Reminder system to enhance safety in gallbladder surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve the implementation of the Critical View of Safety (CVS) during laparoscopic cholecystectomy by utilizing a software-based reminder system called CVS-Notifier. The CVS is a crucial safety principle designed to prevent bile duct injuries, which occur in a small percentage of these surgeries. Despite its importance, CVS is often underutilized, leading to significant complications and costs. By providing a timely reminder to surgeons before critical steps in the procedure, the study hypothesizes that the CVS-Notifier will enhance adherence to safety protocols without disrupting surgical workflows.

Why it matters

Who can join: the full rules

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.

Where it's running

• Visceral and Digestive Surgery, Nouvel Hôpital Civil
  Strasbourg, France Recruiting

Study contacts

• Principal investigator: Silvana PERRETTA, MD, PhD — Hopitaux Universitaires de Strasbourg
• Study coordinator: Armelle TAKEDA, PhD
• Email: armelle.takeda@ihu-strasbourg.eu
• Phone: +33341903608

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.