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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Yu Sun, Dr.; Phone Number: 13501221484; Email: sunyuor@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Yu Sun, Dr.; Phone Number: 13501221484; Email: sunyuor@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Preoperative ASA score ≥III;
2. One-stage combined anterior and posterior surgery of cervical spine;
3. Correction of cervical deformity;
4. Patients with gastric emptied disorders (such as gastroesophageal reflux, chronic history of aspiration, delayed gastric emptied), complete obstruction of the digestive tract, and inability to use enteral preparations;
5. Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial;
6. People with mental disorders, alcohol dependence or drug abuse history;
7. women in the period of lactation and pregnancy;
8. People with allergic constitution or previous allergies to a variety of drugs;
9. Other researchers consider it inappropriate to participate in this study

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ERAS group
Conventional group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Tiantan Hospital; Peking University International Hospital; Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: enhanced recovery after surgery; Posterior cervical surgery; posterior cervical laminoplasty; Clinical pathway
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Ossification, Heterotopic; Spinal Cord Diseases; Ossification of Posterior Longitudinal Ligament
• Other Study ID Numbers: LM2020289

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No