NCT05149404

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

December 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

July 1, 2021

Last Update Submit

November 24, 2021

Conditions

Cervical Spondylotic MyelopathyOssification of Posterior Longitudinal Ligament in Cervical Region

Keywords

enhanced recovery after surgeryPosterior cervical surgeryposterior cervical laminoplastyClinical pathway

Outcome Measures

Primary Outcomes (15)

  • range of motion on X - ray

    range of motion the neck in extension and flexion on X - ray

    preoperation

  • range of motion on X - ray

    range of motion the neck in extension and flexion on X - ray

    intraoperation

  • range of motion on X - ray

    range of motion the neck in extension and flexion on X - ray

    72 hours after surgery

  • range of motion on X - ray

    range of motion the neck in extension and flexion on X - ray

    3 months after surgery

  • range of motion on X - ray

    range of motion the neck in extension and flexion on X - ray

    6 months after surgery

  • Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）

    A questionare to evaluate the severity of cervical spondylosis myelopathy

    preoperation

  • Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）

    A questionare to evaluate the severity of cervical spondylosis myelopathy

    intraoperation

  • Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）

    A questionare to evaluate the severity of cervical spondylosis myelopathy

    72 hours after surgery

  • Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）

    A questionare to evaluate the severity of cervical spondylosis myelopathy

    3 months after surgery

  • Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）

    A questionare to evaluate the severity of cervical spondylosis myelopathy

    6 months after surgery

  • multi-cervical-unit system（MCU）

    To locate the cervical responsible section

    preoperation

  • multi-cervical-unit system（MCU）

    To locate the cervical responsible section

    intraoperation

  • multi-cervical-unit system（MCU）

    To locate the cervical responsible section

    72 hours after surgery

  • multi-cervical-unit system（MCU）

    To locate the cervical responsible section

    3 months after surgery

  • multi-cervical-unit system（MCU）

    To locate the cervical responsible section

    6 months after surgery

Study Arms (2)

ERAS group

Conventional group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Central Study Contacts

Yu Sun, Dr.

CONTACT

13501221484sunyuor@vip.sina.com

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

December 8, 2021

Study Start

August 1, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

December 8, 2021

Record last verified: 2021-06

Locations

CN(1)