Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

Study Overview
=================
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 and 6 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 after surgery.

Official Title
-----------------
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Surgery for unilateral breast reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single-centre, non-randomized interventional study in a single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery for unilateral breast reconstruction<br>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 and 6 months. The Two tests will be performed at 3 moths and 6 months after the surgery. | Procedure: Surgery for unilateral breast reconstruction<br>* 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 and six months : 2 questionnaires + two tests will be perfomed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the muscular moment | 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 6 months post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of muscle moments | 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 and 6 months) | During the 6 months post operation | 
| Comparison of muscular moments | Comparison of muscular moments on the operated and healthy sides at 3 months and 6 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 6 months post operation | 
| Calculation of adduction deficit | 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 6 months post operation | 
| Measurement of surface electromyographic activity | Measurement of surface electromyographic activity (sEMG) of the latissimus dorsi, teres major and pectoralis major muscles is measured before surgery, 3 months and 6 months post-surgery | During the 6 months post operation | 
| Functional clinical impact and quality of life | Functional clinical impact and quality of life is evaluated by DASH questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months and 6 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 6 months post operation | 
| Functional clinical impact and quality of life | Functional clinical impact and quality of life is evaluated by BREAST-Q questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months and 6 months post-surgery. The BREAST-Q questionnaire is a self-administered quality of life questionnaire assessing satisfaction after breast reconstruction. | During the 6 months post operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast, Latissimus dorsi flap