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.
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.
Parallel
Autologous fat transfer
Procedure/SurgeryAutologous fat transfer as total breast reconstruction
Deep inferior epigastric perforator flap
Procedure/SurgeryDeep inferior epigastric perforator flap as breast reconstruction
to determine whether autologous fat transfer (AFT) is non-inferior to DIEP flap breast re-construction regarding breast satisfaction, as measured by the BREAST-Q, 12 months after the final reconstructive procedure in irradiated breast cancer patients;
One of the primary outcomes is the BREAST-Q "Satisfaction with Breasts" score at 12 months post-reconstruction. This validated, patient-reported measure (0-100 scale) as-sesses satisfaction with breast appearance and feel.
to assess whether AFT is superior to DIEP flap reconstruction in terms of the incidence of major complications requiring reoperation or hospital readmission.
The second primary outcome measure is the incidence of major complications (i.e. complications requiring reoperation or hospital readmission such as hematoma, venous/arterial insufficiency, partial/total flap loss, and infection/abscess).
cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated.
The third primary outcome is cost-effective-ness. We will collect detailed healthcare and societal costs per patient using hospital records, CRFs, and a study-adapted patient-reported iMCQ and iPCQ (for health care resource use and productivity loss). QALYs will be calculated from EQ-5D-5L data at multiple timepoints. We will compare cost per QALY (ICER) between AFT and DIEP, and conduct a budget impact analysis.
Physical Well-being: Abdomen (BREAST-Q)
Physical Well-being: Abdomen (donor site), assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better physical well-being of the abdominal donor site.
Complications (Minor & General)
Incidence of minor recipient-site and donor-site com-plications (i.e. complications taking care of at the outpatient clinic) managed conserva-tively (e.g. wound problems/dehiscence, infection, seroma, hematoma, and abdominal bulging), and any general (systemic) complications related to surgery or hospitalization (e.g. pulmonary embolism, pneumonia).
Oncologic Safety
Monitor and compare breast cancer recurrence rates using routine follow-up and PALGA registry to confirm AFT's oncologic safety.
Sensory Recovery
Evaluate return of breast skin sensation at 12 months with mono-filament testing to compare sensory outcomes between techniques \[in MUMC+ only\].
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Maastricht University Medical Center
Lead sponsor
Academisch Ziekenhuis Maastricht
Collaborator
