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

July 16, 2014 updated by: Hillel Yaffe Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Hadera, Israel
        • Hillel Yaffe Medical Center
        • Contact:
        • Principal Investigator:
          • Nadir Reindorp, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients in emergency department with right lower quadrant pain

Exclusion Criteria:

  • patients under 18 years old
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: oral contrast
oral iodinated contrast material
Other: oral iodinated contrast material
diluted in water
Other Names:
  • telebrix 35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appendix identification rate on ultrasound
Time Frame: At the time of ultrasound examination up to 1 hour
Positive identification of the appendix by ultrasound croteria
At the time of ultrasound examination up to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improved rate of correctly diagnosed appendicitis
Time Frame: At time of surgery or patholoy results if available within 14 days
Results acording to surgery or patholoy reports
At time of surgery or patholoy results if available within 14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
shortening waiting time for CT
Time Frame: At time of CT examination up to 1 hour
Measuring time from referal to examination
At time of CT examination up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Nadir Reindorp, MD, Hillel Yaffe Medical Center Hadera Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

June 28, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 028-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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