Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer. (BREAST)
This study will quantify the muscle function after breast reconstruction using a minimally invasive latissimus dorsi flap.
The proposed measures (clinical, isokinetic, electrophysiology, function and quality of life questionnaires) allow a precise, multidisciplinary, objective evaluation of the capacity of the latissimus dorsi muscle before surgery, 3 months, 6 months and 12 months after surgery. A function deficit is expected (decreased moment of adduction and internal rotation) 3 months after surgery and a return to the preoperative state 6 months and 12 months after surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Côte d'Or
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Dijon, Côte d'Or, France, 21000
- Centre Georges-François Leclerc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy.
- Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months
- Age between 18 and 80 years old
- Signature of free and informed consent
Exclusion Criteria:
- Patient with metastasis or disease progression
- Patient whose general condition does not allow her to answer a questionnaire or perform physical and functional measurements (neurocognitive disorders and/or neuro-orthopedic disorders)
- Patient with a poor understanding of the French language
- Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)
- Patient not eligible for MR secondary to cancer (prophylactic mastectomy) or for which the flap was intended to cover loss of substance and not reconstruction
- Patient with a history of contralateral MR (all techniques combined)
- Patient with a history of contralateral breast cancer
- Patient does not have internet access to be able to connect to the "Exolis" software
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Surgery for unilateral breast reconstruction
Patients treated in oncological surgery at the Center Georges-François Leclerc (CGFL) in Dijon for unilateral breast reconstruction after therapeutic total mastectomy. Before the surgery, 2 questionnaires will be completed by patients : BREAST-Q and DASH. Also, the isokinetic test and EMG will be performed. After the surgery, 2 questionnaires will be completed at one month, 3 months, 6 months and 12 months. The Two tests will be performed at 3 months, 6 months and 12 months after the surgery. |
Before the surgery, patient will be completed two questionnaire DASH and BREAST-Q. Two tests will be performed (isokinetic test and EMG). After the surgery, at one month : 2 Questionnaires (DASH / BREAST-Q) will be performed At three months, six months and 12 months: 2 questionnaires + two tests will be perfomed |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the muscular moment
Time Frame: During the 12 months post operation
|
Measurement of the muscular moment of shoulder adduction preoperatively and at 3 months on an isokinetic dynamometer (Biodex®, New York, USA) at an adduction speed of 60 degrees per second during a maximal voluntary contraction
|
During the 12 months post operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of muscle moments
Time Frame: During the 12 months post operation
|
Evaluation of muscle moments, isokinetic measurements, performed on an isokinetic dynamometer (Biodex®, New York, USA) at different speeds (isometric, 30, 60 and 120 degrees per second) of adduction and internal rotation after flap surgery minimally invasive latissimus dorsi (measurements before surgery, at 3, 6 and 12 months)
|
During the 12 months post operation
|
|
Comparison of muscular moments
Time Frame: During the 12 months post operation
|
Comparison of muscular moments on the operated and "healthy" sides at 3 months, 6 months and 12 months.
Perfomed on an isokinetic dynamometer (Biodex®, New York, USA) at different speeds (isometric, 30, 60 and 120 degrees per second) of adduction and internal rotation after flap surgery minimally invasive latissimus dorsi
|
During the 12 months post operation
|
|
Calculation of adduction deficit
Time Frame: During the 12 months post operation
|
Calculation of adduction deficit is defined as a relative difference of more than 5% compared to the measurement taken preoperatively.
Patients who completed at least one physiotherapy session post-surgery and before 3 months will be compared to the others.
|
During the 12 months post operation
|
|
Measurement of surface electromyographic activity
Time Frame: During the 12 months post operation
|
Measurement of surface electromyographic activity (sEMG) of the latissimus dorsi, teres major and pectoralis major muscles is measured before surgery, 3 months, 6 months and 12 months post-surgery
|
During the 12 months post operation
|
|
Functional clinical impact and quality of life
Time Frame: During the 12 months post operation
|
Functional clinical impact and quality of life is evaluated by DASH questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months, 6 months and 12 months post-surgery. The DASH self-questionnaire is an upper limb function assessment scale. It offers the ability to perform 23 activities, the severity of the symptoms and optional sports or instrumental and professional activity. |
During the 12 months post operation
|
|
Functional clinical impact and quality of life
Time Frame: During the 12 months post operation
|
Functional clinical impact and quality of life is evaluated by BREAST-Q questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months, 6 months and 12 months post-surgery. The BREAST-Q questionnaire is a self-administered quality of life questionnaire assessing satisfaction after breast reconstruction. |
During the 12 months post operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Clémentine CJ JANKOWSI, Dr, Centre Georges Francois Leclerc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A03166-35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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