AppendicitisusNCT02194140
Improvement of Appendix Identification and Appendicitis Diagnosis in us After Administration of Oral Contrast Medium
A study testing oral iodinated contrast material in people with Appendicitis, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- oral iodinated contrast material
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Jul 2016
- 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
- patients in emergency department with right lower quadrant pain
Who cannot join
- patients under 18 years old
- pregnant women
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera
Nadir Reindorp, MD, 972-50-6246984, nadirr@hy.health.gov.il
Nadir Reindorp, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Appendicitis
- Being tested
- oral iodinated contrast material
- Keywords
- ultrasound, iodinated contrast material, computed tomography
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral iodinated contrast materialOther
Also called telebrix 35
diluted in water
| Study group | Role | What they receive |
|---|---|---|
| oral contrast | Other | oral iodinated contrast material Receives: Other: oral iodinated contrast material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendix identification rate on ultrasound
Positive identification of the appendix by ultrasound croteria
Measured: At the time of ultrasound examination up to 1 hour
Secondary outcomes (1)
improved rate of correctly diagnosed appendicitis
Results acording to surgery or patholoy reports
Measured: At time of surgery or patholoy results if available within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2016 (estimated)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nadir Reindorp, MD, Principal investigator, Hillel Yaffe Medical Center Hadera Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194140
- Sponsor's protocol ID
- 028-14
- Acronym
- us
- Status last verified
- Jul 2014
- First submitted
- 28 Jun 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22402833
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Appendix Identification and Appendicitis Diagnosis in Ultrasound After Administration of Iodinated Oral Contrast Medium
- ClinicalTrials.gov ID
- NCT02194140
- Acronym / sponsor ID
- us / 028-14
- Conditions
- Appendicitis
- Keywords
- ultrasound, iodinated contrast material, computed tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 18 Jul 2014 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral contrast | Other | Other: oral iodinated contrast materialoral iodinated contrast material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients in emergency department with right lower quadrant pain
Key exclusion criteria (2 listed)
- patients under 18 years old
- pregnant women
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 |
|---|---|---|
| oral iodinated contrast materialAlso: telebrix 35diluted in water | Other | oral contrast |
Primary outcome
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
1 secondary outcome
improved rate of correctly diagnosed appendicitis
Time frame: At time of surgery or patholoy results if available within 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Background: PubMed 22402833Trout 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.
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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.
Nadir Reindorp, MD principal investigator
Hillel Yaffe Medical Center Hadera Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral iodinated contrast material in people with Appendicitis, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadir Reindorp, MD (972-50-6246984, nadirr@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendix identification rate on ultrasound (time frame: At the time of ultrasound examination up to 1 hour). 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 NCT02194140, 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 18 Jul 2014.