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Completed

NCT Number: NCT04169087

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

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

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, KS013, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QoR-15

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2019
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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