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临床试验/NCT01261819
NCT01261819已完成不适用

"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study

AdventHealth1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2009年1月最近更新:
适应症

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

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

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

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (1)

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