Understanding the patients that need but do not undergo emergency abdominal surgery

ISRCTN ISRCTN14556210
DOI https://doi.org/10.1186/ISRCTN14556210
IRAS number 268511
Secondary identifying numbers Version 2.2, IRAS 268511
Submission date
11/12/2019
Registration date
08/01/2020
Last edited
07/10/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Miss Susan Moug
Public

c/o Department of Surgery
Royal Alexandra Hospital, Paisley
Corsebar Road
PA2 9PN
United Kingdom

ORCiD logoORCID ID 0000-0001-9969-9760
Phone +44 (0)141 3146965
Email susan.moug@ggc.scot.nhs.uk

Study information

Study designMulti-centre prospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleDefining the Denominator: Emergency Laparotomy and Frailty Study 2
Study acronymELF 2
Study objectivesIdentify 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(s)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
Health condition(s) or problem(s) studiedOlder adults with pathology requiring an emergency laparotomy
InterventionThe 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 typeProcedure/Surgery
Primary outcome measure90-day mortality after decision not to undergo emergency laparotomy measured by patient records
Secondary outcome measuresThe reasoning behind the NOLAP decision measured using patient records at the time
Overall study start date01/06/2019
Completion date10/01/2022

Eligibility

Participant type(s)Patient
Age groupSenior
Lower age limit65 Years
SexBoth
Target number of participants700
Total final enrolment750
Key inclusion criteria1. 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
Key exclusion criteria1. Under 65 years of age
2. No surgical review
3. Failed conservative management
Date of first enrolment27/01/2020
Date of final enrolment27/01/2021

Locations

Countries of recruitment

  • England
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

Royal Alexandra Hospital
Department of Surgery
Paisley
PA2 9PN
United Kingdom
Wythenshawe Hospital
Manchester University NHS Foundation Trust
Southmoore Road
Wythenshawe
Manchester
M23 9QT
United Kingdom
Huddersfield Royal Infirmary
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield
HD3 3EA
United Kingdom
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
East Surrey Hospital
Surrey And Sussex Healthcare NHS Trust
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Whiston Hospital
Prescot
L35 5DR
United Kingdom
Borders General Hospital
Melrose
TD6 9BS
United Kingdom
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
Forth Valley Royal Hospital
Larbert
FK5 4WR
United Kingdom
Queen Elizabeth University Hospital
Glasgow
G51 4TF
United Kingdom
Royal Gwent Hospital
Newport
NP20 2UB
United Kingdom
Medway Maritime Hospital
Gillingham
ME7 5NY
United Kingdom
Dumfries and Galloway Royal Infirmary
Cargenbridge
DG2 8RX
United Kingdom
Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom
The Royal London Hospital
London
E1 1FR
United Kingdom
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Blackpool Victoria Hospital
Blackpool
FY3 8NR
United Kingdom
Glangwili General Hospital
Carmarthen
SA31 2AF
United Kingdom
Norfolk & Norwich University
Norwich
NR4 7UY
United Kingdom
Aintree University Hospital
Liverpool
L9 7AL
United Kingdom
Countess Of Chester Hospital
Chester
CH2 1HJ
United Kingdom
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
St Thomas’ Hospital
London
SE1 7EH
United Kingdom
New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
University Hopsital of Wales
Cardiff
CF14 4XW
United Kingdom
Tunbridge Wells Hospital
Tunbridge Wells
TN2 4QJ
United Kingdom
Weston General Hospital
Weston-super-Mare
BS23 4TQ
United Kingdom
Royal Devon and Exeter Hospital
Exeter
EX2 5DW
United Kingdom
Morriston Hospital
Swansea
SA6 6NL
United Kingdom
University Hospital Ayr
Ayr
KA6 6DX
United Kingdom
Wrexham Maelor Hospital
Wrexham
LL13 7TD
United Kingdom
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
Raigmore Hospital
Inverness
IV2 3UJ
United Kingdom
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde
Hospital/treatment centre

Dykebar Hospital, Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom

Phone +44 (0)1413144012
Email maureen.travers@ggc.scot.nhs.uk
Website https://www.nhsggc.org.uk/about-us/professional-support-sites/research-development/rd-management-office/#
ROR logo "ROR" https://ror.org/05kdz4d87

Funders

Funder type

Research organisation

Bowel Disease Research Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
BDRF
Location
United Kingdom

Results and Publications

Intention to publish date31/01/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publically available repository

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 2.2 21/08/2019 16/08/2022 No No
HRA research summary 28/06/2023 No No
Results article 19/09/2024 07/10/2024 Yes No

Additional files

ISRCTN14556210 protocol v2.2 21Aug2019.pdf

Editorial Notes

07/10/2024: Publication reference and total final enrolment added.
16/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
06/01/2021: The contact email address was changed.
02/01/2020: Trial’s existence confirmed by West Midlands- Solihull Research Ethics Committee