The Critical View of Safety (CVS) is universally recommended to prevent bile duct injuries in laparoscopic cholecystectomy. However, CVS is underutilized and bile duct injuries are not decreasing. The CVS-Notifier SaMD (Software as a Medical Device) reminds surgeons to verify the CVS before dividing the cystic duct, as recommended by guidelines. It is hypothesized that this systematic and timely reminder could improve the implementation of CVS without disturbing surgical workflows.
Man or woman over 18 years old.
Patient presenting with benign gallbladder disease requiring an elective laparoscopic cholecystectomy.
Patient without contraindications to anaesthesia or laparoscopic cholecystectomy surgery.
Patients capable of understanding and providing their written consent to the study.
Patients presenting with malignant gallbladder disease requiring an elective laparoscopic cholecystectomy.
Pregnant or lactating patient.
Patient in exclusion period (determined by a previous or a current study).
Patient under guardianship or trusteeship.
IHU Strasbourg
Lead sponsor
Scialytics SAS
Collaborator