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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04599231
Enrollment
0
Registered
2020-10-22
Start date
2020-10-12
Completion date
2021-08-24
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Coping Behavior, Depression, Postoperative Complications

Keywords

Postoperative Complications, Anxiety, Depression, Coping Behavior

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.

Interventions

DIAGNOSTIC_TESTQuality of Recovery -15

The investigators plan to evaluate patients' quality of recovery at postoperative day (POD) 1, 2, and 3.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Prospective observational study

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery -15 score at postoperative 72 hoursat postoperative 72 hoursThere 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

MeasureTime frameDescription
Quality of Recovery -15 score at postoperative 24 hoursat postoperative 24 hoursThere 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 hoursat postoperative 48 hoursThere 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 scoreat postoperative 24, 48, and 72 hours11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, no pain; 10, worst pain imaginable
Length of staythrough study completion, an average of 1 yearThe number of days that patients spend in the hospital after surgery
Postoperative nausea or vomitingat postoperative 24, 48, and 72 hoursPatients' postoperative nausea/vomiting: for each, 0, no; 1 yes, but not severe enough to take antiemetics; 2, yes, severe enough to take antiemetics

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026