Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery in Early Gastric Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study group The investigators would perform the following tests preoperatively on the study subjects. Hospital Anxiety and Depression Scale (HADS) Amsterdam Preoperative Anxiety and Information Scale (APAIS) Coping and Adaptation Processing Scale-Short Form (CAPS-SF) 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.
|
Outcome Measures
Primary Outcome Measures
- Quality of Recovery -15 score at postoperative 72 hours [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)
Secondary Outcome Measures
- Quality of Recovery -15 score at postoperative 24 hours [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)
- Quality of Recovery -15 score at postoperative 48 hours [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)
- Postoperative pain score [at postoperative 24, 48, and 72 hours]
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
- Length of stay [through study completion, an average of 1 year]
The number of days that patients spend in the hospital after surgery
- Postoperative nausea or vomiting [at postoperative 24, 48, and 72 hours]
Patients' postoperative nausea/vomiting: for each, 0, no; 1 yes, but not severe enough to take antiemetics; 2, yes, severe enough to take antiemetics
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or above
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Patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy) under general anesthesia
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ASA status I or II
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Able to read and understand the information sheet, the questionnaires, and the consent form.
Exclusion Criteria:
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Unable to read and understand the information sheet, the questionnaires, and the consent form.
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Age above 80 years
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WIth severe medical or psychological diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | KS013 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Hojin Lee, MD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Yoon S, Joo H, Oh YM, Lee J, Bahk JH, Lee HJ. Validation and clinical utility of the Korean version of the Quality of Recovery-15 with enhanced recovery after surgery: a prospective observational cohort study. Br J Anaesth. 2020 Oct;125(4):614-621. doi: 10.1016/j.bja.2020.06.040. Epub 2020 Jul 21.
- 2008-130-1149