NCT04169087

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

November 12, 2019

Last Update Submit

June 22, 2020

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Reliability of the QoR (Quality of Recovery)-15

    24 hours after the surgery

  • Response success rate of the QoR-15

    A day before and 24 hours after the surgery

  • Correlation of postoperative outcomes with QoR-15

    24 hours after the surgery

Study Arms (1)

General anesthesia

Patients undergoing general anesthesia

Other: QoR-15

Interventions

QoR-15OTHER

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.

General anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 10740540RESULT

  • 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.

    PMID: 32703550DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hojin Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 19, 2019

Study Start

November 19, 2019

Primary Completion

April 30, 2020

Study Completion

June 22, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 6 months of study completion
Access Criteria
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement

Locations

KR(1)