NCT00734825

Brief Summary

The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency department. A secondary purpose will be to design a specific CT for appendicitis protocol at our institution at the conclusion of this study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

August 12, 2008

Last Update Submit

June 27, 2012

Conditions

Keywords

AppendicitisIV ContrastOral ContrastCT scan

Outcome Measures

Primary Outcomes (1)

  • sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient.

    immediate reading + blinded reading within 48 hours

Secondary Outcomes (1)

  • If IV contrast alone for CT scan is sensitive for the diagnosis of appendicitis in the adult Emergency department patient

    immediate reading and blinded reading within 48 hours

Study Arms (2)

1

ACTIVE COMPARATOR

IV contrast

Other: Omnipaque

2

ACTIVE COMPARATOR

IV contrast and oral contrast

Other: Omnipaque

Interventions

oral contrast for CT scan

12

Eligibility Criteria

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

You may qualify if:

  • years and older who present to the York Hospital Emergency Department with signs and symptoms suggestive of acute appendicitis, but in whom the diagnosis remains unclear as determined by an attending emergency physician or consulting surgeon and in which a CT scan is needed to further assist in the diagnosis

You may not qualify if:

  • pregnant patients
  • patients with known IV dye or oral contrast allergy
  • patients in whom acute appendicitis is not the primary diagnosis
  • patients with renal insufficiency that may have significant adverse effect from IV dye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kepner AM, Bacasnot JV, Stahlman BA. Intravenous contrast alone vs intravenous and oral contrast computed tomography for the diagnosis of appendicitis in adult ED patients. Am J Emerg Med. 2012 Nov;30(9):1765-73. doi: 10.1016/j.ajem.2012.02.011. Epub 2012 May 23.

MeSH Terms

Conditions

Appendicitis

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Andrew Kepner, MD

    WellSpan Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 14, 2008

Study Start

November 1, 2006

Primary Completion

November 1, 2008

Study Completion

September 1, 2010

Last Updated

June 28, 2012

Record last verified: 2012-06