"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Time Required to Perform Procedure (in Seconds)
研究概览
简要总结
The study aimed to compare the use of a transurethral laparoscope to the use of a traditional cystoscope for evaluation of the bladder and ureters at the time of laparoscopic hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be done safely using a transurethral laparoscope, takes less time than traditional cystoscopy, and is more cost effective than traditional cystoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •any female patient scheduled for a laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) with or without adnexectomy for benign disease
- •able to comprehend and sign the informed consent form
- •able to provide clean-catch urine specimens
- •able to complete a urinary symptom questionnaire pre- and post-operatively
排除标准
- •participants in another research protocol involving an investigational product 30 days before planned randomization
- •pregnant women
- •patients undergoing concomitant incontinence or pelvic support procedures (e.g. transvaginal tape, transobturator tape, pelvic organ prolapse surgery)
- •patients known to have a history of recurrent urinary tract infections
研究组 & 干预措施
transurethral laparoscope
These patients had cystoscopy performed with the transurethral laparoscope.
干预措施: cystoscopy (Device)
Traditional cystoscopy
These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
干预措施: cystoscopy (Device)
结局指标
主要结局
Time Required to Perform Procedure (in Seconds)
时间窗: During Procedure (Up to 15 minutes)
Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy.
次要结局
未报告次要终点