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Trial registered on ANZCTR


Registration number
ACTRN12618000737235
Ethics application status
Approved
Date submitted
13/03/2018
Date registered
3/05/2018
Date last updated
26/04/2019
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Early removal of the plastic tube placed in ureter after kidney transplantation
Scientific title
Does early removal of ureteric stent simultaneously with indwelling urethral catheter post kidney transplantation reduce the infection and healthcare costs?
Secondary ID [1] 294328 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 307048 0
On the waiting list for kidney transplantation 307049 0
Condition category
Condition code
Surgery 306158 306158 0 0
Surgical techniques
Renal and Urogenital 306159 306159 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In Kidney transplantation, placement of a ureteric stent (a plastic tube) in the ureter is beneficial, which will reduce urinary tract complications such as urine leakage from the site of anastomosis and ureteric stenosis. The ureteric stent is usually removed 4-6 weeks after surgery by a procedure of cystoscopy in operating theatre requiring a hospital admission. On the other hand, the presence of a ureteric stent is associated with some increased risk of urinary tract infection, encrustation resulting in ureteric obstruction as well as increased risk of BK virus infection, which can cause long term kidney damage and kidney graft loss. Furthermore, as alluded to above, removal of a ureteric stent requires a day admission to hospital with additional surgical procedure that is adding the cost to health care system.
The aim of this study is to refine the kidney transplant procedure, in which the ureteric stent is connected to the tip of indwelling urethral catheter by a suture string at the time implantation and kidney transplantation by the transplant surgeon. In this way, the ureteric stent can be removed at the same time of removal of urethral indwelling catheter at day 4-5 post surgery. The participants will be recruited from the wait list of kidney transplantation in our institute and an informed consent will be obtained. The data will be collected with respect to surgical complications including urine leakage, ureteric narrowing, urinary tract infection, ureteric blockage, BK virus infection and kidney graft function. The outcomes will be compared with historical control, in which the ureteric stent was routinely removed by cystoscopy 4-6 weeks post transplantation. This project will be expected to benefit patient quality of life and reduce the cost to health care system by not requiring hospital admission for removal of stent as well as reduce the incidence of urinary tract infection, stent encrustation, ureteric obstruction and BK virus infection.


Intervention code [1] 300638 0
Treatment: Surgery
Comparator / control treatment
The historical cohort of kidney transplant recipients will be considered as a control group from January 1, 2013 to June 01,2018. Their medical record will be reviewed for data collection including age, gender, episode of urinary tract infection, BK virus infection, urine leakage, ureteric narrowing, kidney function and cost for cystoscopy removal of ureteric stent and a day hospital admission within first 12 months post kidney transplantation
Control group
Historical

Outcomes
Primary outcome [1] 305168 0
number of urinary tract infection (UTI):
The criteria for diagnosis of UTI includes at least 2 of 3 items below:
1 urinary tract symptoms (dysuria, frequency, urgency)
2. Microbiology positive on urine culture
3. Require antibiotics treatment
Timepoint [1] 305168 0
With in 12 months post kidney transplantation
Primary outcome [2] 305276 0
Cost saving:
It will be calculated by the business manager by comparing the incidence of cystoscopy and the associated cost of day admission for cystoscopy between the groups that is assessed by data linkage to patient medical records.



Timepoint [2] 305276 0
within 12 months post kidney transplantation
Primary outcome [3] 305277 0
Incidence of Urine leakage:
The criterion for diagnosis of urine leakage includes any one of 2 items below;
1. Significant amount of fluid leaking to the wound, The creatinine level in fluid is significantly higher than in blood serum.
2. tracer leaking out of the urinary tract on renal nuclear scan.
Timepoint [3] 305277 0
within 12 months post kidney transplantation
Secondary outcome [1] 344382 0
Kidney graft function: It is assessed by test of serum creatinine level.
Timepoint [1] 344382 0
within 12 months post kidney transplantation.
Secondary outcome [2] 344682 0
BK Virus infection
Diagnosis of BK Viremia: Blood test for Plasma BK viral load if > 5.00 X 10^2 copies/mL. The screening of BK virus infection will be in line with renal team protocol., commence one month after transplantation, then repeat monthly for 3 months, then 3 months within 12 months.
Timepoint [2] 344682 0
within 12 months post kidney transplant
Secondary outcome [3] 345943 0
Incidence of ureter stenosis:
The criterion for diagnosis of ureteric stenosis consist of the elevation of serum creatine level with evidence of narrowing area on pyelogram either by percutaneous ante-grade pyelogram or cystoscopy retrograde pyelogram to the transplant kidney graft.
Timepoint [3] 345943 0
within 12 months post kidney transplantation

Eligibility
Key inclusion criteria
candidate for kidney transplantation
Aged 18-79 years.
Males or females
No history of significant urological surgery such as radical bladder removal, urinary diversion or ileal conduit.
All participants must read the participant information sheet and understand the potential surgical risks and complications of the procedure.
Patient must be willing to sign informed consent form
Must be able to attend renal clinic follow up.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling or unable to sign informed consent form
The history of significant urological surgery such as radical bladder removal, urinary diversion or ileal conduit
unforseen any difficulties encountered during the surgery

Study design
Purpose of the study
Prevention
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
Other
Other design features
By historical contral
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
In order to calculate a clinically significant decrease from 40% to 20% of patients reporting a urinary tract infection following a new surgical kidney transplant technique we require a sample size of 80 patients per group, using a type-I error rate of 0.05, power of 80%.

Statistical Analysis
Initially, differences in the proportion of patients with an infection between those undergoing the current and those undergoing the new surgical kidney transplant technique will be assessed using univariate logistic regression on surgical technique. Subsequently, binary logistic regression will be conducted to investigate the relationship between surgical technique as well as potentially confounding variables, such as patient age and sex, on the presence of a urinary tract infection (event=‘Yes’). Odds ratios, 95% confidence intervals and P-values will be calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
3/01/2019
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10382 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 22060 0
6009 - Nedlands
Recruitment postcode(s) [2] 22061 0
6009 - Broadway Nedlands

Funding & Sponsors
Funding source category [1] 298973 0
Hospital
Name [1] 298973 0
Sir Charles Gairdner Hospital
Country [1] 298973 0
Australia
Primary sponsor type
Individual
Name
Bulang He
Address
Western Australia Liver and Kidney transplant service
6th floor, G block
Sir Charles Gairdner Hospital
Hospital avenue
Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 298196 0
None
Name [1] 298196 0
NA
Address [1] 298196 0
NA
Country [1] 298196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299904 0
Human Research Ethic Committee-Sir Charles Gairdner Hospital
Ethics committee address [1] 299904 0
Ethics committee country [1] 299904 0
Australia
Date submitted for ethics approval [1] 299904 0
16/03/2018
Approval date [1] 299904 0
21/12/2018
Ethics approval number [1] 299904 0
RGS0000000921

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81938 0
A/Prof Bulang He
Address 81938 0
Western Australia Liver and Kidney Transplant Service
6th floor, G block
Hospital Avenue
Nedlands, WA 6009
Country 81938 0
Australia
Phone 81938 0
+61-8-64573333
Fax 81938 0
Email 81938 0
bulang.he@health.wa.gov.au
Contact person for public queries
Name 81939 0
Bulang He
Address 81939 0
Western Australia Liver and Kidney Transplant Service
6th floor, G block
Hospital Avenue
Nedlands, WA 6009
Country 81939 0
Australia
Phone 81939 0
+61-8-64573333
Fax 81939 0
Email 81939 0
bulang.he@health.wa.gov.au
Contact person for scientific queries
Name 81940 0
Bulang HE
Address 81940 0
Western Australia Liver and Kidney Transplant Service
6th floor, G block
Hospital Avenue
Nedlands, WA 6009
Country 81940 0
New Zealand
Phone 81940 0
+61-8-64573333
Fax 81940 0
Email 81940 0
bulang.he@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1800Study protocol    374720-(Uploaded-05-04-2019-13-22-23)-Study-related document.doc
1802Informed consent form    374720-(Uploaded-05-04-2019-13-22-54)-Study-related document.docx
1803Ethical approval    374720-(Uploaded-05-04-2019-13-24-07)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.