Acquired Absence of Breast, Autologous Breast Reconstruction, Breast Cancer
Conditions
Keywords
PAP Flap, Profunda Artery Perforator Flap, Breast Reconstruction, Autologous Breast Reconstruction, Quality of Life, BREAST-Q, PROMIS-29, Aesthetic Outcome, Donor Site Morbidity, Mastectomy
Brief 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.
Detailed description
Background Autologous breast reconstruction is associated with improved patient satisfaction and quality of life after mastectomy. While the deep inferior epigastric perforator (DIEP) flap is considered the standard autologous reconstruction technique, the profunda artery perforator (PAP) flap has emerged as an effective alternative for patients lacking adequate abdominal donor tissue. Despite increasing use of the PAP flap, long-term evidence regarding patient-reported outcomes and objective aesthetic results remains limited. Objective The primary objective is to assess long-term quality of life after breast reconstruction using a PAP flap. Secondary objectives include evaluation of aesthetic outcomes, donor-site morbidity, and correlations between objective and subjective measures of reconstructive success. Study Design This is a single-center, observational, non-interventional study conducted at the Department of Plastic Surgery, European Georges Pompidou Hospital (Paris, France). Women who underwent unilateral or bilateral breast reconstruction using a PAP flap between 2014 and 2024 will be contacted and invited to participate. Outcome Assessment Primary Outcome Quality of life will be assessed using validated patient-reported outcome measures: BREAST-Q Reconstruction Module (French version) PROMIS-29 Profile (French version) Assessments will be performed at least two years after reconstruction. Secondary Outcomes Aesthetic outcomes will be evaluated through a multimodal approach including: Standardized clinical photographs Objective photographic analysis using BCCT.core software Volumetric and symmetry assessment when available Blinded evaluation by a panel of plastic surgeons and lay reviewers Additional analyses will explore the relationship between objective aesthetic measurements and patient-reported satisfaction. Study Population Approximately 264 women who underwent PAP flap breast reconstruction between 2014 and 2024 at the European Georges Pompidou Hospital will be eligible. Significance The study will provide valuable long-term data regarding quality of life, patient satisfaction, aesthetic outcomes, and donor-site sequelae after PAP flap breast reconstruction. These findings may improve patient counseling and optimize reconstructive decision-making for women undergoing breast cancer treatment.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Provided non-opposition/consent to participate according to French regulations.
Exclusion criteria
* 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. * Severe cognitive impairment or major psychiatric disorder preventing questionnaire completion. * Hearing impairment preventing participation in the interview process. * Insufficient French language proficiency. * Missing essential clinical data. * Explicit refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cancer Conservation Treatment cosmetic results (BCCT.core) Aesthetic Classification | At study assessment, at least 2 years after PAP flap breast reconstruction | 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 | At study assessment, at least 2 years after PAP flap breast reconstruction | 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 | At study assessment, at least 2 years after PAP flap breast reconstruction | 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 | At study assessment, at least 2 years after PAP flap breast reconstruction | Assessment of donor-site sequelae and scar-related outcomes at the posterior thigh donor site. |
Countries
France
Contacts
CONTACTMartin Lhuaire, MD, PhD
STUDY_CHAIRLaurent Lantieri, MD
Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015
Outcome results
None listed