Quality of Life After Conservative Oncoplastic Surgery in... | NCT05842148 | Trialant

Quality of Life After Conservative Oncoplastic Surgery in... | NCT05842148 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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. 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.
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Study and recording of post-surgical clinical and pathological data of patients diagnosed with breast cancer undergoing unilateral or bilateral conservative oncoplastic surgery.	Other	Control and review of pathological parameters (oncological radicality resection volume, locoregional extension / TNM / multifocality and tumor biological profile).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

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.

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paolo Orsaria, MD, PhD;	Contact	3282492485		p.orsaria@policlinicocampus.it
Policlinico Universitario Campus Bio-Medico	Contact	+3906225418812		comitato.etico@policlinicocampus.it

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34338466	Background	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.
27460720	Background	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.