NCT02952430

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 2, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 31, 2016

Last Update Submit

November 1, 2016

Conditions

EmergenciesFrail Older AdultLaparotomy

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Patient alive at 90 days (rounded up to the nearest whole day) post operatively

    90 days

Secondary Outcomes (4)

  • Post-operative complications

    30 days

  • Lowering of independence status post-operatively

    30 days

  • Length of stay

    30 days

  • Readmission

    30 days

Study Arms (2)

Frail

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

Not frail

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

Interventions

Emergency laparotomyPROCEDURE

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

FrailNot frail

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the emergency surgical department requiring an emergency laparotomy

You may qualify if:

  • Patients aged 65 years and older
  • Admitted to emergency surgical departments
  • Requiring an emergency laparotomy

You may not qualify if:

  • \- Patients less than 65 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 32723388DERIVED

  • 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.

    PMID: 31188201DERIVED

  • 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.

    PMID: 28988184DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susan Moug, MBChB, PhD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kat Parmar, MBChB, MSc

CONTACT

07817296021klparmar@hotmail.co.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

November 2, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share