Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY)
- Conditions
- Breast Cancer
- Interventions
- 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.
- Registration Number
- NCT05842148
- Lead Sponsor
- Campus Bio-Medico University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 250
- 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.
- Patients who are pregnant or breastfeeding
- Patients in emergency situations
- Subjects unable to understand and want
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques. Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery. 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. Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques. Study and recording of any associated post-surgical complications (of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery. 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. Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques. Study and recording of any associated post-surgical complications (of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery. 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. Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques. 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. 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. Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques. Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery. 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. Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques. 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. 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.
- Primary Outcome Measures
Name Time Method 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 post-surgical staging criteria three years focus on the locoregional extension (TNM staging criteria, American Joint Committee on Cancer, 8th edition)
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 resection volumes three years focus on the resection volume in relation to the surgical technique (cm3).
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).
- Secondary Outcome Measures
Name Time Method 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.
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).
Trial Locations
- Locations (1)
Paolo Orsaria, MD. PhD; [porsaria]
🇮🇹Roma, Italy