Clinical trial NCT04599231: Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery in Early Gastric Cancer
Official title: Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery Among Early Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Complications
Anxiety
Depression
Coping Behavior
Keywords: Postoperative Complications
Anxiety
Depression
Coping Behavior
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational study
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery -15 score at postoperative 72 hours
timeFrame: at postoperative 72 hours
Secondary outcomes:
measure: Quality of Recovery -15 score at postoperative 24 hours
timeFrame: at postoperative 24 hours
measure: Quality of Recovery -15 score at postoperative 48 hours
timeFrame: at postoperative 48 hours
measure: Postoperative pain score
timeFrame: at postoperative 24, 48, and 72 hours
measure: Length of stay
timeFrame: through study completion, an average of 1 year
measure: Postoperative nausea or vomiting
timeFrame: at postoperative 24, 48, and 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hojin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.