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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-25

Study Completion Date

2026-12-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Surgery for unilateral breast reconstruction

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No