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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Surgery for unilateral breast reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Côte d'Or
    • Dijon, Côte d'Or, France, 21000
      • Centre Georges-Francois Leclerc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: 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

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 12 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, 6 and 12 months)	During the 12 months post operation
Comparison of muscular moments	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	During the 12 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 12 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, 6 months and 12 months post-surgery	During the 12 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, 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.	During the 12 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, 6 months and 12 months post-surgery. The BREAST-Q questionnaire is a self-administered quality of life questionnaire assessing satisfaction after breast reconstruction.	During the 12 months post operation

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc
• Investigators: Principal Investigator: Clémentine CJ JANKOWSI, Dr, Centre Georges François Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Estimated): March 6, 2026
• Study Completion (Estimated): December 4, 2026

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Breast; Latissimus dorsi flap
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Surgical Procedures, Operative
• Other Study ID Numbers: 2021-A03166-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No