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NCT Number: NCT07589348

POCD After Major Gynecologic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Health Sciences Kocaeli City Hospital

İzmit, Kocaeli, 41060, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayşe Z Turan Civraz, Assoc.Prof

CONTACT

[email protected]

5054695850

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatihhan Zeytun, MD

CONTACT

[email protected]

5418405937 ext. 90

Sponsors and collaborators

Lead sponsor

Fatihhan Zeytun

Other Gov

Registry information

Official study title

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

Acronym: POCD-GYN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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