Clinical trial NCT04169087: Korean Version of the "Quality of Recovery 15" After General Anesthesia
Official title: Validation and Clinical Implications of the Korean Version of the "Quality of Recovery 15" After General Anesthesia: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective surgery and general anesthesia in 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).

Eligibility criteria: 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

Primary outcomes:
measure: Convergent Validity of the QoR (Quality of Recovery)-15
timeFrame: 24 hours after the surgery
measure: Construct Validity of the QoR (Quality of Recovery)-15
timeFrame: 24 hours after the surgery
measure: Discriminant Validity of the QoR (Quality of Recovery)-15
timeFrame: 24 hours after the surgery
Secondary outcomes:
measure: Reliability of the QoR (Quality of Recovery)-15
timeFrame: 24 hours after the surgery
measure: Response success rate of the QoR-15
timeFrame: A day before and 24 hours after the surgery
measure: Correlation of postoperative outcomes with QoR-15
timeFrame: 24 hours after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hojin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
citation: 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.