Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07186803

AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Led by University Health Network, Toronto · Updated on 2026-01-13

70

Participants Needed

2

Research Sites

45 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Attending surgeons or fellows who perform laparoscopic cholecystectomy at University Health Network
  • Adults 18 years of age or older scheduled for laparoscopic cholecystectomy surgery
Not Eligible

You will not qualify if you...

  • Individuals who are not surgeons or fellows at University Health Network or do not perform laparoscopic cholecystectomy
  • Patients not scheduled for laparoscopic cholecystectomy surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

2

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

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Research Team

A

Ariana Walji, BSc, MSc Candidate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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