Surgery 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
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
* 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
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Centre Georges-François Leclerc
Dijon
Côte d'Or
More Centre Georges Francois Leclerc trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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