Clinical trial NCT06607081: Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
Official title: The Preoperative Risk Evaluation and Perioperative ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Degenerative Spinal Disease
Elderly Patients
Spinal Fusion Acquired
Keywords: Elderly patients
ERAS
Spinal disease
Surgical intervention
Risk factors
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Hospital of Southern Medical University
name: Second Xiangya Hospital of Central South University
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2024-09-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the value of preoperative risk factor evaulation combined with perioperative ERAS measures in improving the clinical prognosis of elderly patients undergo the spinal fusion.

Detailed description: Population ageing is rapid progressing globally. In the United States, the number of people over the age of 80 is expected to grow from 1.9% in 2020 to 4.3% in 2050. According to the Statistical Communique on the Development of Civil Affairs in 2023 issued by the Ministry of Civil Affairs in 2024, the elderly population aged 65 and above in China is 216.76 million, accounting for 15.4% of the total population. Spinal degenerative diseases are the most common diseases among the elderly population. The prevalence of spinal degenerative diseases over 65 years old is about 56%, and there are about 121 million patients in China. Spinal degenerative diseases, including cervical spondylosis, cervical spinal stenosis, lumbar disc herniation, lumbar spinal stenosis, degenerative scoliosis, et al., which can lead to significant nerve compression, pain, neurological dysfunction, and mobility and endurance reduction, leading to reduced quality of life. Elderly patients preferentially choose non-surgical treatment such as drug intervention, but most conservative treatment methods have limited efficacy and cannot completely relieve nerve compression. Spinal fusion surgery is the most fundamental solution to the treatment of spinal degenerative diseases. Because of the elderly patients with multiple diseases, multi-drug use, multi-organ dysfunction, therefore, the perioperative safety management of such patients is a difficult problem faced by clinicians.

Preoperative high-risk factor evaluation and pre-enhanced recovery after surgery (Pre ERAS) are effective preoperative optimization strategies to benefit elderly patients. Patients are comprehensively evaluated before surgery by multidisciplinary consultation group to assess the high risk factors of spinal fusion surgery. On this basis, multidisciplinary intervention, exercise, nutritional support and psychological intervention were carried out to increase patients' preoperative physiological reserve, reduce the incidence of postoperative adverse events, and ultimately improve patients' perioperative functional status and prognosis. However, there is still a significant lack of unified understanding and willingness to implement preoperative screening and surgical management for elderly patients.

On the basis of "Chinese Expert Consensus on Multidisciplinary Evaluation of Perioperative Period in Elderly Spinal Surgery Patients", this study intends to further specify the concept of Pre ERAS for diagnosis and treatment measures, and form an operable Pre ERAS protocol. Through multi-center, prospective clinical study, to comprehensively evaluate the comprehensive impact of preoperative high-risk factor assessment combined with Pre ERAS measures on the clinical prognosis of elderly patients undergoing spinal fusion surgery, which lays an evidence-based medical foundation for the extensive application of this concept and measures in clinical practice.

The overall aim of this work is to evaluate the effects of preoperative risk factors and Pre ERAS on clinical outcomes in elderly (≥75 years) spinal fusion patients.

This study is a multi-center, prospective, randomized controlled clinical trial including a total of 2500 patients in the experimental group and the control group, respectively. The research centers include: Shenzhen Hospital of Southern Medical University, the Second Xiangya Hospital of Central South University, and Shanghai General Hospital. Patients were recruited according to inclusion criteria and exclusion criteria. The experimental group received Pre ERAS during perioperative period, while the control group received conventional ERAS during perioperative period. According to the clinical study protocol, patients were subjected to perioperative intervention, clinical follow-up, results recorded, adverse events were discovered and recorded in time and reported according to regulations, and cases meeting the exclusion criteria were excluded. This study will start in October 2024. The recruitment period will be 12 months, with a follow-up of 12 months. The results of the study will be expected in October 2027.

Eligibility criteria: Inclusion Criteria:

* 1.Age ≥75 years old;
* 2.Have degenerative spinal diseases, including cervical, thoracic and lumbar spine diseases;
* 3.With severe neurological symptoms fail to conservative treatment and have to undergo the spinal fusion surgery;
* 4.No serious cognitive impairment (MoCA score ≥8);
* 5.No surgical contraindications;
* 6.Anesthesia assessment patients can safely undergo surgery;
* 7.Patients who voluntarily participate in and sign informed consent, can independently complete effective questionnaires, and are willing to follow up according to clinical requirements.

Exclusion Criteria:

* 1.Patients who could not cooperate with doctors to complete preoperative evaluation and postoperative follow-up;
* 2.Patients requiring spinal intervention due to spinal infection, fracture or metastatic disease;
* 3.Patients with cerebrovascular accidents in the last 30 days;
* 4.Patients with hepatic encephalopathy or acute active hepatitis;
* 5.Patients with severe renal insufficiency with creatinine\>2.5mg/dL or undergoing hemodialysis;
* 6.Patients with severe lung and cardiovascular diseases, coagulation disorders, and anesthesia contraindications;
* 7.Patients with poorly controlled diabetes (HBAlc\>8.0%);
* 8.Patients who are participating in clinical trials of other drugs or medical devices;
* 9.Patients requiring emergency surgery;
* 10.Patients who are considered by the investigator to be unable to participate in this clinical trial due to other circumstances.

Primary outcomes:
measure: Comprehensive Complication Index
timeFrame: 24 weeks postoperation
Secondary outcomes:
measure: Neck disability index (NDI) score/Oswestry disability index (ODI) score
timeFrame: 24 weeks postoperation
measure: North American Spine Satisfaction (NASS) Score
timeFrame: 24 weeks postoperation
measure: Japanese Orthopaedic Association (JOA) score
timeFrame: 24 weeks postoperation
measure: Bone minral density (BMD) evaluation
timeFrame: 24 weeks postoperation
measure: Spinal fusion rates
timeFrame: 24 weeks postoperation
measure: Length of hospital stay
timeFrame: 2 weeks postoperation
measure: Discharge rate
timeFrame: 2 weeks postoperation
measure: Readmission rate
timeFrame: 4 weeks postoperation
measure: 90-day unplanned readmission rates
timeFrame: 90 days postoperation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Xian
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
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