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临床试验/NCT06520423
NCT06520423进行中(未招募)不适用

Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents With Hypospadias: A Multicenter Randomized Controlled Trial

Xing Liu2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
150
试验地点
2
主要终点
Overall complication rate

研究概览

简要总结

This multicenter randomized controlled 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients undergoing meatal advancement and glanuloplasty (MAGPI) only.
  • Patients undergoing penile recurvature correction only.
  • Patients undergoing only urethral fistula formation/urethrostomy.
  • Patients with a prostatic utricle.
  • 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.

研究组 & 干预措施

Urinary catheter drainage

Active Comparator

These patients will undergo urinary catheter drainage for seven days following urethroplasty

干预措施: Urinary catheter drainage (Procedure)

Urethral stent tube irrigation (combined with urinary catheter drainage)

Experimental

These patients will undergo urinary catheter drainage (combined with urinary catheter drainage) for seven days following urethroplasty

干预措施: Urethral stent tube irrigation (Procedure)

Urethral stent tube irrigation (combined with urinary catheter drainage)

Experimental

These patients will undergo urinary catheter drainage (combined with urinary catheter drainage) for seven days following urethroplasty

干预措施: Urinary catheter drainage (Procedure)

结局指标

主要结局

Overall complication rate

时间窗: 12 months

Probability of overall complications following urethroplasty in adolescent boys with hypospadias.

Specific complication rates

时间窗: 12 months

Probability of specific complications following urethroplasty in adolescent boys with hypospadias.

次要结局

  • Urinary function(12 months)
  • Cosmetic outcomes(12 months)

研究者

发起方
Xing Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xing Liu

Professor, Doctor

Children's Hospital of Chongqing Medical University

研究点 (2)

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