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临床试验/NCT04687826
NCT04687826已完成不适用

Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy - How to Reduce Postoperative Complications

Helsinki University Central Hospital0 个研究点目标入组 168 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
主要终点
Intraoperative fluid volume

研究概览

简要总结

Postoperative complication rates in patients undergoing pancreaticoduodenectomy remain high although the operation techniques have developed a lot in recent years. There is evidence that restrictive intraoperative fluid therapy could decrease postoperative complication rates but the results of the former studies have been somewhat controversial. The aim of this study is to examine whether the intraoperative and postoperative fluid therapy affect to the postoperative complication rates in patients undergoing pancreaticoduodenectomy.

详细描述

The study is a retrospective cohort study. The first cohort consists of patients who underwent pancreaticoduodenectomy in year 2015 when intraoperative fluid therapy were managed using goal directed fluid therapy technique. The second cohort consists of patients who underwent pancreaticoduodenectomy in year 2017 when intraoperative fluid therapy were based on the consideration of the anaesthesiologist. In 2015 most of the patients spent the first postoperative night in the ICU where the fluid management and monitoring of the urine output and vital functions were more controlled than in the normal ward. In 2017 most of the patients got in the regular ward right after the surgery. The aim of the study is to examine whether there are differences in the amounts of the intraoperative and postoperative fluids between the cohorts and does the perioperative fluid therapy affect to the complication rates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 or over
  • patients who underwent pancreaticoduodenectomy in 2015 or in 2017

排除标准

  • patients whose patient record information is insufficient

结局指标

主要结局

Intraoperative fluid volume

时间窗: The duration of the surgery

The amount of fluid (crystalloids and albumin) patients got during the surgery

Postoperative complications (Clavien-Dindo classification)

时间窗: Postoperative day 0-30

The rate of severe Clavien-Dindo complications (3-5)

次要结局

  • Cardiopulmonary complications(Postoperative day 0-30)
  • Postoperative fluid balance(Postoperative day 1-3)
  • Severe surgical complications(Postoperative day 0-30)
  • Pancreatic fistulas(Postoperative day 0-30)
  • Postoperative fluid volume(Postoperative day 0-3)
  • Intraoperative fluid balance(The duration of the surgery)

研究者

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

Piia Peltoniemi

M.D. Principal Investigator

Helsinki University Central Hospital

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