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Impact of Oral Contrast in the Large Intestine on the Recognition of Appendix

Primary Purpose

Appendicitis

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ultrasound
iodine based solution of oral contrast material
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • HaEmek medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

first

Arm Description

a repeat abdominal ultrasound exam to patients following the filling of bowel with contrast material per os.

Outcomes

Primary Outcome Measures

statistically significant improvement in the detection rate of the appendix
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.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2015
Last Updated
February 12, 2020
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT02497183
Brief Title
Impact of Oral Contrast in the Large Intestine on the Recognition of Appendix
Official Title
Impact of Presence of Oral Contrast Material in the Large Intestine on the Recognition of Appendix During an Ultrasound Exam
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
July 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. expected number of recruited patients: 200

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
first
Arm Type
Experimental
Arm Description
a repeat abdominal ultrasound exam to patients following the filling of bowel with contrast material per os.
Intervention Type
Device
Intervention Name(s)
ultrasound
Intervention Description
A repeat ultrasound exam following oral contrast material consumption
Intervention Type
Other
Intervention Name(s)
iodine based solution of oral contrast material
Other Intervention Name(s)
Telebrix Gastro
Intervention Description
A solution of oral contrast material that is routinely used in our institution prior to performing a computed tomographic (CT) examinations of the gastrointestinal tract will be given prior to performing the repeat ultrasound/
Primary Outcome Measure Information:
Title
statistically significant improvement in the detection rate of the appendix
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: pregnant patients patients with known allergy to oral contrast material (TELEBRIX gastro)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid Roshkovan, M.D
Organizational Affiliation
haemek medical center
Official's Role
Study Chair
Facility Information:
Facility Name
HaEmek medical center
City
Afula
Country
Israel

12. IPD Sharing Statement

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Impact of Oral Contrast in the Large Intestine on the Recognition of Appendix

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