"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261819
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : December 21, 2010
Information provided by:
Florida Hospital

October 28, 2010
December 17, 2010
December 21, 2010
January 2009
July 2009   (Final data collection date for primary outcome measure)
Prospective assessment of safety of a novel technique called transurethral laparoscopic cystoscopy [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT01261819 on Archive Site
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"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy
"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study
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.
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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Lower Urinary Tract Injury
Device: cystoscopy
  • Experimental: transurethral laparoscope
    These patients had cystoscopy performed with the transurethral laparoscope.
    Intervention: Device: cystoscopy
  • Active Comparator: Traditional cystoscopy
    These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
    Intervention: Device: cystoscopy
Kratz KG, Spytek SH, Caceres A, Lukman R, McCarus SD. A randomized, single-blinded pilot study evaluating use of a laparoscope or a cystoscope for cystoscopy during gynecologic surgery. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):606-14. doi: 10.1016/j.jmig.2012.06.002. Epub 2012 Jul 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. any female patient scheduled for a laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) with or without adnexectomy for benign disease
  2. able to comprehend and sign the informed consent form
  3. able to provide clean-catch urine specimens
  4. able to complete a urinary symptom questionnaire pre- and post-operatively

Exclusion Criteria:

  1. participants in another research protocol involving an investigational product 30 days before planned randomization
  2. pregnant women
  3. patients undergoing concomitant incontinence or pelvic support procedures (e.g. transvaginal tape, transobturator tape, pelvic organ prolapse surgery)
  4. patients known to have a history of recurrent urinary tract infections
Sexes Eligible for Study: Female
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
FH Project #2142-4860
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Katherine Kratz, M.D.
Florida Hospital
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Principal Investigator: Katherine Kratz, M.D. Florida Hospital
Florida Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP