Text Size

"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
History of Changes
  Purpose

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.


Condition Intervention
Lower Urinary Tract Injury
 Device: cystoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: "Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Prospective assessment of safety of a novel technique called transurethral laparoscopic cystoscopy [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transurethral laparoscope
These patients had cystoscopy performed with the transurethral laparoscope.
 Device: cystoscopy
Active Comparator: Traditional cystoscopy
These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
 Device: cystoscopy

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261819

Locations
United States, Florida
Florida Hospital
Winter Park and Celebration, Florida, United States
Sponsors and Collaborators
Florida Hospital
Investigators
Principal Investigator: Katherine Kratz, M.D. Florida Hospital
  More Information

No publications provided by Florida Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Katherine Kratz, M.D.
ClinicalTrials.gov Identifier: NCT01261819     History of Changes
Other Study ID Numbers: FH Project #2142-4860
Study First Received: October 28, 2010
Last Updated: December 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Hospital:
cystoscopy, minimally invasive hysterectomy

ClinicalTrials.gov processed this record on May 19, 2013