ERAS on Cervical Surgery

Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery

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

Study Overview

• Status: Completed
• Conditions: Cervical Spondylosis
• Intervention / Treatment: Procedure: Enhanced recovery after surgery

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 Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100083
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the patients who underwent cervical spine surgery

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERAS Group; Patients were treated by enhanced recovery after surgery	Procedure: Enhanced recovery after surgery; ERAS management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.
Control Group; Patients were not treated by enhanced recovery after surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Enhanced Recovery after Surgery, Cervical Spondylosis, Outcome measures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis
• Other Study ID Numbers: LM2019195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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