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

Recruiting

• Conditions: Breast Cancer

• 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.

Study Timeline

• Study Start: 2023-03-25
• Study First Submitted: 2023-04-08
• Study First Submitted QC: 2023-04-22
• Status Verified: 2023-05
• Study First Posted: 2023-05-03
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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