NCT04599231

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

October 12, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2021

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

October 6, 2020

Last Update Submit

December 5, 2022

Conditions

Postoperative ComplicationsAnxietyDepressionCoping Behavior

Keywords

Postoperative ComplicationsAnxietyDepressionCoping Behavior

Outcome Measures

Primary Outcomes (1)

  • 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)

    at postoperative 72 hours

Secondary Outcomes (5)

  • Quality of Recovery -15 score at postoperative 24 hours

    at postoperative 24 hours

  • Quality of Recovery -15 score at postoperative 48 hours

    at postoperative 48 hours

  • Postoperative pain score

    at postoperative 24, 48, and 72 hours

  • Length of stay

    through study completion, an average of 1 year

  • Postoperative nausea or vomiting

    at postoperative 24, 48, and 72 hours

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

Quality of Recovery -15DIAGNOSTIC_TEST

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

Study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to read and understand the information sheet, the questionnaires, and the consent form.
  • Age above 80 years
  • WIth severe medical or psychological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 32703550BACKGROUND

  • 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.

    PMID: 23411725BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Hojin Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Prospective observational study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 22, 2020

Study Start

October 12, 2020

Primary Completion

June 24, 2021

Study Completion

August 24, 2021

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

KR(1)