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

NCT07728565 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 264

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Breast Cancer
  • Acquired Absence of Breast
  • Autologous Breast Reconstruction

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Laurent Lantieri, MD · Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-08-31
Completion
2028-08-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728565 on ClinicalTrials.gov