Breast Cancer
Conditions
Interventions
Full Breast Reconstruction by means of Autologous Fat Transfer
Sponsors
ZonMw & Zorginstituut Nederland (ZiN)
Eligibility
Inclusion criteria
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
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 |
|---|---|
| Breast-related Quality of Life (Measured by the BREAST-Q questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| Aesthetic result Complications Oncological safety Cost-effectiveness | — |
Contacts
Public ContactSander Schop
Maastricht University Medical Center
Outcome results
None listed