Benefits of Retained Cystoscopy Fluid Following Benign Laparoscopic and Robotic Hysterectomy; A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Time to spontaneous void
研究概览
简要总结
The purpose of this research study is to compare outcomes for women in two study arms that include retaining the cystoscopy distending fluid after minimally invasive hysterectomy verses completely emptying the cystoscopy distending fluid. The outcomes being measured for research purposes include the time spent to first spontaneous urination after surgery, rate of indwelling catheter insertion, length of recovery room stay, the amount of bladder discomfort immediately postoperative and over the first 24 hours postoperative, bladder symptoms over the first 24 hours postoperative, and patient satisfaction.
详细描述
Acute urinary retention can be a common postoperative complication following hysterectomy. One of the many benefits of minimally invasive surgery is shorter hospital stay following a major procedure such as laparoscopic or robotic hysterectomy. An important postoperative milestone before discharge from the postoperative anesthesia care unit (PACU) is spontaneous voiding. If unable to spontaneously void due to urinary retention, insertion of an indwelling catheter may be required. Awaiting a spontaneous void in the recovery room can lead to longer hospital and PACU stays, greater cost, and patient dissatisfaction. At the conclusion of traditional laparoscopic or robotic-assisted hysterectomy, intraoperative cystoscopy is performed to evaluate for urologic injury. One possible strategy to more quickly facilitate a postoperative spontaneous void is to retain the cystoscopy distending fluid at conclusion of cystoscopy rather than emptying the bladder of the distending fluid. Although there is no published research investigating voiding time following laparoscopic or robotic hysterectomy using strategies such as backfilling the bladder before removal of the indwelling catheter or retaining the cystoscopy distending fluid following diagnostic cystoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Care Provider)
盲法说明
PACU nurses and patients will not be aware of which arm patient was randomized to.
入排标准
- 年龄范围
- 18 Years 至 —(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
- •Undergoing laparoscopic or robotic hysterectomy for benign indications by one of the three minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix.
排除标准
- •Preoperative indications of pelvic organ prolapse
- •Preoperative indications of urinary incontinence
- •Lower urologic (bladder or ureteric) injury identified at time of hysterectomy or during intraoperative cystoscopy
- •Patients given any measure to aid in visualization of ureteral patency including dextrose, phenazopyridine, indigo carmine, methylene blue, sodium fluorescein, or furosemide.
结局指标
主要结局
Time to spontaneous void
时间窗: From surgery end time up to 4 hours
Measure of time to spontaneous urination in the recovery room post hysterectomy. Time of urination is measured by the recovery room nurse from surgery end time.
次要结局
- 2-Item Bladder pain Measure(12 hours)
- 3-Item Bladder pain Measure(24 hours)
- Foley catheter insertion rate(2 weeks)
- Length of recovery room stay(From time of randomization up to 12 hours postoperative)
- 4-Item Patient Satisfaction Measure(12 hours)
- 3-Item Bladder Symptoms Measure(24 hours)
- 2-Item Patient Satisfaction Measure(24 hours)
研究者
Rachael Bailey Smith
Dr. Rachael Smith, Principal Investigator
University of Arizona
