Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy
- Conditions
- Breast Cancer
- Interventions
- Procedure: breast implantProcedure: autologous fat transfer
- Registration Number
- NCT02339779
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 196
- Female gender
- Age of 18 years and older
- History or in candidate for a mastectomy procedure in the near future
- Patients' choice to undergo a breast reconstruction
- Wanting to participate in this study
- Patient is able to wear the BRAVA device
- 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
- Claustrophobia for an MRI-scan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reconstruction with breast implants breast implant Control group will receive implant-based reconstruction, in some cases preceded by the implantation of a tissue expander. Autologous fat transfer reconstruction autologous fat transfer Breast reconstruction achieved by serial autologous fat transfer (AFT) procedures, accompanied by external tissue expansion of the breast.
- Primary Outcome Measures
Name Time Method Breast-related Quality of life (BREAST_Q) 1 year Measured by the BREAST-Q questionnaire (quality of life subdivision) preoperatively and 1 year postoperatively
- Secondary Outcome Measures
Name Time Method Complications 1 year 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 and compared between both grops.
Aesthetic result 1 year 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.
Donor site satisfaction 2 years Measurement of quality of life and satisfaction at AFT donor sites, as measured by the BODY-Q questionnaire and additional questions concerning liposuction sites.
Cost-effectiveness 1 year 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).
Sensibility 1 year Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery.
Trial Locations
- Locations (7)
VU Medical Center
🇳🇱Amsterdam, Netherlands
Amstelland Hospital
🇳🇱Amstelveen, Netherlands
Bronovo-MCH Hospital
🇳🇱Hague, Netherlands
Alexander Monro Breast cancer hospital
🇳🇱Bilthoven, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Ziekenhuis Groep Twente Hospital
🇳🇱Hengelo, Netherlands
Maastricht University Medical Centre (MUMC+)
🇳🇱Maastricht, Netherlands