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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 3660 0
Condition category
Condition code
Cancer 3827 3827 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3377 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 4728 0
Breast sensation: Semmes-Weinstein monofilaments, 2-point discrimination, and hot/cold discrimination
Timepoint [1] 4728 0
2 years
Secondary outcome [1] 7981 0
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
Timepoint [1] 7981 0
2 years

Eligibility
Key inclusion criteria
Women with mastectomy receiving free TRAM flap breast reconstruction
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women receiving other types of breast reconstruction (implants or latissimus dorsi myocutaneous flaps)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1196 0
Canada
State/province [1] 1196 0

Funding & Sponsors
Funding source category [1] 3891 0
Charities/Societies/Foundations
Name [1] 3891 0
Canadian Society of Plastic Surgeons Educational Foundation
Address [1] 3891 0
1469 St. Joseph Blvd. E. #4
Montreal, QC Canada H2J 1M6
Country [1] 3891 0
Canada
Primary sponsor type
Hospital
Name
St. Joseph's Health Care Centre
Address
268 Grosvenor St
London, ON
N6A 4L6
Country
Canada
Secondary sponsor category [1] 3545 0
Other Collaborative groups
Name [1] 3545 0
Hand and Upper Limb Centre
Address [1] 3545 0
268 Grosvenor St
London, On
N6A 4L6
Country [1] 3545 0
Canada

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 28914 0
Address 28914 0
Country 28914 0
Phone 28914 0
Fax 28914 0
Email 28914 0
Contact person for public queries
Name 12071 0
Claire Temple
Address 12071 0
Hand and Upper Limb Centre
268 Grosvenor St
London, Ontario
N6A 4L6
Country 12071 0
Canada
Phone 12071 0
519 646 6389
Fax 12071 0
Email 12071 0
ctemple4@uwo.ca
Contact person for scientific queries
Name 2999 0
Claire Temple
Address 2999 0
Hand and Upper Limb Centre
268 Grosvenor St
London, Ontario
N6A 4L6
Country 2999 0
Canada
Phone 2999 0
519 646 6389
Fax 2999 0
Email 2999 0
ctemple4@uwo.ca

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary