Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life

Study Overview
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Brief Summary
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The dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility. In recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of this surgery. The objective of this prospective study is to evaluate the functional and aesthetic results in patients who have undergone who have undergone this procedure (prospective cohort) or who will undergo this procedure or prosthetic reconstruction (prospective cohort). The investigators also wish to evaluate the quality of life of patients after reconstruction with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.

Detailed Description
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Retrospective Cohort : Clinical data reconstruction and follow-up up to 1 year DASH questionnaire Breast Q aesthetic evaluation (patient and surgeon and other health professional) Prospective Cohort : Clinical data reconstruction and follow-up up to 1 year DASH questionnaire (pre-op, at 6 month and at 12 month) Breast Q(pre-op, at 6 month and at 12 month) aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and at 12 month)

Official Title
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Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Breast reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a desire for breast reconstruction Indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin, Breast reconstruction procedure by LDPM performed between January 2017 and September2021, (retrospective cohort ) Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022 (prospective cohort) Information to the patient and collection of her non-opposition Affiliation to a social security system, or beneficiary of such a system Exclusion Criteria: Performance of a breast reconstruction by a technique other than LDPM or prosthesis Patient opposed to the use of her data for research Person in an emergency situation, adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to express his consent, Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological psychological reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A Retrospective<br>A = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021 | Procedure: Breast reconstruction<br>* Muscle sparing Latissimus Dorsi Flap or prothesis<br>|
| B Prospective<br>B = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment) | Procedure: Breast reconstruction<br>* Muscle sparing Latissimus Dorsi Flap or prothesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional evaluation of the shoulder and upper limb (mobility and pain) | Disabilities of the Arm, Shoulder and Hand (DASH) (0 = no disability to 100 = maximum disability) | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction of aesthetic by the patient and by the surgeon | 5 numerical scales (from 0 to 5) measuring overall satisfaction with the reconstruction, general appearance of the breast, breast shape, breast consistency and breast volume | 6 month | 
| occurrence of postoperative complications | complications | 6 month | 
| quality of life through the Breast-Q questionnaire | Breast-Q questionnaire | 6 months |