Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

Recruiting now · Not applicable

Conditions studied: Cholecystectomy, Laparoscopic

In brief

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.

Key facts

Study ID

NCT06895200

Run by

IHU Strasbourg

People needed

40

Starts

2025-04-03

Expected to finish

2026-05-01

Last updated by the study team

2025-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Visceral and Digestive Surgery, Nouvel Hôpital Civil — Strasbourg, France (enrolling)

Full record on ClinicalTrials.gov

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