Evaluating the Clinical Impact of Artificial Intelligence on Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Critical View of Safety Achievement Rate
研究概览
简要总结
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
详细描述
To measure the clinical impact of artificial intelligence (AI) guidance on the achievement of safety milestones in laparoscopic cholecystectomy compared to standard care, the study team will conduct a randomized controlled trial of 10 surgeons or fellows and 50 patients undergoing laparoscopic cholecystectomy procedures at two hospital sites part of the University Health Network in Toronto, Ontario, Canada (Toronto General Hospital and Toronto Western Hospital). Surgeons or fellows randomized to the intervention group (AI) will each perform 5 procedures using two AI models that provide real-time feedback to guide safe dissections and the achievement of the critical view of safety. Surgeons or fellows randomized to the control group will each perform 5 procedures using the standard care approach. Internal laparoscopic recordings will be collected from both the intervention and control groups for post-operative outcome analysis by blinded expert surgeon reviewers.
The research team will evaluate whether the use of AI during the procedure improves the achievement rate of the Critical View of Safety as compared to standard procedures.
Additionally, secondary outcomes will be assessed including the proportion of dissections that occurred above the line of safety, surgeon feedback on the use of AI during the procedure, observational notes recorded by the research coordinator present during each procedure, and 30-day post operation chart review.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Surgeon participants: Anyone who is not a surgeon or fellow at University Health Network or that does not perform laparoscopic cholecystectomies.
- •Patient participants: Any patient who is not having a laparoscopic cholecystectomy surgery.
研究组 & 干预措施
Standard Surgical Procedure
Surgeons/fellows will perform the procedure, as per standard care measures.
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.
干预措施: Artificial Intelligence Guidance Models (Device)
结局指标
主要结局
Critical View of Safety Achievement Rate
时间窗: Post-procedure through study completion (up to 1 year)
Blinded expert surgeons will review the laparoscopic video recordings to determine whether the Critical View of Safety (CVS) was fully achieved, defined as meeting all three required criteria. The proportion of cases with fully achieved CVS in the intervention group will be compared with the proportion in the control group.
次要结局
- Dissections above Line of Safety(Post-procedure through study completion (up to 1 year))
- Surgeon-reported outcomes(Immediately after the procedure)
- Observer-reported outcomes(During the procedure)
- Post-operative chart review(Up to 30 days post-procedure.)
研究者
Amin Madani
Endocrine and Acute Care Surgeon and Researcher at The Institute for Education Research
University Health Network, Toronto