Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study - A Prospective Observational Cohort Study Evaluating Major Cardiovascular and Adverse Events in Patients Undergoing Elective Same-day Noncardiac Surgery

Conditions
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Preoperative Care, Surgery--Complications, Myocardial Infarction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45-64 years of age with at least one risk factor, or ≥65 years of age; undergoing elective noncardiac same-day surgery; planned duration in the operating room 60 minutes or more; provided written consent. Exclusion Criteria: intervention does not require the presence of an anesthesiologist; procedure is performed by a nonsurgical specialty (e.g., gastroenterology, pneumology, radio-oncology or radiology); intervention is an ophthalmologic procedure; previously enrolled in the VALIANCE study.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unplanned admission | the number of patients who have to be admitted to the hospital after undergoing a surgery planned as same-day | 90 days | 
| unplanned outpatient visit | the number of patient who had a medical visit in an outpatient setting after undergoing same-day surgery | 90 days | 
| emergency room visit | the number of patients who visited the emergency room without subsequent hospitalization after undergoing same-day surgery | 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 | 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 | 90 days | 
| myocardial injury after noncardiac surgery (MINS) | the number of patients who experience a MINS | 90 days | 
| myocardial infarction | the number of patients who experience a myocardial infarction | 90 days | 
| non-fatal cardiac arrest | the number of patients who experience a non-fatal cardiac arrest | 90 days | 
| coronary revascularization | the number of patients who undergo coronary revascularization | 90 days | 
| stroke | the number of patients who experience a stroke | 90 days | 
| transient ischemic attack | the number of patients who experience a transient ischemic attack | 90 days | 
| new clinically important arrythmia | the number of patients who experience a new clinically important arrythmia | 90 days | 
| acute congestive heart failure | the number of patients who experience an acute congestive heart failure episode | 90 days | 
| deep vein thrombosis | the number of patients who experience a deep vein thrombosis | 90 days | 
| pulmonary embolism | the number of patients who experience a pulmonary embolism | 90 days | 
| major postoperative and life-threatening bleeding | the number of patients who experience a major postoperative and/or life-threatening bleeding | 90 days | 
| postoperative infection | the number of patients who experience a postoperative infection | 90 days | 
| acute kidney injury | the number of patients who experience a acute kidney injury | 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) | 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) | 90 days | 
| frailty | change in the level on the Clinical Frailty Scale (level 1 to 9) | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Care, Surgery, Postoperative complications, Same-day surgery, Ambulatory surgery, Outpatient surgery