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

Completed
Conditions
Postoperative Complications
Interventions
Other: QoR-15
Registration Number
NCT04169087
Lead Sponsor
Seoul National University Hospital
Brief Summary

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

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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
General anesthesiaQoR-15Patients undergoing general anesthesia
Primary Outcome Measures
NameTimeMethod
Convergent Validity of the QoR (Quality of Recovery)-1524 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.

Discriminant Validity of the QoR (Quality of Recovery)-1524 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

Construct Validity of the QoR (Quality of Recovery)-1524 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.

Secondary Outcome Measures
NameTimeMethod
Response success rate of the QoR-15A day before and 24 hours after the surgery

Defined as success if the patient has answered all items.

Correlation of postoperative outcomes with QoR-1524 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

Reliability of the QoR (Quality of Recovery)-1524 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.

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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