ERAS in Posterior Approach of Cervical Spine Operation

Completed

• Conditions: Cervical Myelopathy
• Interventions: Procedure: Enhanced recovery after surgery

• Registration Number: NCT04962256
• Lead Sponsor: Peking University Third Hospital

Brief 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.

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 Timeline

• Study Start: 2019-03-20
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-04
• Study First Posted: 2021-07-14
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Enhanced recovery after surgery	Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty

Primary Outcome Measures

Name	Time	Method
Outcomes of pain	3 months after surgery.	Visual analogue scale 3-month after surgery, 0 to 10 points, higher means severer the pain is.
Length of stay	Admission to discharge, an average of 3 days	Length of stay
Neurological function	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	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	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	At 3-month follow-up	Personal interviews of patients at 3-month follow-up

Trial Locations

Locations (1)

Feifei Zhou; 🇨🇳 Beijing, Beijing, China