Early Postoperative Cognitive Dysfunction After Major Gynecological Surgery: Incidence and Perioperative Risk Factors in a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Early Postoperative Cognitive Dysfunction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Early Postoperative Cognitive Dysfunction
时间窗: 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.
次要结局
- 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).)
研究者
Fatihhan Zeytun
MD
Kocaeli City Hospital