POCD After Major Gynecologic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFatihhan Zeytun
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult female patients undergoing elective major gynecological surgery under general anesthesia at Kocaeli City Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Preoperative baseline assessment within 0-14 days before surgery and postoperative day 3 (±1 day)Secondary outcomes
1
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).
Time frame
T0: preoperative baseline assessment within 0-14 days before surgery, T1: postoperative day 3 (±1 day)2
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.
Time frame
Preoperative frailty assessment within 0-14 days before surgery; postoperative cognitive assessment on postoperative day 3 (±1 day).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fatihhan Zeytun
Lead sponsor
Kocaeli City Hospital
Sponsor institution
Source ClinicalTrials.gov