ERAS in Posterior Approach of Cervical Spine Operation

NCT ID: NCT04962256

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-20

Study Completion Date

2022-03-31

Brief Summary

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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

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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

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Cervical Myelopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty

Enhanced recovery after surgery

Intervention Type PROCEDURE

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.

Interventions

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Enhanced recovery after 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients should be diagnosed as CSM based on the history, symptoms, Physical signs and radiographic results.
2. Patients did not respond to the 3-month conventional treatment.
3. Patients were performed posterior approach of cervical spine operation.
4. Patients should have complete pre- and post-operative data.

Exclusion Criteria

1. Patients with severe organic diseases.
2. Patients with previous history of cervical spine surgery.
3. Patients with mental or psychological abnormality.
4. Patients with severe osteoporosis (T value \<-2.5).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Feifei Zhou

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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M2019144

Identifier Type: -

Identifier Source: org_study_id

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