Clinical trial NCT06520423: Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents with Hypospadias
Official title: Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents with Hypospadias: a Prospective, Cluster-Randomized, Crossover, Multicenter Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypospadias
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 160
Sex: MALE
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Eligible hospitals were randomly assigned in a 1:1 ratio to two intervention groups. Two treatment protocols were implemented in two groups of hospitals. When one group reaches a predetermined number of enrollees, hospitals in both groups will cross over to implement the alternate intervention.
Primary purpose: PREVENTION

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 postoperative wound infections compared to urinary catheter drainage alone in adolescents with hypospadias.

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 urethral opening, penile recurvature, and abnormal distribution of the prepuce. Currently, urethroplasty is the only treatment for hypospadias, with surgery recommended within the first three years of life. However, due to economic, cultural, and social factors, many children miss the optimal age for surgery and require initial or re-repair surgery during puberty. Additionally, some children who underwent hypospadias repair before puberty develop penile recurvature and other complications during adolescence, necessitating reoperation. Physiological changes during puberty, such as penile growth, pubic hair development, increased skin appendages, secretions, and frequency of erections, increase the risk of wound infection and poor healing post-surgery. To address these issues, we placed a stent in the reconstructed urethra of adolescents with hypospadias and performed urethral irrigation postoperatively.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with hypospadias and in Tanner stages II-V at the Department of Urology, Affiliated Children's Hospital of Chongqing Medical University.
2. 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 Criteria:

1. Patients undergoing meatal advancement and glanuloplasty (MAGPI) only.
2. Patients undergoing penile recurvature correction only.
3. Patients undergoing urethrostomy only.
4. Patients with contraindications to the procedure, such as severe cardiac disease, systemic or localized infection, thrombocytopenia, coagulation disorders, congenital immunodeficiencies, or uncontrolled diabetes mellitus.
5. 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.

Primary outcomes:
measure: Postoperative complication rate
timeFrame: 6 months
Secondary outcomes:
measure: Bacterial culture types
timeFrame: 7 days
measure: Colony number
timeFrame: 7 days
measure: Patient satisfaction scores regarding the treatment process
timeFrame: 7 days
measure: Patient satisfaction scores regarding the treatment outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Xing Liu, Doctor
role: STUDY_DIRECTOR
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