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.
Study Type
OBSERVATIONAL
Enrollment
350
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.
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands
ENROLLING_BY_INVITATIONViecuri Venlo
Venlo, Limburg, Netherlands
RECRUITINGAmsterdam University Medical Center (VUMC)
Amsterdam, Netherlands
Breast-related Quality of life
Measured by the BREAST-Q questionnaire (quality of life subdivision)
Time frame: 2 years
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).
Time frame: 2 years
Complications
Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.
Time frame: 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.
Time frame: 5 years
Cost-effectiveness
Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment.
Time frame: 2 years
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Rijnstate
Arnhem, Netherlands
ENROLLING_BY_INVITATIONAlexander Monro, Bilthoven
Bilthoven, Netherlands
ENROLLING_BY_INVITATIONAmphia
Breda, Netherlands
ENROLLING_BY_INVITATIONZiekenhuis groep Twente (ZGT)
Hengelo, Netherlands
RECRUITINGMedical Center Leeuwarden
Leeuwarden, Netherlands
RECRUITING