Cervical SpondylosisNCT04955496
ERAS on Cervical Surgery
An observational study of Cervical Spondylosis, run by Peking University Third Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Enhanced recovery after surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients who underwent cervical spine surgery
Who may be able to join
- ① patients with cervical spondylosis were definitely diagnosed; ② Cervical spine surgery was performed under general anesthesia; ③ Age ≥ 18 years old;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
About this study
Official title: Evaluation of the Effect of Enhanced Recovery After Surgery for 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
Read the 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.
- Conditions
- Cervical Spondylosis
- Being tested
- Enhanced recovery after surgery
- Keywords
- Enhanced Recovery after Surgery, Cervical Spondylosis, Outcome measures
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| ERAS Group | Patients were treated by enhanced recovery after surgery Receives: Procedure: Enhanced recovery after surgery | |
| Control Group | Patients were not treated by enhanced recovery after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ability of daily living
The medical history related to the ability of daily living
Measured: Baseline
the ability of daily living
The medical history related to the ability of daily living
Measured: 90-day follow-up after surgery
the length of hospital stay
the length of hospital stay
Measured: Admission to discharge, an average of 3 days
the cost of hospitalization
the cost of hospitalization
Measured: Admission to discharge, an average of 3 days
the rehospitalization rate
the rehospitalization rate of 90 days
Measured: 90-day follow-up after surgery
Secondary outcomes (10)
VAS (visual analog scale ) score
VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
Measured: Baseline
VAS (visual analog scale ) score
VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
Measured: 90-day follow-up after surgery
NDI (neck disability index) score
NDI score, 0-100%, higher means worse outcomes
Measured: Baseline
NDI (neck disability index) score
NDI score, 0-100%, higher means worse outcomes
Measured: 90-day follow-up after surgery
symptoms of neck and shoulder
The presence or absence of neck and shoulder pain symptoms
Measured: Baseline
symptoms of neck and shoulder
The presence or absence of neck and shoulder pain symptoms
Measured: 90-day follow-up after surgery
symptoms of neck and shoulder
The presence or absence of neck and shoulder stiffness symptoms
Measured: Baseline
symptoms of neck and shoulder
The presence or absence of neck and shoulder stiffness symptoms
Measured: 90-day follow-up after surgery
neurological function
the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes
Measured: Baseline
neurological function
the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes
Measured: 90-day follow-up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Sep 2019
- Primary completion20 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955496
- Sponsor's protocol ID
- LM2019195
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery
- ClinicalTrials.gov ID
- NCT04955496
- Acronym / sponsor ID
- LM2019195
- Conditions
- Cervical Spondylosis
- Keywords
- Enhanced Recovery after Surgery, Cervical Spondylosis, Outcome measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS Group | – | Procedure: Enhanced recovery after surgeryPatients were treated by enhanced recovery after surgery |
| Control Group | – | –Patients were not treated by enhanced recovery after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients who underwent cervical spine surgery
Key inclusion criteria (1 listed)
- ① patients with cervical spondylosis were definitely diagnosed; ② Cervical spine surgery was performed under general anesthesia; ③ Age ≥ 18 years old;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after surgeryERAS 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. | Procedure or surgery | ERAS Group |
Primary outcome
the ability of daily living
Time frame: Baseline
The medical history related to the ability of daily living
the ability of daily living
Time frame: 90-day follow-up after surgery
The medical history related to the ability of daily living
the length of hospital stay
Time frame: Admission to discharge, an average of 3 days
the length of hospital stay
the cost of hospitalization
Time frame: Admission to discharge, an average of 3 days
the cost of hospitalization
the rehospitalization rate
Time frame: 90-day follow-up after surgery
the rehospitalization rate of 90 days
10 secondary outcomes
VAS (visual analog scale ) score
Time frame: Baseline
VAS (visual analog scale ) score
Time frame: 90-day follow-up after surgery
NDI (neck disability index) score
Time frame: Baseline
NDI (neck disability index) score
Time frame: 90-day follow-up after surgery
symptoms of neck and shoulder
Time frame: Baseline
symptoms of neck and shoulder
Time frame: 90-day follow-up after surgery
symptoms of neck and shoulder
Time frame: Baseline
symptoms of neck and shoulder
Time frame: 90-day follow-up after surgery
neurological function
Time frame: Baseline
neurological function
Time frame: 90-day follow-up after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Cervical Spondylosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Recruiting
Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
Cervical Spondylosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylosis, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ability of daily living (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.