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Ureteric Visualization: Vitamin B Vs 5% Dextrose in Water

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ClinicalTrials.gov Identifier: NCT03089671
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : September 3, 2018
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
Women's College Hospital
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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 infection. Sample size calculation based on previous studies demonstrated a need for 125 patients per study arm.

Anticipated Clinical Significance: The findings of this study will be relevant to all surgeons performing intraoperative cystoscopy where ureteric visualization is required. The investigators believe the outcome of this study will help make cystoscopy shorter and more efficient for surgeons who often feel the pressure of time constraints within the operating room setting. In turn, decreasing the time of cystoscopy may reduce operating times which will benefit both the patient and hospital.


Condition or disease Intervention/treatment Phase
Pelvic Floor Disorders Ureter; Kink Other: Vitamin B (riboflavin, vitamin B2) Other: 5% Dextrose in Water (D5W) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded, randomized controlled trial
Masking: Double (Participant, Care Provider)
Masking Description:

Patient packages will be created and assigned a patient number. For those randomized to the vitamin B group, the package will consist of a pill of vitamin B2 that is inside an opaque gelatin capsule that is matched to a litre bag of normal saline that is wrapped in an opaque covering. For those randomized to the D5W group, the package will consist of a pill that is an empty opaque gelatin capsule that is matched to a litre bag of D5W that is wrapped in an opaque covering. These packages will be coupled with the patient according to her randomization group in the preoperative area.

In the preoperative area, all patients will be given the pill in their package by mouth 60 to 120 minutes before the start of surgery. The covered bag will then accompany the patient to the operating room and will be set up as the instillation fluid for cystoscopy. This way, the patient and operating team will be blinded to what agent was used for ureteric visualization.

Primary Purpose: Diagnostic
Official Title: Optimal Ureteric Visualization At the Time of Pelvic Reconstructive Surgery: Vitamin B Versus 5% Dextrose in Water
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitamin B
Vitamin B: Patients in this arm will receive 100mg of riboflavin (vitamin B2) 60 to 120 minutes prior to surgery for the purpose of turning the urine bright yellow to see if this helps with detection of ureteric jets during cystoscopy which will be done using normal saline.
Other: Vitamin B (riboflavin, vitamin B2)
Vitamin B is a natural health product approved as a colouring agent.

Active Comparator: D5W (5% dextrose in water)
5% Dextrose in Water: Patients in this arm will receive a placebo in the pre-operative area (for the purpose of blinding the surgical team) 60 to 120 minutes prior to surgery. Intraoperative cystoscopy will then be performed using D5W to see if this helps with detection of ureteric jets.
Other: 5% Dextrose in Water (D5W)
5% Dextrose in Water is an irrigation/instillation fluid, commonly used in intravenous lines.




Primary Outcome Measures :
  1. 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 fluorescein for visualization and this would be considered a failed detection. ]
    Visual queue: detection will be counted as occurring when both ureteric jets are seen


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Difference in urinary tract infection rates after surgery after using vitamin B or D5W. [ Time Frame: Urine will be collected 3 to 10 days after surgery. ]
    Infection rates



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All patients recruited for the study will be undergoing female pelvic floor surgery.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females undergoing pelvic reconstructive surgery for pelvic organ prolapse where cystoscopy is necessary to assess ureteric integrity

Exclusion Criteria:

  • Known kidney disease
  • Known ureteral disease or previous ureteric compromise
  • Patients with known hypersensitivity to cyanocobalamin or cobalt
  • Known malabsorption disorder
  • Known allergy to fluorescein dye
  • Unable to present for one week post-operative assessment due to geographic or transportation issues
  • Unable to provide written consent to the study as a result of language barriers or cognitive disabilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089671


Contacts
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Contact: Colleen D McDermott, MD, FRCSC 416-586-4800 ext 6490 colleen.mcdermott@sinaihealthsystem.ca
Contact: Danny Lovatsis, MD 416-586-4566 danny.lovatsis@sinaihealthsystem.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Louise-Helene Gagnon, MD, FRCSC    416-480-5845    louise-helene.gagnon@sunnybrook.ca   
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Colleen D McDermott, MD    4165864800 ext 6490    colleen.mcdermott@sinaihealthsystem.ca   
Contact: Danny Lovatsis, MD    4165864800    danny.lovatsis@sinaihealthsystem.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
Women's College Hospital
Investigators
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Principal Investigator: Colleen D McDermott, MD Mount Sinai Hospital, Canada

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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03089671     History of Changes
Other Study ID Numbers: FPMRS McD 001
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mount Sinai Hospital, Canada:
Vitamin B
5% Dextrose in Water
Cystoscopy
Ureter

Additional relevant MeSH terms:
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Pelvic Floor Disorders
Pregnancy Complications
Vitamins
Riboflavin
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents