Assessing Frailty and Its Impacts in Older Patients Facing Major Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
研究概览
简要总结
The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future.
详细描述
Over 40% of patients with bowel cancer are over the age of 75. In older patients, rates of ill health and frailty are high, with frailty found in 6 in 10 patients over the age of 90. Surgery is the main treatment for bowel cancer, but the risks of surgery are higher in older people especially if they are frail. The main features of frailty are weight loss, lack of energy, weakness, slow walking speed and low activity levels. Frailty is a condition linked to an increased risk of death and major complications after surgery. As a result, older and frailer patients are often refused surgery for their cancer. If we could identify frailty more reliably before surgery, we could offer patients better counselling about the surgical risks and benefits. We could also offer treatments that might improve their fitness, making the surgery safer (pre-operative exercise, better post-operative support). Surgeons are not very good at measuring frailty because the clinical tests for it are complicated and take a long time to complete.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •Aged 70 years and over.
- •Patients with a diagnosis of primary operable colorectal cancer where treatment includes a planned curative surgical procedure.
- •About to undergo elective surgery for cancer.
- •Mental capacity to consent.
排除标准
- •Patients with unresectable cancer.
- •Patients presenting as an emergency.
- •Patients who are having chemotherapy or radiotherapy before their surgery.
结局指标
主要结局
The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
时间窗: 01/12/2029
A further potential measure of frailty is tissue levels of senescence. Senescent cells are rare in the tissues of young organisms but become more common as tissues age, especially in adipose tissue, muscle and skin (Tchkonia et al., 2010). Both ageing and frailty are associated with cellular senescence, a mechanism of irreversible cell cycle arrest caused by persistent stress and damage, which contributes to the process of ageing, frailty and a range of diseases (Xu et al., 2018; Hickson et al., 2019). Senescent cells are causal to a wide range of diseases such as arthritis, arteriosclerosis and dementia and are also linked to the development of frailty in animal models.
The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
时间窗: 01/12/2029
The development of biochemical assessments of frailty could also provide valuable information to guide the treatment of the older patient although there are very few that have been validated for clinical use across a range of settings.
The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
时间窗: 01/12/2029
A simple, validated biomarker of frailty, capable of identification of patients who are at an increased risk of adverse outcomes from surgery, would be of great value in the surgical decision-making process.
次要结局
- Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)(01/12/2029)
- Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events)(01/12/2029)
- Overall survival at 3 months and 5 years (the latter via cancer registry returns)(01/12/2029)
- Adverse events related to surgery assessed CTCAE classifications(01/12/2029)
- Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0.(01/12/2029)
- Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L(01/12/2029)
- Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)(01/12/2029)