Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent … (NCT06607081) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
China5,000 participantsStarted 2024-10-15
Plain-language 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.
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 circumstance…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.