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Improvement of Appendix Identification and Appendicitis Diagnosis in us After Administration of Oral Contrast Medium (us)

Primary Purpose

Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
oral iodinated contrast material
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis focused on measuring ultrasound, iodinated contrast material, computed tomography

Eligibility Criteria

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

Inclusion Criteria:

  • patients in emergency department with right lower quadrant pain

Exclusion Criteria:

  • patients under 18 years old
  • pregnant women

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

oral contrast

Arm Description

oral iodinated contrast material

Outcomes

Primary Outcome Measures

Appendix identification rate on ultrasound
Positive identification of the appendix by ultrasound croteria

Secondary Outcome Measures

improved rate of correctly diagnosed appendicitis
Results acording to surgery or patholoy reports

Full Information

First Posted
June 28, 2014
Last Updated
July 16, 2014
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02194140
Brief Title
Improvement of Appendix Identification and Appendicitis Diagnosis in us After Administration of Oral Contrast Medium
Acronym
us
Official Title
Improvement of Appendix Identification and Appendicitis Diagnosis in Ultrasound After Administration of Iodinated Oral Contrast Medium
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Rate of appendix localization on ultrasound is not high. We suggest a way to improve it's localization by oral administration of iodinated contrast material.
Detailed Description
The administration of oral iodinated contrast material might facilitate identification of the appendix and accurate diagnosis of appendicitis. When indicated will shorten time to CT examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
ultrasound, iodinated contrast material, computed tomography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
oral contrast
Arm Type
Other
Arm Description
oral iodinated contrast material
Intervention Type
Other
Intervention Name(s)
oral iodinated contrast material
Other Intervention Name(s)
telebrix 35
Intervention Description
diluted in water
Primary Outcome Measure Information:
Title
Appendix identification rate on ultrasound
Description
Positive identification of the appendix by ultrasound croteria
Time Frame
At the time of ultrasound examination up to 1 hour
Secondary Outcome Measure Information:
Title
improved rate of correctly diagnosed appendicitis
Description
Results acording to surgery or patholoy reports
Time Frame
At time of surgery or patholoy results if available within 14 days
Other Pre-specified Outcome Measures:
Title
shortening waiting time for CT
Description
Measuring time from referal to examination
Time Frame
At time of CT examination up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients in emergency department with right lower quadrant pain Exclusion Criteria: patients under 18 years old pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadir Reindorp, MD
Phone
972-50-6246984
Email
nadirr@hy.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadir Reindorp, MD
Organizational Affiliation
Hillel Yaffe Medical Center Hadera Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadir Reindorp, MD
Phone
972-50-6246984
Email
nadirr@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Nadir Reindorp, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22402833
Citation
Trout AT, Sanchez R, Ladino-Torres MF, Pai DR, Strouse PJ. A critical evaluation of US for the diagnosis of pediatric acute appendicitis in a real-life setting: how can we improve the diagnostic value of sonography? Pediatr Radiol. 2012 Jul;42(7):813-23. doi: 10.1007/s00247-012-2358-6. Epub 2012 Mar 9.
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Improvement of Appendix Identification and Appendicitis Diagnosis in us After Administration of Oral Contrast Medium

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