Cervical Spondylotic MyelopathyNCT05149404
The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery
An observational study of Cervical Spondylotic Myelopathy and Ossification of Posterior Longitudinal Ligament in Cervical Region, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study intends to establish a multidisciplinary collaborative ERAS clinical pathway of cervical posterior surgery,and to verify its effectiveness, safety and value in health economics. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Spondylotic Myelopathy, Ossification of Posterior Longitudinal Ligament in Cervical Region
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 30 Dec 2021
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: 1. Preoperative ASA score ≥III; 2. One-stage combined anterior and posterior surgery of cervical spine; 3. Correction of cervical deformity; 4. Patients with gastric emptied disorders (such as gastroesophageal reflux, chronic history of aspiration, delayed gastric emptied), complete obstruction of the digestive tract, and inability to use enteral preparations; 5. Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial; 6. People with mental disorders, alcohol dependence or drug abuse history; 7. women in the period of lactation and pregnancy; 8. People with allergic constitution or previous allergies to a variety of drugs; 9. Other researchers consider it inappropriate to participate in this study
Who may be able to join
- Age 18-70, gender unlimited;
- Diagnostic diagnosis of cervical spondylosis and consistent with the indications of posterior spinal canal extended laminoplasty;
- Basis of serious diseases of centerlessness, brain, lung, kidney or other important organs, preoperative ASA score I-II;
- Agree to participate in the study and sign the informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yu Sun, Dr., 13501221484, sunyuor@vip.sina.com
About this study
Official title: The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery:a Multicenter, Non-interventional Cohort Study
This study intends to establish a multidisciplinary collaborative ERAS clinical pathway of cervical posterior surgery,and to verify its effectiveness, safety and value in health economics.
Read the detailed description
Enhanced recovery after surgery (ERAS) is a new model of deep cooperation between surgery，rehabilitation medicine, anesthesiology, nursing and other disciplines in recent years, which enables patients to start rehabilitation training as soon as possible after surgery and improves the comprehensive effect of surgery. Posterior cervical surgery is traumatic, and it is significant to enhance postoperative rehabilitation to improve the overall efficacy of patients. Currently, there are no clear guidelines supporting the clinical effectiveness of ERAS in reducing complications, reducing costs, and enhancing recovery after posterior cervical surgery. Therefore, this study aims to establish a multidisciplinary ERAS model for posterior cervical surgery in Peking University Third Hospital and verify its clinical effectiveness. This is a multi-center, multidisciplinary prospective cohort study,in which the orthopedics department was combined with the anesthesiology department, rehabilitation department, nutrition department, operating room and nursing team to establish the ERAS clinical pathways for posterior cervical spine surgery. Clinical pathways include surgical procedure optimization, rehabilitation procedure optimization, anesthesia and nursing procedure optimization. As it is optimized and promoted,the ERAS clinical pathways will improve the curative effect and prognosis of posterior cervical surgery, so that more patients with cervical spondylosis will benefit.
- Conditions
- Cervical Spondylotic Myelopathy, Ossification of Posterior Longitudinal Ligament in Cervical Region
- Keywords
- enhanced recovery after surgery, Posterior cervical surgery, posterior cervical laminoplasty, Clinical pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Not described | |
| Conventional group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion on X - ray
range of motion the neck in extension and flexion on X - ray
Measured: preoperation
range of motion on X - ray
range of motion the neck in extension and flexion on X - ray
Measured: intraoperation
range of motion on X - ray
range of motion the neck in extension and flexion on X - ray
Measured: 72 hours after surgery
range of motion on X - ray
range of motion the neck in extension and flexion on X - ray
Measured: 3 months after surgery
range of motion on X - ray
range of motion the neck in extension and flexion on X - ray
Measured: 6 months after surgery
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
A questionare to evaluate the severity of cervical spondylosis myelopathy
Measured: preoperation
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
A questionare to evaluate the severity of cervical spondylosis myelopathy
Measured: intraoperation
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
A questionare to evaluate the severity of cervical spondylosis myelopathy
Measured: 72 hours after surgery
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
A questionare to evaluate the severity of cervical spondylosis myelopathy
Measured: 3 months after surgery
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
A questionare to evaluate the severity of cervical spondylosis myelopathy
Measured: 6 months after surgery
multi-cervical-unit system（MCU）
To locate the cervical responsible section
Measured: preoperation
multi-cervical-unit system（MCU）
To locate the cervical responsible section
Measured: intraoperation
multi-cervical-unit system（MCU）
To locate the cervical responsible section
Measured: 72 hours after surgery
multi-cervical-unit system（MCU）
To locate the cervical responsible section
Measured: 3 months after surgery
multi-cervical-unit system（MCU）
To locate the cervical responsible section
Measured: 6 months 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 Dec 2021
- Study start1 Aug 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spondylotic MyelopathyStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Chao Yang Hospital, Peking University International Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149404
- Sponsor's protocol ID
- LM2020289
- Status last verified
- Jun 2021
- First submitted
- 1 Jul 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery:a Multicenter, Non-interventional Cohort Study
- ClinicalTrials.gov ID
- NCT05149404
- Acronym / sponsor ID
- LM2020289
- Conditions
- Cervical Spondylotic Myelopathy, Ossification of Posterior Longitudinal Ligament in Cervical Region
- Keywords
- enhanced recovery after surgery, Posterior cervical surgery, posterior cervical laminoplasty, Clinical pathway
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Chao Yang Hospital, Peking University International Hospital
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 8 Dec 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 intends to establish a multidisciplinary collaborative ERAS clinical pathway of cervical posterior surgery,and to verify its effectiveness, safety and value in health economics.
Detailed description
Enhanced recovery after surgery (ERAS) is a new model of deep cooperation between surgery，rehabilitation medicine, anesthesiology, nursing and other disciplines in recent years, which enables patients to start rehabilitation training as soon as possible after surgery and improves the comprehensive effect of surgery. Posterior cervical surgery is traumatic, and it is significant to enhance postoperative rehabilitation to improve the overall efficacy of patients. Currently, there are no clear guidelines supporting the clinical effectiveness of ERAS in reducing complications, reducing costs, and enhancing recovery after posterior cervical surgery. Therefore, this study aims to establish a multidisciplinary ERAS model for posterior cervical surgery in Peking University Third Hospital and verify its clinical effectiveness. This is a multi-center, multidisciplinary prospective cohort study,in which the orthopedics department was combined with the anesthesiology department, rehabilitation department, nutrition department, operating room and nursing team to establish the ERAS clinical pathways for posterior cervical spine surgery. Clinical pathways include surgical procedure optimization, rehabilitation procedure optimization, anesthesia and nursing procedure optimization. As it is optimized and promoted,the ERAS clinical pathways will improve the curative effect and prognosis of posterior cervical surgery, so that more patients with cervical spondylosis will benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | – | – |
| Conventional group | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Preoperative ASA score ≥III; 2. One-stage combined anterior and posterior surgery of cervical spine; 3. Correction of cervical deformity; 4. Patients with gastric emptied disorders (such as gastroesophageal reflux, chronic history of aspiration, delayed gastric emptied), complete obstruction of the digestive tract, and inability to use enteral preparations; 5. Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial; 6. People with mental disorders, alcohol dependence or drug abuse history; 7. women in the period of lactation and pregnancy; 8. People with allergic constitution or previous allergies to a variety of drugs; 9. Other researchers consider it inappropriate to participate in this study
Key inclusion criteria (4 listed)
- Age 18-70, gender unlimited;
- Diagnostic diagnosis of cervical spondylosis and consistent with the indications of posterior spinal canal extended laminoplasty;
- Basis of serious diseases of centerlessness, brain, lung, kidney or other important organs, preoperative ASA score I-II;
- Agree to participate in the study and sign the informed consent.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
range of motion on X - ray
Time frame: preoperation
range of motion the neck in extension and flexion on X - ray
range of motion on X - ray
Time frame: intraoperation
range of motion the neck in extension and flexion on X - ray
range of motion on X - ray
Time frame: 72 hours after surgery
range of motion the neck in extension and flexion on X - ray
range of motion on X - ray
Time frame: 3 months after surgery
range of motion the neck in extension and flexion on X - ray
range of motion on X - ray
Time frame: 6 months after surgery
range of motion the neck in extension and flexion on X - ray
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
Time frame: preoperation
A questionare to evaluate the severity of cervical spondylosis myelopathy
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
Time frame: intraoperation
A questionare to evaluate the severity of cervical spondylosis myelopathy
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
Time frame: 72 hours after surgery
A questionare to evaluate the severity of cervical spondylosis myelopathy
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
Time frame: 3 months after surgery
A questionare to evaluate the severity of cervical spondylosis myelopathy
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
Time frame: 6 months after surgery
A questionare to evaluate the severity of cervical spondylosis myelopathy
multi-cervical-unit system（MCU）
Time frame: preoperation
To locate the cervical responsible section
multi-cervical-unit system（MCU）
Time frame: intraoperation
To locate the cervical responsible section
multi-cervical-unit system（MCU）
Time frame: 72 hours after surgery
To locate the cervical responsible section
multi-cervical-unit system（MCU）
Time frame: 3 months after surgery
To locate the cervical responsible section
multi-cervical-unit system（MCU）
Time frame: 6 months after surgery
To locate the cervical responsible section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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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.
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 Spondylotic Myelopathy and Ossification of Posterior Longitudinal Ligament in Cervical Region, 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 4 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: status not confirmed, as of the sponsor's last update on 8 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Sun, Dr. (13501221484, sunyuor@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion on X - ray (time frame: preoperation). The study lists 15 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 Dec 2021.