DJ stent removal after one-week versus six-weeks in paediatric laparoscopic pyeloplasty: A prospective randomised controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Stent related discomfort such as Flank pain/ supra-pubic pain on Visual analog score, frequency of urination, urgency, need for medications - anticholinergics. The outcomes are assessed prior to stent removal in both the groups.
研究概览
简要总结
This study is a randomised, parallel group, active controlle single centre study comparing the outcomes of DJ stent removal in children undergoing laparoscopic pyeloplasty for pelvi-ureteric junction obstruction at one week versus six weeks. The primary outcome will be stent related discomfort at one week and six weeks. The secondary outcomes will be rates of infection, obstruction, need for repeat stenting/ pyeloplasty, change in relative function and drainage of the affected kidney, length of hospital stay and cost at one week, six weeks & six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between one year and 16 years of age undergoing Laparoscopic pyeloplasty for Pelvi-ureteric junction.
排除标准
- •Open pyeloplasty, Age> 16 years, recurrent PUJO, those unwilling to participate, any patient with intra-op decision for longer duration of stenting, lost to follow-up in less than six months.
结局指标
主要结局
Stent related discomfort such as Flank pain/ supra-pubic pain on Visual analog score, frequency of urination, urgency, need for medications - anticholinergics. The outcomes are assessed prior to stent removal in both the groups.
时间窗: One week for treatment group and six weeks in the control group.
次要结局
- Rates of infection, obstruction, need for(repeat stenting/ pyeloplasty, change in relative function and drainage of the affected kidney, length of hospital stay and cost.)
研究者
Dr Badhrinath J
Christian Medical College Vellore