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Clinical Trials/NCT04962256
NCT04962256
Completed
Not Applicable

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

Peking University Third Hospital1 site in 1 country204 target enrollmentMarch 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Myelopathy
Sponsor
Peking University Third Hospital
Enrollment
204
Locations
1
Primary Endpoint
Outcomes of pain
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2019
End Date
March 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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: 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: 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

Study Sites (1)

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