AppendicitisNCT02497183
Impact of Oral Contrast in the Large Intestine on the Recognition of Appendix
A study testing ultrasound and iodine based solution of oral contrast material in people with Appendicitis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Acute appendicitis is the most common cause of abdominal pain requiring surgical intervention. The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its effectiveness, the test involves exposure to a high dose of radiation. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- ultrasound and iodine based solution of oral contrast material
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Jul 2017
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 14 years to 120 years
- patients that underwent an ultrasound exam that proved to be equivocal or not diagnostic
- patients who were sent to perform a CT scan that includes drinking oral contrast material.
Who cannot join
- pregnant patients
- patients with known allergy to oral contrast material (TELEBRIX gastro)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Presence of Oral Contrast Material in the Large Intestine on the Recognition of Appendix During an Ultrasound Exam
Acute appendicitis is the most common cause of abdominal pain requiring surgical intervention.
The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its effectiveness, the test involves exposure to a high dose of radiation.
Read more
Using ultrasound to diagnose this condition has been described extensively in the medical literature, and this test has a very high specificity (over 95%), however sensitivity of the test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test include operator dependency as well as factors such as body habitus of the patient, presence of technical disturbances (artifacts) caused by gas in the large intestine and inadequate cooperation from the patient during the exam. All of these factors may affect the ability to detect sonographic signs of appendicitis.
The investigators believe that it is possible to reduce the amount of artifacts caused by the presence of gas in the intestine by filling of the colon with liquid suspension that is routinely given in the investigators' hospital before performing an abdominal CT and performing an additional ultrasound scan to those patients in which the initial ultrasound examination (without any preparation) proved to be equivocal or not diagnostic.
The target population for the study is any patient who arrives to the emergency room with complaints of right lower quadrant abdominal pain and it is decided by the referring physician in the ER to start diagnostic workup for suspected appendicitis by performing an ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided that the patient needs to continue investigation by performing a CT scan, the patient will receive contrast material orally for approximately 180 minutes and prior to the CT the investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat ultrasound will allow a statistically significant improvement in the detection rate of the appendix.
Read the detailed description
Acute appendicitis is the most common cause of abdominal pain requiring surgical intervention.
The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its effectiveness, the test involves exposure to a high dose of radiation.
Using ultrasound to diagnose this condition has been described extensively in the medical literature, and this test has a very high specificity (over 95%), however sensitivity of the test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test include operator dependency as well as factors such as body habitus of the patient, presence of technical disturbances (artifacts) caused by gas in the large intestine and inadequate cooperation from the patient during the exam. All of these factors may affect the ability to detect sonographic signs of appendicitis.
The investigators believe that it is possible to reduce the amount of artifacts caused by the presence of gas in the intestine by filling of the colon with liquid suspension that is routinely given in the investigators' hospital before performing an abdominal CT and performing an additional ultrasound scan to those patients in which the initial ultrasound examination (without any preparation) proved to be equivocal or not diagnostic.
The target population for the study is any patient who arrives to the emergency room with complaints of right lower quadrant abdominal pain and it is decided by the referring physician in the ER to start diagnostic workup for suspected appendicitis by performing an ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided that the patient needs to continue investigation by performing a CT scan, the patient will receive contrast material orally for approximately 180 minutes and prior to the CT the investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat ultrasound will allow a statistically significant improvement in the detection rate of the appendix.
expected number of recruited patients: 200
- Conditions
- Appendicitis
- Being tested
- ultrasound, iodine based solution of oral contrast material
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
A repeat ultrasound exam following oral contrast material consumption
iodine based solution of oral contrast materialOther
Also called Telebrix Gastro
A solution of oral contrast material that is routinely used in our institution prior to performing a computed tomographic (CT) examinations of the gastrointestinal tract will be given prior to performing the repeat ultrasound/
| Study group | Role | What they receive |
|---|---|---|
| first | Experimental | a repeat abdominal ultrasound exam to patients following the filling of bowel with contrast material per os. Receives: Device: ultrasound; Other: iodine based solution of oral contrast material |
What is being measured
The primary outcome is the main question the study is designed to answer.
statistically significant improvement in the detection rate of the appendix
ultrasound exam with filling of the colon with liquid suspension will allow a statistically significant improvement in the detection rate of the appendix compared to an exam without any preparation.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2017
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonid Roshkovan, M.D, Study chair, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497183
- Sponsor's protocol ID
- 0053-15-EMC
- Status last verified
- Feb 2020
- First submitted
- 25 Jun 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Presence of Oral Contrast Material in the Large Intestine on the Recognition of Appendix During an Ultrasound Exam
- ClinicalTrials.gov ID
- NCT02497183
- Acronym / sponsor ID
- 0053-15-EMC
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 1 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Jul 2015 (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.
Acute appendicitis is the most common cause of abdominal pain requiring surgical intervention.
The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its effectiveness, the test involves exposure to a high dose of radiation.
Using ultrasound to diagnose this condition has been described extensively in the medical literature, and this test has a very high specificity (over 95%), however sensitivity of the test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test include operator dependency as well as factors such as body habitus of the patient, presence of technical disturbances (artifacts) caused by gas in the large intestine and inadequate cooperation from the patient during the exam. All of these factors may affect the ability to detect sonographic signs of appendicitis.
The investigators believe that it is possible to reduce the amount of artifacts caused by the presence of gas in the intestine by filling of the colon with liquid suspension that is routinely given in the investigators' hospital before performing an abdominal CT and performing an additional ultrasound scan to those patients in which the initial ultrasound examination (without any preparation) proved to be equivocal or not diagnostic.
The target population for the study is any patient who arrives to the emergency room with complaints of right lower quadrant abdominal pain and it is decided by the referring physician in the ER to start diagnostic workup for suspected appendicitis by performing an ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided that the patient needs to continue investigation by performing a CT scan, the patient will receive contrast material orally for approximately 180 minutes and prior to the CT the investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat ultrasound will allow a statistically significant improvement in the detection rate of the appendix.
Detailed description
Acute appendicitis is the most common cause of abdominal pain requiring surgical intervention.
The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its effectiveness, the test involves exposure to a high dose of radiation.
Using ultrasound to diagnose this condition has been described extensively in the medical literature, and this test has a very high specificity (over 95%), however sensitivity of the test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test include operator dependency as well as factors such as body habitus of the patient, presence of technical disturbances (artifacts) caused by gas in the large intestine and inadequate cooperation from the patient during the exam. All of these factors may affect the ability to detect sonographic signs of appendicitis.
The investigators believe that it is possible to reduce the amount of artifacts caused by the presence of gas in the intestine by filling of the colon with liquid suspension that is routinely given in the investigators' hospital before performing an abdominal CT and performing an additional ultrasound scan to those patients in which the initial ultrasound examination (without any preparation) proved to be equivocal or not diagnostic.
The target population for the study is any patient who arrives to the emergency room with complaints of right lower quadrant abdominal pain and it is decided by the referring physician in the ER to start diagnostic workup for suspected appendicitis by performing an ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided that the patient needs to continue investigation by performing a CT scan, the patient will receive contrast material orally for approximately 180 minutes and prior to the CT the investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat ultrasound will allow a statistically significant improvement in the detection rate of the appendix.
expected number of recruited patients: 200
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| first | Experimental | Device: ultrasound, Other: iodine based solution of oral contrast materiala repeat abdominal ultrasound exam to patients following the filling of bowel with contrast material per os. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age 14 years to 120 years
- patients that underwent an ultrasound exam that proved to be equivocal or not diagnostic
- patients who were sent to perform a CT scan that includes drinking oral contrast material.
Key exclusion criteria (2 listed)
- pregnant patients
- patients with known allergy to oral contrast material (TELEBRIX gastro)
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 |
|---|---|---|
| ultrasoundA repeat ultrasound exam following oral contrast material consumption | Device | first |
| iodine based solution of oral contrast materialAlso: Telebrix GastroA solution of oral contrast material that is routinely used in our institution prior to performing a computed tomographic (CT) examinations of the gastrointestinal tract will be given prior to performing the repeat ultrasound/ | Other | first |
Primary outcome
statistically significant improvement in the detection rate of the appendix
Time frame: one year
ultrasound exam with filling of the colon with liquid suspension will allow a statistically significant improvement in the detection rate of the appendix compared to an exam without any preparation.
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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.
Leonid Roshkovan, M.D study chair
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and iodine based solution of oral contrast material in people with Appendicitis, run by HaEmek Medical Center, Israel 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 3 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: stopped early, as of the sponsor's last update on 13 Feb 2020. 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?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
statistically significant improvement in the detection rate of the appendix (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2020.