Evaluation of quality of life after conservative oncoplastic surgery in patients with breast cancer
The aim of the study is the evaluation of the oncological, aesthetic and functional results after conservative oncoplastic breast surgery using unilateral or bilateral remodeling techniques in a prospective sample of 250 patients. Endpoints: * evaluation of post-surgical histopathological data with a selective focus on the achievement of oncological radicality in relation to the surgical technique ( resection volume, locoregional extension / TNM / multifocality and tumor biological profile) and any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).This data will be collected through the compilation of a database by the health personnel. * evaluation of aesthetic and functional results related to the quality of life after oncoplastic conservative surgery (unilateral or bilateral), as data perceived by the surgeon (technical analysis), and by the patient (psychosocial well-being, physical discomfort, adverse effects of radiotherapy). This data will be collected through the administration of a questionnaire whose data will be entered into the database by the healthcare personnel.
Study Type
OBSERVATIONAL
Enrollment
250
Control and review of pathological parameters (oncological radicality resection volume, locoregional extension / TNM / multifocality and tumor biological profile).
Control and review of post-surgical complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).
Paolo Orsaria, MD. PhD; [porsaria]
Roma, Italy
RECRUITINGevaluation of post-surgical data
focus on the achievement of oncological radicality in relation to the surgical technique (yes or no).
Time frame: three years
evaluation of resection volumes
focus on the resection volume in relation to the surgical technique (cm3).
Time frame: three years
evaluation of post-surgical staging criteria
focus on the locoregional extension (TNM staging criteria, American Joint Committee on Cancer, 8th edition)
Time frame: three years
evaluation of multifocality
focus on the multifocality (yes or no).
Time frame: three years
evaluation of tumor biological profile
focus on the tumor biological profile ( luminal A, luminal B HER2-, luminal B HER2+, HER2+, triple-negative).
Time frame: three years
evaluation of any post-surgical associated complications
focus on any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).
Time frame: three years
evaluation of post-surgical aesthetic results
focus on data perceived by the surgeon (technical analysis) through a questionnaire with scores ranging from 1 to 3.
Time frame: three years
evaluation of post-surgical functional results related to the quality of life after oncoplastic conservative surgery (unilateral or bilateral) through a questionnaire with scores ranging from 1 to 3.
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Control and review of technical analysis by the surgeon, and of psychosocial well-being, physical discomfort, adverse effects of radiotherapy by the patient collected through the administration of a questionnaire.
focus on data perceived by the patient (psychosocial well-being, physical discomfort, adverse effects of radiotherapy).
Time frame: three years