Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000005055
Ethics application status
Approved
Date submitted
31/12/2009
Date registered
5/01/2010
Date last updated
27/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain Injury in Surgery Study
Scientific title
Incidence of cerebral ischemia in participants undergoing bowel surgery determined by post-operative magnetic resonance brain imaging with diffusion weighted imaging (DWI).
Secondary ID [1] 1230 0
None
Universal Trial Number (UTN)
Trial acronym
BISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-operative cerebral ischemia 256456 0
Condition category
Condition code
Stroke 256625 256625 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Post-operative magnetic resonance (MRI) brain imaging with diffusion weighted imaging (DWI) and FLAIR sequences.
The MRI technique of DWI is a simple and non-invasive means of identifying areas of cerebral ischemia with high sensitivity and specificity. Increased DWI signal intensity change occurs within minutes of the ischemic event and remains “positive” for 7-14 days even in the absence of clinical signs of stroke. This allows areas of acute ischemia to be distinguished from old infarction. Each scan is estimated to take 20 minutes in duration.
Participants will also undergo clinical and cognitive assessments both pre- and post- operatively. Clinical and cognitive assessments will be performed within the week prior to surgery. The clinical assessment will be repeated between 3-7 days after the operation and then again at 6-8 weeks. Cognitive assessment will be repeated at 6-8 weeks only.
Intervention code [1] 255746 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257515 0
Presence of new ischemic change on post-operative MRI brain scans with DWI in patients undergoing bowel surgery.
Timepoint [1] 257515 0
The MRI brain scans will be performed once the participant is clinically stable at 3-7 days following their operation.
Secondary outcome [1] 262737 0
Incidence of peri-operative stroke, transient ischemic attack and acute confusional state in bowel surgery patients.
Timepoint [1] 262737 0
Participants will undergo a clinical assessment at 3-7 days following their operation.

Eligibility
Key inclusion criteria
1.Thirty consecutive patients undergoing bowel surgery (right hemicolectomy, anterior resection or abdominoperineal resection) at the Auckland City Hospital. 2.Able to give informed consent. 3.Able to undergo the clinical and cognitive assessments 4.Able to tolerate a post-operative MRI brain scan.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Previous neurological disease, including stroke or transient ischemia attack (TIA), or cognitive impairment as determined by Abbreviated Mental Test Score (AMT<7), or past psychiatric disease that would interfere with the interpretation of clinical and radiological data.
2.Contraindications to MRI brain scanning including permanent pacemaker/implantable defibrillator, metallic foreign bodies, claustrophobia.
3.Any patient that the assessing clinician or treating surgeon or anaesthetist does not believe would be an appropriate candidate for the study.

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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/09/2010
Actual
19/01/2011
Date of last participant enrolment
Anticipated
Actual
19/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 2380 0
New Zealand
State/province [1] 2380 0
Auckland

Funding & Sponsors
Funding source category [1] 256222 0
Hospital
Name [1] 256222 0
Auckland District Health Board Neurology Residual Research Funds
Country [1] 256222 0
New Zealand
Funding source category [2] 257225 0
Hospital
Name [2] 257225 0
Auckland District Health Board A+ Trust
Country [2] 257225 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital Research Review Committee
Address
Level 14
Support Building
Auckland City Hospital
Park Road
Grafton
AUCKLAND 1023
Country
New Zealand
Secondary sponsor category [1] 251558 0
None
Name [1] 251558 0
Address [1] 251558 0
Country [1] 251558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258320 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 258320 0
3rd Floor, BNZ Building, 354 Victoria Street, HAMILTON 3204
Ethics committee country [1] 258320 0
New Zealand
Date submitted for ethics approval [1] 258320 0
24/05/2010
Approval date [1] 258320 0
20/10/2010
Ethics approval number [1] 258320 0
NTY/10/06/052

Summary
Brief summary
There is clear evidence that heart surgery can lead to clinically evident and asymptomatic brain injury. There is some debate as to whether this is due to clots forming in the heart and going to the brain, the need to use heart-lung bypass, anaesthetic factors, or other factors that occur during the operation such as low blood pressure leading to reduced blood flow to the brain. We wish to determine the risk of brain injury following bowel surgery and any factors that may predict this risk. This will be done by performing clinical and cognitive testing before and after surgery and magnetic resonance imaging brain scans in the week following surgery. The results of this study will be compared to those seen in heart surgery patients. The aim is to shed more light on the mechanisms of brain injury following surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30650 0
Dr Cheryl Johnson
Address 30650 0
C/o Older Adults and Home Health
Waitemata District Health Board
Private Bag 93-503
Takapuna
AUCKLAND 0740
Country 30650 0
New Zealand
Phone 30650 0
+6421393860
Fax 30650 0
Email 30650 0
[email protected]
Contact person for public queries
Name 13897 0
Prof Professor Alan Barber
Address 13897 0
Neurology Department
Auckland City Hospital
Level 8
Auckland City Hospital
Park Road, Grafton
AUCKLAND 1023
Country 13897 0
New Zealand
Phone 13897 0
0064 9 923 6520
Fax 13897 0
0064 9 367 7146
Email 13897 0
[email protected]
Contact person for scientific queries
Name 4825 0
Prof Professor Alan Barber
Address 4825 0
Neurology Department
Auckland City Hospital
Level 8
Auckland City Hospital
Park Road, Grafton
AUCKLAND 1023
Country 4825 0
New Zealand
Phone 4825 0
0064 9 923 6520
Fax 4825 0
0064 9 367 7146
Email 4825 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
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