POCD After Major Gynecologic Surgery

NCT07589348 — Recruiting, 72 participants, Fatihhan Zeytun

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Early Postoperative Cognitive Dysfunction After Major Gynecological Surgery: Incidence and Perioperative Risk Factors in a Prospective Cohort Study

RegistryNCT07589348, acronym POCD-GYN
StatusRecruiting
Study typeObservational
Enrollment72 (Estimated)
SponsorFatihhan Zeytun (Other gov)
ConditionsPostoperative Cognitive Dysfunction, Perioperative Neurocognitive Disorder
Datesstart 2026-05-06, primary completion 2026-09-15 (estimated), completion 2026-09-15 (estimated), first posted 2026-05-15, last updated 2026-06-12
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Cognitive Dysfunction All trials for Perioperative Neurocognitive Disorder

-Summary

This prospective observational cohort study aims to determine the incidence of early postoperative cognitive dysfunction (POCD) in patients undergoing major gynecological surgery. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) preoperatively and on postoperative day 3. POCD will be defined as a ≥20% relative decline or ≥2-point decrease in MoCA score. The study will also evaluate the association between POCD and perioperative clinical, surgical, and inflammatory parameters.

Expand all sections  ·  Collapse all

+Detailed description

This prospective observational cohort study aims to investigate the incidence of early postoperative cognitive dysfunction (POCD) and associated perioperative risk factors in adult patients undergoing major gynecological surgery under general anesthesia. Eligible patients undergoing total abdominal hysterectomy and/or bilateral salpingo-oophorectomy through open or laparoscopic approaches will be included. Cognitive function will be evaluated using the Turkish version of the Montreal Cognitive Assessment (MoCA) before surgery and again on postoperative day 3 (±1 day). POCD will be defined as either a relative decline of ≥20% from baseline MoCA score or an absolute decrease of ≥2 points. Demographic characteristics, frailty status, menopausal status, hematologic-inflammatory markers including hemoglobin, RDW, and neutrophil-to-lymphocyte ratio, as well as intraoperative hemodynamic and surgical variables, will be recorded. The associations between these perioperative factors and POCD development will be analyzed. The findings may help identify high-risk patients preoperatively and contribute to individualized perioperative neuroprotective strategies.

+Outcome measures

Primary outcomes

  • Early Postoperative Cognitive Dysfunction [Preoperative baseline assessment within 0-14 days before surgery and postoperative day 3 (±1 day)]: Postoperative cognitive dysfunction assessed using the Montreal Cognitive Assessment (MoCA; score range 0 to 30, with higher scores indicating better cognitive function). POCD will be defined as either a ≥20% relative decline or a ≥2-point decrease from the preoperative baseline MoCA score.

Secondary outcomes

  • Change in MoCA Score [T0: preoperative baseline assessment within 0-14 days before surgery, T1: postoperative day 3 (±1 day)]: Absolute change (points) and relative change (%) in Montreal Cognitive Assessment (MoCA; score range 0 to 30, with higher scores indicating better cognitive function) scores at postoperative day 3 (T1) compared with preoperative baseline (T0).
  • Correlation Between Preoperative Frailty Status and Postoperative Cognitive Dysfunction [Preoperative frailty assessment within 0-14 days before surgery; postoperative cognitive assessment on postoperative day 3 (±1 day).]: Correlation between preoperative frailty status assessed by the Clinical Frailty Scale (CFS-TR v2; score range 1 to 9, with higher scores indicating greater frailty) and change in Montreal Cognitive Assessment (MoCA) score (points and %) from baseline to postoperative day 3.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Female patients aged ≥18 years
* Scheduled for elective major gynecological surgery under general anesthesia
* Total abdominal hysterectomy and/or bilateral salpingo-oophorectomy
* Open or laparoscopic surgical approach
* Ability to complete the Turkish version of the Montreal Cognitive Assessment (MoCA)
* Ability to understand and provide written informed consen

Exclusion Criteria:

* Pre-existing dementia or major neurocognitive disorder
* History of cerebrovascular event within the previous 3 months
* Severe visual or hearing impairment preventing cognitive assessment
* Emergency or hemodynamically unstable surgery
* Planned postoperative sedation or mechanical ventilation longer than 72 hours
* Postoperative delirium detected during assessment
* Inability to communicate or cooperate
* Refusal to participate

+Locations (1)

FacilityCityCountryStatus
University of Health Sciences Kocaeli City Hospitalİzmit, KocaeliTurkey (Türkiye)Recruiting

+Publications

  • Ren S, Yuan F, Yuan S, Zang C, Zhang Y, Lang B. Early Cognitive Dysfunction in Elderly Patients after Total Knee Arthroplasty: An Analysis of Risk Factors and Cognitive Functional Levels. Biomed Res Int. 2022 Feb 18;2022:5372603. doi: 10.1155/2022/5372603. eCollection 2022. PMID 35224095