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

Cervical Spondylotic Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149404
• Other study ID #: LM2020289
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Yu Sun, Dr.
• Phone: 13501221484
• Email: sunyuor[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cervical Spondylotic Myelopathy
• Ossification of Posterior Longitudinal Ligament
• Spinal Cord Diseases

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Chao Yang Hospital, Beijing Tiantan Hospital, Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of motion on X - ray	range of motion the neck in extension and flexion on X - ray	preoperation
Primary	range of motion on X - ray	range of motion the neck in extension and flexion on X - ray	intraoperation
Primary	range of motion on X - ray	range of motion the neck in extension and flexion on X - ray	72 hours after surgery
Primary	range of motion on X - ray	range of motion the neck in extension and flexion on X - ray	3 months after surgery
Primary	range of motion on X - ray	range of motion the neck in extension and flexion on X - ray	6 months after surgery
Primary	Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire(JOACMEQ)	A questionare to evaluate the severity of cervical spondylosis myelopathy	preoperation
Primary	Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire(JOACMEQ)	A questionare to evaluate the severity of cervical spondylosis myelopathy	intraoperation
Primary	Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire(JOACMEQ)	A questionare to evaluate the severity of cervical spondylosis myelopathy	72 hours after surgery
Primary	Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire(JOACMEQ)	A questionare to evaluate the severity of cervical spondylosis myelopathy	3 months after surgery
Primary	Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire(JOACMEQ)	A questionare to evaluate the severity of cervical spondylosis myelopathy	6 months after surgery
Primary	multi-cervical-unit system(MCU)	To locate the cervical responsible section	preoperation
Primary	multi-cervical-unit system(MCU)	To locate the cervical responsible section	intraoperation
Primary	multi-cervical-unit system(MCU)	To locate the cervical responsible section	72 hours after surgery
Primary	multi-cervical-unit system(MCU)	To locate the cervical responsible section	3 months after surgery
Primary	multi-cervical-unit system(MCU)	To locate the cervical responsible section	6 months after surgery