Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
- Conditions
- Breast Cancer
- Registration Number
- NL-OMON21198
- Lead Sponsor
- ZonMw & Zorginstituut Nederland (ZiN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 350
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Breast-related Quality of Life (Measured by the BREAST-Q questionnaire)
- Secondary Outcome Measures
Name Time Method Aesthetic result<br>Complications<br>Oncological safety<br>Cost-effectiveness