Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY)
NCT ID: NCT05842148
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2023-03-25
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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).
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).
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.
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).
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).
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.
Interventions
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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).
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).
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.
Eligibility Criteria
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Inclusion Criteria
* Must be able for conservative oncoplastic surgery with type 1 and 2 procedures who give informed consent to the study.
Exclusion Criteria
* Patients in emergency situations
* Subjects unable to understand and want
18 Years
85 Years
FEMALE
No
Sponsors
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Campus Bio-Medico University
OTHER
Responsible Party
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Paolo Orsaria, MD. PhD;
Oncoplastic Breast Surgery Consultant
Principal Investigators
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Paolo Orsaria, Surgeon;
Role: PRINCIPAL_INVESTIGATOR
Policlinico Universitario Campus Bio-Medico
Locations
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Paolo Orsaria, MD. PhD; [porsaria]
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PAR 13.23 OSS
Identifier Type: -
Identifier Source: org_study_id
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