Clinical trial NCT05149404: The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery
Official title: The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery:a Multicenter, Non-interventional Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Spondylotic Myelopathy
Ossification of Posterior Longitudinal Ligament in Cervical Region
Keywords: enhanced recovery after surgery
Posterior cervical surgery
posterior cervical laminoplasty
Clinical pathway
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Chao Yang Hospital
name: Peking University International Hospital
First posted: 2021-12-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Preoperative ASA score ≥III;
2. One-stage combined anterior and posterior surgery of cervical spine;
3. Correction of cervical deformity;
4. Patients with gastric emptied disorders (such as gastroesophageal reflux, chronic history of aspiration, delayed gastric emptied), complete obstruction of the digestive tract, and inability to use enteral preparations;
5. Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial;
6. People with mental disorders, alcohol dependence or drug abuse history;
7. women in the period of lactation and pregnancy;
8. People with allergic constitution or previous allergies to a variety of drugs;
9. Other researchers consider it inappropriate to participate in this study

Brief summary: This study intends to establish a multidisciplinary collaborative ERAS clinical pathway of cervical posterior surgery,and to verify its effectiveness, safety and value in health economics.

Detailed description: Enhanced recovery after surgery (ERAS) is a new model of deep cooperation between surgery，rehabilitation medicine, anesthesiology, nursing and other disciplines in recent years, which enables patients to start rehabilitation training as soon as possible after surgery and improves the comprehensive effect of surgery. Posterior cervical surgery is traumatic, and it is significant to enhance postoperative rehabilitation to improve the overall efficacy of patients. Currently, there are no clear guidelines supporting the clinical effectiveness of ERAS in reducing complications, reducing costs, and enhancing recovery after posterior cervical surgery. Therefore, this study aims to establish a multidisciplinary ERAS model for posterior cervical surgery in Peking University Third Hospital and verify its clinical effectiveness. This is a multi-center, multidisciplinary prospective cohort study,in which the orthopedics department was combined with the anesthesiology department, rehabilitation department, nutrition department, operating room and nursing team to establish the ERAS clinical pathways for posterior cervical spine surgery. Clinical pathways include surgical procedure optimization, rehabilitation procedure optimization, anesthesia and nursing procedure optimization. As it is optimized and promoted,the ERAS clinical pathways will improve the curative effect and prognosis of posterior cervical surgery, so that more patients with cervical spondylosis will benefit.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70, gender unlimited;
2. Diagnostic diagnosis of cervical spondylosis and consistent with the indications of posterior spinal canal extended laminoplasty;
3. Basis of serious diseases of centerlessness, brain, lung, kidney or other important organs, preoperative ASA score I-II;
4. Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: range of motion on X - ray
timeFrame: preoperation
measure: range of motion on X - ray
timeFrame: intraoperation
measure: range of motion on X - ray
timeFrame: 72 hours after surgery
measure: range of motion on X - ray
timeFrame: 3 months after surgery
measure: range of motion on X - ray
timeFrame: 6 months after surgery
measure: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
timeFrame: preoperation
measure: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
timeFrame: intraoperation
measure: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
timeFrame: 72 hours after surgery
measure: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
timeFrame: 3 months after surgery
measure: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）
timeFrame: 6 months after surgery
measure: multi-cervical-unit system（MCU）
timeFrame: preoperation
measure: multi-cervical-unit system（MCU）
timeFrame: intraoperation
measure: multi-cervical-unit system（MCU）
timeFrame: 72 hours after surgery
measure: multi-cervical-unit system（MCU）
timeFrame: 3 months after surgery
measure: multi-cervical-unit system（MCU）
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: