Prevalence of Multi-morbid Frailty in a Cohort of Subjects Undergoing Cancer Related Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- In-hospital mortality
研究概览
简要总结
Subjects undergoing cancer related surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori - Milano will be consecutively recruited. Data regarding presence of co-morbidities, frailty, cancer staging, and inflammatory status (CRP protein measurement) will be collected preoperatively. Intra-operative data collection will comprehend type and duration of surgery, kind of anesthesia, complications. In-hospital mortality will be considered as the primary endpoint, while secondary outcome measures will be duration of hospital stay and admission to intensive care.
详细描述
A prospective data collection of pre-intra and postoperative variables will be collected in a cohort of subjects undergoing cancer relate surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
BEFORE SURGERY Subjects will be stratified before surgery according to the following three main clusters: 1) Systemic inflammation: baseline levels of C Reactive Protein; 2) Cancer staging: TNM will be taken into account, together with the type of cancer, previous radio or chemo therapy, and planned/performed surgical procedure; 3) Frailty: subjects will be stratified according to their overall status, taking into account elements of frailty. Co-existing diseases such as diabetes, hypertension, cardiac heart failure, acute myocardial infarction, chronic obstructive disease/asthma, kidney or liver disease (past or present) will be considered. Functional status will be assessed by means of ASA, ECOG status and Possum scores. Frailty will be explored using the mFI and G8 score, the WHO scale, and considering age. Absolute BMI and loss of weight will be used to assess malnutrition.
DURING SURGERY Duration and type of surgery, kind of anesthesia and intra-operative complications will be considered.
AFTER SURGERY Hospital mortality, length of stay, and admission to intensive care will be considered as outcome measures. Major complications, such as myocardial infarction, arrhythmia, cardio circulatory arrest, shock, stroke, pulmonary embolism, kidney failure, delirium, pneumonia or SSI will also be considered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing cancer related surgery at the Fondazione IRCSS Istituto Nazionale dei Tumori, Milano
排除标准
- •Day case surgery
结局指标
主要结局
In-hospital mortality
时间窗: 30 days
次要结局
- Duration of hospital stay(30 days)
- Admission to intensive care.(30 days)
