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

Primary Purpose

Postoperative Complications, Anxiety, Depression

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quality of Recovery -15
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postoperative Complications focused on measuring Postoperative Complications, Anxiety, Depression, Coping Behavior

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

The investigators would perform the following tests preoperatively on the study subjects. Hospital Anxiety and Depression Scale (HADS) Amsterdam Preoperative Anxiety and Information Scale (APAIS) Coping and Adaptation Processing Scale-Short Form (CAPS-SF) Quality of Recovery -15 (QOR-15)

Outcomes

Primary Outcome Measures

Quality of Recovery -15 score 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

Quality of Recovery -15 score 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)
Quality of Recovery -15 score 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)
Postoperative pain score
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Length of stay
The number of days that patients spend in the hospital after surgery
Postoperative nausea or vomiting
Patients' postoperative nausea/vomiting: for each, 0, no; 1 yes, but not severe enough to take antiemetics; 2, yes, severe enough to take antiemetics

Full Information

First Posted
October 6, 2020
Last Updated
December 5, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04599231
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Considering the various conditions (other ongoing prospective studies, lack of manpower), we decided not to proceed with this study.
Study Start Date
October 12, 2020 (Anticipated)
Primary Completion Date
June 24, 2021 (Anticipated)
Study Completion Date
August 24, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Anxiety, Depression, Coping Behavior
Keywords
Postoperative Complications, Anxiety, Depression, Coping Behavior

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
The investigators would perform the following tests preoperatively on the study subjects. Hospital Anxiety and Depression Scale (HADS) Amsterdam Preoperative Anxiety and Information Scale (APAIS) Coping and Adaptation Processing Scale-Short Form (CAPS-SF) Quality of Recovery -15 (QOR-15)
Intervention Type
Diagnostic Test
Intervention Name(s)
Quality of Recovery -15
Intervention Description
The investigators plan to evaluate patients' quality of recovery at postoperative day (POD) 1, 2, and 3.
Primary Outcome Measure Information:
Title
Quality of Recovery -15 score at postoperative 72 hours
Description
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)
Time Frame
at postoperative 72 hours
Secondary Outcome Measure Information:
Title
Quality of Recovery -15 score at postoperative 24 hours
Description
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)
Time Frame
at postoperative 24 hours
Title
Quality of Recovery -15 score at postoperative 48 hours
Description
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)
Time Frame
at postoperative 48 hours
Title
Postoperative pain score
Description
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Time Frame
at postoperative 24, 48, and 72 hours
Title
Length of stay
Description
The number of days that patients spend in the hospital after surgery
Time Frame
through study completion, an average of 1 year
Title
Postoperative nausea or vomiting
Description
Patients' postoperative nausea/vomiting: for each, 0, no; 1 yes, but not severe enough to take antiemetics; 2, yes, severe enough to take antiemetics
Time Frame
at postoperative 24, 48, and 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hojin Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
KS013
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32703550
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.
Results Reference
background
PubMed Identifier
23411725
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.
Results Reference
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Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery in Early Gastric Cancer

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