Evaluating the Clinical Impact of Artificial Intelligence on Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Objective: To determine whether the AI improves surgeons' ability to achieve the Critical View of Safety, a key step for safe gallbladder removal, compared to standard procedures. Secondary
Objectives: * Determine whether the AI helps the surgeon perform more safe dissections compared to the standard procedures. * Collect surgeon feedback on the use of AI during the procedure
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Surgeon participants: Attending surgeons or fellows that perform laparoscopic cholecystectomy at University Health Network.
• Patients participants: Adults 18 years of age and over, scheduled for laparoscopic cholecystectomy surgery.
Locations
Other Locations
Canada
Toronto General Hospital
RECRUITING
Toronto
Toronto Western Hospital
RECRUITING
Toronto
Contact Information
Primary
Ariana Walji, BSc, MSc Candidate
ariana.walji@uhn.ca
416-603-5185
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 70
Treatments
No_intervention: Standard Surgical Procedure
Surgeons/fellows will perform the procedure, as per standard care measures.
Experimental: Artificial Intelligence Feedback
Surgeons or fellows in the intervention group will have access to two AI models during their procedure. A research coordinator will operate and monitor the AI models, which are displayed on a single monitor in the operating room. Participants may request to toggle between models or turn them off at any point during the procedure, as per their needs.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto