Reminder system to enhance safety in gallbladder surgery
CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
This study is testing a new reminder system for surgeons to help them follow important safety steps during gallbladder surgery to prevent injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IHU Strasbourg Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06895200 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with benign gallbladder disease who require elective laparoscopic cholecystectomy.
Not a fit: Patients with malignant gallbladder disease or those in emergency situations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of bile duct injuries during laparoscopic cholecystectomy, improving patient safety and outcomes.
How similar studies have performed: Previous studies have shown that structured time-outs can improve adherence to safety protocols in surgical settings, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Strasbourg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.