Emergency Laparotomy and Frailty; a National Multicentre Prospective Cohort Study of Older Surgical Patients (ELF Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 主要终点
- Mortality
研究概览
简要总结
Patients aged over 65 comprise more than half the emergency general surgical workload, however, available risk-prediction tools for such patients are extrapolated from younger cohorts. Research suggests that high pre-operative frailty scores correlate with increased post-operative mortality and morbidity. Validated frailty assessments may help identify high risk older emergency surgical patients, facilitating decision-making and informing patient choice.
We propose the first prospective UK observational study assessing frailty as an independent predictor of outcome in the older surgical patient undergoing emergency laparotomy.
Prospective data collection of patients over 65 undergoing emergency laparotomy will be performed in 20 NHS Trusts. Pre-operative frailty scores will be evaluated using the Rockwood Frailty Scale. Primary outcome measure is 30-day mortality. Secondary outcome measures are post-operative complications, altered independence status and length of stay.
Results will be disseminated at national/international surgical meetings and published in a peer-reviewed journal.
详细描述
The ELF steering committee will run this project as part of the North West Research Collaborative(NWRC), consisting of surgical trainees with a successful record of publishing credible research and establishing clinical trials.
Following ethical approval, data will be collected from NHS Trusts throughout the UK. Trained leads will facilitate data collection adhering to a study protocol and local clinical governance.
Patients over 65 undergoing emergency laparotomy will be identified prospectively over 3 months. Demographics, time to surgical intervention, length of stay(LOS), pre- and post-admission independence, intermediate care stay, Clavien-Dindo post-operative complications, 30-day mortality and 30-day re-admission data will be collected on a secure database. Pre-operative frailty will be assessed using the Rockwood Frailty Scale.
500 patients are required for a statistically significant difference in primary outcome (30 day mortality). Secondary outcome measures are complications, change in independence status and LOS. Outcomes will be analysed to compare the impact of frailty.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years and older
- •Admitted to emergency surgical departments
- •Requiring an emergency laparotomy
排除标准
- •Patients less than 65 years old
结局指标
主要结局
Mortality
时间窗: 90 days
Patient alive at 90 days (rounded up to the nearest whole day) post operatively
次要结局
- Post-operative complications(30 days)
- Lowering of independence status post-operatively(30 days)
- Length of stay(30 days)
- Readmission(30 days)