Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery in Early Gastric Cancer

Depression Clinical Trial

Official title:

Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery Among Early Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04599231
• Other study ID #: 2008-130-1149
• Status: Withdrawn
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: August 24, 2021

Study information

• Verified date: December 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 24, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Unable to read and understand the information sheet, the questionnaires, and the consent form.

• Age above 80 years

• WIth severe medical or psychological diseases

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Coping Behavior
• Depression
• Depressive Disorder
• Postoperative Complications

Intervention

Diagnostic Test:
• Quality of Recovery -15
The investigators plan to evaluate patients' quality of recovery at postoperative day (POD) 1, 2, and 3.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	at postoperative 72 hours
Secondary	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)	at postoperative 24 hours
Secondary	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)	at postoperative 48 hours
Secondary	Postoperative pain score	11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"	at postoperative 24, 48, and 72 hours
Secondary	Length of stay	The number of days that patients spend in the hospital after surgery	through study completion, an average of 1 year
Secondary	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	at postoperative 24, 48, and 72 hours