ERAS on Cervical Surgery

Cervical Spondylosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04955496
• Other study ID #: LM2019195
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 30, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ? patients with cervical spondylosis were definitely diagnosed; ? Cervical spine surgery was performed under general anesthesia; ? Age = 18 years old;

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cervical Spondylosis
• Spondylosis

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ability of daily living	The medical history related to the ability of daily living	Baseline
Primary	the ability of daily living	The medical history related to the ability of daily living	90-day follow-up after surgery
Primary	the length of hospital stay	the length of hospital stay	Admission to discharge, an average of 3 days
Primary	the cost of hospitalization	the cost of hospitalization	Admission to discharge, an average of 3 days
Primary	the rehospitalization rate	the rehospitalization rate of 90 days	90-day follow-up after surgery
Secondary	VAS (visual analog scale ) score	VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes	Baseline
Secondary	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
Secondary	NDI (neck disability index) score	NDI score, 0-100%, higher means worse outcomes	Baseline
Secondary	NDI (neck disability index) score	NDI score, 0-100%, higher means worse outcomes	90-day follow-up after surgery
Secondary	symptoms of neck and shoulder	The presence or absence of neck and shoulder pain symptoms	Baseline
Secondary	symptoms of neck and shoulder	The presence or absence of neck and shoulder pain symptoms	90-day follow-up after surgery
Secondary	symptoms of neck and shoulder	The presence or absence of neck and shoulder stiffness symptoms	Baseline
Secondary	symptoms of neck and shoulder	The presence or absence of neck and shoulder stiffness symptoms	90-day follow-up after surgery
Secondary	neurological function	the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes	Baseline
Secondary	neurological function	the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes	90-day follow-up after surgery