ERAS on Cervical Surgery

Completed

• Conditions: Cervical Spondylosis
• Interventions: Procedure: Enhanced recovery after surgery

• Registration Number: NCT04955496
• Lead Sponsor: Peking University Third Hospital

Brief Summary

This study is to evaluate the application effect of the concept of accelerated rehabilitation surgery in the perioperative period of patients with cervical spondylosis through a retrospective cohort study

Detailed Description

To evaluate the effect of a series of optimization measures in ERAS among the patients during perioperative period who underwent cervical surgery.

Methods:

A retrospective cohort study was conducted for the patients who underwent cervical spine surgery in a top three hospital in Beijing from April to December 2018. According to whether to implement enhanced recovery surgery, the patients were divided into enhanced recovery surgery group (eras group) and control group. The self-designed data collection table was used to collect data in the patient's medical records, including general demographic data and disease treatment data, implementation of accelerated rehabilitation surgery and application effect. Among them, the application effect includes the operation related complications, the visual analog scale (VAS) score of neck and shoulder pain, the ability of daily living after discharge, the length of stay, the cost of hospitalization and other recent rehabilitation effect indicators, as well as the rehospitalization rate of 90 days and the Japanese Orthopaedic Society four months after operation Association (JOA) score, neck disability index (NDI) score, neck and shoulder pain symptoms, neck and shoulder stiffness symptoms and other long-term rehabilitation indicators. Independent sample t-test, rank sum test and chi square test were used to compare the differences between the two groups. On the basis of single factor analysis, combined with multi factor analysis, the impact of groups on outcome indicators was clarified, included 90-day readmission, reexamination time, follow-up JOA score, NDI score, neck and shoulder pain symptoms and neck and shoulder stiffness symptoms.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• ① patients with cervical spondylosis were definitely diagnosed; ② Cervical spine surgery was performed under general anesthesia; ③ Age ≥ 18 years old;

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Exclusion Criteria

• ① patients with cervical deformity correction surgery; ② Patients who underwent secondary cervical spine surgery; ③ Patients with spinal cord injury caused by trauma (4) patients with thoracic and atlantoaxial diseases and corresponding surgery; ⑤ Ankylosing spondylitis patients; ⑥ Patients with cerebral infarction, cerebral palsy and nerve root injury.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERAS Group	Enhanced recovery after surgery	Patients were treated by enhanced recovery after surgery

Primary Outcome Measures

Name	Time	Method
the rehospitalization rate	90-day follow-up after surgery	the rehospitalization rate of 90 days
the ability of daily living	90-day follow-up after surgery	The medical history related to the ability of daily living
the cost of hospitalization	Admission to discharge, an average of 3 days	the cost of hospitalization
the length of hospital stay	Admission to discharge, an average of 3 days	the length of hospital stay

Secondary Outcome Measures

Name	Time	Method
VAS (visual analog scale ) score	90-day follow-up after surgery	VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
NDI (neck disability index) score	90-day follow-up after surgery	NDI score, 0-100%, higher means worse outcomes
symptoms of neck and shoulder	90-day follow-up after surgery	The presence or absence of neck and shoulder stiffness symptoms
neurological function	90-day follow-up after surgery	the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes

Trial Locations

Locations (1)

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