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

IRONY: lIfe afteR ONcoplastic surgerY

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: 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.

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Paolo Orsaria, MD, PhD;; Phone Number: 3282492485; Email: p.orsaria@policlinicocampus.it
• Study Contact Backup: Name: Policlinico Universitario Campus Bio-Medico; Phone Number: +3906225418812; Email: comitato.etico@policlinicocampus.it

Study Locations

• Italy
  • Roma, Italy, 00128
    • Recruiting
    • Paolo Orsaria, MD. PhD; [porsaria]
    • Contact: Paolo O MD. PhD; [porsaria]; Phone Number: 3282492485; Email: p.orsaria@policlinicocampus.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients with clinical-instrumental diagnosis of breast cancer, candidates for conservative oncoplastic surgery with type 1 and 2 procedures who give informed consent to the study, will be included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques.; 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.; Control and review of pathological parameters (oncological radicality resection volume, locoregional extension / TNM / multifocality and tumor biological profile).; Other: Study 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).; 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.; 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.
Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques.; 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.; Control and review of pathological parameters (oncological radicality resection volume, locoregional extension / TNM / multifocality and tumor biological profile).; Other: Study 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).; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Investigators: Principal Investigator: Paolo Orsaria, Surgeon;, Policlinico Universitario Campus Bio-Medico

Publications and helpful links

General Publications

• Orsaria P, Grasso A, Caggiati L, Altomare M, Altomare V. Update on oncoplastic techniques in breast conserving surgery: algorithms for predictable results and custom-made reconstructions. Minerva Surg. 2021 Dec;76(6):512-525. doi: 10.23736/S2724-5691.21.08976-0. Epub 2021 Aug 2.
• Cali Cassi L, Vanni G, Petrella G, Orsaria P, Pistolese C, Lo Russo G, Innocenti M, Buonomo O. Comparative study of oncoplastic versus non-oncoplastic breast conserving surgery in a group of 211 breast cancer patients. Eur Rev Med Pharmacol Sci. 2016 Jul;20(14):2950-4.
• Orsaria P, Grasso A, Soponaru G, Carnevale F, Scorsone V, Ippolito E, Pantano F, Sammarra M, Piccolo C, Altomare M, Perrone G, Altomare V. Subaxillary Replacement Flap Compared with the Round Block Displacement Technique in Oncoplastic Breast Conserving Surgery: Functional Outcomes of a Feasible One Stage Reconstruction. Curr Oncol. 2022 Nov 30;29(12):9377-9390. doi: 10.3390/curroncol29120736.
• Orsaria P, Grasso A, Ippolito E, Pantano F, Sammarra M, Altomare C, Cagli B, Costa F, Perrone G, Soponaru G, Caggiati L, Vanni G, Buonomo OC, Altomare V. Clinical Outcomes Among Major Breast Cancer Subtypes After Neoadjuvant Chemotherapy: Impact on Breast Cancer Recurrence and Survival. Anticancer Res. 2021 May;41(5):2697-2709. doi: 10.21873/anticanres.15051.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: April 22, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Therapeutic Mammoplasty; Oncoplastic Breast Surgery; Chest Wall Perforated Flaps
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PAR 13.23 OSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No