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

NCT05278741 | Active Not Recruiting

• 1 other identifier: 2021-A03166-35
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Breast Cancer

Keywords

Breast; Latissimus dorsi flap

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluation of muscle moments

  During the 12 months post operation

• Comparison of muscular moments

  During the 12 months post operation

• Calculation of adduction deficit

  During the 12 months post operation

• Measurement of surface electromyographic activity

  During the 12 months post operation

• Functional clinical impact and quality of life

  During the 12 months post operation

Study Arms (1)

Surgery for unilateral breast reconstruction

EXPERIMENTAL

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

Interventions

Surgery for unilateral breast reconstruction PROCEDURE

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

Surgery for unilateral breast reconstruction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges-François Leclerc

Dijon, Côte d'Or, 21000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clémentine CJ JANKOWSI, Dr

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-centre, non-randomized interventional study in a single arm

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 14, 2022
• Study Start: November 25, 2022
• Primary Completion: March 6, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)