Status:
RECRUITING
Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
Lead Sponsor:
IHU Strasbourg
Collaborating Sponsors:
Scialytics SAS
Conditions:
Cholecystectomy, Laparoscopic
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06895200
Start Date
April 3 2025
End Date
May 1 2026
Last Update
April 30 2025
Active Locations (1)
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1
Visceral and Digestive Surgery, Nouvel Hôpital Civil
Strasbourg, France, 67000