Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, 75015, France
NCT Number: NCT07728565
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Paris, Île-de-France Region, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
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.
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Health-related quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1, French version). Scores are reported as standardized T-scores (population mean = 50, SD = 10; typical observed range approximately 20-80). Higher scores indicate better health for the Physical Function and Ability to Participate in Social Roles domains, whereas higher scores indicate worse symptoms for Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity domains.
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Aesthetic outcome will be evaluated using standardized clinical photographs analyzed with Breast Cancer Conservation Treatment cosmetic results (BCCT.core) software. Cosmetic results are classified into four categories: Excellent, Good, Fair, and Poor, with Excellent representing the best aesthetic outcome and Poor the worst aesthetic outcome.
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Standardized photographs will be independently evaluated by blinded plastic surgeons and lay reviewers using a 10-point Visual Analogue Scale (VAS; range 0-10) and a 5-point Likert scale (range 1-5). Higher scores indicate a better aesthetic outcome.
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Breast symmetry will be evaluated using objective photographic analysis and volumetric assessment when available. Greater symmetry (corresponding to smaller differences between reconstructed and contralateral breasts) indicates a better aesthetic outcome.
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Assessment of donor-site sequelae and scar-related outcomes at the posterior thigh donor site.
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: QUALIPAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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