IRONY: lIfe afteR ONcoplastic surgerY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- evaluation of post-surgical data
研究概览
简要总结
Evaluation of quality of life after conservative oncoplastic surgery in patients with breast cancer
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who are pregnant or breastfeeding
- •Patients in emergency situations
- •Subjects unable to understand and want
结局指标
主要结局
evaluation of post-surgical data
时间窗: three years
focus on the achievement of oncological radicality in relation to the surgical technique (yes or no).
evaluation of post-surgical staging criteria
时间窗: three years
focus on the locoregional extension (TNM staging criteria, American Joint Committee on Cancer, 8th edition)
evaluation of multifocality
时间窗: three years
focus on the multifocality (yes or no).
evaluation of tumor biological profile
时间窗: three years
focus on the tumor biological profile ( luminal A, luminal B HER2-, luminal B HER2+, HER2+, triple-negative).
evaluation of resection volumes
时间窗: three years
focus on the resection volume in relation to the surgical technique (cm3).
evaluation of any post-surgical associated complications
时间窗: three years
focus on any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).
次要结局
- evaluation of post-surgical aesthetic results(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.(three years)
研究者
Paolo Orsaria, MD. PhD;
Oncoplastic Breast Surgery Consultant
Campus Bio-Medico University