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Trial registered on ANZCTR
Registration number
ACTRN12608000512325
Ethics application status
Approved
Date submitted
10/09/2008
Date registered
1/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Sensibility following Innervated Free Transverse Abdominis Myocutaneous (TRAM) Flap for Breast Reconstruction: Innervation Improves Patient-rated Quality of Life
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Scientific title
In women undergoing mastectomy and breast reconstruction with a free transverse abdominis myocutaneous flap, does innervation of the flap result in improved breast sensation and quality of life than not innervating the flap?
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
3660
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Condition category
Condition code
Cancer
3827
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Innervation of TRAM flap : During breast reconstruction surgery, a nerve repair between the 4th intercostal nerve of the breast and the 10th intercostal nerve of the flap is performed using the operating microscope. The intervention adds 15 minutes to the procedure, which takes 8 hours overall.
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Intervention code [1]
3377
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Treatment: Surgery
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Comparator / control treatment
Patients undergoing standard free transverse rectus abdominis myocutaneous (TRAM) flap reconstruction for breast reconstruction (no innervation of TRAM flap). The procedure takes 8 hours overall.
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Control group
Active
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Outcomes
Primary outcome [1]
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Breast sensation: Semmes-Weinstein monofilaments, 2-point discrimination, and hot/cold discrimination
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Assessment method [1]
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Quality of Life: Functional Assessment of Cancer Therapy - Breast (FACT-B), BIBCQ (Body Image After Breast Reconstruction Questionnaire), and Short Form - 36 (SF-36) questionnairess
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Assessment method [1]
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Timepoint [1]
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2 years
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Eligibility
Key inclusion criteria
Women with mastectomy receiving free TRAM flap breast reconstruction
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Women receiving other types of breast reconstruction (implants or latissimus dorsi myocutaneous flaps)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
12/05/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
27
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
1196
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Canada
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State/province [1]
1196
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Canadian Society of Plastic Surgeons Educational Foundation
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Address [1]
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1469 St. Joseph Blvd. E. #4
Montreal, QC Canada H2J 1M6
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Country [1]
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Canada
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Primary sponsor type
Hospital
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Name
St. Joseph's Health Care Centre
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Address
268 Grosvenor St
London, ON
N6A 4L6
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Country
Canada
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Hand and Upper Limb Centre
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Address [1]
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268 Grosvenor St
London, On
N6A 4L6
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Country [1]
3545
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Canada
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Claire Temple
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Address
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Hand and Upper Limb Centre
268 Grosvenor St
London, Ontario
N6A 4L6
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Country
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Canada
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Phone
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519 646 6389
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Claire Temple
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Address
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Hand and Upper Limb Centre
268 Grosvenor St
London, Ontario
N6A 4L6
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Country
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Canada
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Phone
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519 646 6389
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Fax
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Email
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[email protected]
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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.
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