Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruc… (NCT07728565) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap
France264 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
BREAST-Q Reconstruction Module Domain Scores
Timeframe: At study assessment, at least 2 years after PAP flap breast reconstruction
2
Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1) Domain Scores
Timeframe: At study assessment, at least 2 years after PAP flap breast reconstruction