Understanding Cauda Equina Syndrome:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 621
- 试验地点
- 1
- 主要终点
- Identify the number of cases of Cauda Equina Syndrome (CES) in the UK in all collaborating centres
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •• 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
结局指标
主要结局
Identify the number of cases of Cauda Equina Syndrome (CES) in the UK in all collaborating centres
时间窗: 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.
次要结局
- 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)