Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000966099
Ethics application status
Approved
Date submitted
8/11/2010
Date registered
9/11/2010
Date last updated
14/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
How common is bacteria in the urine of patients with urinary catheters after radical surgery on the prostate for prostate cancer and does it get cleared one week after removing the catheter
Scientific title
In patients who have had radical prostatectomy for prostate carcinoma, what is the incidence of bacteriuria at the time of urinary catheter removal and does it get cleared 1 week post-removal
Secondary ID [1] 253048 0
Nil
Universal Trial Number (UTN)
U1111-1117-8133
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacteriuria in patients undergoing radical prostatectomy 258610 0
Condition category
Condition code
Infection 258755 258755 0 0
Studies of infection and infectious agents
Cancer 258764 258764 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Rate of bacteriuria in patients having radical prostatectomy at time of catheter removal and 1 week post-removal
Intervention code [1] 257572 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259615 0
Rate of bacteriuria at time of catheter removal - assessed with mid-stream urine microscopy and culture
Timepoint [1] 259615 0
At time of catheter removal
Primary outcome [2] 259616 0
Rate of bacteriuria 1 week post catheter removal - assessed with mid-stream urine microscopy and culture
Timepoint [2] 259616 0
1 week post catheter removal
Secondary outcome [1] 266260 0
Nil
Timepoint [1] 266260 0
Nil

Eligibility
Key inclusion criteria
All patients having radical prostatectomy in Hollywood Private Hospital, St John of God Hospital Subiaco & Sir Charles Gairdner Hospital
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existent infection

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3430 0
6009
Recruitment postcode(s) [2] 3431 0
6008

Funding & Sponsors
Funding source category [1] 258026 0
Charities/Societies/Foundations
Name [1] 258026 0
Hollywood Hospital Research Foundation
Country [1] 258026 0
Australia
Primary sponsor type
Individual
Name
Mr Robert Davies
Address
Urologist
Western Urology
26 McCourt Street
Leederville, WA 6007
Country
Australia
Secondary sponsor category [1] 257219 0
Individual
Name [1] 257219 0
Dr Siva Sundararajan
Address [1] 257219 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA 6009
Country [1] 257219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260023 0
Hollywood Hospital Research Ethics Committee
Ethics committee address [1] 260023 0
Monash Avenue
Nedlands, WA 6009
Ethics committee country [1] 260023 0
Australia
Date submitted for ethics approval [1] 260023 0
08/11/2010
Approval date [1] 260023 0
Ethics approval number [1] 260023 0

Summary
Brief summary
The incidence of bacteria in the urine after radical prostatectomy when patients still have their catheters is not known. How qucikly the bacteria clears after the catheter is removed is also not known. Presence of bacteria is a risk for infection which can increase patient morbidity. We want to investigate the rate of bacteria in the urine before and after catheter removal and the incidence of symptomatic urinary tract infection
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31888 0
Address 31888 0
Country 31888 0
Phone 31888 0
Fax 31888 0
Email 31888 0
Contact person for public queries
Name 15135 0
Dr Siva Sundararajan
Address 15135 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA 6009
Country 15135 0
Australia
Phone 15135 0
+61 8 93463333
Fax 15135 0
Email 15135 0
[email protected]
Contact person for scientific queries
Name 6063 0
Dr Siva Sundararajan
Address 6063 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA 6009
Country 6063 0
Australia
Phone 6063 0
+61 8 93463333
Fax 6063 0
Email 6063 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.