Postoperative Cognitive DysfunctionPOCD-GYNNCT07589348
POCD After Major Gynecologic Surgery
An observational study of Postoperative Cognitive Dysfunction and Perioperative Neurocognitive Disorder, run by Fatihhan Zeytun at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Perioperative Neurocognitive Disorder
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2026to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients undergoing elective major gynecological surgery under general anesthesia at Kocaeli City Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Kocaeli City Hospital
İzmit, Kocaeli, 41060
Ayşe Z Turan Civraz, Assoc.Prof, 5054695850, ayse.zeynep@gmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- Postoperative Cognitive Dysfunction, Perioperative Neurocognitive Disorder
- Medical subject headings
- Postoperative Cognitive Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative baseline assessment within 0-14 days before surgery and postoperative day 3 (±1 day)
Secondary outcomes (2)
Change in MoCA Score
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).
Measured: 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
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.
Measured: Preoperative frailty assessment within 0-14 days before surgery; postoperative cognitive assessment on postoperative day 3 (±1 day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start6 May 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatihhan Zeytun
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Fatihhan Zeytun, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589348
- Sponsor's protocol ID
- KSH-FZ-01
- Other IDs
- 2025-191
- Acronym
- POCD-GYN
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35224095
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Cognitive Dysfunction After Major Gynecological Surgery: Incidence and Perioperative Risk Factors in a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07589348
- Acronym / sponsor ID
- POCD-GYN / KSH-FZ-01
- Keywords
- Postoperative Cognitive Dysfunction, Perioperative Neurocognitive Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fatihhan ZeytunOther government
- Study start
- 6 May 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients undergoing elective major gynecological surgery under general anesthesia at Kocaeli City Hospital.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 35224095Ren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Perioperative Neurocognitive Disorder, run by Fatihhan Zeytun at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatihhan Zeytun, MD (5418405937 ext. 90, fatihhanzeytun95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Postoperative Cognitive Dysfunction (time frame: Preoperative baseline assessment within 0-14 days before surgery and postoperative day 3 (±1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07589348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.