Emergency Laparotomy and Frailty Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Emergency Laparotomy and Frailty; a National Multicentre Prospective Cohort Study of Older Surgical Patients (ELF Study)

Conditions
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Emergencies, Frail Older Adult, Laparotomy

Intervention / Treatment
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* Procedure: Emergency laparotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 65 years and older Admitted to emergency surgical departments Requiring an emergency laparotomy Exclusion Criteria: - Patients less than 65 years old

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Frail<br>Patients over 65 year old having emergency laparotomy with a Frailty score (Modified Rockwood score) of greater than or equal to five. This group will then be observed after intervention to review outcomes. | Procedure: Emergency laparotomy<br>* Patients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed.<br>|
| Not frail<br>Patients over 65 year old having emergency laparotomy with a Frailty score (Modified Rockwood score) of less than five. This group will then be observed after intervention to review outcomes. | Procedure: Emergency laparotomy<br>* Patients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Patient alive at 90 days (rounded up to the nearest whole day) post operatively | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | Evidence of post-operative complications at 30 days (rounded up to the nearest whole day) post operatively. Measured using the Clavein Dindo classification | 30 days | 
| Lowering of independence status post-operatively | Change in living status from pre to post operatively. Including increased care required at home and discharge to increased care (such as residential or nursing home care). | 30 days | 
| Length of stay | Length of hospital admission - rounded up to whole days | 30 days | 
| Readmission | All cause readmission to hospital for emergency care - within 30 days post-operatively (rounded up to the nearest whole day). | 30 days |