NCT02806167

Brief Summary

Expedient diagnosis and management of acute cauda equina syndrome (CES) is essential to prevent long-term neurological sequelae for these patients. The clinical diagnosis of CES is confirmed using magnetic resonance imaging (MRI). However the clinical features of CES (secondary to bladder and bowel sphincter dysfunction) are variable and are common presenting features of other pathologies of the bladder and bowel, therefore most patients who undergo MRI for suspected CES have no compressive lesion evident on the MRI, excluding the diagnosis of CES. Urgent MRI scanning performed out of hours is therefore often unnecessary, however, the morbidity to the patient due to a delay in diagnosis is so significant that urgent MRI scanning is the current gold standard and duty of care in all cases of suspected CES. More objective methods of assessing patients with suspected acute CES could allow rationing of out of hours MRI scanning and reduce inappropriate admission without impacting patient safety. The aim of this study is to evaluate the effectiveness of a clinical algorithm which utilises digital rectal examination and ultrasound bladder scanning to stratify patients into high and low risk groups. Patients considered high risk will be admitted and sent for urgent MRI, whereas low risk patients will be discharged and undergo MRI scan within 5 days of presentation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 11, 2018

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

June 15, 2016

Last Update Submit

April 10, 2018

Conditions

Polyradiculopathy

Outcome Measures

Primary Outcomes (1)

  • Successful risk stratification

    The study will aim to stratify patients into high and low risk of CES though implementation of an algorithm which uses bladder scanning. The algorithm will be deemed successful if no patients are missed.

    36 months

Secondary Outcomes (1)

  • Correlation between clinical assessment and residual urine volume

    36 months

Study Arms (1)

Clinical algorithm

EXPERIMENTAL

This is a single arm study. All eligible patients will be subject to our clinical algorithm.

Other: Clinical algorithm

Interventions

Clinical algorithmOTHER

Patients presenting with suspected acute CES will be assessed in accordance with the algorithm previously outlined.

Clinical algorithm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected CES
  • Minimum age 18 years.
  • Both sexes
  • Able to provide informed consent for their data to be included in the study

You may not qualify if:

  • Patients with pre-existing urinary tract pathologies (neuropathic bladder, urologic pathologies or surgery, history of urinary incontinence.)
  • Under age of 18 years.
  • Patients with urinary catheter for whatever reason.
  • Prisoners.
  • Patients unable to provide informed consent for themselves.
  • Previous spinal surgery
  • Patients with urinary tract infections
  • Patients with pre-existing neurological conditions affecting:
  • Central nervous system such as multiple sclerosis
  • Peripheral nervous system such as diabetic neuropathy, B12 deficiencies, thyroid abnormalities
  • Autonomic nervous system such as multiple system atrophy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Polyradiculopathy

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Oliver Stokes, FRCS

    Royal Devon and Exeter NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 20, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2019

Study Completion

November 1, 2019

Last Updated

April 11, 2018

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)