This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Each procedure consists of the transfer of syringe-aspirated fat (form the abdomen, thighs, flanks) to the breast by injection in the subcutaneous planes. Typically three separate procedures are needed for a complete breast reconstruction: 1. First session comprises of sub- and intrapectoral fat transfer during the primary mastectomy surgery, providing volume to the deep tissue planes. 2. Second session is preceeded by wearing an external pre-expansion device to prepare the recipient site for grafting. It aims to give the breast its shape and initial volume. 3. Third session is also preceded by external pre-expansion and aims to provide extra volume of the breast to achieve symmetry with the healthy breast.
Implant-based reconstruction typically will occur as follows: 1. During the primary mastectomy surgery, a tissue expander will be implanted subpectorally. 2. The tissue expander will be gradually filled with sterile saline during outpatient clinic visits. 3. When the desired volume is achieved, a second operation will be planned, to exchange the tissue expanded with the definite breast implant. (Note: in patients who are receiving encapsulectomy and implant exchange, the first 2 steps are skipped.)
Amstelland Hospital
Amstelveen, Netherlands
VU Medical Center
Amsterdam, Netherlands
Alexander Monro Breast cancer hospital
Bilthoven, Netherlands
Amphia Hospital
Breda, Netherlands
Breast-related Quality of life (BREAST_Q)
Measured by the BREAST-Q questionnaire (quality of life subdivision) preoperatively and 1 year postoperatively
Time frame: 1 year
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) at 1 year postoperatively.
Time frame: 1 year
Complications
Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.
Time frame: 1 year
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 and compared between both grops.
Time frame: 5 years
Cost-effectiveness
Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment. It will be calculated according to the guidelines of the "Instuction manual cost-effectiveness analysis" (Handleiding kostenonderzoek) of the Dutch Health Institute (Zorginstituut Nederland).
Time frame: 1 year
Sensibility
Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ziekenhuis Groep Twente Hospital
Hengelo, Netherlands
Maastricht University Medical Centre (MUMC+)
Maastricht, Netherlands
Bronovo-MCH Hospital
The Hague, Netherlands
Time frame: 1 year
Donor site satisfaction
Measurement of quality of life and satisfaction at AFT donor sites, as measured by the BODY-Q questionnaire and additional questions concerning liposuction sites.
Time frame: 2 years