Emergency Laparotomy and Frailty Study

Emergencies Clinical Trial

— ELF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02952430
• Other study ID #: NWRC- ELF
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2016
• Last updated: November 1, 2016
• Start date: December 2016
• Est. completion date: May 2017

Study information

• Verified date: October 2016
• Source: North Western Research Collaborative
• Contact: Kat Parmar, MBChB, MSc
• Phone: 07817296021
• Email: klparmar[@]hotmail.co.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Frail Older Adult
• Laparotomy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
North Western Research Collaborative	Older persons Surgical Outcomes Collaboration

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Patient alive at 90 days (rounded up to the nearest whole day) post operatively	90 days	No
Secondary	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	No
Secondary	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	No
Secondary	Length of stay	Length of hospital admission - rounded up to whole days	30 days	No
Secondary	Readmission	All cause readmission to hospital for emergency care - within 30 days post-operatively (rounded up to the nearest whole day).	30 days	No