Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,600
- 主要终点
- Textbook Outcome in Liver Surgery (TOLS)
研究概览
简要总结
LIVEROBOT is a collaboration of high-volume liver surgical centers in Europe (≥60 liver resections per year), supported by the European-African Hepato-Pancreato-Biliary Association Education Committee (E-AHPBA), and the European Registry of Minimally Invasive Liver Surgery (E-MILS) aiming to support the step-up implementation and safety of advanced surgical expertise of robotic liver surgery (RLS) on a European basis. The LIVEROBOT training program aims to promote the safe implementation of RLS throughout Europe. The data from all patients operated on during a surgeons' participation in the training program will be prospectively gathered allowing for learning curve and outcome analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age equal or above 18 years
- •Eligible for elective minimally invasive and open hepatectomy for malignant, pre-malignant or benign disease located in the liver or biliary tract
- •Eligible for both minimally invasive and open surgery according to the operating surgeon
- •Fit to undergo the indicated operation according to both the anaesthesiologist and surgeon
排除标准
- •Pregnancy
结局指标
主要结局
Textbook Outcome in Liver Surgery (TOLS)
时间窗: 30 days
TOLS is a novel composite measure that captures the most desirable surgical outcomes into a single indicator and is defined as the absence of intraoperative incidents of grade ≥ 2 (defined according to the Oslo classification), postoperative bile leakage of grade B or C (according to the severity grading of the International Study Group of Liver Surgery), Clavien-Dindo ≥ Grade 3 complications, 30-day readmission, in-hospital mortality and the presence of R0 resection margin.
次要结局
- Conversion to open surgery(at operation completion)
- CUSUM operative time (Learning curve)(After completion of 50 minor and 50 major robotic liver surgery cases per surgeon)
- Textbook Outcome in Liver Surgery + (TOLS+)(30 days)
- Performance grading using the modified OSATS score(2 years (expected))
- Estimated operative blood loss(at operation completion)
- Blood transfusions(at operation completion)
- Length of Hospital Stay(Expected 4-10 days depending on if minor or major liver resection)
- Intra-operative ICG-margin assessment(at operation completion)
研究者
Dr. R.J. (Rutger-Jan) Swijnenburg
Principal Investigator
Amsterdam UMC, location VUmc