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Trial registered on ANZCTR


Registration number
ACTRN12609000105246
Ethics application status
Not yet submitted
Date submitted
11/11/2008
Date registered
13/02/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of breast reconstruction on the incidence of post-operative cognitive dysfunction.
Scientific title
Does the addition of reconstruction to mastectomy alone in women undergoing mastectomy for treatment of breast disease, affect incidence of post-operative cognitive dysfunction.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative cognitive dysfunction 3962 0
Condition category
Condition code
Mental Health 4158 4158 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Postoperative cognitive dysfunction will be measured at 1 week, 3 months and 12 months in women undergoing implant breast reconstruction or autologous breast reconstruction in addition to mastectomy.
Intervention code [1] 3681 0
Not applicable
Comparator / control treatment
Women undergoing mastectomy alone as part of their treatment of breast disease.
Control group
Active

Outcomes
Primary outcome [1] 5056 0
Post-operative changes in objective measures of cognition function.
Cognitive dysfunction will be measured by a battery of validated tests examining abnormal impairment in memory and concentration.
Timepoint [1] 5056 0
Preoperatively, 1 week, 3 months and 12 months post-operatively.
Secondary outcome [1] 8504 0
Post-operative changes in subjective measures of cognitive function.
The measurement of subjective complaints of cognitive dysfunction will be completed through a battery of validated questionnaires.
Timepoint [1] 8504 0
Preoperatively, 1 week, 3 months and 12 months postoperatively.

Eligibility
Key inclusion criteria
Undergoing mastectomy for treatment of breast disease.
Considering reconstruction
Minimum age
25 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing neurological disorder.
Severe auditory and /or visual impairments.
Illiteracy
Previous cardiac or neurological surgery.
Alcohol and /or drug dependence.
Inability to comply with protocol.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1367 0
Canada
State/province [1] 1367 0

Funding & Sponsors
Funding source category [1] 4142 0
Self funded/Unfunded
Name [1] 4142 0
Country [1] 4142 0
Canada
Primary sponsor type
Hospital
Name
St. Joseph's Hospital
Address
268 Grosvenor Street
London, Ontario
N6A 4V2
Country
Canada
Secondary sponsor category [1] 3729 0
University
Name [1] 3729 0
University of Western Ontario
Address [1] 3729 0
1151 Richmond Street,
London, Ontario,
N6A 3K7
Country [1] 3729 0
Canada

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6213 0
Ethics committee address [1] 6213 0
Ethics committee country [1] 6213 0
Date submitted for ethics approval [1] 6213 0
10/09/2008
Approval date [1] 6213 0
Ethics approval number [1] 6213 0
15355E

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

Contacts
Principal investigator
Name 29118 0
Address 29118 0
Country 29118 0
Phone 29118 0
Fax 29118 0
Email 29118 0
Contact person for public queries
Name 12275 0
Dr. Claire Temple
Address 12275 0
Hand and Upper Limb Clinic
St. Joseph's Hospital
268 Grosvenor Street
London, Ontario
N6A 4V2
Country 12275 0
Canada
Phone 12275 0
(519) 646-6000
Fax 12275 0
Email 12275 0
ctemple4@uwo.ca
Contact person for scientific queries
Name 3203 0
Dr. Claire Temple
Address 3203 0
Hand and Upper Limb Clinic
St. Joseph's Hospital
268 Grosvenor Street
London, Ontario
N6A 4V2
Country 3203 0
Canada
Phone 3203 0
(519)-646-6000
Fax 3203 0
Email 3203 0
ctemple4@uwo.ca

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.