NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap

NCT07728565

Not Yet RecruitingN/A

Sponsor: Assistance Publique - Hôpitaux de Paris

Conditions: Breast Cancer, Acquired Absence of Breast, Autologous Breast Reconstruction

Countries: France

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (1)

Paris, Île-de-France Region, France