"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

This study has been completed.
Sponsor:
Information provided by:
Florida Hospital
ClinicalTrials.gov Identifier:
NCT01261819
First received: October 28, 2010
Last updated: December 20, 2010
Last verified: November 2009

October 28, 2010
December 20, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01261819 on ClinicalTrials.gov 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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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
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
Female
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01261819
FH Project #2142-4860
No
Katherine Kratz, M.D.
Florida Hospital
Not Provided
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