Clinical trial · Observational
Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acquired Absence of Breast | — | UNRESOLVED | — |
| Autologous Breast Reconstruction | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- PAP Flap Breast Reconstruction
- description
- Women aged 18 years or older who underwent unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap following mastectomy for breast cancer between 2014 and 2024 at the European Georges Pompidou Hospital (Paris, France). Participants will complete BREAST-Q and PROMIS-29 questionnaires and undergo standardized clinical and photographic assessment to evaluate long-term quality of life, aesthetic outcomes, and donor-site morbidity.
Primary outcomes (2)
- measure
- BREAST-Q Reconstruction Module Domain Scores
- timeFrame
- At study assessment, at least 2 years after PAP flap breast reconstruction
- description
- 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.
- measure
- Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1) Domain Scores
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available