An observational study in Postoperative Delirium (POD), Gynecologic Cancers and Malnutitrion, sponsored by Elazıg Fethi Sekin Sehir Hastanesi. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Elazıg Fethi Sekin Sehir Hastanesi · Observational
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 systems combining nutritional biomarkers (serum albumin, total cholesterol) and immune-inflammatory markers (absolute lymphocyte count, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio). Concurrently, intraoperative neuromonitoring (such as processed electroencephalography / bispectral index monitoring) provides continuous assessment of cerebral anesthetic depth and electrophysiological patterns like burst suppression, which have been implicated in acute cerebral dysfunction.
The objective of this prospective observational study is to evaluate the individual and combined predictive utility of preoperative immunonutritional indices (CONUT and Naples Prognostic Score) alongside intraoperative neuromonitoring parameters for the occurrence of early postoperative delirium in elderly patients undergoing elective gynecologic oncological surgery.
Elderly patients presenting for major gynecologic oncological surgeries frequently exhibit subclinical cachexia, hypoalbuminemia, and chronic systemic inflammation resulting from both malignancy and advanced age. These baseline alterations can accentuate central nervous system vulnerability during surgical stress. Concurrently, extensive open or laparoscopic cytoreductive surgeries often require extended operative durations and deep general anesthesia, increasing the likelihood of intraoperative cerebral hypoperfusion, excessive anesthetic depth, or prolonged burst suppression patterns.
Although preoperative nutritional deficiency and systemic inflammation have individually been linked to adverse surgical outcomes, the synergistic predictive capability of comprehensive immunonutritional scores-specifically the CONUT score and the Naples Prognostic Score (NPS)-in conjunction with real-time intraoperative cerebral depth monitoring remains unexplored in gynecologic oncology cohorts.
In this prospective observational cohort study, consecutive female patients aged 65 years and older scheduled for elective major gynecologic oncological surgeries (e.g., radical hysterectomy, cytoreductive surgery for ovarian, cervical, or endometrial malignancies) under general anesthesia will be enrolled.
Prior to surgery, standard preoperative laboratory workups will be documented to calculate:
The CONUT score: based on serum albumin levels, total cholesterol concentrations, and absolute peripheral lymphocyte counts.
The Naples Prognostic Score: combining serum albumin, total cholesterol, neutrophil-to-lymphocyte ratio (NLR), and lymphocyte-to-monocyte ratio (LMR).
Intraoperatively, all participants will receive standardized general anesthesia with continuous processed EEG / neuromonitoring (recording index values, duration spent below target anesthetic depth, and presence/duration of burst suppression). Postoperative delirium will be screened prospectively using a validated screening tool (such as the CAM-ICU or 3D-CAM) twice daily during the first 72 postoperative hours.
Univariable and multivariable logistic regression analyses, together with Receiver Operating Characteristic (ROC) curve comparisons, will be performed to determine the predictive accuracy, sensitivity, specificity, and optimal cut-off thresholds for CONUT, Naples Prognostic Score, and intraoperative neuromonitoring parameters in identifying elderly patients at high risk for early postoperative delirium.
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's planned enrollment of 80 is below the median of 154 across 288 observational studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Elazıg Fethi Sekin Sehir Hastanesi is the lead sponsor of 30 studies on the registry; 8 are open to participants now.
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Elderly female patients aged 65 years and older undergoing elective major cytoreductive or radical oncological surgery for gynecologic malignancies (including ovarian and cervical cancers) under general anesthesia at a tertiary care medical center.
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Exclusion Criteria:
Preoperative assessment comprises the calculation of the Controlling Nutritional Status (CONUT) score (evaluating serum albumin, total cholesterol, and total lymphocyte count) and the Naples Prognostic Score (integrating albumin, cholesterol, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio) from routine pre-incision blood samples. Intraoperatively, patients receive standard general anesthesia accompanied by continuous processed EEG / neuromonitoring to track anesthetic depth indices and electroencephalographic burst suppression patterns. Delirium screening is conducted during the early postoperative period.
Incidence of Early Postoperative Delirium
Area under the receiver operating characteristic curve (AUC-ROC) of the preoperative Controlling Nutritional Status (CONUT) score for predicting early postoperative delirium.
Time frame: Baseline to 72 hours postoperatively
Predictive Performance of Baseline CONUT Score for Delirium
Discriminative performance evaluated via Receiver Operating Characteristic (ROC) curve analysis, calculating the Area Under the Curve (AUC), sensitivity, and specificity of baseline Controlling Nutritional Status (CONUT) and Naples Prognostic scores for predicting postoperative delirium.
Time frame: Preoperative baseline through postoperative day 1
Predictive Performance of Baseline Naples Prognostic Score for Delirium
Area under the receiver operating characteristic curve (AUC-ROC) of the preoperative Naples Prognostic Score for predicting early postoperative delirium.
Time frame: Baseline to 72 hours postoperatively
Cumulative Duration of Deep Anesthesia (BIS < 40)
Total intraoperative duration (in minutes) spent at excessive anesthetic depth, defined as Bispectral Index (BIS) values below 40.
Time frame: Intraoperative period (from anesthesia induction to extubation)
Length of Postoperative Hospital Stay
Total duration of hospitalization (measured in days) from the date of surgery until hospital discharge.
Time frame: Up to 30 days postoperatively
Plan to share: Yes — De-identified individual participant data that underlie the results reported in the published article will be made available to researchers who provide a methodologically sound proposal.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available following publication of the primary manuscript and will remain accessible for a period of up to 3 years.
Access criteria: Data requests should be directed to the corresponding author via email. Requestors will be required to sign a data access agreement to ensure data confidentiality and compliance with ethical standards.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jan 2027, 3 months after the start.
Of 187 non-industry observational studies under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 3 months is below that.
Counting every sponsor, half of 188 studies reached it within 20 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Elazıg Fethi Sekin Sehir Hastanesi