Korean Version of the "Quality of Recovery 15" After General Anesthesia

June 22, 2020 updated by: Hojin Lee, MD, Seoul National University Hospital

Validation and Clinical Implications of the Korean Version of the "Quality of Recovery 15" After General Anesthesia: A Prospective Observational Cohort Study

The aim of this study is to test the Korean version of QoR-15 for its validity and clinical acceptability and feasibility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Quality of recovery (QoR) after anesthesia is an important measure of the early postoperative health status of patients. The QoR-40 is a widely-used questionnaire for postoperative patients and the short-form version of it (QoR-15) was developed in 2013. The validation of QoR-15 has been reported in the version of English, Portuguese, Danish, Chinese and Swedish. However, the study to validate the Korean version of QoR-15 has not been demonstrated.

Patients undergoing surgery and general anesthesia are asked by the investigators to complete the QoR-15 questionnaire and Korean 36-Item Short Form Health Survey (SF-36) a day before surgery. They are then asked to repeat the QoR-15 questionnaire 24 h postoperatively and also rate their overall postoperative pain score using 11-point numeric rating scale (NRS).

Study Type

Observational

Enrollment (Actual)

200

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

Sampling Method

Probability Sample

Study Population

Adult patients undergoing elective surgery and general anesthesia in Seoul National University Hospital.

Description

Inclusion Criteria:

  • Patients scheduled to undergo elective general surgery, thoracic surgery and gynecological surgery under general anesthesia
  • Age between 18 and 80 years
  • Willingness and ability to sign an informed consent document
  • Ability to understand the contents of questionnaires

Exclusion Criteria:

  • Age under 18 or over 80.
  • Do not understand our study
  • Medical or psychological disease that can affect the treatment response

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anesthesia
Patients undergoing general anesthesia
Other: QoR-15
The QoR-15 is the questionnaire to provide an evaluation of the postoperative quality of recovery. Patients undergoing surgery and general anesthesia are asked by the investigators to complete the QoR-15 questionnaire before and 24h after the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Convergent Validity of the QoR (Quality of Recovery)-15
Time Frame: 24 hours after the surgery
The QoR-15 (0-150) is compared with the global QoR visual analog scale (VAS) (0-100), 36-Item Short Form Health Survey (SF-36) and interitem correlations are measured.
24 hours after the surgery
Construct Validity of the QoR (Quality of Recovery)-15
Time Frame: 24 hours after the surgery
To investigate if there is an correlation between the QoR-15 (0-150) and age (yr), gender (male/female), American Society of Anesthesiologists (ASA) physical status (I-IV), type of surgery (minor/major), postoperative complication (Clavien Dindo grade II or high, %) and 11-point numeric rating scale (NRS) pain score.
24 hours after the surgery
Discriminant Validity of the QoR (Quality of Recovery)-15
Time Frame: 24 hours after the surgery
To investigate if there is differences in the QoR-15 (0-150) and postoperative complications (Clavien Dindo grade II or high, %) between the high QoR score group and low QoR score group
24 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of the QoR (Quality of Recovery)-15
Time Frame: 24 hours after the surgery
Compare the two QoR-15 results measured at 60 minutes intervals using an intraclass correlation coefficient, and calculate the Cronbach alpha to investigate the internal consistency.
24 hours after the surgery
Response success rate of the QoR-15
Time Frame: A day before and 24 hours after the surgery
Defined as success if the patient has answered all items.
A day before and 24 hours after the surgery
Correlation of postoperative outcomes with QoR-15
Time Frame: 24 hours after the surgery
To investigate if there is an correlation between the QoR-15 (0-150) at POD1 and length of hospital stay (day), postoperative complications (Clavien Dindo grade II or high, %), C-reactive protein (mg/L) at POD1, Granulocyte/lymphocyte ratio at POD1, readmission rate within 1 month
24 hours after the surgery

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 (ACTUAL)

November 19, 2019

Primary Completion (ACTUAL)

April 30, 2020

Study Completion (ACTUAL)

June 22, 2020

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-2019-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for primary outcome measures will be made available

IPD Sharing Time Frame

Data will be available within 6 months of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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