Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Postoperative short-term outcomes
研究概览
简要总结
Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes
详细描述
Since 1994, when the first pancreatectomy surgeries, distal and proximal, conducted minimally invasively, were published, efforts have been made to understand the value of this approach in the context of a surgery as complex and burdened with specific complications as pancreatic surgery. The adoption of such an approach with regard to pancreatic surgery has been less rapid and parceled out than in other surgical fields and not supported by a large body of scientific publications. However, worldwide, referral centers for pancreatic surgery routinely use the minimally invasive approach in selected cases, and its diffusion has recently shown a marked increase. Even in Italy, a recent survey promoted by some of the major surgical societies showed a fair diffusion of the use of the minimally invasive approach in pancreatic surgery but with extremely variable ways and uses in the different territorial realities with evident and potentially risky paradoxes. Monitoring the diffusion of minimally invasive pancreatic surgery, the methods of application and the results of this approach has become of primary importance and for this reason the foundation of a national registry has been proposed by several scientific surgical societies.
This study aims to investigate what is the real diffusion of minimally invasive techniques in Italy and what postoperative outcomes the adoption of this approach generates.
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 > 18 years;
- •Underwent minimally invasive pancreatic surgery
排除标准
- •Pregnant woman
- •Minor or unable to give informed consent
结局指标
主要结局
Postoperative short-term outcomes
时间窗: 90 days
any complication graded according to Clavien-Dindo classification
Long-term oncological outcomes
时间窗: 2 years
Disease recurrence or disease related death
次要结局
- Rate of cases that after a minimally invasive approach had to be converted to and open approach(Intraoperative)
- Surgeon learning curve(Intraoperative)
