Condition category
Nervous System Diseases
Date applied
25/06/2018
Date assigned
31/07/2018
Last edited
12/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Ms Julie Woodfield

ORCID ID

Contact details

Department of Clinical Neurosciences
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Type

Public

Additional contact

Dr Ingrid Hoeritzauer

ORCID ID

Contact details

Department of Clinical Neurosciences
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Type

Public

Additional contact

Mr Aimun Jamjoom

ORCID ID

Contact details

Neurosurgery Department
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom

Type

Scientific

Additional contact

Mr Patrick Statham

ORCID ID

Contact details

Department of Clinical Neurosciences
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v3

Study information

Scientific title

Understanding cauda equina syndrome (UCES)

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

South East Scotland Research Ethics Committee 02, 01/06/2018, IRAS Project ID: 233515, REC ref: 18/SS/0047

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

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 trial start date

03/01/2017

Overall trial end date

30/11/2020

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

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

United Kingdom

Trial participating centre

NHS Lothian
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

NHS Grampian
Aberdeen Royal Infirmary Department of Neurosurgery Forrester Hill
Aberdeen
AB9 2ZB
United Kingdom

Trial participating centre

NHS Greater Glasgow & Clyde
Institute of Neurological Sciences University Department of Neurosurgery Southern General Hospital NHS Trust
Glasgow
G51 4TF
United Kingdom

Trial participating centre

NHS Tayside
Ninewells Hospital And Medical School Dept of Neurosurgery South Block Level 6
Dundee
DD1 9SY
United Kingdom

Trial participating centre

Belfast Health and Social Care Trust
Royal Victoria Hospital Department of Neurosurgery Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Trial participating centre

The Walton Centre NHS Foundation Trust
Lower Lane Fazakerley
Liverpool
L9 7LJ
United Kingdom

Trial participating centre

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Royal Victoria Infirmary Department of Neurosurgery Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
James Cook University Hospital Department of Neurosurgery Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Lancashire Teaching Hospitals NHS Foundation Trust
Royal Preston Hospital Department of Neurosurgery Sharoe Green Lane North Fulwood
Preston
PR2 4HT
United Kingdom

Trial participating centre

City Hospitals Sunderland NHS Foundation Trust
Sunderland Royal Hospital
Sunderland
SR4 7TP
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Hope Hospital Department of Neurosurgery Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

Hull and East Yorkshire Hospitals NHS Trust
Hull Royal Infirmary Department of Neurosurgery Anlaby Road
Hull
HU3 2KZ
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
The General Infirmary at Leeds Department of Neurosurgery Great George Street
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Royal Hallamshire Hospital Department of Neurosurgery Glossop Road
Sheffield
S10 2JF
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Queen’s Medical Centre Department of Neurosurgery C Floor, West Block University Hospital Clifton Boulevard
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
Royal Derby Hospital Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

University Hospital Birmingham NHS Foundation Trust
Queen Elizabeth Neuroscience Centre Department of Neurosurgery The Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Walsgrave Hospital Department of Neurosurgery Clifford Bridge Road Walsgrave
Coventry
CV2 2DX
United Kingdom

Trial participating centre

University Hospital Southampton NHS Foundation Trust
Wessex Neurological Centre Department of Neurosurgery Southampton General Hospital Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
Addenbrooke’s Hospital, Neurosurgery Unit Hills Road
Cambridge
CB2 2QQ
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Ln
Norwich
NR4 7UY
United Kingdom

Trial participating centre

East Kent Hospitals University NHS Foundation Trust
Kent and Canterbury Hospital Ethelbert Road
Canterbury
CT1 3NG
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Trust
Oxford Radcliffe NHS Trust Department of Neurosurgery Level 3, West Wing John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

North Bristol NHS Trust
Southmead Hospital Ground Floor Academic Centre Level 2, Gate 6, Brunel building Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Plymouth Hospitals NHS Trust
University Hospitals Plymouth NHS Trust Department of Neurosurgery Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Royal Devon and Exeter NHS Foundation Trust
North Devon District Hospital
EX31 4JB
United Kingdom

Trial participating centre

Taunton and Somerset NHS Foundation Trust
Musgrove Park Hospital, Parkfield Drive
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Buckinghamshire Healthcare NHS Trust
Stoke Mandeville Hospital Mandeville Rd Aylesbury
HP21 8AL
United Kingdom

Trial participating centre

Milton Keynes Hospital NHS Trust
Milton Keynes University Hospital NHS Foundation Trust Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Barts Health NHS Trust
St Bartholomew’s and Royal London Hospital Department of Neurosurgery Whitechapel
London
E1 1BB
United Kingdom

Trial participating centre

Barking Havering and Redbridge University Hospitals NHS Trust
Essex Neurosciences Centre Department of Neurosurgery Second floor, Admin Block Queen’s Hospital Rom Valley Way
Romford
RM7 0AG
United Kingdom

Trial participating centre

King’s College Hospital NHS Foundation Trust
King’s College Hospital Department of Neurosurgery Denmark Road
London
SE5 9RS
United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
Hurstwood Park Neurological Centre Department of Neurosurgery The Princess Royal Hospital Haywards Heath West Sussex
RH17 7RS
United Kingdom

Trial participating centre

St George’s Healthcare NHS Foundation Trust
Atkinson Morely Wing Department of Neurosurgery St George's Hospital Blackshaw Road Tooting
London
SW17 OQT
United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
The National Hospital for Neurology & Neurosurgery Victor Horsley Department of Neurosurgery Queen Square
London
WC1N 3BG
United Kingdom

Trial participating centre

Imperial College Healthcare NHS Trust
Charing Cross Hospital, Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor information

Organisation

NHS Lothian

Sponsor details

NHS Lothian Research & Development Office
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

British Neurosurgical Trainee Research Collaborative

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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).

Intention to publish date

30/11/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.