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Emergency Laparotomy and Frailty Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02952430
Acronym
ELF
Enrollment
500
Registered
2016-11-02
Start date
2016-12-31
Completion date
2017-05-31
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies, Frail Older Adult, Laparotomy

Brief summary

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

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.

Interventions

Patients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed.

Sponsors

Older persons Surgical Outcomes Collaboration
CollaboratorUNKNOWN
North Western Research Collaborative
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality90 daysPatient alive at 90 days (rounded up to the nearest whole day) post operatively

Secondary

MeasureTime frameDescription
Post-operative complications30 daysEvidence of post-operative complications at 30 days (rounded up to the nearest whole day) post operatively. Measured using the Clavein Dindo classification
Lowering of independence status post-operatively30 daysChange 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).
Length of stay30 daysLength of hospital admission - rounded up to whole days
Readmission30 daysAll cause readmission to hospital for emergency care - within 30 days post-operatively (rounded up to the nearest whole day).

Contacts

Primary ContactKat Parmar, MBChB, MSc
klparmar@hotmail.co.uk07817296021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026