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Recruitment delayed because of Sars-CoV-2 pandemic, elective surgery stopped, funding for undefinite extension not available
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Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades.
It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delirium | |||
| No Delirium |
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| Measure | Description | Time Frame |
|---|---|---|
| postoperative delirium - incidence | screening through Nu-DESC (Nursing Delirium Screening Scale) ≥ 2 and verification of screening procedure by DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) criteria once during each shift | ≤ 3 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative delirium - duration | screening through Nu-DESC ≥ 2 and verification of screening procedure by DSM-V criteria DSM-V once during each shift | ≤ 3 days postoperatively or until delirium resolves |
| postoperative delirium - severity |
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Inclusion Criteria:
Exclusion Criteria:
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All patients seen in a neurosurgical oupatient clinic will be screened for eligibility.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Fleischmann, MD | Department of Neurology | Principal Investigator |
| Jonas Müller, MD | Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41115102 | Derived | Ruhnau J, Muller J, Nowak S, Strack S, Sperlich D, Pohl A, Dilz J, Rehberg S, Usichenko T, Hahnenkamp K, Weidemeier M, Ehler J, Floel A, Schroeder HWS, Muller JU, Fleischmann R, Vogelgesang A. Exploring Neuroinflammation and Its Role in Postoperative Cognitive Dysfunction following Spine Surgery. Gerontology. 2026;72(1):29-40. doi: 10.1159/000548923. Epub 2025 Oct 20. | |
| 32053113 |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| D000079690 | Postoperative Cognitive Complications |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003221 | Confusion |
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rated through CAM-S (Confusion Assessment Method - Severity) if patient was identified to be delirious
| ≤ 3 days postoperatively or until delirium resolves |
| postoperative cognitive dysfunction - severity | CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease - Plus) | baseline and 3 months postoperatively |
| pre- and postoperative intelligence | MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B) | baseline and 3 months postoperatively |
| Markers of systemic inflammation | C-reactive protein, Interleukins, Tumor necrosis factor among others | ≤ 2 days postoperatively |
| Markers of neuroinflammation | Glial fibrillary acidic protein among others | ≤ 2 days postoperatively |
| Markers of oxidative and metabolic stress | Malondialdehyd | ≤ 2 days postoperatively |
| Patient Reported Quality of life | PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating) | baseline and 3 months postoperatively |
| Patient Reported Quality of life - 2 | SF-36 (Short Form 36) | baseline and 3 months postoperatively |
| Anxiety and depression | HADS (Hospital Anxiety and Depression Scale) | baseline and 3 months postoperatively |
| Frailty | Groningen Frailty Scale | baseline and 3 months postoperatively |
| Structural magnetic resonance imaging | White matter lesions | baseline and 3 months postoperatively |
| Functional magnetic resonance imaging | Resting state networks | baseline and 3 months postoperatively |
| Cerebral vasculature | Ultrasound of extra- and intracranial cerebral arteries | baseline |
| Genetic polymorphisms | baseline |
| Muller J, Nowak S, Vogelgesang A, von Sarnowski B, Rathmann E, Schmidt S, Rehberg S, Usichenko T, Kertscho H, Hahnenkamp K, Floel A, Schroeder HW, Muller JU, Fleischmann R. Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial. JMIR Res Protoc. 2020 Feb 13;9(2):e15488. doi: 10.2196/15488. |
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D007249 | Inflammation |