CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of CVS-Notifier SaMD related complications
研究概览
简要总结
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.
详细描述
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 bile duct injury (BDI). This major complication translates into a threefold increase in mortality at 1 year, frequent medico-legal litigations, and an annual cost of about 1 billion dollars in the USA alone.
The visual perceptual illusion causing major BDIs can be prevented by implementing the Critical View of Safety (CVS). CVS consists of the clearance of the hepatocystic triangle from fat and connective tissue, the division of the lower part of the gallbladder from its liver bed, and ensuring that only two tubular structures-the cystic duct and the cystic artery-connected to the gallbladder are visible. Unfortunately, CVS implementation in surgical practices is as low as 9% and, in turn, BDIs do not decrease.
To improve the implementation of the CVS, multi-society consensus guidelines recommend to time-out to confirm CVS achievement before dividing cystic structures. A large quality improvement study demonstrated that a short time-out to recall CVS principles significantly increases CVS implementation rates. However, the implementation of the time-out and CVS decreases over time.
The CVS-Notifier SaMD reminds surgeons to time-out to verify the CVS before the division of the cystic duct. Such a systematic intraoperative reminder to implement best practices could help consistently perform safe laparoscopic cholecystectomies.
This first-in-human, exploratory study aims at evaluating the safety, usability, and potential impact of the CVS-Notifier SaMD in laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Study
干预措施: CVS-Notifier SaMD (Device)
结局指标
主要结局
Rate of CVS-Notifier SaMD related complications
时间窗: From the day of the procedure up to 30 days after surgery
The rate of CVS-Notifier SaMD related complications defined as any complications caused directly or indirectly by the device. Postoperative complication will be classified according to the Clavien-Dindo classification (Grade 1 to Grade 5).
次要结局
- Rate of CVS implementation(The day of the procedure)
- Rate of intraoperative time-out(The day of the procedure)
- Surgeons' acceptance(The day of the procedure)
- Patients' acceptance(The day of the procedure)