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

Not Applicable

Withdrawn

• Conditions: Coping Behavior; Postoperative Complications; Anxiety; Depression
• Interventions: Diagnostic Test: Quality of Recovery -15

• Registration Number: NCT04599231
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2020-10-06
• Study Start: 2020-10-12
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Primary Completion: 2021-06-24
• Study Completion: 2021-08-24
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Quality of Recovery -15	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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"
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)
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
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)
Length of stay	through study completion, an average of 1 year	The number of days that patients spend in the hospital after surgery

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of