Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
500 participants
OBSERVATIONAL
2016-12-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Emergency laparotomy
Patients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed.
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.
Emergency laparotomy
Patients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Emergency laparotomy
Patients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Admitted to emergency surgical departments
* Requiring an emergency laparotomy
Exclusion Criteria
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Older persons Surgical Outcomes Collaboration
UNKNOWN
North Western Research Collaborative
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susan Moug, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NWRC- ELF
Identifier Type: -
Identifier Source: org_study_id