ERAS on Cervical Surgery

NCT ID: NCT04955496

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Cervical Spondylosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ERAS Group

Patients were treated by enhanced recovery after surgery

Enhanced recovery after surgery

Intervention Type PROCEDURE

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

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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LM2019195

Identifier Type: -

Identifier Source: org_study_id

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