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Trial Title:
Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY)
NCT ID:
NCT05842148
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Oncoplastic Breast Surgery
Therapeutic Mammoplasty
Chest Wall Perforated Flaps
Quality of Life
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.
Description:
Control and review of pathological parameters (oncological radicality resection volume,
locoregional extension / TNM / multifocality and tumor biological profile).
Arm group label:
Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques.
Arm group label:
Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques.
Intervention type:
Other
Intervention name:
Study and recording of any associated post-surgical complications (of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.
Description:
Control and review of post-surgical complications (dehiscence, liponecrosis, infection,
seroma, hematoma, fibrosis, scar hypertrophy).
Arm group label:
Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques.
Arm group label:
Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques.
Intervention type:
Other
Intervention name:
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.
Description:
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.
Arm group label:
Patients undergoing oncoplastic surgery with type 1 (unilateral) techniques.
Arm group label:
Patients undergoing oncoplastic surgery with type 2 (bilateral) techniques.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Paolo Orsaria, MD. PhD; [porsaria]
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo O MD. PhD; [porsaria]
Phone:
3282492485
Email:
p.orsaria@policlinicocampus.it
Start date:
March 25, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Campus Bio-Medico University
Agency class:
Other
Source:
Campus Bio-Medico University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842148
