Breast Cancer
Conditions
Keywords
Breast, Latissimus dorsi flap
Brief summary
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.
Interventions
PROCEDURESurgery for unilateral breast reconstruction
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
Sponsors
Centre Georges Francois Leclerc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-centre, non-randomized interventional study in a single arm
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy. 2. Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months 3. Age between 18 and 80 years old 4. Signature of free and informed consent *
Exclusion criteria
1. Patient with metastasis or disease progression 2. 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) 3. Patient with a poor understanding of the French language 4. Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal) 5. 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 6. Patient with a history of contralateral MR (all techniques combined) 7. Patient with a history of contralateral breast cancer 8. Patient does not have internet access to be able to connect to the Exolis software
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the muscular moment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of muscle moments | 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) |
| Comparison of muscular moments | 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 |
| Calculation of adduction deficit | 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. |
| Measurement of surface electromyographic activity | 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 |
| Functional clinical impact and quality of life | 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. |
Countries
France
Outcome results
None listed