Breast Cancer
Conditions
Keywords
Oncoplastic Breast Surgery, Therapeutic Mammoplasty, Chest Wall Perforated Flaps, Quality of Life
Brief summary
Evaluation of quality of life after conservative oncoplastic surgery in patients with breast cancer
Detailed description
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.
Interventions
OTHERStudy and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.
Control and review of pathological parameters (oncological radicality resection volume, locoregional extension / TNM / multifocality and tumor biological profile).
OTHERStudy and recording of any associated post-surgical complications (of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.
Control and review of post-surgical complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).
OTHERStudy and recording of aesthetic and functional post-surgical results related to the quality of life, as data perceived by the surgeon (technical analysis), and by the patient.
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.
Sponsors
Campus Bio-Medico University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of breast cancer * Must be able for conservative oncoplastic surgery with type 1 and 2 procedures who give informed consent to the study.
Exclusion criteria
* Patients who are pregnant or breastfeeding * Patients in emergency situations * Subjects unable to understand and want
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of any post-surgical associated complications | three years | focus on any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy). |
| evaluation of multifocality | three years | focus on the multifocality (yes or no). |
| evaluation of tumor biological profile | three years | focus on the tumor biological profile ( luminal A, luminal B HER2-, luminal B HER2+, HER2+, triple-negative). |
| evaluation of post-surgical data | three years | focus on the achievement of oncological radicality in relation to the surgical technique (yes or no). |
| evaluation of resection volumes | three years | focus on the resection volume in relation to the surgical technique (cm3). |
| evaluation of post-surgical staging criteria | three years | focus on the locoregional extension (TNM staging criteria, American Joint Committee on Cancer, 8th edition) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | three years | focus on data perceived by the patient (psychosocial well-being, physical discomfort, adverse effects of radiotherapy). |
| evaluation of post-surgical aesthetic results | three years | focus on data perceived by the surgeon (technical analysis) through a questionnaire with scores ranging from 1 to 3. |
Countries
Italy
Contacts
Primary ContactPaolo Orsaria, MD, PhD;
Backup ContactPoliclinico Universitario Campus Bio-Medico
Outcome results
None listed