Pre-operative Risk Assessment Combined With Targeted Intervention in Chinese Elderly With Spine Surgery

Study Overview
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Brief Summary
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With the extended life expectancy of the Chinese population and improvements in surgery and anesthesia techniques, the number of aged patients undergoing surgery has been increasing annually. However, safety, effectiveness, and quality of life of aged patients undergoing surgery are facing major challenges. This study aims to develop a perioperative multidisciplinary evaluation system for aged patients over 75 years undergoing surgery, which could identify and stratify risks, formulate preoperative, intraoperative and postoperative intervention strategies. The investigators will conduct a perioperative risk evaluation and targeted intervention, with follow-ups at 1, 3, and 6 months after surgery. The primary goal of this study is to develop a CGA-based calculator for predicting adverse events after spinal fusion surgery in patients aged 75 and over, and evaluate the importance of several common CGA items to predict postoperative complications and poor postoperative recovery. The secondary objective is to construct a new perioperative management protocol which includes pre-operative risk assessment and targeted intervention.

Detailed Description
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According to the United Nations 2022 Revision of World Population Prospects, the proportion of people over 65 years of age is expected to increase from approximately 9.7% in 2022 to 16.4% in 2050. The burden of spine disorders has increased substantially with the unprecedented aging population and the increase in life expectancy. Recent studies using multicenter data have showed that the increase in spinal fusions for spinal degenerative diseases was highest among patients over 75 years. Despite improved quality-adjusted life years and symptomatic benefits with spinal fusion surgery, there is an observed excess of adverse postoperative outcomes in older patients (aged 75 years and older) compared with younger patients. In addition to the comorbid risk factors that older patients share with younger ones, older patients may also have malnutrition and cognitive or functional impairment. In older patients, the accumulation of geriatric frailty and various geriatric syndromes leads to decreased physiological reserves, resulting in a challenging recovery process after spine surgery. A possible way to overcome this variability and therefore to identify the patients at risk of adverse events (AEs) is to use specific tools developed by geriatricians and included in the so-called Comprehensive Geriatric Assessment (CGA). CGA is a multi-dimensional diagnostic process designed to evaluate an elderly patient's medical, psychosocial, functional, and environmental resources and links them with an overall plan of treatment and follow-up. Guidelines and recommendations have addressed the importance of combined geriatric assessment and operational risks as an alternative to traditional preoperative assessment in elderly patients. The value of CGA in predicting long-term quality-of-life and functional decline has been demonstrated in previous studies on cancer surgery and hip fracture surgery; however, few studies on spine surgery included CGA in their analyses. Although some items in CGA, such as frailty and depression, have been shown to be associated with postoperative complications after spinal surgery, few studies have performed a complete evaluation of CGA in older patients. The reluctance of site leads and participants to use the comprehensive tool may reflect the volume of information it included, which may have made it difficult for clinicians to identify and use relevant sections. Most older people who have spinal disorders are frail, have comorbidities, and show a functional deterioration, which adversely affects quality of life and delays postoperative rehabilitation. More evidence is thus required to support the use of geriatric assessment and to help select suitable rating scale for older patients with spinal fusion surgery. The primary goal of this study is to develop a CGA-based calculator for predicting adverse events after spinal fusion surgery in patients aged 75 and over, and evaluate the importance of several common CGA items to predict postoperative complications and poor postoperative recovery. The secondary objective is to construct a new perioperative management protocol which includes pre-operative risk assessment and targeted intervention. Study design and setting This study is a single-center, parallel, randomized, controlled study. This study will be carried out in Xuanwu Hospital, Capital Medical University, which is a tertiary teaching hospital in China. The control group will undergo anesthesia and surgery according to an established clinical routine. The preoperative risk-stratification tool will be used for the intervention group to assist in perioperative clinical decision-making by identifying risks and providing suggestions for mitigating interventions to be carried out. Preoperative evaluation will be completed within 48 h after the patient is admitted to hospital. Follow up assessments will be conducted at 1, 3, and 6 months after surgery. The multidisciplinary team will include specialists in surgery, anesthesiology, geriatrics, neurology, cardiology, pharmacy, nutrition, nursing, and rehabilitation. The study will started in January 2024. The recruitment period will be 30 months, with a follow-up of 6 months. The results of the study will be expected in mid-2025. Primary outcomes: Incidence of non-specialty severe systemic complications (acute stroke, postoperative delirium, acute respiratory failure, acute heart failure, acute myocardial injury and acute renal injury) and all-cause mortality over the first 30 days. Secondary outcomes: (1) Quality of life score, severe complications of certain specialties, anesthesia complications, complications of concomitant medication, performance status, functional rehabilitation of certain specialties, and postoperative rehabilitation process (including off-bed activities, intake of food and drinks, etc.), and postoperative nutritional status; (2) Length of hospital stay, hospitalization expenses, ICU admission rate, length of ICU stay, and readmission rate.

Official Title
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Pre-operative Risk Assessment Combined With Targeted Intervention in Chinese Elderly With Spine Surgery

Conditions
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Spine Degeneration, Spine Fusion, Frailty Syndrome

Intervention / Treatment
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* Combination Product: Pre-operative risk assessment combined with targeted intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 75 years and older; Elective spinal fusion surgery No severe cognitive impairment. Exclusion Criteria: Undergoing emergency or day surgery With urgent condition that needs to be managed before the surgery Unable to cooperate with the evaluation Refusal to participate in study

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRACTICE group<br>Pre-operative risk assessment combined with targeted intervention Including anti-frailty management, malnutrition management, depression management, cognitive impairment management, and prevention of postoperative delirium. | Combination Product: Pre-operative risk assessment combined with targeted intervention<br>* Preoperative risk assessment and targeted intervention provided by multidisciplinary team<br>|
| No Intervention: Control group<br>The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of non-specialty severe systemic complications | Postoperative complications were divided into medical and surgical complications. | up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | This study assess quality of life using the Short-Form 12 (SF-12).A score greater than 37 indicates a good quality of life, a score between 25 and 36 indicates intermediate quality of life, and a score less than 24 indicates poor quality of life. | up to 2 months after surgery | 
| Length of hospital stay | Length of stay was defined as the time from patient registration to leaving the hospital. | up to 6 months after surgery | 
| Readmisson | Proportion of readmission within 90 days after surgery | up to 90 days after surgery |