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Completed

NCT Number: NCT04955496

ERAS on 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced recovery after surgery

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.

Primary outcomes

  1. the ability of daily living

    Time frame: Baseline

    The medical history related to the ability of daily living

  2. the ability of daily living

    Time frame: 90-day follow-up after surgery

    The medical history related to the ability of daily living

  3. the length of hospital stay

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

    the length of hospital stay

  4. the cost of hospitalization

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

    the cost of hospitalization

  5. the rehospitalization rate

    Time frame: 90-day follow-up after surgery

    the rehospitalization rate of 90 days

Secondary outcomes

  1. VAS (visual analog scale ) score

    Time frame: Baseline

    VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes

  2. VAS (visual analog scale ) score

    Time frame: 90-day follow-up after surgery

    VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes

  3. NDI (neck disability index) score

    Time frame: Baseline

    NDI score, 0-100%, higher means worse outcomes

  4. NDI (neck disability index) score

    Time frame: 90-day follow-up after surgery

    NDI score, 0-100%, higher means worse outcomes

  5. symptoms of neck and shoulder

    Time frame: Baseline

    The presence or absence of neck and shoulder pain symptoms

  6. symptoms of neck and shoulder

    Time frame: 90-day follow-up after surgery

    The presence or absence of neck and shoulder pain symptoms

  7. symptoms of neck and shoulder

    Time frame: Baseline

    The presence or absence of neck and shoulder stiffness symptoms

  8. symptoms of neck and shoulder

    Time frame: 90-day follow-up after surgery

    The presence or absence of neck and shoulder stiffness symptoms

  9. neurological function

    Time frame: Baseline

    the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes

  10. neurological function

    Time frame: 90-day follow-up after surgery

    the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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