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.
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
Male patients
Patients not suitable for surgical treatment
Patients undergoing subpectoral reconstruction
Patients undergoing breast reconstruction with autologous tissue.
All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient. The therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.
Cohort
Prospective
pre-pectoral breast reconstruction
Procedure/Surgeryto 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
Number of patients with Implant-loss at three months postoperatively
Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication
Number of patients with Infection
Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary;
Number of patients with re-admission and re-operation
Rate of re-admission and re-operation
Evaluation of Quality of life
Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire)
Number of Early onset complication
Early onset complication at 3 month follow up: seroma, hematoma/bleeding, skin flap or T junction necrosis, nipple necrosis, wound dehiscence, implant malposition (i.e. rotation, displacement etc..), red-breast syndrome
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European Breast Cancer Research Association of Surgical Trialists
Lead sponsor
IRCCS San Raffaele
Sponsor institution
EUBREAST ETS
Collaborator