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

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Seoul National University

Status

Withdrawn

Conditions

Postoperative Complications
Coping Behavior
Depression
Anxiety

Treatments

Diagnostic Test: Quality of Recovery -15

Study type

Interventional

Funder types

Other

Identifiers

NCT04599231
2008-130-1149

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Study group
Experimental group
Description:
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)
Treatment:
Diagnostic Test: Quality of Recovery -15

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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