Incidence and Risk Factors of Chronic Postoperative Pain in Same-day Surgery: A Prospective Cohort Study.
Melodie Fanay Boko, Ashish K Khanna, Frederick D'Aragon...
https://pubmed.ncbi.nlm.nih.gov/38669010Actively Recruiting
Age: 45Years +
All Genders
ID04973397
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
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-03-19
15000
Participants Needed
16
Research Sites
17 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the risks and outcomes of patients undergoing elective same-day noncardiac surgeries, focusing on major cardiovascular and other complications within 90 days after surgery. This large observational study aims to better understand how often these events occur, what factors increase risk, and to develop tools that help predict patient outcomes after same-day surgery. The study will also assess changes in quality of life and validate several questionnaires used to measure physical function and frailty in this context. The study follows 15,000 adults undergoing elective same-day noncardiac surgery lasting at least 60 minutes. These patients will be observed without receiving experimental treatments, allowing researchers to collect real-world data on postoperative complications such as heart attacks, strokes, infections, bleeding, and kidney injury. Quality of life and physical function will be evaluated using validated questionnaires like the EQ-5D-5L and Duke Activity Status Index. Pain will also be assessed using the Brief Pain Inventory score. Participants will be followed for 90 days after surgery through medical record reviews and questionnaires to capture unplanned healthcare visits, cardiovascular events, and other adverse outcomes. The study will measure functional capacity, frailty, and quality of life changes during this time. The main outcome is unplanned healthcare use within 90 days, including hospital admissions and emergency visits. This observational approach helps identify risk factors and improve patient selection and care planning for same-day surgeries.
CONDITIONS
Brief Title
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Who Can Participate
Age: 45Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 45 to 64 years with at least one risk factor, or 65 years and older
- Undergoing elective noncardiac same-day surgery
- Planned surgery duration of 60 minutes or more in the operating room
- Provided written consent to participate
You will not qualify if you...
- Procedures not requiring an anesthesiologist
- Surgery performed by a nonsurgical specialty such as gastroenterology, pneumology, radio-oncology, or radiology
- Ophthalmologic procedures
- Previous enrollment in the VALIANCE study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Surgery
Duration - Same day
Participants undergo elective same-day noncardiac surgery lasting 60 minutes or more.
1 day surgery visit (in-person)
Post-operative Follow-up
Duration - 90 days
Participants are followed for 90 days after surgery to monitor for major cardiovascular and other adverse postoperative complications, and to assess quality of life and functional capacity changes.
Follow-up assessments over 90 days including questionnaires and health status monitoring
Trial Site Locations
Total: 16 locations
1
Wake Forest Baptist Medical Centre
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
2
Cleveland Clinic Foundation Fairview Campus
Cleveland, Ohio, United States, 44111
Actively Recruiting
3
Cleveland Clinic Foundation Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Memorial Hermann Texas Medical Center UT Health
Houston, Texas, United States, 77030
Actively Recruiting
6
St-Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Active, Not Recruiting
7
Hamilton General Hospital
Hamilton, Ontario, Canada
Actively Recruiting
8
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
Actively Recruiting
9
McMaster University Medical Centre
Hamilton, Ontario, Canada
Actively Recruiting
10
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
11
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
12
St-Micheal's Hospital
Toronto, Ontario, Canada
Actively Recruiting
13
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X0C1
Actively Recruiting
14
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Active, Not Recruiting
15
Maasstad Ziekenhuis Rotterdam
Rotterdam, Netherlands
Actively Recruiting
16
Hospital Clinic Barcelona
Barcelona, Spain
Actively Recruiting
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Research Team
M
Melodie Fanay Boko, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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