ERAS in Posterior Approach of Cervical Spine Operation

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04962256

Collaborator

(none)

204

Enrollment

Location

36.4

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Myelopathy	Procedure: Enhanced recovery after surgery

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

Study Type:

Observational

Anticipated Enrollment :

204 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 20, 2019

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Study group Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty	Procedure: 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.

Arm

Intervention/Treatment

Study group

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Outcomes of pain [Preoperation]
Visual analogue scale before after surgery
Outcomes of pain [3 months after surgery.]
Visual analogue scale 3-month after surgery
Length of stay [Admission to discharge, an average of 3 days]
Length of stay
Neurological function [Preoperation]
Modified Japanese Orthopaedic Association score before surgery
Neurological function [3 months after surgery.]
Modified Japanese Orthopaedic Association score 3-month after surgery
Outcomes of quality of life [Preoperation]
36-Item Short Form Survey score before surgery
Outcomes of quality of life [3 months after surgery]
36-Item Short Form Survey score 3-month after surgery
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

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.

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Feifei Zhou	Beijing	Beijing	China	100191

Sponsors and Collaborators

Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT04962256

Other Study ID Numbers:

M2019144

First Posted:

Jul 14, 2021

Last Update Posted:

Jul 14, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking University Third Hospital

Cervical Myelopathy

Enhanced recovery after surgery

Surgical outcome

Additional relevant MeSH terms:

Spinal Cord Diseases

Bone Marrow Diseases

Study Results

No Results Posted as of Jul 14, 2021