An interventional study of Quality of Recovery -15 in Postoperative Complications, Anxiety and Depression, sponsored by Seoul National University Hospital. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Screening
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.
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.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
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Exclusion Criteria:
The investigators would perform the following tests preoperatively on the study subjects. 1. Hospital Anxiety and Depression Scale (HADS) 2. Amsterdam Preoperative Anxiety and Information Scale (APAIS) 3. Coping and Adaptation Processing Scale-Short Form (CAPS-SF) 4. Quality of Recovery -15 (QOR-15)
Diagnostic Test: Quality of Recovery -15
The investigators plan to evaluate patients' quality of recovery at postoperative day (POD) 1, 2, and 3.
Quality of Recovery -15 score 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)
Time frame: at postoperative 72 hours
Quality of Recovery -15 score at postoperative 24 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)
Time frame: at postoperative 24 hours
Quality of Recovery -15 score at postoperative 48 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)
Time frame: at postoperative 48 hours
Postoperative pain score
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Time frame: at postoperative 24, 48, and 72 hours
Length of stay
The number of days that patients spend in the hospital after surgery
Time frame: through study completion, an average of 1 year
Postoperative nausea or vomiting
Patients' postoperative nausea/vomiting: for each, 0, no; 1 yes, but not severe enough to take antiemetics; 2, yes, severe enough to take antiemetics
Time frame: at postoperative 24, 48, and 72 hours
This study is withdrawn, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital