Incidence Of Urethrocutaneous Fistula Formation In Patients Undergoing Urethroplasty With And Without Stent For Hypospadias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Incidence of Urethrocutaneous Fistula at 12 Weeks After Urethroplasty
研究概览
简要总结
Hypospadias is a birth condition in which the urine opening is on the underside of the penis. Surgery (urethroplasty) is the standard treatment. Surgeons sometimes leave a small tube ("stent") inside the new urine passage after surgery, but it is unclear whether using a stent affects the risk of a common complication called a urethrocutaneous fistula (a small leak from the new urethra to the skin).
This study will compare two routine surgical approaches for boys 1-12 years old with distal or mid-penile hypospadias who need urethroplasty: (1) surgery with a temporary stent and (2) surgery without a stent. Children will be randomly assigned to one of the two groups. All surgeries will be performed by a consultant pediatric surgeon using a standardized technique, and all children will receive usual postoperative care.
Families will return for follow-up at 2, 6, and 12 weeks after surgery. At these visits, the team will check for fistula using a simple saline test and record any other concerns. We aim to learn which approach leads to fewer complications, less discomfort, and fewer additional procedures for children undergoing hypospadias repair.
详细描述
Objective. To compare the incidence of urethrocutaneous fistula (UCF) after hypospadias urethroplasty performed with versus without a postoperative urethral stent. Primary endpoint: UCF at 12 weeks post-operation, defined by saline injection into the neourethra with proximal compression; visible saline spillage between two points is counted as positive.
Design and Setting. Single-center, randomized controlled trial at the Department of Pediatric Surgery, Children's Hospital Multan. Duration: 6 months from synopsis approval. Target sample size: 110 (power 80%, two-proportion test; expected UCF 13.3% with stent vs 33.3% without stent; α=0.05). Allocation by sealed opaque-envelope lottery to two parallel groups.
Participants. Inclusion: boys aged 1-12 years with distal or mid-penile hypospadias scheduled for urethroplasty. Exclusion: prior failed urethroplasty or planned staged repair. Written informed consent from parents/guardians.
Interventions.
Group A (Stent urethroplasty): Standardized urethroplasty with a 6-8 Fr nasogastric tube as temporary stent (size by age). Stent removed on postoperative day 7; discharge thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Boys aged 1-12 years
- •Distal or mid-penile hypospadias planned for urethroplasty
- •Parent/guardian provides written informed consent
排除标准
- •Previous failed urethroplasty
- •1. Planned staged repair
结局指标
主要结局
Incidence of Urethrocutaneous Fistula at 12 Weeks After Urethroplasty
时间窗: twelve weeks post operation
Urethrocutaneous fistula (UCF) will be determined by injecting normal saline under pressure into the terminal neourethra while compressing the penile base; visible saline spillage between two points is counted as positive. Outcome is the proportion of participants with UCF in each arm (stent vs stentless). Assessments occur at routine follow-ups (2, 6, and 12 weeks), with the primary analysis at 12 weeks.
次要结局
未报告次要终点
研究者
Saira Shafee
Principal Investigator
Children's Hospital and Institute of Child Health, Multan