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Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group:20 patients undergoing two stage liver-operation | Patients undergo two liver operations.First surgery: insitu-split for induction of proliferation in the remaining liver tissue; Second surgery: resection of the liver Tumor (4 cognitive measurements: Baseline, 7 days, 3 months and 1 year) | ||
| Control group: 20 patients (ASA class II/III) | Relatives from study personel or patients from outpatient clinics from Charité in Berlin and surrounding area (4 cognitive measurements: Baseline, 7 days, 3 months and 1 year) |
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| Measure | Description | Time Frame |
|---|---|---|
| POCD | Measured by Cambridge Neurophysiological Test Automated Battery (CANTAB); calculated in relation to a healthy control group without intervention | At postoperative day 7 after second liver operation |
| Delirium | Measured by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) | At postoperative day 7 after second liver operation |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Measured by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and Confusion Assessment Method (CAM) and Intensive Care Delirium Screening Checklist (ICDSC) and Delirium Detection Scale (DDS) and Delirium Rating Scale (DRS) and The Nursing Delirium Screening Scale (NU-DESC) | At postoperative day 7 after second liver operation |
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Study Group:
Inclusion Criteria:
Exclusion Criteria:
Control Group:
Inclusion criteria:
•Male and female ASA II/III patients, aged ≥ 18 years
Exclusion Criteria:
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Adult female and male patients undergoing two stage liver-operations
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD Prof. | Charite University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum | Berlin | 13353 | Germany |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Change of POCD | Measured by Cambridge Neurophysiological Test Automated Battery (CANTAB) calculated in relation to a healthy control group without intervention | Change from pre-operative (Baseline) up to 365 days after surgery |
| Simplifies Acute Physiology Score (SAPS II) | Simplifies Acute Physiology Score (SAPS II) | At postoperative day 7 after second liver operation |
| Length of post-operative hospital stay | Post-anaesthesia Discharge Scoring Stay (PADSS) | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Length of post-operative intensive care unit stay | Criteria of internal standard operating procedures (SOP) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| Pain | Measured by Numeric Rating Scale (NRS) or Verbal Rating Scale (VRS) or Visual Analogue Scale (VAS) or Behavioural Pain Scale (BPS) | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| The rate of post-operative organ dysfunctions and complications | Cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunctions | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Incidence of systemic inflammatory response syndrome (SIRS) and infection | Centers for Disease Control (CDC) and American Thoracic Society (ATS) criteria | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Change of 36-item short form health survey (SF-36) | 36-item short form health survey (SF-36) | Change from pre-operative (Baseline) up to 365 days after surgery |
| Mortality | postoperative survival | after 90 days, after 182 days and after 365 days |
| Acute Physiological and Chronic Health Evaluation (Apache II) | Acute Physiological and Chronic Health Evaluation (Apache II) | At postoperative day 7 after second liver operation |
| Sequental Organ Failure Assessment (SOFA) | Sequental Organ Failure Assessment (SOFA) | At postoperative day 7 after second liver operation |
| TISS | Therapeutic Interventions Scoring System (TISS) | At postoperative day 7 after second liver operation |
| RASS | Richmonds Agitation Sedations Scale (RASS) | At postoperative day 7 after second liver operation |
| GCS | Glasgow Coma Scale (GCS) | At postoperative day 7 after second liver operation |
| RIFLE criteria | Risk Injury Failure Loss End Stage Kidney Disease (RIFLE = risk (R), injury (I), and failure (F), sustained loss (L) and end-stage kidney disease (E)) | At postoperative day 7 after second liver operation |
| Change of EuroQoL instrument (EQ-5D) | EuroQoL instrument (EQ-5D) | Change from pre-operative (Baseline) up to 365 days after surgery |
| Change of Barthel Index(for Activities of Daily Living, ADL) | Barthel Index (for Activities of Daily Living, ADL) | Change from pre-operative (Baseline) up to 365 days after surgery |
| Change of Instrumentelle Aktivität im täglichen Leben (IATL) | Instrumentelle Aktivität im täglichen Leben (IATL) | Change from pre-operative (Baseline) up to 365 days after surgery |
| Change of Geriatric Depression Scale (GDS) | Geriatric Depression Scale (GDS) | Change from pre-operative (Baseline) up to 365 days after surgery |
| Change of Cornell Depression Scale (CDS) | Cornell Depression Scale (CDS) | Change from pre-operative (Baseline) up to 365 days after surgery |
| Change of Hospital Anxiety and Depression Scale deutsche Version (HADS-D) | Hospital Anxiety and Depression Scale deutsche Version (HADS-D) | Change from pre-operative (Baseline) up to 365 days after surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |