Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 172
- 试验地点
- 22
- 主要终点
- Change in Urinary Symptom Scores
研究概览
简要总结
The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.
详细描述
The rationale for this study is to determine if there is a difference in symptoms or complications among patients undergoing uncomplicated ureteroscopy for stone removal with shorter indwelling stent duration. Currently there are only a few small studies exploring the optimal duration of stent placement after stent placement and no multicenter randomized control trials. The investigation aim is to determine if earlier ureteral stent removal will reduce urinary symptoms after stent removal and improve quality of life without increasing risk of negative side effects. Using questionnaires for stent related symptoms the researchers will assess stent indwelling time effect on patient reported side effects.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants undergoing unilateral stone treatment. Patients may have stones present bilaterally, but must only be having unilateral intervention.
- •The ureteroscopy must be uncomplicated
- •Patients undergoing semi-rigid ureteroscopy only, flexible ureteroscopy only, or a combination
排除标准
- •Pregnancy
- •A stent or nephrostomy tube placed prior to surgery
- •Complex ureteroscopy - ureteral injury, ureteral perforation, ureteral stricture, impacted stone
- •Infection or struvite stones
- •Recurrent Urinary Tract Infection (UTI): 2 culture proven UTI in 6 months or 3 culture proven UTIs in one year
- •No stone evident on ureteroscopic evaluation of ureter or kidney
- •Transplant kidney
- •Variant anatomy (horseshoe, pelvic kidney)
研究组 & 干预措施
Uncomplicated Ureteroscopy and Stent Placement for 3-5 days
After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days
干预措施: Ureteral stent (Device)
Uncomplicated Ureteroscopy and Stent Placement for 7-9 days
After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days
干预措施: Ureteral stent (Device)
结局指标
主要结局
Change in Urinary Symptom Scores
时间窗: Post-operative day 2-3 and 2-3 days after stent removal
The urinary symptoms will be assessed using the self-reported Canadian Endourology Group Stent Symptom Score. Seven item questionnaire to assess urinary stent symptoms using a 5-point Likert scale; higher score indicated worse outcome.
次要结局
- Change in Pain Scores(Post-operative day 2-3 and 2-3 days after stent removal)
- Change in Quality of life(Post-operative day 2-3 and 2-3 days after stent removal)
- Return to work(30 days)
- Complications(30 days)
研究者
Karen L. Stern
Principal Investigator
Mayo Clinic