The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery

• Conditions: Ossification of Posterior Longitudinal Ligament in Cervical Region; Cervical Spondylotic Myelopathy

• Registration Number: NCT05149404
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2021-06
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
range of motion on X - ray	6 months after surgery	range of motion the neck in extension and flexion on X - ray
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）	6 months after surgery	A questionare to evaluate the severity of cervical spondylosis myelopathy
multi-cervical-unit system（MCU）	6 months after surgery	To locate the cervical responsible section

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China