AFT: Introduction of a Full Breast Reconstructive Method

Study Overview
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Brief Summary
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A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.

Official Title
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Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method

Conditions
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Breast Cancer, Reconstructive Surgery, Breast Reconstruction

Intervention / Treatment
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* Procedure: Autologous Fat Transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender Age of 18 years and older History or in candidate for a mastectomy procedure in the near future Patients undergoing preventive mastectomy Patients' choice to undergo a breast reconstruction Wanting to participate in this study Patient is able to wear the external expansion device Exclusion Criteria: Active smoker or a history of smoking 4 weeks prior to surgery Current substance abuse History of lidocaine allergy History of silicone allergy 4 weeks or less after chemotherapy History of radiation therapy in the breast region Oncological treatment includes radiotherapy after mastectomy Kidney disease Steroid dependent asthma (daily or weekly) or other diseases Immune-suppressed or compromised disease Uncontrolled diabetes BMI>30 Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction The treating plastic surgeon has strong doubts on the patient's treatment compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autologous Fat Transfer<br> | Procedure: Autologous Fat Transfer<br>* Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.<br>* Other names: Lipofilling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast-related Quality of life | Measured by the BREAST-Q questionnaire (quality of life subdivision) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic result | The overall aesthetic result will be measured using 3D-photographs which will be assessed by a panel of independent plastisch surgeons, ex-breast cancer patients and healthy volunteers. In addition, the volume, shape and symmetry will be assessed by the patient using the BREAST-Q questionnaire (satisfaction with breasts subdivisions). | 2 years | 
| Complications | Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events. | 2 years | 
| Oncological safety | Oncological follow-up will comply to the guidelines for breast cancer and will take place by a yearly consult with the oncological surgeon (including physical examination and mammography/ultrasound/MRI) for 5 years postoperatively. All (loco)regional and distant recurrences will be recorded. | 5 years | 
| Cost-effectiveness | Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment. | 2 years |