NCT07235579

Brief Summary

Cauda equina syndrome is a potentially devastating condition caused by compression of the cauda equina nerve roots. This can result in bowel, bladder and sexual dysfunction plus lower limb weakness, numbness, and pain. Cauda equina syndrome occurs infrequently but has serious potential morbidity and medico-legal consequences. 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. This will provide accurate incidence figures, establish current clinical practice, allow assessment of the adherence to national published standards of care, and determine patient outcomes from this condition. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
621

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2022

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
Last Updated

November 19, 2025

Status Verified

June 1, 2024

Enrollment Period

3.6 years

First QC Date

May 8, 2019

Last Update Submit

November 17, 2025

Conditions

Cauda Equina Syndrome

Outcome Measures

Primary Outcomes (1)

  • Identify the number of cases of Cauda Equina Syndrome (CES) in the UK in all collaborating centres

    Cases will be identified by neurosurgical or orthopaedic trainees in each specialist centre through daily screening of tertiary referrals and admissions to specialist spinal services. All patients managed as CES by the treating team will be counted.

    June 2018-June 2021

Secondary Outcomes (5)

  • Describe the presenting symptoms and signs in patients with CES

    June 2018-June 2021

  • Describe the pathways of presentation to specialist spinal services for patients with CES in the UK and Ireland

    June 2018-June 2021

  • Describe the type and timing of investigation of patients with CES

    June 2018-June 2021

  • Describe the medical and surgical management of CES

    June 2018- June 2021

  • Describe clinical outcomes for patients with CES using validated patient reported outcome measures, stratified by presentation, investigations, and management

    June 2018-June 2021

Study Arms (1)

Cauda Equina Syndrome

For inclusion in this study, the patient must: * be over 18 years old; * be admitted to a specialist spinal service in the UK between 1st June 2018 and 31st May 2019; * have capacity to provide informed consent for participation in this study; and * have a 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.

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All neurosurgical and orthopaedic units managing patients with CES in the UK will be invited to participate. All patients admitted with radiologically confirmed CES will be identified by the lead local investigator via the screening of referral and admission systems at their spinal unit. All lead local investigators must be members of the clinical team caring for patients with CES in their unit. Capture-recapture methods will be used to ensure complete case ascertainment. In December 2018, June 2019, and December 2019 all local investigators will check their case ascertainment by asking their local coding departments for all discharges coded as CES using the diagnostic code ICD-10 G83.4.

You may qualify if:

  • be over 18 years old;
  • be admitted to a specialist spinal service in the UK between 1st June 2018 and 31st May 2019;
  • have capacity to provide informed consent for participation in this study; and
  • have a 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.

You may not qualify if:

  • Patients under 18 years old
  • Patients undergoing emergent decompression for unilateral motor or sensory symptoms (eg foot drop), without clinical evidence of CES
  • Patients referred with suspected CES where the diagnosis is not confirmed, for example:
  • o Patients with the clinical symptoms and signs of CES without radiological evidence of cauda equina compression
  • Patients not admitted to participating spinal centres in the UK
  • Patients admitted to a participating spinal centre before 1st June 2018 or after 31st May 2019
  • Patients who are unable to provide informed consent for participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosciences, Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Cauda Equina Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPolyradiculoneuropathyPolyneuropathies

Study Officials

  • Julie Woodfield, MBChB PhD

    University of Edinburgh

    STUDY CHAIR

  • Aimun Jamjoom

    University of Edinburgh

    STUDY DIRECTOR

  • Ingrid Hoeritzauer, MBBChBAO

    University of Edinburgh

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2019

First Posted

November 19, 2025

Study Start

June 1, 2018

Primary Completion

January 8, 2022

Study Completion

January 8, 2022

Last Updated

November 19, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Ownership of the complete dataset arising from this study resides with the steering committee and the BNTRC. On completion of the study, the data will be analysed and tabulated, and a report will be prepared. Local data collected as part of this study belongs to the local team collecting that data.

Locations

GB(1)