Clinical Trial

AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Recruiting Phase 3
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Record status
This record was last updated January 13, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Today, the majority of gallbladder removals surgeries are done using minimally invasive techniques through small cuts to help patients recover faster. However, these procedures are technically more challenging because surgeons have a restricted view of the patient's anatomy, which can increase the risk of serious complications. Artificial intelligence (AI) tools have been developed to guide surgeons during surgery and help them make safer decisions that reduce the risk of injury to the patient. This study will use a randomized controlled trial to compare outcomes between surgeries with AI assistance and standard procedures without AI. Primary 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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-18.
Trial Details
NCT Number NCT07186803
Lead Sponsor University Health Network, Toronto
Conditions Laparoscopic Cholecystectomy
Enrollment 70 participants
Start Date 2025-09-17
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-13