Clinical Trial: Ureteric Visualization: Vitamin B Vs 5% Dextrose in Water

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Optimal Ureteric Visualization At the Time of Pelvic Reconstructive Surgery: Vitamin B Versus 5% Dextrose in Water

Brief Summary:

Background: The risk of ureteric injury at the time of pelvic reconstructive surgery can be as high as 3% and the American College of Obstetricians and Gynecologists has stated that intraoperative cystoscopy should be done after all such procedures. Intravenous indigo carmine was routinely given during surgery to colour the urine bright blue and allow for assessment of ureteric integrity. In 2014, indigo carmine was no longer available worldwide and since then, surgeons have been searching for suitable alternatives. Vitamin B is a water soluble vitamin that colours the urine bright yellow and can be given immediately before surgery to help with ureteric visualization. Alternatively, 5% dextrose in water (D5W) can be used as the instillation fluid during cystoscopy to allow for urine jet visualization due to the difference in fluid viscosity. Both agents have been shown to be better than instillation with normal saline and are affordable and accessible in Canada.

Objective: To identify which agent is superior for intraoperative ureteric visualization at the time of cystoscopy by determining the difference in detection rate of both ureteric jets using either preoperative oral vitamin B or intraoperative cystoscopic distension with D5W.

Methods: This study will be a three-site (Mount Sinai Hospital, Sunnybrook Health Sciences Centre, St. Michael's Hospital), double-blinded, randomized control trial whereby female patients undergoing pelvic reconstructive surgery will be randomized to receive either preoperative vitamin B or intraoperative D5W cystoscopic instillation fluid. Parameters measured during surgery will include whether both ureteric jets were seen, time to visualization of both ureters, colour of jets, and surgeon satisfaction. Patients will also be seen at one week after surgery to assess for urinary tract infectio

Detailed Summary:
Sponsor: Mount Sinai Hospital, Canada

Current Primary Outcome: Detection rates of both ureteric jets at the time of intraoperative cystoscopy using either preoperative oral vitamin B or intraoperative distension with D5W. [ Time Frame: If ten minutes has passed and no jets are seen the surgeon is allowed to ask for iv fluoroscein for visualization and this would be considered a failed detection. ]

Visual queue: detection will be counted as occurring when both ureteric jets are seen


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Difference in time to visualization of one and both ureters using either preoperative oral vitamin B or intraoperative cystoscopic distension with D5W. [ Time Frame: Time will be measured from the time the surgeon states they have started looking for ureteric jets to the time that one and both ureteric jets are seen. This time period will be up to ten minutes. ]
    Time assessment
  • Difference in the number of times intravenous fluorescein is used as a rescue agent to visualize ureters when vitamin B or D5W has failed. [ Time Frame: Number of times fluorescein is used during intraoperative cystoscopy to visualize ureters when experimental agents have failed. ]
    Count
  • Difference in surgeon satisfaction when using vitamin B or D5W. [ Time Frame: Done after surgery is complete in the operating room ]
    Visual analog satisfaction scale
  • Difference in UTI rates after surgery after using vitamin B or D5W. [ Time Frame: Urine will be collected 3 to 10 days after surgery. ]
    Infection rates


Original Secondary Outcome: Same as current

Information By: Mount Sinai Hospital, Canada

Dates:
Date Received: March 13, 2017
Date Started: June 2017
Date Completion: March 2019
Last Updated: March 23, 2017
Last Verified: March 2017