Clinical trial NCT02952430: Emergency Laparotomy and Frailty Study
Official title: Emergency Laparotomy and Frailty; a National Multicentre Prospective Cohort Study of Older Surgical Patients (ELF Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Frail Older Adult
Laparotomy
Lead sponsor: North Western Research Collaborative
Sponsor class: NETWORK
Collaborators: name: Older persons Surgical Outcomes Collaboration
First posted: 2016-11-02
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the emergency surgical department requiring an emergency 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: Post-operative complications
timeFrame: 30 days
measure: Lowering of independence status post-operatively
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Readmission
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
name: Susan Moug, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bisset CN, Carter B, Law J, Hewitt J, Parmar K, Moug SJ; ELF Study Group Collaborative Authorship. The influence of social media on recruitment to surgical trials. BMC Med Res Methodol. 2020 Jul 28;20(1):201. doi: 10.1186/s12874-020-01072-1.
citation: Parmar KL, Law J, Carter B, Hewitt J, Boyle JM, Casey P, Maitra I, Farrell IS, Pearce L, Moug SJ; ELF Study Group. Frailty in Older Patients Undergoing Emergency Laparotomy: Results From the UK Observational Emergency Laparotomy and Frailty (ELF) Study. Ann Surg. 2021 Apr 1;273(4):709-718. doi: 10.1097/SLA.0000000000003402.
citation: Parmar KL, Pearce L, Farrell I, Hewitt J, Moug S. Influence of frailty in older patients undergoing emergency laparotomy: a UK-based observational study. BMJ Open. 2017 Oct 6;7(10):e017928. doi: 10.1136/bmjopen-2017-017928.