NCT04955496

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

19 days

First QC Date

July 1, 2021

Last Update Submit

July 7, 2021

Conditions

Keywords

Enhanced Recovery after Surgery, Cervical Spondylosis, Outcome measures

Outcome Measures

Primary Outcomes (5)

  • the ability of daily living

    The medical history related to the ability of daily living

    Baseline

  • the ability of daily living

    The medical history related to the ability of daily living

    90-day follow-up after surgery

  • the length of hospital stay

    the length of hospital stay

    Admission to discharge, an average of 3 days

  • the cost of hospitalization

    the cost of hospitalization

    Admission to discharge, an average of 3 days

  • the rehospitalization rate

    the rehospitalization rate of 90 days

    90-day follow-up after surgery

Secondary Outcomes (10)

  • VAS (visual analog scale ) score

    Baseline

  • VAS (visual analog scale ) score

    90-day follow-up after surgery

  • NDI (neck disability index) score

    Baseline

  • NDI (neck disability index) score

    90-day follow-up after surgery

  • symptoms of neck and shoulder

    Baseline

  • +5 more secondary outcomes

Study Arms (2)

ERAS Group

Patients were treated by enhanced recovery after surgery

Procedure: Enhanced recovery after surgery

Control Group

Patients were not treated by enhanced recovery after surgery

Interventions

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.

ERAS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the patients who underwent cervical spine surgery

You may qualify if:

  • ① patients with cervical spondylosis were definitely diagnosed; ② Cervical spine surgery was performed under general anesthesia; ③ Age ≥ 18 years old;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 8, 2021

Study Start

September 1, 2019

Primary Completion

September 20, 2019

Study Completion

September 30, 2019

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations