Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001528842
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
10/11/2021
Date last updated
10/11/2021
Date data sharing statement initially provided
10/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient preference and safety of self-removal of ureteric stents
Scientific title
Efficacy and safety of ureteric stents in patients who have recently undergone ureteroscopy for stone disease
Secondary ID [1] 303402 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urolithiasis 320690 0
Nephrolithiasis 323996 0
Ureteroscopy 323997 0
Condition category
Condition code
Surgery 318535 318535 0 0
Surgical techniques
Renal and Urogenital 321502 321502 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-removal of ureteric stents via string extraction by patients

The process of ureteric stent removal involves patients being given both written (public), verbal (private) and video information (private) - which has been designed specifically for this study. Participants will be provided with a link to view the video after their appointment. The video duration is approximately 2 minutes.

The instructions for ureteric stent removal by patient are as follows:
1. Wash your hands
2. Stand up to remove
3. To remove the stent, the visible string is held firmly and a steady, continuous pulling action should be applied until the entire stent comes out. The stent is flexible and should uncurl and come out easily.
4. Check the stent has been completely removed - blue plastic tube approximately 20cm long
5. Expect some mild discomfort in your back and urethra on removal. A small amount of blood in the urine is normal after removal but should settle.

If there are any concerns regarding the stent removal, please contact the Urology Registrar at Royal North Shore Hospital.

This information above is provided on a written handout which also has the time and date of stent removal for patients. I.e Remove on Monday the 18th October at 0900am

Patients will remove the stent in their own home. Other methods of removal include by a nurse in an outpatient clinic/surgeons' rooms or via a flexible cystoscopy performed either in hospital theatre or in the outpatient clinic

Patients are self-selecting method of removal.

Patients will submit a questionnaire and be called by the Primary Investigator 1 week following stent removal.

Stents are being left generally for 3-5 days post procedure
Intervention code [1] 319707 0
Treatment: Other
Intervention code [2] 321977 0
Treatment: Devices
Comparator / control treatment
Patients who have their ureteric stent removed either through a subsequent flexible cystoscopy under local anaesthesia or by a health professional (doctor or nurse) via string extraction in a hospital clinic

Patients will elect which method they would like their ureteric stent removed. If there is no preference patient's will be allocated to the self-removal group.
Control group
Active

Outcomes
Primary outcome [1] 326489 0
Successful removal of ureteric stent

Assessed by patient via survey and through follow-up with Principal Investigator
Timepoint [1] 326489 0
7-14 days post-operatively
Secondary outcome [1] 391674 0
Hospital Readmission

By speaking directly with patient during follow up and via accessing medical records as appropriate
Timepoint [1] 391674 0
2 weeks post-operatively
Secondary outcome [2] 391675 0
Urinary Tract Infection

Confirmed by patient and with Urine MSU result
Timepoint [2] 391675 0
2 weeks post-operatively

Eligibility
Key inclusion criteria
Inclusion Criteria
• Patients undergoing elective ureteropyeloscopy and laser lithotripsy of renal or ureteric calculi who will have double J ureteric stents placed
• Patients aged between 20-70
• Patients who are independent in their activities of daily living (ADLs)
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• Patients who had ureteric stents placed for non-calculous disease – i.e. cancer, renal disease, ureteric stricture
• Patients <20 and >70 years of age
• Patients who are semi-dependent or completely dependent in their ADLs (i.e. nursing home residents)
• Patients who have physical difficulties which limit their ability in removing stents
• Patients who have had stents left for > 2 weeks prior to removal, which increases the risk of encrustation and therefore potential difficulty in removing the stent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed using the SPSS software.

Mean and standard deviations will be used to characterise the demographic variables. Assuming the data is parametric, the Chi-squared test will be used to compare binomial outcomes within the independent samples. When comparing continuous variables, the student’s t-test will be used. A p-value of <0.05 will be considered statistically significant. Analysis will be overseen by a statistician

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/10/2021
Date of last participant enrolment
Anticipated
31/01/2023
Actual
Date of last data collection
Anticipated
17/02/2023
Actual
Sample size
Target
180
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18665 0
Gosford Hospital - Gosford
Recruitment hospital [2] 18666 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 18667 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [4] 18668 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [5] 20782 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 33103 0
2250 - Gosford
Recruitment postcode(s) [2] 33104 0
2065 - St Leonards
Recruitment postcode(s) [3] 33105 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [4] 33106 0
2086 - Frenchs Forest

Funding & Sponsors
Funding source category [1] 307818 0
Hospital
Name [1] 307818 0
Royal North Shore Hospital
Country [1] 307818 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Road
St Leonards
Sydney
NSW 2065
Country
Australia
Secondary sponsor category [1] 308524 0
None
Name [1] 308524 0
Address [1] 308524 0
Country [1] 308524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307824 0
North Sydney HREC
Ethics committee address [1] 307824 0
Research Office, Level 13 Kolling Building
10 Westbourne St
St Leonards
NSW 2065
Ethics committee country [1] 307824 0
Australia
Date submitted for ethics approval [1] 307824 0
08/02/2021
Approval date [1] 307824 0
04/05/2021
Ethics approval number [1] 307824 0

Summary
Brief summary
Following treatment of urinary tract stones, ureteric stents are typically left in for one to two weeks post-operatively. Removal of these stents can be performed in multiple ways - either by the patient themselves, by a nurse or via a subsequent procedure. This study investigates these methods of ureteric stent removal to see which is better tolerated by patients. We hypothesise that self-removal of ureteric stents will be preferable. This is because of convenience, reducing risk of potential exposure to COVID-19 and reducing hospital costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108630 0
Dr Cameron James Parkin
Address 108630 0
Royal North Shore Hospital
Department of Urology
Reserve Road
St. Leonards
Sydney
NSW 2065
Country 108630 0
Australia
Phone 108630 0
+61 437060192
Fax 108630 0
Email 108630 0
[email protected]
Contact person for public queries
Name 108631 0
Dr Cameron James Parkin
Address 108631 0
Royal North Shore Hospital
Department of Urology
Reserve Road
St. Leonards
Sydney
NSW 2065
Country 108631 0
Australia
Phone 108631 0
+61 2 9926 7111
Fax 108631 0
Email 108631 0
[email protected]
Contact person for scientific queries
Name 108632 0
Dr Cameron James Parkin
Address 108632 0
Royal North Shore Hospital
Department of Urology
Reserve Road
St. Leonards
Sydney
NSW 2065
Country 108632 0
Australia
Phone 108632 0
+61 2 9926 7111
Fax 108632 0
Email 108632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPC will not be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13626Ethical approval    See attached 381393-(Uploaded-18-10-2021-15-48-38)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.