None listed
Conditions
Brief summary
The research objective is to see if riboflavin (Vitamin B2) can be given as a single oral dose prior to gynaecologic surgery to enhance the visualisation of urine flow from the ureter during cystoscopy. Placing a scope inside the bladder during pelvic surgery is commonly performed to detect operative injury during gynaecologic surgery. It is important to be able to see the urine flow out of the opening of the ureter to exclude injury to the ureter. Intravenous medications are commonly given to assess the ureter in such circumstances. These medications have some risk of allergic reactions and the medications commonly used have become unavailable on numerous occasions recently related to manufacturer shortages. Having a safe, effective, inexpensive and readily available alternative to the intravenous agents would be clinically beneficial and cost saving.
Interventions
Women scheduled for gynaecologic surgery where cystoscopy is planned as a routine component of the surgical procedure will be randomized to receive either four capsules of riboflavin (Vitamin B2) totaling 400 mg orally the night prior to surgery (Solgar Inc., Leonia, NJ, USA), or placebo. We will ask subjects if they have taken the vitamin tablets and request that they return the empty packet to ensure compliance.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patient over age 18 undergoing gynaecologic surgery where diagnostic cystoscopy is a planned part of the surgical procedure.
Exclusion criteria
Age under 18 years of age. Not having planned cystoscopy as part of procedure. Hyperparathyroidism Active kidney stones
Outcome results
None listed