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Optimizing the Diagnosis of Acute Appendicitis (OPTIMA)

2019年10月3日 更新者：Tomas Poskus、Vilnius University

Optimizing the Diagnosis of Acute Appendicitis - Open, Randomized, Parallel Groups, Prospective Clinical Trial

Aim of the study: to identify the signs of acute appendicitis delta signs - clinical, laboratory or ultrasound signs, whose change (delta) would allow to identify or deny the diagnosis of acute appendicitis without a computed tomography examination and thus to lower computed tomography rates.

研究概览

地位

未知

条件

干预/治疗

详细说明

This study consists of two parts:

  • In the first part investigators enroll all patients (except pregnant) that are refered to Vilnius University Hospital Santaros clinics with suspected acute appendicitis in order to get cohort data. All patient get primary clinical evaluation, laboratory tests (WBC, CRP) an ultrasound examination.
  • After primary evaluation if final diagnosis could not be made, and investigator still suspect acute appendicitis, participant is included in to randomised study part.
  • Randomised sudy part has two arms: control and observation groups.
  • Control group get the traditional diagnostic path - is refered to CT scan examination.
  • Observation group get repeated evaluation after 8-12 hours and only than is diagnosis stays unclear, patient gets a CT scan.
  • All patient are contacted after 30 days after visit to our hospital, to get information about their health status and possible additional visits to other hospitals or operations.

研究类型

介入性

注册 (预期的)

200

阶段

  • 不适用

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

  • 立陶宛
      • Vilnius、立陶宛
        • 招聘中
        • Faculty of medicine, Institue of clinical medicine, Clinic of gastroenterology, nephrourology and surgery
        • 接触：

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

描述

Inclusion Criteria:

  • Patient with the symptoms of acute appendicitis: pain in the right lower quadrant, pain migration from epigastrium to right lower quadrant, nausea, rebound pain, elevated temperature.

Exclusion Criteria for randomized part:

  • Pregnant patient.

Inclusion Criteria for randomized part:

  • After primary clinical, laboratory and ultrasound examination diagnosis of acute appendicitis could not be confirmed or excluded.
  • No other gynecological, urological ir gastroenterological pathology is confirmed.

Exclusion Criteria for randomized part:

  • Clinical symptoms lasts for longer than 48 hours
  • Signs of peritonitis

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

  • 主要用途：诊断
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：Control
Patient gets usual diagnostic path: after inconclusive ultrasound is refered to CT scan.
有源比较器：Observation
Patient after inconclusive primary evaluation is observed in emergency room for 8-12 hours and after the clinical evaluation, laboratory results and ultrasound examination is repeated.
程序：Observation
Patient after primary investigation is observed for 8-12 hours, (instead of being send directly to CT scan), after observation repeated clinical evaluation, laboratory tests and ultrasound examination are done , if final diagnosis stays unclear the patient is refered to CT scan.

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
Reduction of the CT scans number
大体时间：24 hours
when performing alternative diagnostic protocol, that includes patient observation for short period we expect to reduce a number of CT scans performed, for the patients with suspected acute appendicitis.
24 hours
Negative appendectomy rate
大体时间：30 days
We expect the negative appendectomy rate will will not increase while using alternative diagnostic protocol that includes patient observation.
30 days

次要结果测量

结果测量
措施说明
大体时间
Delta marker White blood cell count
大体时间：12 hours
The changes in white blood cell count over the time that might show higher or lower probability of possible acute appendicitis.
12 hours
Delta marker CRP count
大体时间：12 hours
The changes CRP level over the time that might show higher or lower probability of possible acute appendicitis.
12 hours
Delta marker Alvarado acute appendicitis risk evaluation score
大体时间：12 hours
Delta marker Alvarado acute appendicitis risk evaluation score Tha changes in score over the time that might show higher or lower probability of possible acute appendicitis. Scale ranges decribe a prediction of having acute appendicitis: 1-4 33 % of having appendicitis, 5-6 66 % of hanving, 7-10 93 % of having appendicitis.
12 hours
Delta marker changes in ultrasound results
大体时间：12 hours
The changes in ultrasound findings over the time may progress and influence investigator to change opinion about the concusion. Repeated ultrasound diagnosis might change from unequivocal to acute apendicitis (and CT scan can be avoided then). We do use structured conclusions of the ultrasound exam, that might be: accute appendicitis; apendix visualised but changes are equivocal; apendix visualised uninflamed; apendix not visualised, but there are secondary findings; apendix not visualised and there is no secondary findings. We are going to measure the change in final ultrasound diagnosis over the time.
12 hours
'Appendicitis Inflammatory Response (AIR) Score'
大体时间：12 hours
'Appendicitis Inflammatory Response (AIR) Score') evaluates the risk for acute appendicitis. scale ranges are: 0-4 low probability outpatient follow up, 5-8 inermediate probability in hospital observation, 9-12 high probability, surgical treatment..
12 hours

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。

赞助

Vilnius University

调查人员

  • 首席研究员：Tomas Poskus, Professor、Vilnius University, Faculty of medicine, Institute of clinical medicine

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 (实际的)

2018年12月1日

初级完成 (预期的)

2021年1月1日

研究完成 (预期的)

2021年5月1日

研究注册日期

首次提交

2019年6月29日

首先提交符合 QC 标准的

2019年10月3日

首次发布 (实际的)

2019年10月7日

研究记录更新

最后更新发布 (实际的)

2019年10月7日

上次提交的符合 QC 标准的更新

2019年10月3日

最后验证

2019年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • UADO-1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

There are no future intensions make IPD available.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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