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临床试验/NCT02497183
NCT02497183终止不适用

Impact of Presence of Oral Contrast Material in the Large Intestine on the Recognition of Appendix During an Ultrasound Exam

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
statistically significant improvement in the detection rate of the appendix

研究概览

简要总结

Acute appendicitis is the most common cause of abdominal pain requiring surgical intervention.

The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its effectiveness, the test involves exposure to a high dose of radiation.

Using ultrasound to diagnose this condition has been described extensively in the medical literature, and this test has a very high specificity (over 95%), however sensitivity of the test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test include operator dependency as well as factors such as body habitus of the patient, presence of technical disturbances (artifacts) caused by gas in the large intestine and inadequate cooperation from the patient during the exam. All of these factors may affect the ability to detect sonographic signs of appendicitis.

The investigators believe that it is possible to reduce the amount of artifacts caused by the presence of gas in the intestine by filling of the colon with liquid suspension that is routinely given in the investigators' hospital before performing an abdominal CT and performing an additional ultrasound scan to those patients in which the initial ultrasound examination (without any preparation) proved to be equivocal or not diagnostic.

The target population for the study is any patient who arrives to the emergency room with complaints of right lower quadrant abdominal pain and it is decided by the referring physician in the ER to start diagnostic workup for suspected appendicitis by performing an ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided that the patient needs to continue investigation by performing a CT scan, the patient will receive contrast material orally for approximately 180 minutes and prior to the CT the investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat ultrasound will allow a statistically significant improvement in the detection rate of the appendix.

详细描述

Acute appendicitis is the most common cause of abdominal pain requiring surgical intervention.

The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its effectiveness, the test involves exposure to a high dose of radiation.

Using ultrasound to diagnose this condition has been described extensively in the medical literature, and this test has a very high specificity (over 95%), however sensitivity of the test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test include operator dependency as well as factors such as body habitus of the patient, presence of technical disturbances (artifacts) caused by gas in the large intestine and inadequate cooperation from the patient during the exam. All of these factors may affect the ability to detect sonographic signs of appendicitis.

The investigators believe that it is possible to reduce the amount of artifacts caused by the presence of gas in the intestine by filling of the colon with liquid suspension that is routinely given in the investigators' hospital before performing an abdominal CT and performing an additional ultrasound scan to those patients in which the initial ultrasound examination (without any preparation) proved to be equivocal or not diagnostic.

The target population for the study is any patient who arrives to the emergency room with complaints of right lower quadrant abdominal pain and it is decided by the referring physician in the ER to start diagnostic workup for suspected appendicitis by performing an ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided that the patient needs to continue investigation by performing a CT scan, the patient will receive contrast material orally for approximately 180 minutes and prior to the CT the investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat ultrasound will allow a statistically significant improvement in the detection rate of the appendix.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • age 14 years to 120 years
  • patients that underwent an ultrasound exam that proved to be equivocal or not diagnostic
  • patients who were sent to perform a CT scan that includes drinking oral contrast material.

排除标准

  • pregnant patients
  • patients with known allergy to oral contrast material (TELEBRIX gastro)

结局指标

主要结局

statistically significant improvement in the detection rate of the appendix

时间窗: one year

ultrasound exam with filling of the colon with liquid suspension will allow a statistically significant improvement in the detection rate of the appendix compared to an exam without any preparation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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