The proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. Little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. The main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.
The VALIANCE Study is a 15,000 patient, multicentre, prospective observational cohort of adults undergoing elective same-day noncardiac surgery and who will be followed for 90 days after surgery. The primary objective of the study is to determine the incidence of major cardiovascular complications after same-day surgery. Patients will also be followed for the occurence of other adverse postoperative complications and determine their change in quality of life at 90 days after surgery. VALIANCE will inform on the risk factors for postoperative complications and allow to develop risk prediction tools to guide patient selection and risk stratification of patients undergoing same-day surgery. The study will also look at validating the use of the Duke Activity Status Index questionnaire, Clinical Frailty Scale, and the Revised Cardiac Risk Index. Postoperative pain will be evaluated using the Brief pain inventory score and quality of life using the EQ-5D-5L questionnaire.
Study Type
OBSERVATIONAL
Enrollment
15,000
Wake Forest Baptist Medical Centre
Winston-Salem, North Carolina, United States
RECRUITINGCleveland Clinic Foundation Fairview Campus
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic Foundation Main Campus
Cleveland, Ohio, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGMemorial Hermann Texas Medical Center UT Health
Houston, Texas, United States
RECRUITINGSt-Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
ACTIVE_NOT_RECRUITINGHamilton General Hospital
Hamilton, Ontario, Canada
RECRUITINGJuravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
RECRUITINGMcMaster University Medical Centre
Hamilton, Ontario, Canada
RECRUITINGMount Sinai Hospital
Toronto, Ontario, Canada
RECRUITING...and 6 more locations
Unplanned healthcare utilization
the number of patients who have at least one of the following: unplanned admission after surgery, unplanned outpatient visit, emergency room visit and rehospitalization after same-day surgery
Time frame: 90 days
unplanned admission
the number of patients who have to be admitted to the hospital after undergoing a surgery planned as same-day
Time frame: 90 days
unplanned outpatient visit
the number of patient who had a medical visit in an outpatient setting after undergoing same-day surgery
Time frame: 90 days
emergency room visit
the number of patients who visited the emergency room without subsequent hospitalization after undergoing same-day surgery
Time frame: 90 days
re-hospitalization
the number of patients who have to be readmitted to the hospital after being discharged home following their same-day surgery
Time frame: 90 days
major cardiovascular complications
the number of patients who have at least one of the following: myocardial injury or infarction, non-fatal cardiac arrest, coronary revascularization, stroke, transient ischemic attack, new clinically significant arrythmia, congestive heart failure, unplanned postoperative admission for vascular reasons, emergency room visit for vascular reasons, rehospitalization for vascular reasons, and all-cause mortality
Time frame: 90 days
myocardial injury after noncardiac surgery (MINS)
the number of patients who experience a MINS
Time frame: 90 days
myocardial infarction
the number of patients who experience a myocardial infarction
Time frame: 90 days
non-fatal cardiac arrest
the number of patients who experience a non-fatal cardiac arrest
Time frame: 90 days
coronary revascularization
the number of patients who undergo coronary revascularization
Time frame: 90 days
stroke
the number of patients who experience a stroke
Time frame: 90 days
transient ischemic attack
the number of patients who experience a transient ischemic attack
Time frame: 90 days
new clinically important arrythmia
the number of patients who experience a new clinically important arrythmia
Time frame: 90 days
acute congestive heart failure
the number of patients who experience an acute congestive heart failure episode
Time frame: 90 days
deep vein thrombosis
the number of patients who experience a deep vein thrombosis
Time frame: 90 days
pulmonary embolism
the number of patients who experience a pulmonary embolism
Time frame: 90 days
major postoperative and life-threatening bleeding
the number of patients who experience a major postoperative and/or life-threatening bleeding
Time frame: 90 days
postoperative infection
the number of patients who experience a postoperative infection
Time frame: 90 days
acute kidney injury
the number of patients who experience a acute kidney injury
Time frame: 90 days
quality of life score on the 5-level EQ-5D version (EQ-5D-5L) questionnaire
score on the EQ-5D-5L questionnaire on 4 health profiles (level 1 to 5), overall self-rated health status (0-100 visual analogue scale), and EQ-5D-5L index value (0.01-0.99)
Time frame: 90 days
functional capacity score on the Duke Activity Status Index (DASI)
change in the score on the Duke Activity Status Index (DASI) questionnaire (0 to 58.2 points)
Time frame: 90 days
frailty
change in the level on the Clinical Frailty Scale (level 1 to 9)
Time frame: 90 days
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