Early repair of small urethrocutaneous fistula in children after hypospadias surgery- A randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary outcome would be assessed by the comparison of the two groups with regards to number of patients having fistula
研究概览
简要总结
This is an open label randomisedcontrolled trial to determine the feasibility and efficavy of earlyrepair of small urethrocutaneous fistulae (≤4 mm) in children after hypospadiassurgery. Childrenwith small UC fistula developing within four weeks after catheter removal shallbe assessed for eligibility based oninclusion/exclusion criteria. Followinginformed parental consent, eligible children shall be randomised to receive a “figureof eight†stitch while ensuringallocation concealment. Randomizedcontrol subjects who would only be subjected to traditional follow up withneo-meatal calibration and finger occlusion micturition. The patients shall befollowed during the study duration and monitored for recurrence of fistulas,urinary stream and wound infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- Male
入选标准
- •(a) Have undergone primary urethroplasty for hypospadias at AIIMS b) Fistula manifesting within four weeks after catheter removal c) Single small (≤4 mm) UCF.
排除标准
- •a) Wound infection with slough around the fistula b) UCF > 4mm.
结局指标
主要结局
Primary outcome would be assessed by the comparison of the two groups with regards to number of patients having fistula
时间窗: At the end of 6 months of follow up in the two groups
次要结局
- Secondary outcome shall be assessed by the number of patients allocated to the test arm who successfully receive the intervention without requiring another admission(At the end of 6 months of follow up in the two groups)