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Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology

Recruitingn/aAges 65 Years - 80 YearsFemaleElazıg Fethi Sekin Sehir Hastanesi
NCT07877285 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Early postoperative delirium (POD) is a common and distressing neuropsychiatric complication frequently observed in elderly patients undergoing major surgical interventions, including radical and cytoreductive gynecologic oncological procedures (such as ovarian, cervical, and endometrial cancer surgeries). Delirium is associated with prolonged hospital and intensive care unit stays, functional decline, elevated healthcare expenditures, and increased perioperative morbidity. The pathogenesis of postoperative delirium is multifactorial, involving baseline patient vulnerability and intraoperative triggering factors. Malnutrition and systemic inflammation are recognized as critical predisposing factors that disrupt blood-brain barrier integrity and trigger neuroinflammatory cascades. The Controlling Nutritional Status (CONUT) score and the Naples Prognostic Score (NPS) are objective scoring

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Female patients aged 65 years or older. 2. Scheduled for elective major gynecologic oncological surgery (e.g., radical hysterectomy, cytoreductive surgery for ovarian, cervical, or endometrial cancer). 3. American Society of Anesthesiologists (ASA) physical status II-IV. 4. Planned to undergo general anesthesia with continuous intraoperative neuromonitoring / processed EEG. 5. Signed written informed consent provided prior to surgery. Exclusion Criteria: 1. Pre-existing dementia, significant cognitive impairment, or baseline Mini-Mental State Examination (MMSE) score below validated cut-offs. 2. History of major neuropsychiatric disorders, active neurodegenerative disease, or acute cerebrovascular accident within the preceding 6 months. 3. Patients undergoing emergency surgical procedures. 4. Uncorrected severe sensory deficits (auditory or visual impairments) precluding postoperative delirium assessments. 5. Missing preoperative baseline nutritional or hematological laboratory parameters required for CONUT or Naples scoring. 6. Inability to comply with post-anesthesia cognitive evaluations or re-operation required during the observation window.
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What it tests

  • Preoperative Immunonutritional Scoring and Intraoperative Neuromonitoring
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Where

1 site
Fethi Sekin City Hospital
Elâzığ, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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