EmergenciesELFNCT02952430
Emergency Laparotomy and Frailty Study
An observational study of Emergencies and Frail Older Adult, run by North Western Research Collaborative.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Emergencies, Frail Older Adult, Laparotomy
- What is being tested?
- Emergency laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to the emergency surgical department requiring an emergency laparotomy
Who may be able to join
- Patients aged 65 years and older
- Admitted to emergency surgical departments
- Requiring an emergency laparotomy
Who cannot join
- Patients less than 65 years old
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Emergency Laparotomy and Frailty; a National Multicentre Prospective Cohort Study of Older Surgical Patients (ELF Study)
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.
Read more
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.
Read the 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.
- Conditions
- Emergencies, Frail Older Adult, Laparotomy
- Being tested
- Emergency laparotomy
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency laparotomyProcedure or surgery
Patients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Emergency laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patient alive at 90 days (rounded up to the nearest whole day) post operatively
Measured: 90 days
Secondary outcomes (4)
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
Measured: 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).
Measured: 30 days
Length of stay
Length of hospital admission - rounded up to whole days
Measured: 30 days
Readmission
All cause readmission to hospital for emergency care - within 30 days post-operatively (rounded up to the nearest whole day).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Western Research Collaborative
- Sponsor type
- Research network
- Collaborators
- Older persons Surgical Outcomes Collaboration
- Responsible party
- Sponsor
- Investigators
- Susan Moug, MBChB, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952430
- Sponsor's protocol ID
- NWRC- ELF
- Acronym
- ELF
- Status last verified
- Oct 2016
- First submitted
- 31 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32723388Parmar 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.
PubMed 31188201Parmar 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.
PubMed 28988184
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Laparotomy and Frailty; a National Multicentre Prospective Cohort Study of Older Surgical Patients (ELF Study)
- ClinicalTrials.gov ID
- NCT02952430
- Acronym / sponsor ID
- ELF / NWRC- ELF
- Conditions
- Emergencies, Frail Older Adult, Laparotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- North Western Research CollaborativeResearch network
- Collaborators
- Older persons Surgical Outcomes Collaboration
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail | – | Procedure: Emergency laparotomyPatients 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. |
| Not frail | – | Procedure: Emergency laparotomyPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the emergency surgical department requiring an emergency laparotomy
Key inclusion criteria (3 listed)
- Patients aged 65 years and older
- Admitted to emergency surgical departments
- Requiring an emergency laparotomy
Key exclusion criteria (1 listed)
- Patients less than 65 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency laparotomyPatients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed. | Procedure or surgery | Frail, Not frail |
Primary outcome
Mortality
Time frame: 90 days
Patient alive at 90 days (rounded up to the nearest whole day) post operatively
4 secondary outcomes
Post-operative complications
Time frame: 30 days
Lowering of independence status post-operatively
Time frame: 30 days
Length of stay
Time frame: 30 days
Readmission
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 32723388Bisset 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.
- Derived from this study: PubMed 31188201Parmar 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.
- Derived from this study: PubMed 28988184Parmar 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.
- Individual participant dataSharing planned: No
Related trials for Emergencies
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
Active, not recruiting
Impact of Vitamin C on opioïd Consumption After an Emergency Department Visit for Acute Musculoskeletal Pain
Pain, Acute
Not yet recruitingObservational study
Comparison of Sepsis Prediction Algorithms
Sepsis
RecruitingObservational study
Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet
End-of-life Care, Palliative Care
Recruiting
Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
HIV Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Moug, MBChB, PhD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Frail Older Adult, run by North Western Research Collaborative.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kat Parmar, MBChB, MSc (07817296021, klparmar@hotmail.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02952430, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016; AzTrials last refreshed its copy on 28 Oct 2026.