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

Centre Georges Francois Leclerc

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: Surgery for unilateral breast reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05278741

2021-A03166-35

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Surgery for unilateral breast reconstruction

Experimental group

Description:

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.

Treatment:

Procedure: Surgery for unilateral breast reconstruction