Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap

Condition(s) studied

Study summary

Breast reconstruction using autologous tissue is an important option for women undergoing mastectomy for breast cancer. The profunda artery perforator (PAP) flap is a reliable alternative when abdominal tissue is unavailable or unsuitable for reconstruction. Although the PAP flap is increasingly used, limited data are available regarding long-term patient-reported quality of life, aesthetic outcomes, and donor-site morbidity.

This monocentric observational study aims to evaluate long-term quality of life in women who underwent breast reconstruction with a PAP flap at the European Georges Pompidou Hospital between 2014 and 2024. Participants will complete validated patient-reported outcome questionnaires (BREAST-Q Reconstruction Module and PROMIS-29) and undergo a standardized clinical and photographic assessment. Aesthetic outcomes will be evaluated using objective photographic analysis and blinded expert review.

The study will provide comprehensive information on patient satisfaction, functional outcomes, aesthetic results, and donor-site sequelae following PAP flap breast reconstruction.

Eligibility

Primary outcome measure(s)

• BREAST-Q Reconstruction Module Domain Scores — At study assessment, at least 2 years after PAP flap breast reconstruction
  Long-term patient-reported quality of life and satisfaction will be assessed using the BREAST-Q Reconstruction Module (French version). Domain scores are transformed to a 0-100 scale, where 0 represents the poorest outcome and 100 the best outcome. Higher scores indicate greater satisfaction and better health-related quality of life.
• Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1) Domain Scores — At study assessment, at least 2 years after PAP flap breast reconstruction
  Health-related quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1, French version). Scores are reported as standardized T-scores (population mean = 50, SD = 10; typical observed range approximately 20-80). Higher scores indicate better health for the Physical Function and Ability to Participate in Social Roles domains, whereas higher scores indicate worse symptoms for Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity domains.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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