ERAS in Posterior Approach of Cervical Spine Operation

Peking University

Status: Completed

Conditions: Cervical Myelopathy

Treatments: Procedure: Enhanced recovery after surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04962256

M2019144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

204 participants in 1 patient group

Study group

Description:

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

Treatment:

Procedure: Enhanced recovery after surgery