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

Browse trials for

• Breast Neoplasms 12,544

Keywords

• Oncoplastic Breast Surgery
• Therapeutic Mammoplasty
• Chest Wall Perforated Flaps
• Quality of Life

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 250 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Lead sponsor

Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.

Study population

Groups and cohorts

• 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. · 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.

Interventions

• OtherStudy 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).

• OtherStudy 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).

• OtherStudy 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.

Primary outcomes

1. evaluation of post-surgical data

   focus on the achievement of oncological radicality in relation to the surgical technique (yes or no).

   Time frame: three years

2. evaluation of resection volumes

   focus on the resection volume in relation to the surgical technique (cm3).

   Time frame: three years

3. evaluation of post-surgical staging criteria

   focus on the locoregional extension (TNM staging criteria, American Joint Committee on Cancer, 8th edition)

   Time frame: three years

4. evaluation of multifocality

   focus on the multifocality (yes or no).

   Time frame: three years

5. evaluation of tumor biological profile

   focus on the tumor biological profile ( luminal A, luminal B HER2-, luminal B HER2+, HER2+, triple-negative).

   Time frame: three years

6. evaluation of any post-surgical associated complications

   focus on any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).

   Time frame: three years

Secondary outcomes

1. 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.

   Time frame: three years

2. 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).

   Time frame: three years

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. PubMed 34338466 ↗
• 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. PubMed 27460720 ↗
• 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. PubMed 36547150 ↗
• 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. PubMed 33952501 ↗

Individual participant data

Plan to share: Undecided