International Prospective REgistry on Pre-pectorAl Breast REconstruction
Recruiting · NCT05817175 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
pre-pectoral breast reconstruction
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Male patients
- Patients not suitable for surgical treatment
- Patients undergoing subpectoral reconstruction
- Patients undergoing breast reconstruction with autologous tissue.
Where it is running
11 locations listed.
- Mansoura Insurance - Al Mansurah, Egypt
- Mansoura Oncology - Al Mansurah, Egypt
- National ans Kapodistrian University of Athens - Athens, Greece
- Hospital del Mar - Barcelona, Spain
- Univesidad de Buenos Aires - Buenos Aires, Argentina
- Prof. Dr. Ion Chiricuta Institute of Oncology - Cluj-Napoca, Romania
- Marmara University School of medicine - Istanbul, Turkey (Türkiye)
- University Hospitals of Leicester - Leicester, United Kingdom
- University Hospital of Karol Marcinkowski - Zielona Góra, Poland
- Ospedale San Raffaele - Milan, MI, Italy
- Fondazione Policlinico Universitario Agostino Gemelli - Roma, RM, Italy