Status:
NOT_YET_RECRUITING
Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Shenzhen Hospital of Southern Medical University
Second Xiangya Hospital of Central South University
Conditions:
Degenerative Spinal Disease
Elderly Patients
Eligibility:
All Genders
75+ years
Phase:
NA
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 Commu...
Eligibility Criteria
Inclusion
- Age ≥75 years old;
- Have degenerative spinal diseases, including cervical, thoracic and lumbar spine diseases;
- With severe neurological symptoms fail to conservative treatment and have to undergo the spinal fusion surgery;
- No serious cognitive impairment (MoCA score ≥8);
- No surgical contraindications;
- Anesthesia assessment patients can safely undergo surgery;
- 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
- Patients who could not cooperate with doctors to complete preoperative evaluation and postoperative follow-up;
- Patients requiring spinal intervention due to spinal infection, fracture or metastatic disease;
- Patients with cerebrovascular accidents in the last 30 days;
- Patients with hepatic encephalopathy or acute active hepatitis;
- Patients with severe renal insufficiency with creatinine\>2.5mg/dL or undergoing hemodialysis;
- Patients with severe lung and cardiovascular diseases, coagulation disorders, and anesthesia contraindications;
- Patients with poorly controlled diabetes (HBAlc\>8.0%);
- Patients who are participating in clinical trials of other drugs or medical devices;
- Patients requiring emergency surgery;
- Patients who are considered by the investigator to be unable to participate in this clinical trial due to other circumstances.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06607081
Start Date
October 15 2024
End Date
October 31 2027
Last Update
September 23 2024
Active Locations (2)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
2
Xijing Hospital
Xi'an, Shaanxi, China, 710032