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.
Single group
CVS-Notifier SaMD
DeviceThe CVS-Notifier SaMD reminds surgeons to time-out to check the CVS before the division of the cystic duct.
Rate of CVS-Notifier SaMD related complications
The rate of CVS-Notifier SaMD related complications defined as any complications caused directly or indirectly by the device. Postoperative complication will be classified according to the Clavien-Dindo classification (Grade 1 to Grade 5).
Rate of intraoperative time-out
The rate of intraoperative time-out is defined as a pause in surgical activities lasting at least 2 seconds before clipping and cutting the cystic duct or the cystic artery.
Rate of CVS implementation
The rate of implementation of the CVS will be assessed postoperatively on surgical videos
Surgeons' acceptance
Surgeons' use and acceptance of the technology will be assessed with a specifically designed survey
Patients' acceptance
Patients' acceptability and expectations on the device will be assessed with a specifically designed survey
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IHU Strasbourg
Lead sponsor
Scialytics SAS
Collaborator
