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Recruiting NCT07589348

POCD After Major Gynecologic Surgery

Observational Postoperative Cognitive Dysfunction Perioperative Neurocognitive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Postoperative Cognitive Dysfunction, Perioperative Neurocognitive Disorder. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Early Postoperative Cognitive Dysfunction [Time frame: Preoperative baseline assessment within 0-14 days before surgery and postoperative day 3 (±1 day)]
Secondary outcome measures (2)
  • Change in MoCA Score [Time frame: T0: preoperative baseline assessment within 0-14 days before surgery, T1: postoperative day 3 (±1 day)]
  • Correlation Between Preoperative Frailty Status and Postoperative Cognitive Dysfunction [Time frame: Preoperative frailty assessment within 0-14 days before surgery; postoperative cognitive assessment on postoperative day 3 (±1 day).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • University of Health Sciences Kocaeli City Hospital — İzmit

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

Identifiers

NCT: NCT07589348 · KSH-FZ-01 · 2025-191

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗