Artificial Intelligence Guidance in Laparoscopic Cholecystectomy Safety
Artificial Intelligence Guidance Models
Prevention Study
Summary
Study start date: September 17, 2025
Actual date on which the first participant was enrolled.This study focuses on using artificial intelligence (AI) to potentially make laparoscopic gallbladder surgeries safer. Laparoscopic cholecystectomy is a minimally invasive surgery to remove the gallbladder, and achieving the Critical View of Safety is crucial to avoid complications. This research is conducted at two hospitals in Toronto, Canada, and involves surgeons and fellows performing surgeries. The study compares procedures done with AI guidance to standard procedures. AI models provide real-time feedback to help surgeons during the operation, and the study aims to see if this guidance improves the safety of the surgery. During the trial, 10 surgeons or fellows will perform 5 surgeries each, with some using AI assistance and others following standard methods. The AI group uses tools that help ensure safe dissection and proper visibility of critical structures. Outcomes are measured by reviewing internal video recordings of the surgeries to see if the AI contributes to safer procedures. Other aspects being evaluated include how often dissections occur safely, feedback from the surgeons about the AI, and observations made by the research team. Researchers will also check patient health records 30 days after surgery to assess any differences in recovery or complications between the two groups.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Toronto Western Hospital
Toronto, Canada