Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
Recruiting
N/A
Interventional Study
Cholecystectomy, Laparoscopic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 40 (estimated)
- Sponsor
- IHU Strasbourg · Other
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About This Trial
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 r…
Trial Locations
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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 providin…
Contacts