An Observational Retrospective Study in Postoperative Pancreatic Fistula
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pancreatic fistula
研究概览
简要总结
The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and classification system of postoperative pancreatic fistula (POPF), and received widespread recognition. Currently, it has become an important reference for clinical treatment of POPF.
详细描述
The definition of POPF released by ISGPS in 2016 still seems to have certain deficiency. For example, in both definitions in 2005 and 2016, the re-operation is used as an important judgment index of "Grade C POPF". But a unified standard or consensus is still lacked for the indication of POPF re-operation, which may finally impact the diagnosis of "Grade C POPF". Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.
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
- •Must have a diagnosis of POPF;
- •Aged 18 or older;
- •Of either sex.
排除标准
- •No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial.
结局指标
主要结局
Pancreatic fistula
时间窗: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria
次要结局
- Hospital stays(From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days)
- Mortality(From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days)
- Number of hospitalizations(From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days)