Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Time in Seconds to Complete the Cystourethroscopy
研究概览
简要总结
Objective:
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
- patient position during the cystoscopy (Trendelenburg (head down) or flat)
- Abdominal insufflation (insufflation versus no insufflation)
详细描述
This is a randomized controlled trial assessing time to completion of cystoscopy in seconds after minimally invasive gynecologic surgery.
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
- patient position during the cystoscopy (Trendelenburg (head down) or flat)
- Abdominal insufflation (insufflation versus no insufflation).
Both interventions are used as usual care and depend on surgeon preference without evidence why one would be faster at completing the cystoscopy. Also note that these two interventions are performed multiple times during the surgery itself and outside the cystoscopy procedure routinely. The investigator's main objective is to assess which intervention or combination of interventions is more efficient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation).
排除标准
- •Pregnancy
- •Known urologic anomaly
- •Unplanned cystoscopy
- •Cancer surgery
- •Urogynecology surgery
- •comorbidities including cardiac disease, chronic hypertension, any stage kidney disease (including abnormal creatinine level), and use of diuretics.
- •Undergoing extensive ureterolysis
- •Blood loss more than 500 milliliters (mLs)
- •Contra-indications to position change and insufflation
结局指标
主要结局
Time in Seconds to Complete the Cystourethroscopy
时间窗: From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)
Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra).
次要结局
未报告次要终点
研究者
Randa Jalloul
Associate Professor
The University of Texas Health Science Center, Houston