Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001454460p
Ethics application status
Submitted, not yet approved
Date submitted
13/10/2016
Date registered
18/10/2016
Date last updated
18/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Significance of the Suprarenal Aortic Diameter and Surgical Complications in Patients who have undergone Endovascular Aortic Aneurysm Repair.
Scientific title
The Significance of the Suprarenal Aortic Diameter in the Occurrence of Late Proximal Neck Complications Following Endovascular Aortic Aneurysm Repair.
Secondary ID [1] 290331 0
None
Universal Trial Number (UTN)
U1111-1188-6736
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endoleaks and other complications, and their association with suprarenal aortic diameter following endovascular aneurysm repair. 300600 0
Condition category
Condition code
Cardiovascular 300452 300452 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
CT scans for the 6 month follow up after endovascular repair will be examined to assess the diameter or the suprarenal aorta. This will be the only observational point for each participant in this study.
Intervention code [1] 296144 0
Not applicable
Comparator / control treatment
There is no control group. We are looking at the association of aortic diameter with complications.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299887 0
To determine the association between endoleaks following endovascular abdominal aortic aneurysm repair and suprarenal aortic calibres. The occurrence of endoleaks will be determined by a review of the patient's medical records, and the suprarenal aortic calibres will be assessed by CT scan.
Timepoint [1] 299887 0
After the 6 month follow-up for endovascular aneurysm repair (EVAR).
Secondary outcome [1] 328398 0
Our first secondary objective is to determine whether there is an association between aortic calibres and re-intervention after endovascular aneurysm repair as determined by the patient's medical record.
Timepoint [1] 328398 0
After the 6 month follow- up post EVAR.
Secondary outcome [2] 328473 0
Our second secondary objective is to determine whether there is an association between aortic calibres and aneurysm related mortality as assessed by patient medical records.
Timepoint [2] 328473 0
After the 6 month follow up post EVAR.
Secondary outcome [3] 328474 0
Our third secondary objective is to determine whether there is an association between aortic calibres and all cause mortality, as assessed by patient medical records.
Timepoint [3] 328474 0
After the 6 month follow up post EVAR
Secondary outcome [4] 328475 0
Our fourth secondary objective is to determine whether there is an association between aortic calibres and aneurysmal sac growth as determined by patient medical records.
Timepoint [4] 328475 0
After the 6 month follow up post EVAR.

Eligibility
Key inclusion criteria
Patients with infrarenal abdominal aortic aneurysms who have undergone endovascular aneurysm repair( EVAR) at Dunedin Public Hospital, as identified through unit audit databases and hospital coding data.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have not undergone EVAR at Dunedin Public Hospital, and who have not had a 6 month follow-up CT scan.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
If there is evidence of a difference in mean aortic diameters between the complications and no complications groups (using a two-sample t-test if model assumptions hold and a Mann-Whitney-Wilcoxon test should assumptions not hold and not be otherwise correctable), logistic regression will be used to investigate associations between aortic diameter and complication status while adjusting for prognostic variables which could confound the association. Given the possibility of 30 or fewer cases, Peduzzi et al. (1996) would suggest only one or two potential confounders could be simultaneously included in the models alongside aortic diameter and so the effect of adding age, gender, height, weight, type of graft, and pre-EVAR co-morbidities individually will be examined to see if this alters any association between aortic diameter and complication status. The Hosmer-Lemeshow test and a specification test will be used to assess issues with model fit, including non-linearities with respect to continuous predictors. Statistical analyses will be performed using Stata 14.1 or R 3.3.1 (or later versions) and two-sided p<0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
134
Accrual to date
Final
Recruitment outside Australia
Country [1] 8317 0
New Zealand
State/province [1] 8317 0
Otago

Funding & Sponsors
Funding source category [1] 294714 0
University
Name [1] 294714 0
University of Otago, Surgical Sciences
Country [1] 294714 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
201 Great King Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 293559 0
None
Name [1] 293559 0
Address [1] 293559 0
Country [1] 293559 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296135 0
University of Otago Human Ethics Committee
Ethics committee address [1] 296135 0
Ethics committee country [1] 296135 0
New Zealand
Date submitted for ethics approval [1] 296135 0
07/10/2016
Approval date [1] 296135 0
Ethics approval number [1] 296135 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69678 0
Dr Jo Krysa
Address 69678 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country 69678 0
New Zealand
Phone 69678 0
+64 3 470 9850
Fax 69678 0
Email 69678 0
jo.krysa@southerndhb.govt.nz
Contact person for public queries
Name 69679 0
Kari Clifford
Address 69679 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country 69679 0
New Zealand
Phone 69679 0
+64210668369
Fax 69679 0
Email 69679 0
kari.clifford@gmail.com
Contact person for scientific queries
Name 69680 0
Kari Clifford
Address 69680 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country 69680 0
New Zealand
Phone 69680 0
+64 2 1066 8369
Fax 69680 0
Email 69680 0
kari.clifford@gmail.com

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.