Clinical trial NCT05842148: Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY)
Official title: IRONY: lIfe afteR ONcoplastic surgerY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Oncoplastic Breast Surgery
Therapeutic Mammoplasty
Chest Wall Perforated Flaps
Quality of Life
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: evaluation of post-surgical data
timeFrame: three years
measure: evaluation of resection volumes
timeFrame: three years
measure: evaluation of post-surgical staging criteria
timeFrame: three years
measure: evaluation of multifocality
timeFrame: three years
measure: evaluation of tumor biological profile
timeFrame: three years
measure: evaluation of any post-surgical associated complications
timeFrame: three years
Secondary outcomes:
measure: evaluation of post-surgical aesthetic results
timeFrame: three years
measure: 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.
timeFrame: three years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Paolo Orsaria, MD. PhD; [porsaria]
Study officials:
affiliation: Policlinico Universitario Campus Bio-Medico
name: Paolo Orsaria, Surgeon;
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.