Immunonutrition and Brain Monitoring to See if Delirium Happens After Gynecologic Cancer Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational cohort study enrolls women aged 65+ scheduled for elective major gynecologic oncologic procedures under general anesthesia with intraoperative neuromonitoring. It examines whether preoperative immunonutrition scores (CONUT) and Naples Prognostic Score, combined with real-time intraoperative cerebral depth monitoring, relate to the occurrence of postoperative delirium. Data collected include preoperative nutritional and inflammatory markers, intraoperative neuromonitoring metrics, and postoperative delirium assessments. The goal is to improve understanding of how nutritional status and brain monitoring may predict or correlate with POD in this high-risk population. The study is conducted at Elazığ City Hospital under local leadership, with no stated randomization or intervention beyond observation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fethi Sekin City Hospital
  Elâzığ, Elâzığ, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Muhammed BaŞpınar, M.D. — Elazıg Fethi Sekin Sehir Hastanesi
• Study coordinator: Muhammed Başpınar, M.D. / Specialist
• Email: bspnr.muhammed@gmail.com
• Phone: +90 539 583 11 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.