Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients
The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are: Does AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients? Researchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients. Participants will: Undergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation
• Female, aged \>18 years.
• BMI between \> 22 and \<35 kg/m2
• History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).
• May include contralateral/bilateral prophylactic mastectomy if at least one side had cancer and radiation.
• Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.
• Medically fit for surgery (ASA I-III).
• Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).
• No evidence of active cancer at enrollment; remission confirmed.
• Able to wear the EVE device (if randomized in AFT).
• Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.