Breast Cancer, Breast Reconstruction, Reconstructive Surgery
Conditions
Brief summary
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.
Interventions
PROCEDUREAutologous Fat Transfer
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.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast-related Quality of life | 2 years | Measured by the BREAST-Q questionnaire (quality of life subdivision) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic result | 2 years | 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). |
| Complications | 2 years | Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events. |
| Oncological safety | 5 years | 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. |
| Cost-effectiveness | 2 years | Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment. |
Countries
Netherlands
Contacts
Primary ContactJamilla Wederfoort, MD, MSc
Outcome results
None listed