Understanding Cauda Equina Syndrome

NCT ID: NCT07235579

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-01-08

Brief Summary

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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.

Detailed Description

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Understanding Cauda Equina Syndrome (UCES) is a prospective cohort study of patients with confirmed CES managed at specialist spinal centres in the UK.

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 included in this audit. CES will be divided into CES suspected (CESS), CES incomplete (CESI), and CES retention (CESR).

Data regarding timing and type of symptom onset, referral, investigation, management, and outcome will be recorded anonymously on a secure database by the local trainee investigator during the patient's hospital admission and after discharge. Patient consent will be sought for the use of their data and patients will be asked to complete patient reported outcome measures representing their condition before surgery and up to one year after surgery. This data will be compared with care quality statements and published outcome data for CES.

The study will recruit for one year. Cases will be identified from admissions to spinal units between 1st June 2018 until 31st May 2019. The last one year follow up assessments will be sent to participants on 1st June 2020.

This is an observational study. No changes to routine patient care will occur during this study.

Conditions

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Cauda Equina Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* • 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role collaborator

East Kent Hospitals University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Somerset NHS Foundation Trust

OTHER

Sponsor Role collaborator

Buckinghamshire Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Milton Keynes University Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

The Ipswich Hospital NHS Trust

OTHER

Sponsor Role collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role collaborator

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role collaborator

Royal Cornwall Hospitals Trust

OTHER

Sponsor Role collaborator

Walton Centre NHS Foundation Trust

OTHER

Sponsor Role collaborator

South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Lancashire Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

City Hospitals Sunderland NHS Foundation Trust

OTHER

Sponsor Role collaborator

Northern Care Alliance NHS Foundation Trust

OTHER

Sponsor Role collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

North Bristol NHS Trust

OTHER

Sponsor Role collaborator

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role collaborator

Barking, Havering and Redbridge University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Brighton and Sussex University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

St George's University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie Woodfield, MBChB PhD

Role: STUDY_CHAIR

University of Edinburgh

Aimun Jamjoom

Role: STUDY_DIRECTOR

University of Edinburgh

Ingrid Hoeritzauer, MBBChBAO

Role: STUDY_DIRECTOR

University of Edinburgh

Locations

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Department of Neurosciences, Western General Hospital

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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160318

Identifier Type: -

Identifier Source: org_study_id

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