Evaluation of the CVS-Notifier Device as a Smart Reminder to Improve Safety in Elective Laparoscopic Gallbladder Surgery

What this Trial Is About

Laparoscopic cholecystectomy is the preferred surgical method for gallbladder removal but carries a risk of bile duct injury, which can increase mortality and healthcare costs. The Critical View of Safety CVS technique helps prevent these injuries but is underused in practice. This study evaluates the CVS-Notifier Software as a Medical Device SaMD, designed to remind surgeons to verify CVS during surgery, aiming to improve safety without disrupting surgical workflow. The CVS-Notifier SaMD will be connected to the laparoscopic video system and display a visual reminder on an auxiliary operating room screen when surgeons begin dissecting the hepatocystic triangle. This reminder prompts a time-out to confirm CVS achievement before dividing the cystic duct, as recommended by guidelines. This single-center, exploratory study will enroll patients undergoing elective laparoscopic cholecystectomy to assess the safety, usability, and impact of this device. Participants will undergo standard surgical procedures with the CVS-Notifier active. After surgery, both surgeons and patients will complete surveys about their experience. Researchers will collect clinical, surgical, and device-related data, focusing on complications related to the CVS-Notifier within 30 days after surgery. Additional measures include rates of intraoperative time-outs, CVS implementation, and acceptance by surgeons and patients. The study aims to improve surgical safety during gallbladder removal.

Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy