Clinical trial NCT04962256: ERAS in Posterior Approach of Cervical Spine Operation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Myelopathy
Keywords: Cervical Myelopathy
Enhanced recovery after surgery
Surgical outcome
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with posterior approach of cervical spine operation

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Outcomes of pain
timeFrame: Preoperation
measure: Outcomes of pain
timeFrame: 3 months after surgery.
measure: Length of stay
timeFrame: Admission to discharge, an average of 3 days
measure: Neurological function
timeFrame: Preoperation
measure: Neurological function
timeFrame: 3 months after surgery.
measure: Outcomes of quality of life
timeFrame: Preoperation
measure: Outcomes of quality of life
timeFrame: 3 months after surgery
measure: Focus group meetings
timeFrame: Admission to discharge, an average of 3 days
measure: Personal interviews
timeFrame: At 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Feifei Zhou
state: Beijing
Study officials:
References: