breast reconstruction breast reconstructive surgery Breast reconstruction using lipofilling
Conditions
Interventions
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
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 |
|---|---|
| The patients* quality of life will be the main outcome measure of this study, using the BREAST-Q questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| The quality of the breast reconstruction will be measured by the volume and shape over time (3D photography or MRI), patient satisfaction (questionnaire) and aesthetic judgement (panel rating pre- and post operative photos). Complications during treatment and follow-up will be registered and compared. Oncological follow-up will be studied, with patients undergoing imaging over a period of 5 years. At last, a cost-effectiveness analysis will be performed to research the economic characteristics of this new technique. | — |
Countries
Netherlands
Contacts
Public ContactW.B.W. Venne
Maastricht Universitair Medisch Centrum +
Outcome results
None listed