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Clinical Trials/NCT04955496
NCT04955496
Completed
N/A

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

Peking University Third Hospital1 site in 1 country2,000 target enrollmentSeptember 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cervical Spondylosis
Sponsor
Peking University Third Hospital
Enrollment
2000
Locations
1
Primary Endpoint
the rehospitalization rate
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
September 30, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the rehospitalization rate

Time Frame: 90-day follow-up after surgery

the rehospitalization rate of 90 days

the ability of daily living

Time Frame: 90-day follow-up after surgery

The medical history related to the ability of daily living

the cost of hospitalization

Time Frame: Admission to discharge, an average of 3 days

the cost of hospitalization

the length of hospital stay

Time Frame: Admission to discharge, an average of 3 days

the length of hospital stay

Secondary Outcomes

  • VAS (visual analog scale ) score(90-day follow-up after surgery)
  • NDI (neck disability index) score(90-day follow-up after surgery)
  • symptoms of neck and shoulder(90-day follow-up after surgery)
  • neurological function(90-day follow-up after surgery)

Study Sites (1)

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