Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000349044
Ethics application status
Approved
Date submitted
25/04/2010
Date registered
30/04/2010
Date last updated
30/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Ureteric stenting in kidney transplant: optimal timing for stent removal
Scientific title
Pilot study: prospective randomized controlled trial of ureteric JJ stenting with early vs standard stent removal to improve graft and patient outcome and reduce urological complications after renal transplantation
Secondary ID [1] 251659 0
Nil
Universal Trial Number (UTN)
U1111-1114-7210
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal transplant 257197 0
Condition category
Condition code
Surgery 257341 257341 0 0
Surgical techniques
Renal and Urogenital 257398 257398 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the establishment of general anaesthesia, an indwelling catheter will be inserted into the bladder and irrigated with neostigmine. urinary continuity will be re-established by anastomosing the donor ureter to the recipient bladder using a standard technique over a double-J ureteric stent as per our Transplant Unit's protocol. In the intervention arm, at the time the double-J stent is inserted during the transplant operation the distal end of the stent will be sutured to the indwelling bladder catheter. At the time the bladder catheter is removed on day 4 post kidney transplant the ureteric stent will be simultaneously removed, eliminating the need for cystoscopy.
Intervention code [1] 256327 0
Treatment: Surgery
Comparator / control treatment
Standard protocol will be followed as the comparator arm, namely the ureteric double-J stent will be removed as an outpatient procedure by flexible cystoscopy at 4-6 weeks post kidney transplant with bladder catheter being removed at day 4 post transplant)
Control group
Active

Outcomes
Primary outcome [1] 258240 0
Graft outcome - assessed using histology from renal biopsy, serum creatinine levels and estimated glomerular filtration rate (eGFR).
Timepoint [1] 258240 0
At 12 months post kidney transplant
Primary outcome [2] 258241 0
Patient outcome - where mortality rates will be used to assess outcome (all patients are followed up post-renal transplant as part of the Australian and New Zealand Datavase of Transplantation (ANZDATA) so data on mortality rates will be retrieved from this source, data is linked using national health information numbers)
Timepoint [2] 258241 0
At 12 months post kidney transplant
Secondary outcome [1] 263902 0
Major Urological Complications (defined as any structural or functional abnormality of the ureteric-urinary bladder anastomosis, subclassified into either obstructive or leak complications, assessed using computed tomography (CT) scan, blood analysis, clinical examination and return to theatre for definitive diagnosis and management where indicated)
Timepoint [1] 263902 0
At 12 months post kidney transplant

Eligibility
Key inclusion criteria
All adult patients (>16 years at time of transplant) placed on the waiting list for kidney transplantation at Auckland City Hospital will be eligible.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <16 years at time of transplant
2. Neurogenic bladder dysfunction diagnosed pre-transplant by the presence of large residual volumes on bladder scan in the presence of peripheral neuropathy
3. Re-transplants
4. Patients in whom pre-operative consent cannot be obtained.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2591 0
New Zealand
State/province [1] 2591 0

Funding & Sponsors
Funding source category [1] 256832 0
Self funded/Unfunded
Name [1] 256832 0
Country [1] 256832 0
New Zealand
Primary sponsor type
University
Name
Department of Surgery, University of Auckland
Address
Department of Surgery
Level 12
Auckland City Hospital Support Building
Park Road, Grafton
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 256107 0
None
Name [1] 256107 0
Address [1] 256107 0
Country [1] 256107 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Kidney transplantation is the best treatment option for patients with end-stage kidney disease (ESKD). Re-establishing urine drainage by anastomosing the donor ureter to the recipients bladder is prone to complications (leak, obstruction). These complications are associated with significant morbidity and potential mortality. Previous studies have shown that placing a stent across the ureteric anastomosis at the time of the transplant reduces the chance of ureteric complications. The optimal timing for removal of these stents remains unknown. The probability of stent related complications increases the longer the stent remains in situ. A balance between prevention of early ureteric complications and development of stent-related complications needs to be achieved. It is our current practice to remove the ureteric stent at 4-6 weeks following transplant by cystoscopy. There is evidence to suggest that removal of the ureteric stent as early as day 4 post-transplant may still prevent early urological complications. In addition, tying the stent to the urinary catheter at the time of the operation allows for the stent to be removed at the same time the urinary catheter is taken out on day 4, thereby preventing the need for a cystoscopy procedure. The aim of this study is to undertake a pilot study to compare early removal (day 4) with the current practice of leaving the ureteric stent for 4 weeks in patients with ESKD undergoing kidney transplantation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31066 0
Address 31066 0
Country 31066 0
Phone 31066 0
Fax 31066 0
Email 31066 0
Contact person for public queries
Name 14313 0
Dr Adam Bartlett
Address 14313 0
Department of Surgery
Level 12
Auckland City Hospital Support Building
Park Road, Grafton
Private Bag 92019
Auckland 1142
Country 14313 0
New Zealand
Phone 14313 0
+64 9 3074949
Fax 14313 0
Email 14313 0
[email protected]
Contact person for scientific queries
Name 5241 0
Dr Adam Bartlett
Address 5241 0
Department of Surgery
Level 12
Auckland City Hospital Support Building
Park Road, Grafton
Private Bag 92019
Auckland 1142
Country 5241 0
New Zealand
Phone 5241 0
+64 9 3074949
Fax 5241 0
Email 5241 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.