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This single-center, prospective pilot study will examine dietary fat consumption and its relationship with inflammatory markers before surgery and the incidence of perioperative neurocognitive disorders in older surgical patients. The study will assess the feasibility getting diet-related information in a surgical setting and will establish baseline dietary patterns in older adults. It will also measure the incidence of postoperative cognitive impairment (POCI) in patients with high fat consumption and gather patient perspectives to inform future nutrition-focused interventions for older surgical candidates.
This single-center, prospective pilot study will evaluate dietary fat intake and its association with preoperative inflammatory markers and perioperative neurocognitive disorders in older surgical patients. The study will assess the feasibility of obtaining detailed dietary information in a surgical population and will establish baseline dietary information in older adults.
Participants will complete diet assessments prior to surgery, provide blood samples totaling up to 32 mL (with up to 16 mL collected before surgery and up to 16 mL collected the morning after surgery), and-when available-have up to 1 mL of cerebrospinal fluid collected during their clinically indicated spinal anesthesia procedure. Blood and cerebrospinal fluid samples will be analyzed for inflammatory markers.
Cognitive assessments will be performed to evaluate perioperative neurocognitive disorders. Participants will complete a baseline preoperative telephone cognitive assessment to determine cognitive status. Delirium assessments will be conducted twice daily from immediately after surgery until discharge, supplemented by chart review. At three months after surgery, the telephone cognitive assessment will be repeated and compared with the baseline score to estimate persistent neurocognitive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese BMI + THA/TKA | Obese with a BMI >30 undergoing total knee arthroplasty or total hip arthroplasty |
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| Obese BMI + Abdominal/Pelvic | Obese with a BMI >30 undergoing abdominal or pelvic surgery |
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| Normal BMI + THA/TKA | Normal BMI 25-30 undergoing total knee arthroplasty or total hip arthroplasty |
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| Normal BMI + Abdominal/Pelvic | Normal BMI 25-30 undergoing abdominal or pelvic surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflammatory markers test in blood prior to surgery | Diagnostic Test | A total of up to 32 mL of blood, with a maximum of 16 mL collected prior to surgery and another 16 mL will be collected the morning after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between nutritional factors and inflammatory markers in blood and cerebrospinal fluid (CSF) before and after surgery. | Correlation between pre-surgery nutritional factors (fat intake, BMI, waist circumference, frailty status) and inflammatory markers in blood and cerebrospinal fluid (CSF) before and after surgery. | Surgery day and postoperative (PO) Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent perioperative neurocognitive disorder will be assessed using the Telephone Montreal Cognitive Assessment (T-MoCA) | Participants will complete a baseline preoperative Telephone Montreal Cognitive Assessment (T-MoCA) to assess cognitive function. Scores on the T-MoCA range from 0 to 30, with higher scores indicating better cognitive performance. The T-MoCA will be re-administered three months after surgery, and scores will be compared with baseline to identify any persistent perioperative neurocognitive disorder. |
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Inclusion Criteria:
Exclusion Criteria:
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Obese or normal weight patients over the age of 60 scheduled to undergo a major abdominal or pelvic surgery, or total hip or knee joint arthroplasty at OSUWMC and complete the study.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Humeidan | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wwexner Medical Center | Columbus | Ohio | 43210 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 25, 2024 | Feb 25, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2024 | Feb 25, 2026 | ICF_001.pdf |
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| Inflammatory markers test in CSF (cerebrospinal fluid) | Diagnostic Test | 1 mL sample will be collected during the standard local anesthesia spinal block or intrathecal morphine injection. |
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| MOCA test | Diagnostic Test | A baseline preoperative telephone-Montreal Cognitive Assessment (T-MoCA, Appendix B) will be completed prior to surgery |
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| CAM-3D | Diagnostic Test | A confusion assessment method assessment (CAM-3D) will be administered twice daily from postoperative day to discharge |
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| At screening (baseline) and three months later after surgery |
| Patient-centered feedback on Nutrition Perceptions, Behaviors, and Pre-Surgical Readiness for Dietary Change Survey | A self-reported questionnaire using ordinal and nominal variables to assess patients' diet perceptions, prior dietary changes, supplement use, and beliefs about the importance and feasibility of nutrition for recovery. Items use Likert-type scales to evaluate attitudes and readiness for behavior change. The survey identifies nutritional attitudes, willingness to modify diet or use supplements, and potential barriers to preoperative nutritional interventions. | At hospital discharge (assessed up to 5 days postoperatively) |