NCT02194140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

1 year

First QC Date

June 28, 2014

Last Update Submit

July 16, 2014

Conditions

Appendicitis

Keywords

ultrasoundiodinated contrast materialcomputed tomography

Outcome Measures

Primary Outcomes (1)

  • Appendix identification rate on ultrasound

    Positive identification of the appendix by ultrasound croteria

    At the time of ultrasound examination up to 1 hour

Secondary Outcomes (1)

  • improved rate of correctly diagnosed appendicitis

    At time of surgery or patholoy results if available within 14 days

Other Outcomes (1)

  • shortening waiting time for CT

    At time of CT examination up to 1 hour

Study Arms (1)

oral contrast

OTHER

oral iodinated contrast material

Other: oral iodinated contrast material

Interventions

oral iodinated contrast materialOTHER

diluted in water

Also known as: telebrix 35
oral contrast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients in emergency department with right lower quadrant pain

You may not qualify if:

  • patients under 18 years old
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, Israel

Location

Related 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.

    PMID: 22402833BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Nadir Reindorp, MD

    Hillel Yaffe Medical Center Hadera Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadir Reindorp, MD

CONTACT

972-50-6246984nadirr@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2014

First Posted

July 18, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

IL(1)