Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY)

Study Overview
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Brief Summary
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Evaluation of quality of life after conservative oncoplastic surgery in patients with breast cancer

Detailed Description
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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.

Official Title
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IRONY: lIfe afteR ONcoplastic surgerY

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.
* Other: Study and recording of any associated post-surgical complications (of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.
* Other: Study 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.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques.<br>All patients with clinical-instrumental diagnosis of breast cancer, candidates for conservative oncoplastic surgery who give informed consent to the study, will be included in the study. Type 1 procedures generally involve a unilateral approach, able to guarantee good resective quality, without a significant alteration of the volume with respect to the contralateral breast. Post-surgical histopathological data and any associated postsurgical complications will be collected through the compilation of a database. Aesthetic and functional post-surgical results related to the quality of life, as data perceived by the surgeon and by the patient, will be collected through the administration of a questionnaire. | Other: Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.<br>* Control and review of pathological parameters (oncological radicality resection volume, locoregional extension / TNM / multifocality and tumor biological profile).<br>Other: Study and recording of any associated post-surgical complications (of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.<br>* Control and review of post-surgical complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).<br>Other: Study 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.<br>* 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.<br>|
| Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques.<br>All patients with clinical-instrumental diagnosis of breast cancer, candidates for conservative oncoplastic surgery who give informed consent to the study, will be included in the study. Type 2 procedures (therapeutic mammoplasty), offer a greater resective potential, but generally require the use of contralateral surgery to obtain symmetry, simultaneous or delayed. Post-surgical histopathological data and any associated postsurgical complications will be collected through the compilation of a database. Aesthetic and functional post-surgical results related to the quality of life, as data perceived by the surgeon and by the patient, will be collected through the administration of a questionnaire. | Other: Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.<br>* Control and review of pathological parameters (oncological radicality resection volume, locoregional extension / TNM / multifocality and tumor biological profile).<br>Other: Study and recording of any associated post-surgical complications (of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.<br>* Control and review of post-surgical complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).<br>Other: Study 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.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of post-surgical data | focus on the achievement of oncological radicality in relation to the surgical technique (yes or no). | three years | 
| evaluation of resection volumes | focus on the resection volume in relation to the surgical technique (cm3). | three years | 
| evaluation of post-surgical staging criteria | focus on the locoregional extension (TNM staging criteria, American Joint Committee on Cancer, 8th edition) | three years | 
| evaluation of multifocality | focus on the multifocality (yes or no). | three years | 
| evaluation of tumor biological profile | focus on the tumor biological profile ( luminal A, luminal B HER2-, luminal B HER2+, HER2+, triple-negative). | 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). | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | focus on data perceived by the patient (psychosocial well-being, physical discomfort, adverse effects of radiotherapy). | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncoplastic Breast Surgery, Therapeutic Mammoplasty, Chest Wall Perforated Flaps, Quality of Life