Understanding cauda equina syndrome (UCES)
| ISRCTN | ISRCTN16828522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16828522 |
| Secondary identifying numbers | v3 |
- Submission date
- 25/06/2018
- Registration date
- 31/07/2018
- Last edited
- 02/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Cauda equina syndrome is a potentially devastating condition caused by compression of the cauda equina nerve roots in the spine. This can result in bowel, bladder and sexual problems and lower limb weakness, numbness, and pain. Cauda equina syndrome occurs infrequently but has serious potential medical, social, and legal consequences. This study aims to identify and describe the presentation, management, and outcomes of patients with cauda equina syndrome in the United Kingdom.
Who can participate?
Patients over 18 years old with cauda equina syndrome
What does the study involve?
Patients with cauda equina syndrome are identified on admission to spinal units across the UK and asked to participate. Presenting symptoms, investigation and management are recorded and participants are asked to complete questionnaires on admission, at discharge, and at six months and one year after treatment. This provides an accurate description of the number of patients, the types of symptoms, current clinical practice, adherence to national published standards of care, and patient outcomes.
What are the possible benefits and risks of participating?
Accurate, up to date information about the presentation, management, and outcome of patients with cauda equina syndrome will inform standards of service design and delivery for this important but infrequent condition and help to identify future research priorities. There are no direct benefits to taking part in this study but the results from this study might help to improve the healthcare of patients in the future. This study will take up to 40 minutes of the participant’s time over the course of the year following the initial hospital admission.
Where is the study run from?
1. NHS Lothian
2. NHS Grampian
3. NHS Greater Glasgow & Clyde
4. NHS Tayside
5. Belfast Health and Social Care Trust
6. The Walton Centre NHS Foundation Trust
7. The Newcastle Upon Tyne Hospitals NHS Foundation Trust
8. South Tees Hospitals NHS Foundation Trust
9. Lancashire Teaching Hospitals NHS Foundation Trust
10. City Hospitals Sunderland NHS Foundation Trust
11. Salford Royal NHS Foundation Trust
12. Hull and East Yorkshire Hospitals NHS Trust
13. Leeds Teaching Hospitals NHS Trust
14. Sheffield Teaching Hospitals NHS Foundation Trust
15. Nottingham University Hospitals NHS Trust
16. Derby Hospitals NHS Foundation Trust
17. University Hospital Birmingham NHS Foundation Trust
18. University Hospitals Coventry and Warwickshire NHS Trust
19. University Hospital Southampton NHS Foundation Trust
20. Cambridge University Hospitals NHS Foundation Trust
21. Norfolk and Norwich University Hospitals NHS Foundation Trust
22. East Kent Hospitals University NHS Foundation Trust
23. Oxford University Hospitals NHS Trust
24. North Bristol NHS Trust
25. Plymouth Hospitals NHS Trust
26. Royal Devon and Exeter NHS Foundation Trust
27. Taunton and Somerset NHS Foundation Trust
28. Buckinghamshire Healthcare NHS Trust
29. Milton Keynes Hospital NHS Trust
30. Barts Health NHS Trust
31. Barking Havering and Redbridge University Hospitals NHS Trust
32. King’s College Hospital NHS Foundation Trust
33. Brighton and Sussex University Hospitals NHS Trust
34. St George’s Healthcare NHS Foundation Trust
35. University College London Hospitals NHS Foundation Trust
36. Imperial College Healthcare NHS Trust
When is the study starting and how long is it expected to run for?
January 2017 to November 2020
Who is funding the study?
British Neurosurgical Trainee Research Collaborative
Who is the main contact?
1. Ms Julie Woodfield
2. Dr Ingrid Hoeritzauer
3. Mr Aimun Jamjoom
4. Mr Patrick Statham
Contact information
Public
Department of Clinical Neurosciences
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
Public
Department of Clinical Neurosciences
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
Public
Neurosurgery Department
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
Scientific
Department of Clinical Neurosciences
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Understanding cauda equina syndrome (UCES) |
| Study acronym | UCES |
| Study hypothesis | This study aims to identify and describe the presentation and management of patients with cauda equina syndrome in the United Kingdom using trainee research collaborative networks. |
| Ethics approval(s) | South East Scotland Research Ethics Committee 02, 01/06/2018, IRAS Project ID: 233515, REC ref: 18/SS/0047 |
| Condition | Cauda equina syndrome |
| Intervention | Patients with cauda equina syndrome will be identified on admission to spinal units across the UK and asked to participate. Data relating to presentation, hospital admission, investigations, and follow up will be collected by the local trainee investigator who is a member of the clinical team caring for the patient. Study participants who have consented to participate will also be asked to fill out details about their patient journey to the spinal unit, their symptoms, patient reported outcome measures, and service usage. These will be collected electronically anonymously via the electronic database and linked to the patient record. Patient reported outcome measures will include visual analogue scores for back and leg pain, the Oswestry Disability Index, the neurogenic bowel dysfunction score, the short form incontinence questionnaire, and the Arizona sexual experiences scale. Participants will be asked to complete questionnaires on admission, at discharge, and at six months and one year after treatment. This will provide an accurate description of the number of patients, the types of symptoms, current clinical practice, adherence to national published standards of care, and patient outcomes. |
| Intervention type | Other |
| Primary outcome measure | The incidence of CES as measured by the number of cases of CES in the UK in all collaborating centres |
| Secondary outcome measures | 1. The presenting symptoms and signs in patients with CES: 1.1. Back pain and leg pain measured using visual analogue scores on admission 1.2. Low back pain disability measured using Oswestry Disability Index on admission 1.3. Urinary bladder function measured using neurogenic bowel dysfunction score on admission 1.4. Urinary incontinence measured using short form incontinence questionnaire on admission 1.5. Sexual function measured using Arizona sexual experiences scale on admission 2. The pathways of presentation to specialist spinal services for patients with CES in the UK and Ireland; the type and timing of healthcare professionals seen prior to admission with the symptoms causing admission will be assessed by patient questionnaire on admission 3. The type and timing of imaging and other investigation of patients with CES, collected on admission 4. The medical and surgical management of CES, including medications, type and timing of the operation, collected from routine neurosurgical notes 5. The type and timing of investigations and surgery will be compared to the British Association of Spine Surgeons (BASS) standards of care for suspected and confirmed compressive CES issued in 2015 and the Society of British Neurological Surgeons Care Quality Statement issued in October 2015 6. Clinical outcomes for patients with CES assessed using validated patient reported outcome measures, stratified by presentation, investigations, and management: 6.1. Back pain and leg pain measured using visual analogue scores at discharge, 6 months and 1 year 6.2. Low back pain disability measured using Oswestry Disability Index 6 months and 1 year 6.3. Urinary bladder function measured using neurogenic bowel dysfunction score at discharge, 6 months and 1 year 6.4. Urinary incontinence measured using short form incontinence questionnaire at discharge, 6 months and 1 year 6.5. Sexual function measured using Arizona sexual experiences scale at discharge, 6 months and 1 year This data and the type and timing of clinical presentation, investigation, investigation results will be analysed and stratified within one year of study completion. 7. The ability of neurosurgical and orthopaedic surgical trainee networks to collaborate successfully on a prospective cohort study, assessed at the end of the study |
| Overall study start date | 03/01/2017 |
| Overall study end date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Total final enrolment | 659 |
| Participant inclusion criteria | 1. Over 18 years old 2. Admitted to a specialist spinal service in the UK between 1st June 2018 and 31st May 2019 3. Capacity to provide informed consent for participation in this study 4. Diagnosis of clinical CES and structural compression of the cauda equina on imaging as determined by the treating clinician. Clinical CES includes any disturbance of saddle sensation, bladder function, bowel function, sexual dysfunction and bilateral sciatica associated with radiological compression of the cauda equina. The cauda equina compression can be due to any cause, including, but not limited to, disc, tumour, infection, etc |
| Participant exclusion criteria | 1. Patients under 18 years old 2. Patients undergoing emergent decompression for unilateral motor or sensory symptoms (eg foot drop), without clinical evidence of CES 3. Patients referred with suspected CES where the diagnosis is not confirmed, for example patients with the clinical symptoms and signs of CES without radiological evidence of cauda equina compression 4. Patients not admitted to participating spinal centres in the UK 5. Patients admitted to a participating spinal centre before 1st June 2018 or after 31st May 2019 6. Patients who are unable to provide informed consent for participation in this study |
| Recruitment start date | 01/06/2018 |
| Recruitment end date | 30/11/2019 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Edinburgh
EH4 2XU
United Kingdom
Department of Neurosurgery
Forrester Hill
Aberdeen
AB9 2ZB
United Kingdom
University Department of Neurosurgery
Southern General Hospital NHS Trust
Glasgow
G51 4TF
United Kingdom
Dept of Neurosurgery
South Block Level 6
Dundee
DD1 9SY
United Kingdom
Department of Neurosurgery
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Fazakerley
Liverpool
L9 7LJ
United Kingdom
Department of Neurosurgery
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Department of Neurosurgery
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Department of Neurosurgery
Sharoe Green Lane North
Fulwood
Preston
PR2 4HT
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Department of Neurosurgery
Stott Lane
Salford
M6 8HD
United Kingdom
Department of Neurosurgery
Anlaby Road
Hull
HU3 2KZ
United Kingdom
Department of Neurosurgery
Great George Street
Leeds
LS1 3EX
United Kingdom
Department of Neurosurgery
Glossop Road
Sheffield
S10 2JF
United Kingdom
Department of Neurosurgery
C Floor, West Block
University Hospital
Clifton Boulevard
Nottingham
NG7 2UH
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Department of Neurosurgery
The Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Department of Neurosurgery
Clifford Bridge Road
Walsgrave
Coventry
CV2 2DX
United Kingdom
Department of Neurosurgery
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Neurosurgery Unit
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Norwich
NR4 7UY
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Department of Neurosurgery
Level 3, West Wing
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Ground Floor Academic Centre
Level 2, Gate 6, Brunel building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Department of Neurosurgery
Derriford Road
Plymouth
PL6 8DH
United Kingdom
EX31 4JB
United Kingdom
Taunton
TA1 5DA
United Kingdom
Mandeville Rd
Aylesbury
HP21 8AL
United Kingdom
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Department of Neurosurgery
Whitechapel
London
E1 1BB
United Kingdom
Department of Neurosurgery
Second floor, Admin Block
Queen’s Hospital
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Department of Neurosurgery
Denmark Road
London
SE5 9RS
United Kingdom
Department of Neurosurgery
The Princess Royal Hospital
Haywards Heath
West Sussex
RH17 7RS
United Kingdom
Department of Neurosurgery
St George's Hospital
Blackshaw Road
Tooting
London
SW17 OQT
United Kingdom
Victor Horsley Department of Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
London
W6 8RF
United Kingdom
Sponsor information
Hospital/treatment centre
NHS Lothian Research & Development Office, Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
"ROR" |
https://ror.org/03q82t418 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Additional documents for this study are available on the British Neurosurgical Trainee Research Collaborative (BNTRC) website. These include study protocol, study information leaflet, participant information leaflet, GDPR information leaflet, consent form, data collection spreadsheet, contact details. The link to these documents is: https://www.bntrc.org.uk/protocols. In addition, the study protocol has been submitted to BMJ Open for publication. The study report will be used for publication and presentation at scientific meetings. Investigators have the right to publish orally or in writing the results of the study. Summaries of results will also be made available to investigators. Following the initial analysis and publication, study data will be made available to those who submit successful peer-reviewed proposals for use of the data to the steering committee via the BNTRC. All local investigators who enter data for at least one case will be named as contributors on all publications arising from this study and will receive a certificate of collaboration in this study. Authorship of publications arising from this study will be determined in accordance with the guidelines of the International Committee of Medical Journal Editors (ICMJE). |
| IPD sharing plan | Following the initial analysis and publication, study data will be made available to those who submit successful peer-reviewed proposals for use of the data to the steering committee via the BNTRC (British Neurosurgical Trainee Research Collaborative). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/12/2018 | 10/12/2020 | Yes | No |
| Other publications | Demographics of Scotland wide data | 31/10/2022 | 02/12/2022 | Yes | No |
| Results article | 17/11/2022 | 02/12/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
02/12/2022: Publication references added.
18/12/2020: Contact details updated.
10/12/2020: Publication reference added.
10/12/2019: The total final enrolment number has been added.
12/07/2019: IPD sharing statement added.
20/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2019 to 30/11/2019.
2. The overall trial end date was changed from 31/12/2019 to 30/11/2020.
3. The intention to publish date was changed from 01/06/2021 to 30/11/2021.
