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.
Female patients aged 18 years or older.
History of unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap.
Breast reconstruction performed between 2014 and 2024 at the European Georges Pompidou Hospital.
Able to understand study procedures and complete study questionnaires.
Patients younger than 18 years.
Breast reconstruction performed using techniques other than PAP flap.
Breast reconstruction performed outside the study period (2014-2024).
Patients under legal protection measures.
Women who underwent unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap after mastectomy for breast cancer at the European Georges Pompidou Hospital between 2014 and 2024 and who are eligible for long-term quality-of-life and aesthetic outcome assessment.
Cohort
Cross-sectional
Not listed
BREAST-Q Reconstruction Module Domain Scores
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
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.
Breast Cancer Conservation Treatment cosmetic results (BCCT.core) Aesthetic Classification
Aesthetic outcome will be evaluated using standardized clinical photographs analyzed with Breast Cancer Conservation Treatment cosmetic results (BCCT.core) software. Cosmetic results are classified into four categories: Excellent, Good, Fair, and Poor, with Excellent representing the best aesthetic outcome and Poor the worst aesthetic outcome.
Blinded Expert Panel Aesthetic Score
Standardized photographs will be independently evaluated by blinded plastic surgeons and lay reviewers using a 10-point Visual Analogue Scale (VAS; range 0-10) and a 5-point Likert scale (range 1-5). Higher scores indicate a better aesthetic outcome.
Breast Symmetry Assessment
Breast symmetry will be evaluated using objective photographic analysis and volumetric assessment when available. Greater symmetry (corresponding to smaller differences between reconstructed and contralateral breasts) indicates a better aesthetic outcome.
Donor Site Morbidity
Assessment of donor-site sequelae and scar-related outcomes at the posterior thigh donor site.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
