Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Acquired Absence of Breast, Autologous Breast Reconstruction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- BREAST-Q Reconstruction Module Domain Scores [Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction]
- Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1) Domain Scores [Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction]
Secondary outcome measures (4)
- Breast Cancer Conservation Treatment cosmetic results (BCCT.core) Aesthetic Classification [Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction]
- Blinded Expert Panel Aesthetic Score [Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction]
- Breast Symmetry Assessment [Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction]
- Donor Site Morbidity [Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Po — Paris
Identifiers
NCT: NCT07728565 · APHP251552