Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- BREAST-Q Reconstruction Module Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PAP Flap Breast Reconstruction
Women aged 18 years or older who underwent unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap following mastectomy for breast cancer between 2014 and 2024 at the European Georges Pompidou Hospital (Paris, France). Participants will complete BREAST-Q and PROMIS-29 questionnaires and undergo standardized clinical and photographic assessment to evaluate long-term quality of life, aesthetic outcomes, and donor-site morbidity.
结局指标
主要结局
BREAST-Q Reconstruction Module Score
时间窗: At study assessment, at least 2 years after PAP flap breast reconstruction
Quality of life evaluation
PROMIS-29 Profile Score
时间窗: At study assessment, at least 2 years after PAP flap breast reconstruction
Long-term health-related quality of life measured using the PROMIS-29 Profile questionnaire (French version).
BREAST-Q Reconstruction Module Domain Scores
时间窗: 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.
Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1) Domain Scores
时间窗: 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.
次要结局
- Objective Aesthetic Outcome Assessment(At study assessment, at least 2 years after PAP flap breast reconstruction)
- Donor Site Morbidity(At study assessment, at least 2 years after PAP flap breast reconstruction)
- Blinded Expert Panel Aesthetic Score(At study assessment, at least 2 years after PAP flap breast reconstruction)
- Breast Symmetry Assessment(At study assessment, at least 2 years after PAP flap breast reconstruction)
- Breast Cancer Conservation Treatment cosmetic results (BCCT.core) Aesthetic Classification(At study assessment, at least 2 years after PAP flap breast reconstruction)