跳至主要内容
临床试验/NCT06381362
NCT06381362招募中不适用

Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)

Associazione Italiana per lo Studio del Pancreas1 个研究点 分布在 1 个国家目标入组 2,300 人开始时间: 2019年2月28日最近更新:
适应症

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

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)

研究者

发起方
Associazione Italiana per lo Studio del Pancreas
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验