Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000688684
Ethics application status
Not yet submitted
Date submitted
14/06/2014
Date registered
30/06/2014
Date last updated
30/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of 1-2cm renal stones: a pilot randomised trial comparing shock wave lithotripsy, ureterorenoscopic stone removal and percutaneous nephrolithotomy.
Scientific title
Comparison of stone free-rate following shock wave lithotripsy, ureterorenoscopic stone removal or percutaneous nephrolithotomy in a randomised pilot trial for adult renal stones with a maximum diameter of between 10 and 20 mm
Secondary ID [1] 284799 0
Nil
Universal Trial Number (UTN)
U1111-1158-0622
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal stones 292175 0
Condition category
Condition code
Surgery 292515 292515 0 0
Surgical techniques
Renal and Urogenital 292591 292591 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Shock wave lithotripsy - approximately 3000 shock waves focussed onto stone from an external energy source. Can be performed without any anaesthetic taking about 50 minutes.
Ureterorenoscopic stone removal - insertion of a fine flexible telescope into the renal tract through the urethra and destruction of stone with a laser. Requires general anaesthetic and takes about 90 minutes.
Percutaneous nephrolithotomy - creating a tract through the skin to the kidney through which a telescope is inserted, the stone broken up with various energy sources and the fragments removed. Requires a general anaesthetic and takes about 1 hour.
Patients may undergo repeated treatment or offered one of the other alternatives until they are free of stones.
Intervention code [1] 289590 0
Treatment: Surgery
Intervention code [2] 289591 0
Treatment: Devices
Comparator / control treatment
There is no consensus on which of these treatments is the best for these patients
Control group
Active

Outcomes
Primary outcome [1] 292370 0
Stone free rate determined using CT scan
Timepoint [1] 292370 0
4-6 weeks post final treatment
Secondary outcome [1] 308806 0
Cost analysis - by way of cost framework derived for previous studies within our unit. Includes staff, utility, building, drug, equipment and disposable costs.
Timepoint [1] 308806 0
Post final treatment

Eligibility
Key inclusion criteria
Adult patients. Renal stones 10-20mm.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to one/all potential treatments. Pregnant women.

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)
All patients encountered with inclusion criteria will be invited into trail with information sheet. If enrolled will be randomly allocated into one of the 3 arms
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation overseen by our statistician who will be "off-site" as a means of allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Stone free rates will be assessed by a radiologist blinded to the actual treatment
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixture of parametric and non-parametric analyses depending on data variability. All statistics to be designed and performed by university affiliated independent statistician

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
Date of last participant enrolment
Anticipated
31/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2626 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 8291 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 289413 0
Hospital
Name [1] 289413 0
Monash Health
Country [1] 289413 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
62 Kangan Drive, Berwick, Vic 3806
Country
Australia
Secondary sponsor category [1] 288095 0
None
Name [1] 288095 0
Address [1] 288095 0
Country [1] 288095 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291173 0
Monash Health Human Ethics Committee
Ethics committee address [1] 291173 0
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168
Ethics committee country [1] 291173 0
Australia
Date submitted for ethics approval [1] 291173 0
01/08/2014
Approval date [1] 291173 0
Ethics approval number [1] 291173 0

Summary
Brief summary
A randomised pilot study to assess which of the currently used treatments for 10-20mm renal stones provides the best stone free rate
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49198 0
Mr Philip McCahy
Address 49198 0
Dept Urology
Casey Hospital
62 Kangan Drive
Berwick
Vic 3806
Country 49198 0
Australia
Phone 49198 0
+61 3 87681200
Fax 49198 0
Email 49198 0
[email protected]
Contact person for public queries
Name 49199 0
Mr Philip McCahy
Address 49199 0
Dept Urology
Casey Hospital
62 Kangan Drive
Berwick
Vic 3806
Country 49199 0
Australia
Phone 49199 0
+61 3 87681200
Fax 49199 0
Email 49199 0
[email protected]
Contact person for scientific queries
Name 49200 0
Mr Philip McCahy
Address 49200 0
Dept Urology
Casey Hospital
62 Kangan Drive
Berwick
Vic 3806
Country 49200 0
Australia
Phone 49200 0
+61 3 87681200
Fax 49200 0
Email 49200 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.