Cervical MyelopathyNCT04962256
ERAS in Posterior Approach of Cervical Spine Operation
An observational study of Cervical Myelopathy, run by Peking University Third Hospital at 1 site in China.
Trial summary
Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Myelopathy
- What is being tested?
- Enhanced recovery after surgery
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 31 Mar 2022
- 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: Patients with posterior approach of cervical spine operation
Who may be able to join
- Patients should be diagnosed as CSM based on the history, symptoms, Physical signs and radiographic results.
- Patients did not respond to the 3-month conventional treatment.
- Patients were performed posterior approach of cervical spine operation.
- Patients should have complete pre- and post-operative data.
Who cannot join
- Patients with severe organic diseases.
- Patients with previous history of cervical spine surgery.
- Patients with mental or psychological abnormality.
- Patients with severe osteoporosis (T value <-2.5).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application of Enhanced Recovery After Surgery (ERAS) During the Perioperative Period of Patients With Posterior Approach of Cervical Spine Operation: a Mixed Methods Study
Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM.
Read the detailed description
Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases, but up to now, few effort has been done to evaluate the effectiveness of ERAS in patients perioperative management of cervical spine surgery. As a interdisciplinary cooperation system, either qualitative or quantitative method alone can not completely reflect the function of ERAS. Mixed model research (MMR) is a appropriate method to evaluate a complex system, but it has not been used in ERAS evaluation. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM using MMR, including the retrospective quantitative part and prospective qualitative part. In the retrospective part, we will collect the data of length of stay, VAS scores, mJOA scores and SF-36 scores to compare the difference between ERAS group and regular group. In the prospective part, we will collect the data from the focus group meetings and personal interviews of patients, to verify that ERAS has the ability to improve the postoperative outcomes, while maintain an equal surgical effect.
- Conditions
- Cervical Myelopathy
- Being tested
- Enhanced recovery after surgery
- Keywords
- Cervical Myelopathy, Enhanced recovery after surgery, Surgical outcome
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 |
|---|---|---|
| Study group | Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty Receives: Procedure: Enhanced recovery after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes of pain
Visual analogue scale before after surgery, 0 to 10 points, higher means severer the pain is.
Measured: Preoperation
Outcomes of pain
Visual analogue scale 3-month after surgery, 0 to 10 points, higher means severer the pain is.
Measured: 3 months after surgery.
Length of stay
Length of stay
Measured: Admission to discharge, an average of 3 days
Neurological function
Modified Japanese Orthopaedic Association score before surgery, -2 to 17 points, higher means better outcome.
Measured: Preoperation
Neurological function
Modified Japanese Orthopaedic Association score 3-month after surgery, -2 to 17 points, higher means better outcome.
Measured: 3 months after surgery.
Outcomes of quality of life
36-Item Short Form Survey score before surgery, 0 to 100 points, higher means better outcome.
Measured: Preoperation
Outcomes of quality of life
36-Item Short Form Survey score 3-month after surgery, 0 to 100 points, higher means better outcome.
Measured: 3 months after surgery
Focus group meetings
Focus group meetings by specialists, to discuss the effect of ERAS and the what improvements can be made.
Measured: Admission to discharge, an average of 3 days
Personal interviews
Personal interviews of patients at 3-month follow-up
Measured: At 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start20 Mar 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Prospective
- Enrolment
- 204 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
- NCT04962256
- Sponsor's protocol ID
- M2019144
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2021
- Last updated
- 12 Oct 2022
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Enhanced Recovery After Surgery (ERAS) During the Perioperative Period of Patients With Posterior Approach of Cervical Spine Operation: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT04962256
- Acronym / sponsor ID
- M2019144
- Conditions
- Cervical Myelopathy
- Keywords
- Cervical Myelopathy, Enhanced recovery after surgery, Surgical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 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.
Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM.
Detailed description
Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases, but up to now, few effort has been done to evaluate the effectiveness of ERAS in patients perioperative management of cervical spine surgery. As a interdisciplinary cooperation system, either qualitative or quantitative method alone can not completely reflect the function of ERAS. Mixed model research (MMR) is a appropriate method to evaluate a complex system, but it has not been used in ERAS evaluation. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM using MMR, including the retrospective quantitative part and prospective qualitative part. In the retrospective part, we will collect the data of length of stay, VAS scores, mJOA scores and SF-36 scores to compare the difference between ERAS group and regular group. In the prospective part, we will collect the data from the focus group meetings and personal interviews of patients, to verify that ERAS has the ability to improve the postoperative outcomes, while maintain an equal surgical effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Enhanced recovery after surgeryPatients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with posterior approach of cervical spine operation
Key inclusion criteria (4 listed)
- Patients should be diagnosed as CSM based on the history, symptoms, Physical signs and radiographic results.
- Patients did not respond to the 3-month conventional treatment.
- Patients were performed posterior approach of cervical spine operation.
- Patients should have complete pre- and post-operative data.
Key exclusion criteria (4 listed)
- Patients with severe organic diseases.
- Patients with previous history of cervical spine surgery.
- Patients with mental or psychological abnormality.
- Patients with severe osteoporosis (T value <-2.5).
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 | Study group |
Primary outcome
Outcomes of pain
Time frame: Preoperation
Visual analogue scale before after surgery, 0 to 10 points, higher means severer the pain is.
Outcomes of pain
Time frame: 3 months after surgery.
Visual analogue scale 3-month after surgery, 0 to 10 points, higher means severer the pain is.
Length of stay
Time frame: Admission to discharge, an average of 3 days
Length of stay
Neurological function
Time frame: Preoperation
Modified Japanese Orthopaedic Association score before surgery, -2 to 17 points, higher means better outcome.
Neurological function
Time frame: 3 months after surgery.
Modified Japanese Orthopaedic Association score 3-month after surgery, -2 to 17 points, higher means better outcome.
Outcomes of quality of life
Time frame: Preoperation
36-Item Short Form Survey score before surgery, 0 to 100 points, higher means better outcome.
Outcomes of quality of life
Time frame: 3 months after surgery
36-Item Short Form Survey score 3-month after surgery, 0 to 100 points, higher means better outcome.
Focus group meetings
Time frame: Admission to discharge, an average of 3 days
Focus group meetings by specialists, to discuss the effect of ERAS and the what improvements can be made.
Personal interviews
Time frame: At 3-month follow-up
Personal interviews of patients at 3-month follow-up
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 12 Oct 2022.
- Individual participant dataSharing planned: No
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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.
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 Myelopathy, 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 4 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 12 Oct 2022. 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?
Outcomes of pain (time frame: Preoperation). The study lists 9 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 12 Oct 2022.