Frailty In Thoracic Surgery for Esophageal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The portion of frail patients undergoing esophageal resection and 6 -month all-cause of mortality
研究概览
简要总结
Background: In Demark we se an increasing life expectancy and an increasing incidence of esophageal cancer and gastroesophageal junction (c.esophagus), with an average age of 65 years at diagnosis time. The consequence of this is an increased number of patients in need of esophageal resection. Esophageal cancer is currently treated with chemotherapy, radiotherapy and, whenever possible, esophageal resection. This multimodal treatment has increased survival, but is also associated with significant morbidity, mortality and adverse postoperative quality of life. At present, there is no standardized risk assessment for patients with c.esophagus who have to undergo esophageal resection.
This study evaluates the preoperative risk using the frailty score system, CAF (comprehensive assessment of frailty) score, which identify patients being frail or not based on an assessment of the patient's physical condition.
Purpose: Investigate how many patients that are frail undergoing esophageal resection.
With the assumptions that CAF score can identify frail patients and that frail patients, have an increased risk of postoperative complications. With CAF score, we believe to become better of predicting complications following esophageal resection.
Method: Prospective observational study of patients with c.esophagus undergoing esophageal resection. Plan to include 60 patients over one year period. The patients are deemed frail or not with the use of CAF score, which consist of various smaller physical test and questions.
Postoperativley a follow-up after 30-days, six month and 12 month. At follow-up times, data are collected on the somatic readmissions / diagnoses and vital status. Afterwards we compare complications, mortality and quality of life in frail versus non-frail patients.
Side effects, risks and disadvantages: At present, there is no standardized risk assessment used for preoperative risk assessment for patients with c.esophagus undergoing esophageal resection. The introduction of CAF score, will not expose patients to a risk or side effect, since the course or treatment does not change.
Economy: We consider the study to be economically justified, since we hypothesize that this would lead to fewer readmissions, days of intensive care and shorter hospitalization.
Acquisition: The patients will be 60 years or older and are undergoing esophageal resection. They will receive verbal- and written information preoperatively. At the first appearance they meet our project assistant who will answer any questions. Subsequently, the patients will be asked to sign a consent form.
Publication of test results / research ethics statement: The knowledge and results gained through the research will provide essential scientific information of significans for the future course and treatment of patients undergoing esophageal resection in terms of number of hospital days, intensive days and readmissions.
详细描述
Background: The incidence of esophageal cancer and gastroesophageal junction (c.esophagus) has increased significantly in recent decades. In addition, an increasing life expectancy is seen in Denmark and the average age for diagnosis of c. Esophagus is 65 years. Consequences of this are that we are currently seeing an increased number of patients in need of esophageal resection. Esophageal cancer is currently treated with chemotherapy and radiotherapy and, whenever possible, esophageal resection. This multimodal treatment has increased survival, but is also associated with significant morbidity, mortality and adverse postoperative quality of life. C. Esophagus is among the top ten causes of cancer-related deaths worldwide.
At present, there is no standardized risk assessment for patients with c.esophagus who have to undergo esophageal resection and the subjective assessment is often poor in predicting the postoperative course. A few studies have examined the objective assessment of patients' biological age, also called "frailty," in patients with esophageal cancer who need to be resected. Frailty is a term used to assess the true biological status of a patient and defined as a patient's impaired resistance to stressors due to a decline in physiologic reserve.
It has been shown that up to 57% of patients are pre-frail and that frailty is associated with high postoperative mortality and morbidity. Therefore, there is a need to validate preoperative frailty assessment in patients with c.esophagus, to find those surgically vulnerable patients who may benefit from pre-habilitation prior to surgery, postoperative or those patients who cannot tolerate surgery at all.
For frailty assessment in surgical patients, several different tools are found in the literature. None of these frailty risk scores are fully validated and therefore widely adopted. In German and Denmark two larger studies investigated frailty with the use of Comprehensive assessment of frailty (CAF) score, in patients undergoing cardiac surgery. They found CAF score to be strong predictor of mortality and morbidity after surgery. CAF score is based on an assessment of the patient's physical condition based on questions about the patient's medical history and daily physical activity as well as performing minor physical tests, consisting of strength, balance and walking speed. If the patient has a poorer physical condition than expected, the patient is deemed frail.
Aim: In an observational prospective study, we will identify and describe the number of frail patients undergoing first time esophageal resection in our department, compare the risk of short-term and long-term complications and compare quality of life in frail versus non-frail patients. Frailty will be assessed with CAF-score.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 60 years or older
- •Diagnosed with esophageal cancer being squamous-cell carcinoma or adenocarcinoma
- •Referred to esophageal resection
排除标准
- •Not Danish speaking. Need of an interpreter
- •Severe neuropsychiatric impairment
- •Not cooperative (psychiatric diagnosis)
- •Earlier esophageal resection
结局指标
主要结局
The portion of frail patients undergoing esophageal resection and 6 -month all-cause of mortality
时间窗: one year
Identify number of frail patients undergoing esophageal resection. The patients are deemed frail by score comprehensive assessment of frailty. 6 month all-cause mortality in frail vs. non-frail patients (hospital mortality or death within 6 month postoperatively).
次要结局
- One-year all-cause mortality in frail vs. non-frail patients One-year all-cause mortality in frail vs. non-frail patients One-year all-cause mortality in frail vs. non-frail patients(one year)
研究者
Mette Siemsen
Doctor of Medical Science, Principal investigator
Rigshospitalet, Denmark
