CVS-Notifier SaMD: The CVS-Notifier SaMD reminds surgeons to time-out to check the CVS before the division of the cystic duct.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Rate of CVS-Notifier SaMD related complications — From the day of the procedure up to 30 days after surgery 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).
Trial sites (1)
Facility
City
Region
Status
Visceral and Digestive Surgery, Nouvel Hôpital Civil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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