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

December 5, 2022 updated by: Hojin Lee, MD, Seoul National University Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery -15 score at postoperative 72 hours
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery -15 score at postoperative 24 hours
Time Frame: 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
Quality of Recovery -15 score at postoperative 48 hours
Time Frame: 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
Postoperative pain score
Time Frame: 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"
at postoperative 24, 48, and 72 hours
Length of stay
Time Frame: through study completion, an average of 1 year
The number of days that patients spend in the hospital after surgery
through study completion, an average of 1 year
Postoperative nausea or vomiting
Time Frame: 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
at postoperative 24, 48, and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 12, 2020

Primary Completion (Anticipated)

June 24, 2021

Study Completion (Anticipated)

August 24, 2021

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-130-1149

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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