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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 and 6 months. The Two tests will be performed at 3 moths and 6 months after the surgery.

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 and six months : 2 questionnaires + two tests will be perfomed

Surgery for unilateral breast reconstruction

Clémentine CJ JANKOWSKI, Doctor

Paul PO ORNETTI, Professor

SOPHIE PARNALLAND

Clémentine CJ JANKOWSI, Dr

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.

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

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

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

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 and 6 months)

Comparison of muscular moments on the operated and "healthy" sides at 3 months and 6 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 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 (sEMG) of the latissimus dorsi, teres major and pectoralis major muscles is measured before surgery, 3 months and 6 months post-surgery

Functional clinical impact and quality of life is evaluated by DASH questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months and 6 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.

Functional clinical impact and quality of life is evaluated by BREAST-Q questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months and 6 months post-surgery.

The BREAST-Q questionnaire is a self-administered quality of life questionnaire assessing satisfaction after breast reconstruction.

Centre Georges Francois Leclerc

Behaviors and Mental Disorders

Quality of Life

Breast reconstruction performed with TDAP

Breast reconstruction performed with latissimus dorsi

Breast reconstruction performed with a deep inferior epigastric artery perforator flap

Latissimus dorsi flap

Thoracodorsal artery perforator flap to breast

Deep inferior epigastric perforator flap

Emma Hansson, PhD, MD

Emma Hansson, PhD

The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.

1. Validation of scales/instrument for Swedish.
2. Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up.
3. Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction.
4. TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.

Biological women identifying themselves as cis-women.

Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales

Translation and validation of the instrument for Swedish

Measurement of quality of life according to breast-Q in a normative population

Measurement of quality of life according to breast-Q back appaearance scale in a normative population

Measurement of quality of life according to breast-Q back and shoulder function scale in a normative population

Breast Q reconstruction.The BREAST-Q has multiple domains, each scored from 0 to 100 (higher scores indicate greater satisfaction or quality of life), there is no overall BREAST-Q score.

Breast Q the back and shoulder function scale. The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

Breast-Q the back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

Western Ontario Osteoarthritis of the shoulder index (WOOS) provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions.Each question has a possible score from 0-100 giving a total score up to 1900. The highest or most symptomatic score is 1900 and the best or asymptomatic score is 0.

Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100

Measured in patients randomized to TDAP or latissimus dorsi flap.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.	NCT05278741	Breast Cancer	Surgery for uni...	18 Years - 80 Years	Centre Georges Francois Leclerc
Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales	NCT04526561	Breast Cancer	Latissimus dors... Thoracodorsal a... Deep inferior e...	18 Years -	Vastra Gotaland Region
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.	NCT05278741	Breast Cancer	Surgery for uni...	18 Years - 80 Years	Centre Georges Francois Leclerc

Spots Global Cancer Trial Database for latissimus dorsi flap