NCT07589348

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
May 2026Sep 2026

First Submitted

Initial submission to the registry

April 28, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

April 28, 2026

Last Update Submit

June 11, 2026

Conditions

Postoperative Cognitive DysfunctionPerioperative Neurocognitive Disorder

Keywords

Postoperative Cognitive DysfunctionPerioperative Neurocognitive Disorder

Outcome Measures

Primary Outcomes (1)

  • Early Postoperative Cognitive Dysfunction

    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 Outcomes (2)

  • Change in MoCA Score

    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

    Preoperative frailty assessment within 0-14 days before surgery; postoperative cognitive assessment on postoperative day 3 (±1 day).

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Kocaeli City Hospital

İzmit, Kocaeli, 41060, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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: 35224095BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Fatihhan Zeytun, MD

CONTACT

5418405937fatihhanzeytun95@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 15, 2026

Study Start

May 6, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)