Clinical trial NCT06895200: Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
Official title: CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Keywords: Laparoscopic cholecystectomy
Gallbladder
Safety
Critical View of Safety
CVS
Bile Duct Injuries
BDI
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
Collaborators: name: Scialytics SAS
First posted: 2025-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.
* Patient affiliated to the French social security system.

Exclusion Criteria:

* 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.
* Patient under the protection of justice or deprived of liberty.
* Patient in situation of emergency.

Primary outcomes:
measure: Rate of CVS-Notifier SaMD related complications
timeFrame: From the day of the procedure up to 30 days after surgery
Secondary outcomes:
measure: Rate of intraoperative time-out
timeFrame: The day of the procedure
measure: Rate of CVS implementation
timeFrame: The day of the procedure
measure: Surgeons' acceptance
timeFrame: The day of the procedure
measure: Patients' acceptance
timeFrame: The day of the procedure
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Visceral and Digestive Surgery, Nouvel Hôpital Civil
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Silvana PERRETTA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: