Plain English Summary
Background and study aims
Older patients (65 years and above) that require, but do not undergo emergency laparotomy (a surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity). NoLAP are an undefined and uncharacterised population. In contrast to those older adults that do undergo emergency surgery, it is not known how many patients constitute this NoLAP group, what characteristics they have, what the reasons are for not undergoing surgery and what their short-term outcomes are. This is the first multi-centred UK study to attempt to answer these questions to try to improve outcomes for the older adult population.
The study aims to define the population that needs but does not undergo emergency abdominal surgery.
Who can participate?
Any patient over 65 that needs but does not undergo, emergency abdominal surgery.
What does the study involve?
Patient records will be studies to define this patient population as no-one has looked at this group before. (Age, gender, pathology and decision-making in this patient population).
What are the possible benefits and risks of participating?
None
Where is the study run from?
38 sites across the UK with Royal Alexandra Hospital in Paisley as the lead site
When is the study starting and how long is it expected to run for?
27/01/2020 for 18 months
Who is funding the study?
Bowel Disease Research Foundation, UK
Who is the main contact?
Susan Moug, CI
susanmoug@nhs.net
Trial website
Contact information
Type
Public
Primary contact
Miss Susan Moug
ORCID ID
http://orcid.org/0000-0001-9969-9760
Contact details
c/o Department of Surgery
Royal Alexandra Hospital
Paisley
Corsebar Road
PA2 9PN
United Kingdom
+44 (0)1413146965
susanmoug@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Version 2.2, IRAS 268511
Study information
Scientific title
Defining the Denominator: Emergency Laparotomy and Frailty Study 2
Acronym
ELF 2
Study hypothesis
Identify a UK consecutive series of older adults presenting with acute abdominal pathology potentially treatable by emergency laparotomy where the decision is made not to undergo surgery (NoLAP) and their associated 90-day mortality.
Ethics approval
Approved 20/11/2019, West Midlands- Solihull Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8019; NRESCommittee.WestMidlands-Solihull@nhs.net), ref: 19/WM/0304
Study design
Multi-centre prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Older adults with pathology requiring an emergency laparotomy
Intervention
The study is characterising the number of patients that do not undergo emergency abdominal surgery (age, pathology, diagnosis, gender) and trying to understand the reasons behind that decision not to have emergency surgery. Each patient will be followed up for 30, 90 days after surgery to see if they have died and also at 1 year to see if they have died.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
90-day mortality after decision not to undergo emergency laparotomy measured by patient records
Secondary outcome measures
The reasoning behind the NOLAP decision measured using patient records at the time
Overall trial start date
01/06/2019
Overall trial end date
10/01/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 65 years or older
2. Requires emergency laparotomy for pathology consistent with inclusion into NELA
3. Does not undergo emergency laparotomy
4. Had review by trained surgeon
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
700
Participant exclusion criteria
1. Under 65 years of age
2. No surgical review
3. Failed conservative management
Recruitment start date
27/01/2020
Recruitment end date
27/01/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Alexandra Hospital
Department of Surgery
Paisley
PA2 9PN
United Kingdom
Trial participating centre
Wythenshawe Hospital
Manchester University NHS Foundation Trust
Southmoore Road
Wythenshawe
Manchester
M23 9QT
United Kingdom
Trial participating centre
Huddersfield Royal Infirmary
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield
HD3 3EA
United Kingdom
Trial participating centre
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Trial participating centre
East Surrey Hospital
Surrey And Sussex Healthcare NHS Trust
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Trial participating centre
Whiston Hospital
Prescot
L35 5DR
United Kingdom
Trial participating centre
Borders General Hospital
Melrose
TD6 9BS
United Kingdom
Trial participating centre
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
Trial participating centre
Forth Valley Royal Hospital
Larbert
FK5 4WR
United Kingdom
Trial participating centre
Queen Elizabeth University Hospital
Glasgow
G51 4TF
United Kingdom
Trial participating centre
Royal Gwent Hospital
Newport
NP20 2UB
United Kingdom
Trial participating centre
Medway Maritime Hospital
Gillingham
ME7 5NY
United Kingdom
Trial participating centre
Dumfries and Galloway Royal Infirmary
Cargenbridge
DG2 8RX
United Kingdom
Trial participating centre
Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom
Trial participating centre
The Royal London Hospital
London
E1 1FR
United Kingdom
Trial participating centre
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom
Trial participating centre
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Trial participating centre
Blackpool Victoria Hospital
Blackpool
FY3 8NR
United Kingdom
Trial participating centre
Glangwili General Hospital
Carmarthen
SA31 2AF
United Kingdom
Trial participating centre
Norfolk & Norwich University
Norwich
NR4 7UY
United Kingdom
Trial participating centre
Aintree University Hospital
Liverpool
L9 7AL
United Kingdom
Trial participating centre
Countess Of Chester Hospital
Chester
CH2 1HJ
United Kingdom
Trial participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
Trial participating centre
St Thomas’ Hospital
London
SE1 7EH
United Kingdom
Trial participating centre
New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom
Trial participating centre
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
Trial participating centre
University Hopsital of Wales
Cardiff
CF14 4XW
United Kingdom
Trial participating centre
Tunbridge Wells Hospital
Tunbridge Wells
TN2 4QJ
United Kingdom
Trial participating centre
Weston General Hospital
Weston-super-Mare
BS23 4TQ
United Kingdom
Trial participating centre
Royal Devon and Exeter Hospital
Exeter
EX2 5DW
United Kingdom
Trial participating centre
Morriston Hospital
Swansea
SA6 6NL
United Kingdom
Trial participating centre
University Hospital Ayr
Ayr
KA6 6DX
United Kingdom
Trial participating centre
Wrexham Maelor Hospital
Wrexham
LL13 7TD
United Kingdom
Trial participating centre
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
Trial participating centre
Raigmore Hospital
Inverness
IV2 3UJ
United Kingdom
Trial participating centre
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde
Sponsor details
Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
United Kingdom
+44 (0)1413144012
maureen.travers@ggc.scot.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Bowel Disease Research Foundation
Alternative name(s)
BDRF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository
Intention to publish date
31/01/2021
Participant level data
Stored in repository
Basic results (scientific)
Publication list