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This study is a prospective, single-center, randomized controlled trial to compare whether applying nutritional supplementation therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | The entire process is carried out according to Severance Hospital surgical protocols. |
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| intervention group | Experimental | The entire process is carried out according to Severance Hospital surgical protocols. The patients of control group will receive education from the research team about the importance of nutrition and exercise before and after surgery. In addition, the patients of control group will be instructed to take up to 4 doses of the nutritional supplement (Nucare Curact provided by DAESANG Wellife Inc.) per day for approximately 2 weeks before surgery and for about 4 weeks after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control group | Procedure | The entire process is carried out according to Severance Hospital surgical protocols. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative delirium | Confusion assessment methods(CAM) will be used for diagnosing delirium At least two times a day during the hospitalization period. Patients diagnosed with delirium using the CAM were evaluated for the duration, symptoms, and type of delirium (e.g., reduced awareness of the environment; poor cognitive skills; behavioral changes; and emotional disturbances). ** Confusion assessment methods(CAM) diagnostic algorism (positive or negative result, positive means delirium) CAM is considered positive if features 1 and 2 are present, with at least one of features 3 or 4. Below are the four criteria of features :
| from postoperative day 0 to postoperative day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| duration of delirium | The Quality of Recovery-40 (QoR-40) : 40~200(better recovery) | from postoperative day 0 to postoperative day 7 |
| type of delirium | from postoperative day 0 to postoperative day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bon-Nyeo koo, MD | Contact | 82-10-9982-4469 | koobn@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health system, Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Nucare Curact group | Dietary Supplement | The entire process is carried out according to Severance Hospital surgical protocols. The patients of control group will receive education from the research team about the importance of nutrition and exercise before and after surgery. In addition, the patients of control group will be instructed to take up to 4 doses of the nutritional supplement (Nucare Curact provided by DAESANG Wellife Inc.) per day for approximately 2 weeks before surgery and for about 4 weeks after surgery. |
|
| K-FRAIL for frailty | The Korean version of the fatigue, resistance, ambulation, illnesses, and loss of weight (K-FRAIL) scale : 0(healthy)~8(frail). A raw score is standardized. A lower score means cognitive dysfunction. | from postoperative day 0 to postoperative day 7 |
| GDS for depression | Geriatric Depression Scale(GDS) : 0(normal)~ 15(depression). A raw score is standardized. A lower score means cognitive dysfunction. | from postoperative day 0 to postoperative day 7 |
| ADL for independence | Activities of Daily Living(ADL)-Barthel Index : 0(completely dependent )~105( independent). A raw score is standardized. A lower score means cognitive dysfunction. | from postoperative day 0 to postoperative day 7 |
| SNSB-c for cognitive dysfunction | Seoul Neuropsychological Screening Battery-Core(SNSB-C): total score is 617. A raw score is standardized. A lower score means cognitive dysfunction. | from postoperative day 0 to postoperative day 7 |
| QOR-40 for recovery | The Quality of Recovery-40 (QoR-40) : 40~200(better recovery) | from postoperative day 0 to postoperative day 7 |
| K-MoCA for cognitive dysfunction | Korean-Montreal Cognitive Assessment(K-MoCA) : 0~30, cognitive dysfunction<23. | from postoperative day 0 to postoperative day 7 |
| IADL for independence | Instrumental Activities of Daily Living(IADL)-Lawton-Brody Scale : 0~8(complete independence). | from postoperative day 0 to postoperative day 7 |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008722 | Methods |