Clinical trial NCT04955496: ERAS on Cervical Surgery
Official title: Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spondylosis
Keywords: Enhanced Recovery after Surgery, Cervical Spondylosis, Outcome measures
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who underwent cervical spine surgery

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.

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.

Primary outcomes:
measure: the ability of daily living
timeFrame: Baseline
measure: the ability of daily living
timeFrame: 90-day follow-up after surgery
measure: the length of hospital stay
timeFrame: Admission to discharge, an average of 3 days
measure: the cost of hospitalization
timeFrame: Admission to discharge, an average of 3 days
measure: the rehospitalization rate
timeFrame: 90-day follow-up after surgery
Secondary outcomes:
measure: VAS (visual analog scale ) score
timeFrame: Baseline
measure: VAS (visual analog scale ) score
timeFrame: 90-day follow-up after surgery
measure: NDI (neck disability index) score
timeFrame: Baseline
measure: NDI (neck disability index) score
timeFrame: 90-day follow-up after surgery
measure: symptoms of neck and shoulder
timeFrame: Baseline
measure: symptoms of neck and shoulder
timeFrame: 90-day follow-up after surgery
measure: symptoms of neck and shoulder
timeFrame: Baseline
measure: symptoms of neck and shoulder
timeFrame: 90-day follow-up after surgery
measure: neurological function
timeFrame: Baseline
measure: neurological function
timeFrame: 90-day follow-up after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: