Laparoscopic cholecystectomy is the gold standard approach for the surgical removal of
the gallbladder. However, between 0.3 and 1.5% of patients undergoing laparoscopic
cholecystectomy experience a bile duct injury (BDI). This major complication translates
into a threefold increase in mortality at 1 year, frequent medico-legal litigations, and
an annual cost of about 1 billion dollars in the USA alone.
The visual perceptual illusion causing major BDIs can be prevented by implementing the
Critical View of Safety (CVS). CVS consists of the clearance of the hepatocystic triangle
from fat and connective tissue, the division of the lower part of the gallbladder from
its liver bed, and ensuring that only two tubular structures-the cystic duct and the
cystic artery-connected to the gallbladder are visible. Unfortunately, CVS implementation
in surgical practices is as low as 9% and, in turn, BDIs do not decrease.
To improve the implementation of the CVS, multi-society consensus guidelines recommend to
time-out to confirm CVS achievement before dividing cystic structures. A large quality
improvement study demonstrated that a short time-out to recall CVS principles
significantly increases CVS implementation rates. However, the implementation of the
time-out and CVS decreases over time.
The CVS-Notifier SaMD reminds surgeons to time-out to verify the CVS before the division
of the cystic duct. Such a systematic intraoperative reminder to implement best practices
could help consistently perform safe laparoscopic cholecystectomies.
This first-in-human, exploratory study aims at evaluating the safety, usability, and
potential impact of the CVS-Notifier SaMD in laparoscopic cholecystectomy.
The study is a single center, non-comparative, case series. Patients undergoing elective
laparoscopic cholecystectomy who meet the eligibility criteria and express their consent
to participate in the study will be enrolled. The CVS-Notifier SaMD will be installed on
a medical grade computer connected to a secondary output of the laparoscopic video system
(input) and to an auxiliary screen in the operating room (OR) (output). Surgeons will
start the procedure as usual while the CVS-Notifier SaMD unobtrusively analyses the
surgical video. When the beginning of the hepatocystic triangle dissection is detected, a
visual reminder to verify CVS in an intraoperative time-out notification will appear on
the auxiliary OR screen.
Surgeons and patients will be asked to fill in a survey to report their experience, after
the procedure and before discharge, respectively.
Clinical, surgical, and device-related data will be collected and analyzed.