Condition category
Surgery
Date applied
11/12/2019
Date assigned
08/01/2020
Last edited
08/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.nhsggc.org.uk/about-us/professional-support-sites/research-development/rd-management-office/#

Funders

Funder type

Research organisation

Funder name

Bowel Disease Research Foundation

Alternative name(s)

BDRF

Funding Body Type

unknown

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

02/01/2020: Trial’s existence confirmed by West Midlands- Solihull Research Ethics Committee