AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
ConditionLaparoscopic Cholecystectomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Artificial Intelligence Guidance Models
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov