Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Maastricht University Medical Center
With
Academisch Ziekenhuis Maastricht
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Prior autologous breast reconstruction on the intended side. BMI \<22 or \>35 kg/m2
Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).
Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).
Current chemotherapy or completed less than 4 weeks prior to enrollment.
Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).
Active smoker or not abstinent for at least 6 weeks pre-operatively.
Pregnant at time of enrollment.
In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).
Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).
