跳至主要内容
临床试验/NCT04662346
NCT04662346Unknown不适用

Difficulty Scoring System in Robotic Pancreatoduodenectomy

University of Pisa4 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
4
主要终点
correlation to post-operative complication

研究概览

简要总结

Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.

详细描述

Our Robot DIFFICULT Score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. Based on the univariate and multivariate analysis, the elevated BMI, ASA 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of "difficulty" in the robotic pancreatoduodenectomy. The Robot ADDICT Score will be calculated in all cases of the International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS; www.i-mips.com).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • pathology of the head of pancreas requiring surgery

排除标准

  • pathology of the head of pancreas not requiring surgery

结局指标

主要结局

correlation to post-operative complication

时间窗: 6 months

the score increase as complications increase

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Concetta Cacace

principal investigator

University of Pisa

研究点 (4)

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