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Clinical Trials/NCT04599231
NCT04599231
Withdrawn
Not Applicable

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

Seoul National University Hospital1 site in 1 countryOctober 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Complications
Sponsor
Seoul National University Hospital
Locations
1
Primary Endpoint
Quality of Recovery -15 score at postoperative 72 hours
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2020
End Date
August 24, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hojin Lee, MD

Clinical assistant professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Postoperative pain score(at postoperative 24, 48, and 72 hours)
  • Quality of Recovery -15 score at postoperative 24 hours(at postoperative 24 hours)
  • Postoperative nausea or vomiting(at postoperative 24, 48, and 72 hours)
  • Quality of Recovery -15 score at postoperative 48 hours(at postoperative 48 hours)
  • Length of stay(through study completion, an average of 1 year)

Study Sites (1)

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