POCD After Major Gynecologic Surgery (POCD-GYN)

May 11, 2026 updated by: Fatihhan Zeytun

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Kocaeli
      • İzmit, Kocaeli, Turkey (Türkiye), 41060
        • University of Health Sciences Kocaeli City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult female patients undergoing elective major gynecological surgery under general anesthesia at Kocaeli City Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early Postoperative Cognitive Dysfunction
Time Frame: 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.
Preoperative baseline assessment within 0-14 days before surgery and postoperative day 3 (±1 day)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in MoCA Score
Time Frame: 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).
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).
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.
Preoperative frailty assessment within 0-14 days before surgery; postoperative cognitive assessment on postoperative day 3 (±1 day).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fatihhan Zeytun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSH-FZ-01
  • 2025-191 (Other Identifier: Kocaeli City Hospital Ethical Comitte)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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