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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Surgery for unilateral breast reconstruction

• Registration Number: NCT05278741
• Lead Sponsor: Centre Georges Francois Leclerc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Study Start: 2022-11-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17
• Primary Completion: 2025-05-25
• Study Completion: 2025-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery for unilateral breast reconstruction	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.

Trial Locations

Locations (1)

Centre Georges-François Leclerc; 🇫🇷 Dijon, Côte d'Or, France