Understanding Cauda Equina Syndrome
- Conditions
- Cauda Equina Syndrome
- Registration Number
- NCT07235579
- Lead Sponsor
- University of Edinburgh
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 621
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For inclusion in this study, the patient must:
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be over 18 years old;
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be admitted to a specialist spinal service in the UK between 1st June 2018 and 31st May 2019;
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have capacity to provide informed consent for participation in this study; and
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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.
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• Patients under 18 years old
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Patients undergoing emergent decompression for unilateral motor or sensory symptoms (eg foot drop), without clinical evidence of CES
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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
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Patients not admitted to participating spinal centres in the UK
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Patients admitted to a participating spinal centre before 1st June 2018 or after 31st May 2019
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Patients who are unable to provide informed consent for participation in this study
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identify the number of cases of Cauda Equina Syndrome (CES) in the UK in all collaborating centres June 2018-June 2021 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.
- Secondary Outcome Measures
Name Time Method Describe the presenting symptoms and signs in patients with CES June 2018-June 2021 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.
Describe the pathways of presentation to specialist spinal services for patients with CES in the UK and Ireland June 2018-June 2021 Patients will be asked about their care pathway prior to and after entering hospital
Describe the type and timing of investigation of patients with CES June 2018-June 2021 Timing of MRI scans will be gathered by a member of the local clinical care team. Time will be divided into hours from symptom onset (patient and clinician rated).
Describe the medical and surgical management of CES June 2018- June 2021 Type and timing of medical or surgical management of patients with cauda equina syndrome will be gathered by a member of the local clinical care team. Time will be divided into hours from symptom onset (patient and clinician rated), type will be a drop down menu of various types of operation and 'other' with room for explanation.
Describe clinical outcomes for patients with CES using validated patient reported outcome measures, stratified by presentation, investigations, and management June 2018-June 2021 Patient reported outcome measures will be used such as the ODI.
Trial Locations
- Locations (1)
Department of Neurosciences, Western General Hospital
🇬🇧Edinburgh, United Kingdom
Department of Neurosciences, Western General Hospital🇬🇧Edinburgh, United Kingdom