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
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
Public
c/o Department of Surgery
Royal Alexandra Hospital, Paisley
Corsebar Road
PA2 9PN
United Kingdom
 ORCID ID |
0000-0001-9969-9760 |
|---|---|
| Phone | +44 (0)141 3146965 |
| susan.moug@ggc.scot.nhs.uk |
Study information
| Study design | Multi-centre prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Defining the Denominator: Emergency Laparotomy and Frailty Study 2 |
| Study acronym | ELF 2 |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 01/06/2019 |
| Completion date | 10/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 700 |
| Total final enrolment | 750 |
| Key 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 |
| Key exclusion criteria | 1. Under 65 years of age 2. No surgical review 3. Failed conservative management |
| Date of first enrolment | 27/01/2020 |
| Date of final enrolment | 27/01/2021 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Paisley
PA2 9PN
United Kingdom
Southmoore Road
Wythenshawe
Manchester
M23 9QT
United Kingdom
Huddersfield
HD3 3EA
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Canada Avenue
Redhill
RH1 5RH
United Kingdom
L35 5DR
United Kingdom
TD6 9BS
United Kingdom
York
YO31 8HE
United Kingdom
FK5 4WR
United Kingdom
G51 4TF
United Kingdom
NP20 2UB
United Kingdom
ME7 5NY
United Kingdom
DG2 8RX
United Kingdom
BL4 0JR
United Kingdom
E1 1FR
United Kingdom
G4 0SF
United Kingdom
TA1 5DA
United Kingdom
FY3 8NR
United Kingdom
SA31 2AF
United Kingdom
NR4 7UY
United Kingdom
L9 7AL
United Kingdom
CH2 1HJ
United Kingdom
BS2 8HW
United Kingdom
SE1 7EH
United Kingdom
WV10 0QP
United Kingdom
DE22 3NE
United Kingdom
CF14 4XW
United Kingdom
TN2 4QJ
United Kingdom
BS23 4TQ
United Kingdom
EX2 5DW
United Kingdom
SA6 6NL
United Kingdom
KA6 6DX
United Kingdom
LL13 7TD
United Kingdom
AB25 2ZN
United Kingdom
IV2 3UJ
United Kingdom
EH4 2XU
United Kingdom
Sponsor information
Hospital/treatment centre
Dykebar Hospital, Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom
| Phone | +44 (0)1413144012 |
|---|---|
| maureen.travers@ggc.scot.nhs.uk | |
| Website | https://www.nhsggc.org.uk/about-us/professional-support-sites/research-development/rd-management-office/# |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BDRF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The 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
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
