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

Campus Bio-Medico University of Rome

Status: Enrolling

Conditions: Breast Cancer

Treatments: 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.; Other: Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.

Study type: Observational

Funder types: Other

Identifiers

NCT05842148

PAR 13.23 OSS

Details and patient eligibility

About

Evaluation of quality of life after conservative oncoplastic surgery in patients with breast cancer

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques.

Description:

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.

Treatment:

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.

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 post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.

Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques.

Description:

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.

Treatment:

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.

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 post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.