Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607081
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Preoperative Risk Evaluation and Perioperative ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 19 in 2020 to 43 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 21676 million accounting for 154 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None