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NCT Number: NCT07728565

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou

Paris, Île-de-France Region, 75015, France

Location contact

Laurent Lantieri, MD

CONTACT

[email protected]

+33 1 56 09 58 72

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. BREAST-Q Reconstruction Module Score

    Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction

    Quality of life evaluation

  2. PROMIS-29 Profile Score

    Time frame: 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).

Secondary outcomes

  1. Objective Aesthetic Outcome Assessment

    Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction

    Aesthetic outcome assessed using standardized clinical photographs and BCCT.core software analysis.

  2. Blinded Expert Panel Aesthetic Score

    Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction

    Aesthetic evaluation performed by a blinded panel of plastic surgeons and lay reviewers using visual analogue and Likert scales.

  3. Breast Symmetry Assessment

    Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction

    Breast symmetry evaluated using objective photographic analysis and volumetric assessment when available.

  4. Donor Site Morbidity

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Lhuaire, MD, PhD

CONTACT

[email protected]

+33 1 56 09 57 95

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: QUALIPAP

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

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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