Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000310066
Ethics application status
Approved
Date submitted
10/04/2010
Date registered
19/04/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early ureteric stent removal reduces urinary tract infection in kidney transplant recipients,
A Randomized Controlled Trial
Scientific title
Early ureteric stent removal reduces urinary tract infection in kidney transplant recipients,
A Randomized Controlled Trial
Secondary ID [1] 1612 0
nil
Universal Trial Number (UTN)
U1111-1114-6683
Trial acronym
UTI-S
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infectious disease 257123 0
Kidney transplantation 257124 0
Condition category
Condition code
Renal and Urogenital 257279 257279 0 0
Kidney disease
Renal and Urogenital 257334 257334 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early ureteric stent removal (7 days)
Intervention code [1] 256285 0
Prevention
Comparator / control treatment
Routine ureteric stent removal (14 days)
Control group
Active

Outcomes
Primary outcome [1] 258198 0
% of Urinary tract infection
defined as white blood cell(WBC)>5 /high power field(HPF) in urinary analysis plus bacteriuria in urine culture
Timepoint [1] 258198 0
0- 1 month post surgery
Secondary outcome [1] 263845 0
% of Urologic complication
defined as urinary obstruction or urinary leakage
that diagnosis with clinical suspicious plus ultrasonography or renal scan
Timepoint [1] 263845 0
Post operative until 1 week after hospital discharge
Secondary outcome [2] 263846 0
Estimate glomerular filtration rate (eGFR)
Timepoint [2] 263846 0
at hospital discharge
Secondary outcome [3] 263847 0
Length of stay (days)
by use medical records
Timepoint [3] 263847 0
admit to discharge

Eligibility
Key inclusion criteria
Adult patients who undergo for kidney transplant (both living related and cadaveric)
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient who has history of reflux nephropathy or neurogenic lower urinary tract disease
2. Abnormal structure of kidney donor
3. Cold ischemic time > 36 hours
4. Patient who has abnormal urinary tract
5. En bloc kidney from pediatric donor
6. Patient who has difficult intraoperative technique (eg. Small caliber ureter) that defined by urologist
7. Patient who receive antibiotic other than standard regiemen
8. Patient who denied for inform and consent

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)
sealed with opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using computer generated block randomization
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment outside Australia
Country [1] 2581 0
Thailand
State/province [1] 2581 0
Bangkok

Funding & Sponsors
Funding source category [1] 256790 0
Charities/Societies/Foundations
Name [1] 256790 0
Thai Transplantation Society
Country [1] 256790 0
Thailand
Primary sponsor type
Charities/Societies/Foundations
Name
Thai Transplantation Society
Address
4th Floor, The Royal Golden Jubilee Bldg., 2 Soi Soonvijai, New Petchburi Road, Bangkapi, Huaykwang, Bangkok 10310, Thailand.
Country
Thailand
Secondary sponsor category [1] 256065 0
None
Name [1] 256065 0
Address [1] 256065 0
Country [1] 256065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258816 0
Ramathibodi hospital
Ethics committee address [1] 258816 0
Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama 6, Ratchathewi, Bangkok, 10400, Thailand
Ethics committee country [1] 258816 0
Thailand
Date submitted for ethics approval [1] 258816 0
26/02/2010
Approval date [1] 258816 0
Ethics approval number [1] 258816 0

Summary
Brief summary
To determine the potential benefit and harmful of early ureteric stent removal (7 days) compare with routine ureteric stent removal (14 days) in kidney transplant recipient.
Trial website
Trial related presentations / publications
Thai Transplantation Society
Public notes

Contacts
Principal investigator
Name 31036 0
Address 31036 0
Country 31036 0
Phone 31036 0
Fax 31036 0
Email 31036 0
Contact person for public queries
Name 14283 0
Watanyu Parapiboon
Address 14283 0
Renal division, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama 6, Ratchathewi, Bangkok, 10400, Thailand
Country 14283 0
Thailand
Phone 14283 0
66-2-2011400
Fax 14283 0
66-2-2011400
Email 14283 0
[email protected]
Contact person for scientific queries
Name 5211 0
Watanyu Parapiboon
Address 5211 0
Renal division, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama 6, Ratchathewi, Bangkok, 10400, Thailand
Country 5211 0
Thailand
Phone 5211 0
66-2-2011400
Fax 5211 0
66-2-2011400
Email 5211 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.