RecruitingNCT05817175

International Prospective REgistry on Pre-pectorAl Breast REconstruction


Sponsor

IRCCS San Raffaele

Enrollment

1,236 participants

Start Date

Sep 12, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Female patients older than 18 years old
  • Signed informed consent form
  • Patients undergoing mono or bilateral therapeutic mastectomy
  • Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh

Exclusion Criteria4

  • Male patients
  • Patients not suitable for surgical treatment
  • Patients undergoing subpectoral reconstruction
  • Patients undergoing breast reconstruction with autologous tissue.

Interventions

PROCEDUREpre-pectoral breast reconstruction

to prospectively evaluate the utilization of the pre-pectoral approach, and evaluate oncological and aesthetic outcomes related to each type of surgical technique and the use of postmastectomy radiation therapy


Locations(11)

Univesidad de Buenos Aires

Buenos Aires, Argentina

Mansoura Insurance

Al Mansurah, Egypt

Mansoura Oncology

Al Mansurah, Egypt

National ans Kapodistrian University of Athens

Athens, Greece

Ospedale San Raffaele

Milan, MI, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, Italy

University Hospital of Karol Marcinkowski

Zielona Góra, Poland

Prof. Dr. Ion Chiricuta Institute of Oncology

Cluj-Napoca, Romania

Hospital del Mar

Barcelona, Spain

Marmara University School of medicine

Istanbul, Turkey (Türkiye)

University Hospitals of Leicester

Leicester, United Kingdom

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NCT05817175


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