Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery Among Early Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Quality of Recovery -15 score at postoperative 72 hours
研究概览
简要总结
This study aims to investigate preoperative anxiety, depression, and coping strategy of the patients undergoing laparoscopic gastrectomy for early gastric cancer and their effects on short-term postoperative recovery measured by Quality of Recovery-15 (QOR-15). The findings of the study would improve the perioperative management of early gastric cancer patients.
详细描述
The researchers plan to investigate preoperative psychological factors such as anxiety, depression, and coping strategy in association with short-term quality of recovery from surgery in 100 patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy).
The following items are investigated before surgery; Age, sex, BMI, level of education, occupation, marital status, ECOG performance status, ASA physical status, Apfel score, history of mental disorder, type of surgery, past surgical history, the number of days from diagnosis of cancer to surgery, clinical stage of cancer, histological type of cancer, presence of chronic pain, Quality of Recovery-15 (QOR-15), Hospital Anxiety and Depression Scale (HADS), Amsterdam Preoperative Anxiety and Information Scale (APAIS), Coping and Adaptation Scale-Short Form (CAPS-SF).
The QOR-15 is investigated for 24, 48, and 72 hours after surgery. The severity of postoperative pain by the 11-point Numerical Rating Scale (NRS) is concurrently measured at 24, 48, and 72 hours after surgery. In addition, the researchers measure postoperative complications, particularly nausea/vomiting, at 24, 48, and 72 hours after surgery and length of stay by counting the number of days from the day of surgery to discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or above
- •Patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy) under general anesthesia
- •ASA status I or II
- •Able to read and understand the information sheet, the questionnaires, and the consent form.
排除标准
- •Unable to read and understand the information sheet, the questionnaires, and the consent form.
- •Age above 80 years
- •WIth severe medical or psychological diseases
结局指标
主要结局
Quality of Recovery -15 score at postoperative 72 hours
时间窗: at postoperative 72 hours
There are total 15 items where each of them is an 11-point numerical rating scale (for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items, the scoring was reversed; maximum score 150)
次要结局
- Postoperative pain score(at postoperative 24, 48, and 72 hours)
- Quality of Recovery -15 score at postoperative 24 hours(at postoperative 24 hours)
- Postoperative nausea or vomiting(at postoperative 24, 48, and 72 hours)
- Quality of Recovery -15 score at postoperative 48 hours(at postoperative 48 hours)
- Length of stay(through study completion, an average of 1 year)
研究者
Hojin Lee, MD
Clinical assistant professor
Seoul National University Hospital