A Randomized Trial of Artificial Intelligence Assistance for Safer Laparoscopic Gallbladder Surgery

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.

AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial