Actively Recruiting
Evaluating the Clinical Impact of Artificial Intelligence on Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Led by University Health Network, Toronto · Updated on 2026-01-13
70
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how artificial intelligence (AI) can improve safety during laparoscopic cholecystectomy, a minimally invasive gallbladder removal surgery. This study compares surgeries guided by AI tools to standard procedures without AI, focusing on whether AI helps surgeons achieve the Critical View of Safety, a key step to reduce the risk of serious complications. This randomized controlled trial includes surgeons or fellows performing the procedures and aims to collect feedback on AI use and surgical safety outcomes. The study involves 10 surgeons or fellows and 50 adult patients undergoing laparoscopic cholecystectomy at two hospital sites. Participants are randomly assigned to either the control group using standard surgical care or the intervention group where surgeons receive real-time guidance from two AI models displayed on a monitor during surgery. The AI models highlight safe and unsafe dissection zones and provide text feedback on achieving surgical safety milestones. Surgeons can toggle or turn off AI guidance as needed. Procedures are recorded for post-operative review by expert surgeons. During the study, researchers will collect internal laparoscopic recordings, surgeon feedback immediately after surgery, observational notes during procedures, and review patient charts up to 30 days post-operation. The primary outcome is the rate at which surgeons achieve the Critical View of Safety, monitored for up to one year after surgery. Secondary outcomes include the safety of dissections, surgeon experience with AI, and short-term patient outcomes. The study lasts from surgery through one year of follow-up for outcome analysis.
CONDITIONS
Brief Title
AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Attending surgeons or fellows who perform laparoscopic cholecystectomy at University Health Network
- Adults 18 years of age and older scheduled for laparoscopic cholecystectomy surgery
You will not qualify if you...
- Anyone who is not a surgeon or fellow at University Health Network or does not perform laparoscopic cholecystectomy
- Patients not scheduled for laparoscopic cholecystectomy surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical procedure day
Participants undergo laparoscopic cholecystectomy surgery with or without real-time artificial intelligence guidance to support surgical safety.
1 visit (in-person procedure)
Duration - Up to 30 days post-procedure
Participants are monitored for surgical outcomes and safety, including a 30-day post-procedure chart review.
Approximately 1 follow-up visit and chart review
Trial Site Locations
Total: 2 locations
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
A
Ariana Walji, BSc, MSc Candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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