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Clinical Trials/NCT05149404
NCT05149404
Unknown
Not Applicable

The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery:a Multicenter, Non-interventional Cohort Study

Peking University Third Hospital1 site in 1 country400 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Spondylotic Myelopathy
Sponsor
Peking University Third Hospital
Enrollment
400
Locations
1
Primary Endpoint
range of motion on X - ray
Last Updated
4 years ago

Overview

Brief Summary

This study intends to establish a multidisciplinary collaborative ERAS clinical pathway of cervical posterior surgery,and to verify its effectiveness, safety and value in health economics.

Detailed Description

Enhanced recovery after surgery (ERAS) is a new model of deep cooperation between surgery,rehabilitation medicine, anesthesiology, nursing and other disciplines in recent years, which enables patients to start rehabilitation training as soon as possible after surgery and improves the comprehensive effect of surgery. Posterior cervical surgery is traumatic, and it is significant to enhance postoperative rehabilitation to improve the overall efficacy of patients. Currently, there are no clear guidelines supporting the clinical effectiveness of ERAS in reducing complications, reducing costs, and enhancing recovery after posterior cervical surgery. Therefore, this study aims to establish a multidisciplinary ERAS model for posterior cervical surgery in Peking University Third Hospital and verify its clinical effectiveness. This is a multi-center, multidisciplinary prospective cohort study,in which the orthopedics department was combined with the anesthesiology department, rehabilitation department, nutrition department, operating room and nursing team to establish the ERAS clinical pathways for posterior cervical spine surgery. Clinical pathways include surgical procedure optimization, rehabilitation procedure optimization, anesthesia and nursing procedure optimization. As it is optimized and promoted,the ERAS clinical pathways will improve the curative effect and prognosis of posterior cervical surgery, so that more patients with cervical spondylosis will benefit.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18-70, gender unlimited;
  • Diagnostic diagnosis of cervical spondylosis and consistent with the indications of posterior spinal canal extended laminoplasty;
  • Basis of serious diseases of centerlessness, brain, lung, kidney or other important organs, preoperative ASA score I-II;
  • Agree to participate in the study and sign the informed consent.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

range of motion on X - ray

Time Frame: 6 months after surgery

range of motion the neck in extension and flexion on X - ray

Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire(JOACMEQ)

Time Frame: 6 months after surgery

A questionare to evaluate the severity of cervical spondylosis myelopathy

multi-cervical-unit system(MCU)

Time Frame: 6 months after surgery

To locate the cervical responsible section

Study Sites (1)

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