Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001666213
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
10/10/2018
Date last updated
10/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Urological Society of Australia and New Zealand (USANZ) Clinical Quality Registry
Scientific title
The Urological Society of Australia and New Zealand (USANZ) Clinical Quality Registry
Secondary ID [1] 296101 0
Nil Known
Universal Trial Number (UTN)
U1111-1220-7256
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney disease 309678 0
Renal cancer 309814 0
Condition category
Condition code
Surgery 308480 308480 0 0
Surgical techniques
Renal and Urogenital 308581 308581 0 0
Kidney disease
Cancer 308668 308668 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Hours
Description of intervention(s) / exposure
This pilot project will assess the feasibility of data collection into a renal registry in Australia and New Zealand. It will allow refinement of registry protocols and reporting mechanisms. It will assess the feasibility, accuracy and usefulness of outcome reporting. It will allow the USANZ Renal Registry Steering Committee to assess the risks and benefits of wider participation in the registry. Individual service providers contributing data to the registry will benefit from the ability to audit their own clinical service and benchmark against national and international data sets. Service quality improvements may flow from this information.
The Registry will capture and record data on diagnosis by procedure type, technique by procedure type (e.g. laparoscopic/ robotic/ open), average patient risk factors, complication rate (risk adjusted), transfusion rate (risk adjusted), mortality rate, length of stay for all patients undergoing full or partial Nephrectomies or Nephroureterectomy within Australia and New Zealand. Data will be collected once, recording details of the procedure retrospectively as soon as practicable after the surgery.
Intervention code [1] 312438 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307464 0
Diagnosis by Procedure Type - All data is entered in the Dendrite database platform owned by the USANZ and compiled for national benchmarking.
Timepoint [1] 307464 0
Two years of the pilot study
Primary outcome [2] 307545 0
Technique by Procedure Type (E.g. Laparoscopic, Robotic, Open etc.) All data is entered in the Dendrite database platform owned by the USANZ and compiled for national benchmarking.
Timepoint [2] 307545 0
Two years of the pilot study
Primary outcome [3] 307546 0
Patient risk factors - All data is entered in the Dendrite database platform owned by the USANZ and compiled for national benchmarking.
Timepoint [3] 307546 0
Two years of the pilot study
Secondary outcome [1] 351974 0
complication rate (risk adjusted) - All data is entered in the Dendrite database platform owned by the USANZ and compiled for national benchmarking.
Timepoint [1] 351974 0
Two years of the pilot study
Secondary outcome [2] 352270 0
transfusion rate (risk adjusted) - All data is entered in the Dendrite database platform owned by the USANZ and compiled for national benchmarking.
Timepoint [2] 352270 0
Two years of the pilot study
Secondary outcome [3] 352271 0
mortality rate during or after procedure - All data is entered in the Dendrite database platform owned by the USANZ and compiled for national benchmarking.
Timepoint [3] 352271 0
Two years of the pilot study
Secondary outcome [4] 352272 0
length of stay (median and range) - The date of surgery and discharge date will be recorded for all procedures. All data is entered in the Dendrite database platform owned by the USANZ and compiled for national benchmarking.
Timepoint [4] 352272 0
Two years of the pilot study
Secondary outcome [5] 352668 0
Feasibility of the Registry
This pilot project will allow the USANZ Renal Registry Steering Committee to assess the quality and timeliness of data entered by a small group of participating surgeons in Australia and New Zealand, rather than recruitment rates. The accuracy and usefulness of outcome reporting will inform the feasibility of wider participation in the registry.
Timepoint [5] 352668 0
The two years of the pilot study

Eligibility
Key inclusion criteria
All clients undergoing nephrectomy and nephroureterectomy surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Data will be analysed using descriptive statistics
As the dataset is based on the British Association for Urological Surgeons model, the questions included have already been considered for risk adjustment. These include:
The Charlson co-morbidity index
The Body Mass Index (BMI)
Size and stage of the tumour
Other medical conditions affecting the patient
Whether the procedure was performed as part of a more major operation and other risk factors for surgery in general

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/09/2018
Date of last participant enrolment
Anticipated
31/10/2020
Actual
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
2000
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA,VIC
Recruitment hospital [1] 11913 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 11914 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 11915 0
The Townsville Hospital - Douglas
Recruitment hospital [4] 11916 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [5] 11917 0
The Wesley Hospital - Auchenflower
Recruitment hospital [6] 11918 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 11919 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 11920 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [9] 11921 0
Armidale Private Hospital - Armidale
Recruitment hospital [10] 11922 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [11] 11923 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [12] 11924 0
John Hunter Hospital - New Lambton
Recruitment hospital [13] 11925 0
Westmead Private Hospital - Westmead
Recruitment hospital [14] 11926 0
Hurstville Private - Hurstville
Recruitment hospital [15] 11927 0
Lingard Private Hospital - Merewether
Recruitment hospital [16] 11928 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [17] 11929 0
Belmont Hospital - Belmont
Recruitment hospital [18] 11930 0
Darwin Private Hospital - Tiwi
Recruitment hospital [19] 11931 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [20] 11932 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [21] 11933 0
Frankston Hospital - Frankston
Recruitment hospital [22] 11934 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [23] 11935 0
Masada Private Hospital - East St Kilda
Recruitment hospital [24] 11936 0
Bairnsdale Regional Health Service - Bairnsdale
Recruitment hospital [25] 11937 0
The Alfred - Prahran
Recruitment hospital [26] 11938 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [27] 11939 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [28] 11940 0
Osborne Park Hospital - Stirling
Recruitment postcode(s) [1] 24050 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 24051 0
4120 - Greenslopes
Recruitment postcode(s) [3] 24052 0
4814 - Douglas
Recruitment postcode(s) [4] 24053 0
4029 - Herston
Recruitment postcode(s) [5] 24054 0
4066 - Auchenflower
Recruitment postcode(s) [6] 24055 0
5042 - Bedford Park
Recruitment postcode(s) [7] 24056 0
5000 - Adelaide
Recruitment postcode(s) [8] 24057 0
5168 - Noarlunga Centre
Recruitment postcode(s) [9] 24058 0
2350 - Armidale
Recruitment postcode(s) [10] 24059 0
2444 - Port Macquarie
Recruitment postcode(s) [11] 24060 0
2305 - New Lambton Heights
Recruitment postcode(s) [12] 24061 0
2305 - New Lambton
Recruitment postcode(s) [13] 24062 0
2145 - Westmead
Recruitment postcode(s) [14] 24063 0
2220 - Hurstville
Recruitment postcode(s) [15] 24064 0
2291 - Merewether
Recruitment postcode(s) [16] 24065 0
2290 - Gateshead
Recruitment postcode(s) [17] 24066 0
2280 - Belmont
Recruitment postcode(s) [18] 24067 0
0810 - Tiwi
Recruitment postcode(s) [19] 24068 0
3168 - Clayton
Recruitment postcode(s) [20] 24069 0
3199 - Frankston
Recruitment postcode(s) [21] 24070 0
3000 - Melbourne
Recruitment postcode(s) [22] 24071 0
3183 - East St Kilda
Recruitment postcode(s) [23] 24072 0
3875 - Bairnsdale
Recruitment postcode(s) [24] 24073 0
3004 - Prahran
Recruitment postcode(s) [25] 24074 0
6008 - Subiaco
Recruitment postcode(s) [26] 24075 0
6009 - Nedlands
Recruitment postcode(s) [27] 24076 0
6021 - Stirling
Recruitment outside Australia
Country [1] 20851 0
New Zealand
State/province [1] 20851 0

Funding & Sponsors
Funding source category [1] 300688 0
Other Collaborative groups
Name [1] 300688 0
Urological Society of Australia and New Zealand
Country [1] 300688 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Urological Society of Australia and New Zealand
Address
Suite 512 Eastpoint
180 Ocean Street
Edgecliff NSW 2027
Country
Australia
Secondary sponsor category [1] 300218 0
None
Name [1] 300218 0
Address [1] 300218 0
Country [1] 300218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301470 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 301470 0
Ethics committee country [1] 301470 0
Australia
Date submitted for ethics approval [1] 301470 0
22/03/2018
Approval date [1] 301470 0
28/05/2018
Ethics approval number [1] 301470 0
HREC/18/QPAH/238

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3112 3112 0 0
/AnzctrAttachments/376016-2018-238 Ethical Clearance Amended Multi Site[3865].pdf (Ethics approval)
Attachments [2] 3113 3113 0 0
/AnzctrAttachments/376016-Research Protocol - Version 3.0.docx (Protocol)

Contacts
Principal investigator
Name 87122 0
Dr Simon Wood
Address 87122 0
Urology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country 87122 0
Australia
Phone 87122 0
+61 7 3176 6946
Fax 87122 0
Email 87122 0
[email protected]
Contact person for public queries
Name 87123 0
Christudus Morais
Address 87123 0
Urology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country 87123 0
Australia
Phone 87123 0
+61 7 3176 2449
Fax 87123 0
Email 87123 0
[email protected]
Contact person for scientific queries
Name 87124 0
Simon Wood
Address 87124 0
Urology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country 87124 0
Australia
Phone 87124 0
+61 3176 6946
Fax 87124 0
Email 87124 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

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Documents added automatically
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