Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001367437
Ethics application status
Approved
Date submitted
27/09/2016
Date registered
4/10/2016
Date last updated
6/07/2021
Date data sharing statement initially provided
6/07/2021
Date results information initially provided
6/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin B2 use prior to cystoscopy
Scientific title
Use of orally administered riboflavin to confirm ureteral patency during cystoscopy at the time of gynaecologic surgery
Secondary ID [1] 290220 0
Nil
Universal Trial Number (UTN)
UTN U111-1178-0401
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystoscopy 300400 0
Gynaecologic surgery 300401 0
Condition category
Condition code
Surgery 300263 300263 0 0
Surgical techniques
Renal and Urogenital 300310 300310 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295990 0
Treatment: Other
Comparator / control treatment
Subjects in the control arm will receive four capsules of placebo (vitamin D3, cholecalciferol, 1000 IU Integria Healthcare, Auckland) for a total of 4000 IU orally the night prior to surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 299743 0
The primary objective of the study is to determine the strength of yellow colouration of the urine when viewing the ureteric jet during cystoscopy. This will be assessed using a three point scale of colouration and will be assessed by the surgeon at the time of the procedure and again by an independent blinded observer reviewing video of the cystoscopy at a later time. Inter-observer variation will be assessed.
Timepoint [1] 299743 0
At time of cystoscopy and again by independent blinded observer who will review a digital video recording of the cystoscopy procedure within 1-2 weeks of the procedure.
Secondary outcome [1] 327982 0
Assessment of the ease of visualising the ureteric jets on cystoscopy, assessed using a 5 point Likert scale.
Timepoint [1] 327982 0
At the time of cystoscopy and again by independent blinded observer who will review a digital video recording of the cystoscopy procedure within 1-2 weeks of the procedure.
Secondary outcome [2] 327983 0
Assessment of the proportion of participants who have the ureteric jets visualised on cystoscopy, assessed by a dichotomous "Yes/No" score.
Timepoint [2] 327983 0
At the time of cystoscopy and again by independent blinded observer who will review a digital video recording of the cystoscopy procedure within 1-2 weeks of the procedure.

Eligibility
Key inclusion criteria
Adult patient over age 18 undergoing gynaecologic surgery where diagnostic cystoscopy is a planned part of the surgical procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years of age.
Not having planned cystoscopy as part of procedure.
Hyperparathyroidism
Active kidney stones

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As these measures have not been used previously, the sample size estimate was determined using a clinically reasonable sample of 60 (30 per group) that would be suitable to detect a medium to large effect size with 80% power and 0.05 significance level.
The sample size will be appropriate for non-parametric tests (Wilcoxon sign rank test) and to detect the following effect sizes in parametric analyses:
For primary outcome, a sample size of 60 will be sufficient to detect a 0.75 point mean difference between the groups (Assuming SD=1) in the colour scale (1-3) with 80% power and 0.05 significance level.

A sample size of 60 will be sufficient to detect (a) a 1.1 point difference between groups in the mean scale for “ease of visualizing the ureteric jets” scale (assuming SD=1.5); and (b) a difference in proportion of participants with a strong yellow colour of 70% to 30%; with 80% power and 0.05 level of significance. To account for drop-out, 10% will be added to the sample size so a total of 66 subjects will be recruited, 33 in each arm of the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2017
Actual
28/06/2017
Date of last participant enrolment
Anticipated
2/02/2018
Actual
19/02/2018
Date of last data collection
Anticipated
30/04/2018
Actual
17/05/2018
Sample size
Target
66
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 8264 0
New Zealand
State/province [1] 8264 0
Otago

Funding & Sponsors
Funding source category [1] 294587 0
University
Name [1] 294587 0
University of Otago
Country [1] 294587 0
New Zealand
Funding source category [2] 299809 0
Charities/Societies/Foundations
Name [2] 299809 0
Healthcare Otago Charitable Trust
Country [2] 299809 0
New Zealand
Funding source category [3] 299810 0
Charities/Societies/Foundations
Name [3] 299810 0
Australasian Gynaecological Endoscopy & Surgery Society
Country [3] 299810 0
Australia
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
Health Research South
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 293455 0
None
Name [1] 293455 0
None
Address [1] 293455 0
N/A
Country [1] 293455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296028 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 296028 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 296028 0
New Zealand
Date submitted for ethics approval [1] 296028 0
25/08/2016
Approval date [1] 296028 0
19/09/2016
Ethics approval number [1] 296028 0
16/NTA/130

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69278 0
A/Prof Michael Stitely
Address 69278 0
University of Otago
Department of Women's and Children's Health
Section of obstetrics and Gynaecology
Private Bag 1921
Dunedin 9054 New Zealand
Country 69278 0
New Zealand
Phone 69278 0
+64 3 474 0999 ext 8565
Fax 69278 0
Email 69278 0
[email protected]
Contact person for public queries
Name 69279 0
A/Prof Michael Stitely
Address 69279 0
University of Otago
Department of Women's and Children's Health
Section of obstetrics and Gynaecology
Private Bag 1921
Dunedin 9054 New Zealand
Country 69279 0
New Zealand
Phone 69279 0
+64 3 474 0999 ext 8565
Fax 69279 0
Email 69279 0
[email protected]
Contact person for scientific queries
Name 69280 0
A/Prof Michael Stitely
Address 69280 0
University of Otago
Department of Women's and Children's Health
Section of obstetrics and Gynaecology
Private Bag 1921
Dunedin 9054 New Zealand
Country 69280 0
New Zealand
Phone 69280 0
+64 3 474-0999 ext 8565
Fax 69280 0
Email 69280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data is shared. This is de-identified.
When will data be available (start and end dates)?
From publication date (FEB 2019) and will remain available.
Available to whom?
Publicly available.
Available for what types of analyses?
Publicly available.
How or where can data be obtained?
https://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/CQZMZX


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Stitely ML, Harlow K, MacKenzie E. Oral Riboflavin... [More Details]
Other filesNo https://augs.digitellinc.com/augs/sessions/4732/vi... [More Details]
Plain language summaryNo The preoperative oral administration of 400 mg of ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOral Riboflavin to Assess Ureteral Patency during Cystoscopy: A Randomized Clinical Trial.2019https://dx.doi.org/10.1097/AOG.0000000000003063
N.B. These documents automatically identified may not have been verified by the study sponsor.