stent tube irrigation, combined with urinary catheter drainage, prevents postopera...
Detailed Description
Hypospadias is one of the most common genital developmental malformations in pediatric patients, with a prevalence of approximately 0.5%. The primary manifestations of hypospadias include an ectopic u...
Eligibility Criteria
Inclusion
- Patients diagnosed with hypospadias and in Tanner stages II-V at the Department of Urology, Affiliated Children's Hospital of Chongqing Medical University.
- Patients and their guardians have been informed about the nature of the study, understand the protocol, can ensure compliance, and have signed an informed consent form.
Exclusion
- Patients undergoing meatal advancement and glanuloplasty (MAGPI) only.
- Patients undergoing penile recurvature correction only.
- Patients undergoing urethrostomy only.
- Patients with contraindications to the procedure, such as severe cardiac disease, systemic or localized infection, thrombocytopenia, coagulation disorders, congenital immunodeficiencies, or uncontrolled diabetes mellitus.
- Patients already enrolled in or during the follow-up of other clinical studies. Patients who do not wish to participate in this study or demonstrate poor compliance with follow-up requirements.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06520423
Start Date
August 1 2024
End Date
February 1 2027
Last Update
January 31 2025
Active Locations (1)
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1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000