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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169087
• Other study ID #: HS-2019-02
• Status: Completed
• Start date: November 19, 2019
• Est. completion date: June 22, 2020

Study information

• Verified date: June 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 22, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Convergent Validity of the QoR (Quality of Recovery)-15	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
Primary	Construct Validity of the QoR (Quality of Recovery)-15	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
Primary	Discriminant Validity of the QoR (Quality of Recovery)-15	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	Reliability of the QoR (Quality of Recovery)-15	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
Secondary	Response success rate of the QoR-15	Defined as success if the patient has answered all items.	A day before and 24 hours after the surgery
Secondary	Correlation of postoperative outcomes with QoR-15	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