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Imaging Microcirculation and Gross Hemodynamics in Elective Colorectal Surgery (IMAGES)

2018年3月4日 更新者:dr. P. Noordzij、St. Antonius Hospital

Imaging Microcirculation And Gross Hemodynamic Assessment of the Bowel During Elective Colorectal Surgery

Rationale: The interaction between macro and microcirculation remains uncertain. Microvascular alterations can occur when systemic hemodynamic parameters are within an acceptable range. Perfusion changes and microvascular alterations may play an important role in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery. Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to anastomosis creation. However, local oxygen delivery may still be compromised as little is known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging modality incorporated in a hand-held device, which illuminates an area of interest and provides high contrast dynamic images of the microvasculature. DF-imaging enables to visualize the bowel's microcirculation.

Objective: To describe the human gastrointestinal microcirculation during gastrointestinal surgery under general anesthesia and to observe whether there is a correlation between bowel microcirculation and systemic hemodynamic parameters.

Study design: A prospective, single center, observational, clinical, pilot study.

Study population: 70 patients undergoing elective, gastrointestinal surgery during which the gastrointestinal tract is accessible for DF-imaging.

Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both the serosal and mucosal side of the bowel during gastrointestinal surgery under general anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular Flow Index (MFI).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extend of burden and risk associated with participation is negligible. Using DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is described in the study procedure. Previous studies did not show any safety concerns. Measuring will be performed under sterile conditions and the occurrence of tissue damage is highly unlikely. Patients are under general anesthesia and will thus not experience any inconvenience.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (预期的)

70

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nieuwegein、荷兰
        • St Antonius hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

70 patients undergoing elective, gastrointestinal surgery. Surgical procedures included will be:

  • All forms of open colorectal surgery;
  • Pylorus Persevering PancreaticoDuodenectomy (PPPD);
  • Other procedures requiring small bowel resection for cancer;
  • Laparoscopic procedures with extracorporeal creation of the bowel anastomosis. These procedures provide unique access to different parts of the bowel. The PPPD procedure provides access to the mucosal and serosal side of the jejunum. Colorectal surgery provides access to both the serosal and mucosal side of the colon and the terminal ileum is sometimes also accessible. We expect to include around 2 patients per week.

描述

Inclusion Criteria:

  • All patients aged >18 scheduled for elective, gastrointestinal surgery (as described above) with signed informed consent.

Exclusion Criteria:

  • • Age <18 years;

    • Atrial fibrillation (because of possible interference with FloTrac™/Vigileo™ cardiac output monitor);
    • Left ventricular ejection fraction ≤30%;
    • Serious pulmonary disease (resting pO2 <90% at room air);
    • Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula);
    • Liver failure;
    • No signed informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Microvascular flow index (MFI)
大体时间:Intra-operative
During surgery
Intra-operative

次要结果测量

结果测量
大体时间
Perfused vessel density (PVD)
大体时间:Intra-operative
Intra-operative
Proportion of perfused vessels (PPV)
大体时间:Intra-operative
Intra-operative
Total vessel density (TVD)
大体时间:Intra-operative
Intra-operative
Heterogeneity index (HI)
大体时间:During surgery
During surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mat Van Iterson, PhD、St. Antonius Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年5月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2016年2月18日

首先提交符合 QC 标准的

2016年2月22日

首次发布 (估计)

2016年2月23日

研究记录更新

最后更新发布 (实际的)

2018年3月6日

上次提交的符合 QC 标准的更新

2018年3月4日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • NL4833210014

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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