AppendicitisNCT00734825
Emergency Department CT Scanning for Appendicitis
A study testing Omnipaque in people with Appendicitis, run by WellSpan Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- Omnipaque
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
About this study
Official title: Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast
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.
- Conditions
- Appendicitis
- Being tested
- Omnipaque
- Keywords
- Appendicitis, IV Contrast, Oral Contrast, CT scan
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnipaqueOther
oral contrast for CT scan
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | IV contrast Receives: Other: Omnipaque |
| 2 | Active comparator | IV contrast and oral contrast Receives: Other: Omnipaque |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient.
Measured: 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
Measured: immediate reading and blinded reading within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Investigators
- Andrew Kepner, MD, Principal investigator, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734825
- Sponsor's protocol ID
- 0607012
- Status last verified
- Jun 2012
- First submitted
- 12 Aug 2008
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22633722
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast
- ClinicalTrials.gov ID
- NCT00734825
- Acronym / sponsor ID
- 0607012
- Conditions
- Appendicitis
- Keywords
- Appendicitis, IV Contrast, Oral Contrast, CT scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: OmnipaqueIV contrast |
| 2 | Active comparator | Other: OmnipaqueIV contrast and oral contrast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnipaqueoral contrast for CT scan | Other | 1, 2 |
Primary outcome
sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient.
Time frame: immediate reading + blinded reading within 48 hours
1 secondary outcome
If IV contrast alone for CT scan is sensitive for the diagnosis of appendicitis in the adult Emergency department patient
Time frame: immediate reading and blinded reading within 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Derived from this study: PubMed 22633722Kepner 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.
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Kepner, MD principal investigator
WellSpan Health
Questions about this trial
What is this clinical trial studying?
A study testing Omnipaque in people with Appendicitis, run by WellSpan Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient. (time frame: immediate reading + blinded reading within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00734825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.