RecruitingNot ApplicableNCT06895200

Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

Sponsor

IHU Strasbourg

Enrollment

40 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Cholecystectomy, Laparoscopic

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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.

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