Emergencies Clinical Trial
Official title:
Emergency Laparotomy and Frailty; a National Multicentre Prospective Cohort Study of Older Surgical Patients (ELF Study)
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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