Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery

NCT ID: NCT06607081

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2027-10-31

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.

Conditions

Degenerative Spinal Disease; Elderly Patients; Spinal Fusion Acquired

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Perioperative Pre ERAS group

Group Type: EXPERIMENTAL

Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention

Intervention Type: COMBINATION_PRODUCT

The operative risk factors are multidisciplinary evaluated and the corresponded multimodal measures are used to optimize the whole condition of the elderly patient undergo spinal fusion surgery for his/her safty, early and fully recovery.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention

The operative risk factors are multidisciplinary evaluated and the corresponded multimodal measures are used to optimize the whole condition of the elderly patient undergo spinal fusion surgery for his/her safty, early and fully recovery.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role: collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Tianwen Gao, MD

Role: CONTACT

xjyyllwyh@163.com

+86-29-84771794

Facility Contacts

Lianghua Chen

Role: primary

wuzixiang@fmmu.edu.cn

86-029-84771794

Yanyan Jia, MD

Role: backup

86-29-84771794

Zixiang Wu, MD

Role: backup

Yanyan Jia, MD

Role: primary

xjyyllwyh@163.com

86-29-84771794

Zixiang Wu, MD

Role: backup

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Other Identifiers

KY20242310wuzixiang

Identifier Type: -

Identifier Source: org_study_id