The Effect of Patient Positioning on Ureteral Efflux During Intraoperative Cystoscopy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- time to confirmation of bilateral ureteral patency
研究概览
简要总结
The objective of the study is to identify the relationship between patient position during surgery and time to confirmation of ureteral patency on cystoscopy.
详细描述
Patients will be randomized to one of two arms: 0 degree supine position and 10-20 degree angle in reverse Trendelenburg. Our working hypothesis is that positioning a patient in 10-20 degree angle reverse Trendelenburg will result in shorter time to confirmation of bilateral ureteral patency and shorter total cystoscopy time, without a change in delayed diagnosis of ureteric injury.
Primary outcome: time to confirmation of bilateral ureteral patency Secondary outcome: total cystoscopy time, need for alternative modalities to aid in ureteral efflux visualization, delayed diagnosis of ureteric injury (evaluated 6 weeks postoperatively via chart review)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients
- •Greater than or equal to 18 years old
- •English-speaking
- •Scheduled benign gynecologic or urogynecologic surgery in which routine cystoscopy at Banner University Medical Center - Phoenix; Dr. Mourad, Dr. Mahnert or Dr. Rachael Smith.
排除标准
- •Patients with underlying chronic kidney disease (creatinine <1)
- •Known renal anomaly such as prior surgical removal of a kidney or underlying ureteral obstruction
- •Current ureteral stent in place,
- •Contraindication to any of the interventions (i.e., documented allergies)
结局指标
主要结局
time to confirmation of bilateral ureteral patency
时间窗: 1 day
time between initiation of cystoscopy and visualization of second ureteral jet in minutes
次要结局
- need for alternative modalities to aid in ureteral efflux visualization(1 day)
- total cystoscopy time(1 day)
- delayed diagnosis of ureteric injury(6 weeks after surgery)