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

Appendicitis Clinical Trial

— us  

Official title:

Improvement of Appendix Identification and Appendicitis Diagnosis in Ultrasound After Administration of Iodinated Oral Contrast Medium

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02194140
• Other study ID #: 028-14
• Status: Not yet recruiting
• Phase: N/A
• First received: June 28, 2014
• Last updated: July 16, 2014
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2014
• Source: Hillel Yaffe Medical Center
• Contact: Nadir Reindorp, MD
• Phone: 972-50-6246984
• Email: nadirr[@]hy.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients in emergency department with right lower quadrant pain

Exclusion Criteria:

• patients under 18 years old

• pregnant women

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Appendicitis

Intervention

Other:
• oral iodinated contrast material
diluted in water

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	shortening waiting time for CT	Measuring time from referal to examination	At time of CT examination up to 1 hour	No
Primary	Appendix identification rate on ultrasound	Positive identification of the appendix by ultrasound croteria	At the time of ultrasound examination up to 1 hour	No
Secondary	improved rate of correctly diagnosed appendicitis	Results acording to surgery or patholoy reports	At time of surgery or patholoy results if available within 14 days	No