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临床试验/NCT04846283
NCT04846283已完成不适用

Drainage Fluid Biomarkers And Anastomotic Leakage In Colorectal Surgery. A Monocentric Prospective Observational Study

University of Palermo1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2018年6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
207
试验地点
1
主要终点
Measurement of drainage fluid CRP and LDH on postoperative day 3

研究概览

简要总结

Anastomotic leakage (AL) is one of the most feared intra-abdominal septic complications (IASC) after colorectal surgery. It is defined as the leak of intestinal content due to an anastomotic dehiscence. Incidence ranges from 2% to 20%. AL is usually associated to systemic inflammatory response, even if in some cases the presentation may be subclinical. Therefore, AL is suspected in patients with a strong inflammatory response and can be confirmed by imaging with contrast enhanced computed tomography (CT) scan or water-soluble contrast studies. Nevertheless, imaging has varying sensitivity and specificity and is usually performed once the patient has a clinical evidence, thus potentially delaying the correct timing for surgery. Despite several studies about this topic and the plenty of known risk factors as mentioned above, AL is still not easy to predict. Different tools other than imaging have been studied in order to make diagnosis of AL at an early stage, as the measurement of some biomarkers of inflammation in serum and in drainage fluid.

Biomarkers as white cell blood count (WBC), C-reactive protein (CRP), cytokines (e.g. TNFa, IL-6, IL-1b), markers of ischemia (e.g. lactate) and procalcitonin (PCT) have been used for an early detection of AL and other intra-abdominal septic complications. The primary aim of our study was to assess the role of drainage fluid CRP and lactate-dehydrogenase (LDH) in the early detection of anastomotic leakage.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged >16 y undergoing elective or emergency colorectal surgery for cancer
  • patients aged >16 y undergoing elective or emergency colorectal surgery for diverticular disease
  • patients aged >16 y undergoing elective or emergency colorectal surgery for inflammatory bowel-disease
  • patients aged >16 y undergoing elective or emergency colorectal surgery for reversal of Hartmann's procedure.

排除标准

  • patients aged < 16 y undergoing colorectal surgery;
  • patients undergoing Hartman's procedure

结局指标

主要结局

Measurement of drainage fluid CRP and LDH on postoperative day 3

时间窗: Postoperative day 3

Our primary endpoint was to assess the role of drainage fluid CRP and LDH on postoperative day 3.

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

Prof. Antonino Agrusa

Associate professor

University of Palermo

研究点 (1)

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