Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001967279
Ethics application status
Approved
Date submitted
13/11/2018
Date registered
5/12/2018
Date last updated
5/12/2018
Date data sharing statement initially provided
5/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of intra-operative flow rate during prostate resection
Scientific title
The role of intra-operative flow rate during Trans-urethral Resection of Prostate (TURP) procedure as a marker of efficacy – A Feasibility study
Secondary ID [1] 296504 0
Nil known
Universal Trial Number (UTN)
U1111-1223-2126
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
benign prostatic hyperplasia 310289 0
Prostate cancer 310590 0
Condition category
Condition code
Surgery 309024 309024 0 0
Surgical techniques
Cancer 309302 309302 0 0
Prostate
Renal and Urogenital 309303 309303 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before and after the resection of the prostate, the bladder will be filled with fluid as per the standard technique for TURP I.e a rigid cystoscope inserted into the bladder via the urethra and irrigation glycine fluid will fill the bladder to a set measurement of 500ml. The scope will then be removed and pressure applied to the abdomen by the surgeons hand to expel the fluid. The pressure is up to the discretion of the single operator. The voided fluid will then be graded on its flow by the surgeon and study assessor to get a unanimously agreed upon score on the standardised scale.
Intervention code [1] 312823 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307984 0
As this is a feasibility/pilot study the main aim is to see if the method is functional. Determining if the method of flow measurement is feasible I.e can be done and measured, in the context of the study. 1. Checking reproducibility by grading the flow twice to see if consistent.
2. Two assessors of flow to agree on outcome according to flow score
3. Feedback from assessors on the practicality and efficiency of measurement within time constraints and operating constraints of the procedure. Regular meetings will occur to discuss progress and the protocol in case any changes need to be made for practical reasons. No formal questionnaire is being done.
Timepoint [1] 307984 0
At the time of operation and feedback after each procedure within the recruitment period over 6 months
Secondary outcome [1] 353563 0
Specific complication rates e.g. recurrent urinary retention, significant bleeding, further objective uroflowometry, ongoing incontinence, need for alternative management with suprapubic catheter or intermittent self catheterisation. This will be identified by going through medical records and the surgical audit programme prior to follow up. Also these things will be assessed at the follow up appointment in a clinic setting with a history, exam and flowometry at the time.
Timepoint [1] 353563 0
Over 6 weeks follow up
Secondary outcome [2] 353564 0
Patient satisfaction scores according to the International prostate symptoms score IPSS survey
Timepoint [2] 353564 0
At six weeks follow up

Eligibility
Key inclusion criteria
Males proceeding to TURP secondary to BPH/prostate cancer who have indwelling urinary catheter for outlet obstruction
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Those for TURP without catheters, bladder neck obstructions, obstructions caused by structures other than the prostate, procedures not under general anesthetic

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 21022 0
New Zealand
State/province [1] 21022 0

Funding & Sponsors
Funding source category [1] 301093 0
Hospital
Name [1] 301093 0
Southern DHB/Dunedin Hospital
Country [1] 301093 0
New Zealand
Primary sponsor type
Hospital
Name
Southern DHB
Address
201 Great King St Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 300701 0
None
Name [1] 300701 0
Address [1] 300701 0
Country [1] 300701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301842 0
Southern HDEC
Ethics committee address [1] 301842 0
133 molesworth st thorndon Wellington 6011
Ethics committee country [1] 301842 0
New Zealand
Date submitted for ethics approval [1] 301842 0
Approval date [1] 301842 0
31/10/2018
Ethics approval number [1] 301842 0

Summary
Brief summary
Male patients with indwelling urinary catheters proceeding for TURP will be included. Indications must be for outlet obstruction secondary to BPH or prostate cancer. During the procedure for TURP the urologist will fill the bladder, then place manual pressure on the abdomen to void the fluid. The voided fluid will have its flow graded on a preset scale before and after prostate resection. Patients will be followed up at six weeks to monitor complications and measure patient satisfaction with the operation. This intraoperative flow measurement technique may be useful to determine if some patients will have unsuccessful TURP procedures and may instead require suprapubic catheters.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88294 0
Dr Christian Robinson
Address 88294 0
201 Great King St
Urology Department
Dunedin Hospital
Dunedin 9016
Country 88294 0
New Zealand
Phone 88294 0
+64 474 0999
Fax 88294 0
Email 88294 0
[email protected]
Contact person for public queries
Name 88295 0
Dr Christian Robinson
Address 88295 0
201 Great King St
Urology Department
Dunedin Hospital
Dunedin 9016
Country 88295 0
New Zealand
Phone 88295 0
+64 474 0999
Fax 88295 0
Email 88295 0
[email protected]
Contact person for scientific queries
Name 88296 0
Dr Christian Robinson
Address 88296 0
201 Great King St
Urology Department
Dunedin Hospital
Dunedin 9016
Country 88296 0
New Zealand
Phone 88296 0
+64 474 0999
Fax 88296 0
Email 88296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Consent has not been obtained for this. In the ethics committee application it was agreed all inpatient information would be de identified and not available for sharing outside of the study.


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.