Acute AbdomenNCT02467959
Diagnostic Accuracy of Emergency Physician Performed Bedside Ultrasound in Suspected Acute Appendicitis
An observational study of Acute Abdomen and Acute Appendicitis, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the diagnostic yield and accuracy of bedside emergency physician performed ultrasound in the diagnosis of acute appendicitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdomen, Acute Appendicitis
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- 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
Study population: All patients over 18 years of age presented to emergency department with the complaint of right lower abdominal pain
Who may be able to join
- Patient presented with the complaint of right lower abdominal pain
- Suspected acute appendicitis
Who cannot join
- Flank pain
- Previous appendectomy
- Pregnancy
- Unstable vital signs
- Frank peritonitis
- US performed before EP's examination
Trial locations and contacts
1 site in 1 country.
faruk güngör, md contact
faruk güngör, md contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Antalya Training and Research Hospital, Department of Emergency
Antalya, 07100
faruk güngör, MD, +902422494400 ext. 3273, drfarukgungor@gmail.com
faruk güngör, MD
About this study
Official title: Diagnostic Accuracy and Clinic Utility of Bedside Ultrasonography Performed by Emergency Physicians in Suspected Acute Appendicitis
The aim of the study is to evaluate the diagnostic yield and accuracy of bedside emergency physician performed ultrasound in the diagnosis of acute appendicitis.
Read the detailed description
Emergency physician (EP) performed bedside ultrasound is cost effective, repeatable and especially useful in the diagnosis of life treating conditions such as aortic dissection, traumatic bleedings. While abdominal pain is a common complaint in the emergency department and accurate diagnosis of its etiology may affect the patient's outcome, the accuracy and the diagnostic yield of bedside EP performed ultrasound is not well established. The diagnosis of a patient presented to emergency department with right lower abdominal pain is generally problematic and physician has to exclude acute surgical reasons such as acute appendicitis.
In this study, patients who are suspicious to have acute appendicitis base on their clinical findings will be included. EP will record his diagnosis and then patient will undergo emergency physician performed ultrasound. After ultrasound EP will fill the study form according to US findings and record his diagnosis once again.
At the end of the study the investigators evaluate and compare the radiology performed US reports and if there is operational biopsy results with the EP's pre- and post ultrasound diagnosis to estimate the diagnostic yield and accuracy of bedside emergency physician performed ultrasound in the diagnosis of acute appendicitis.
- Conditions
- Acute Abdomen, Acute Appendicitis
- Keywords
- emergency ultrasound, acute appendicitis, bedside ultrasound
- Medical subject headings
- Abdomen, Acute, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Ultrasound evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of emergency physician performed bedside ultrasound in diagnosing of acute appendicitis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute AbdomenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, faruk güngör, Antalya Training and Research Hospital
- Investigators
- faruk güngör, md, Study chair, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467959
- Sponsor's protocol ID
- AntalyaTRH04
- Status last verified
- Jun 2015
- First submitted
- 4 Jun 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hussain S, Rahman A, Abbasi T, Aziz T. Diagnostic accuracy of ultrasonography in acute appendicitis. J Ayub Med Coll Abbottabad. 2014 Jan-Mar;26(1):12-7.
PubMed 25358207Lam SH, Grippo A, Kerwin C, Konicki PJ, Goodwine D, Lambert MJ. Bedside ultrasonography as an adjunct to routine evaluation of acute appendicitis in the emergency department. West J Emerg Med. 2014 Nov;15(7):808-15. doi: 10.5811/westjem.2014.9.21491. Epub 2014 Sep 18.
PubMed 25493122
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy and Clinic Utility of Bedside Ultrasonography Performed by Emergency Physicians in Suspected Acute Appendicitis
- ClinicalTrials.gov ID
- NCT02467959
- Acronym / sponsor ID
- AntalyaTRH04
- Conditions
- Acute Abdomen, Acute Appendicitis
- Keywords
- emergency ultrasound, acute appendicitis, bedside ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Jun 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.
The aim of the study is to evaluate the diagnostic yield and accuracy of bedside emergency physician performed ultrasound in the diagnosis of acute appendicitis.
Detailed description
Emergency physician (EP) performed bedside ultrasound is cost effective, repeatable and especially useful in the diagnosis of life treating conditions such as aortic dissection, traumatic bleedings. While abdominal pain is a common complaint in the emergency department and accurate diagnosis of its etiology may affect the patient's outcome, the accuracy and the diagnostic yield of bedside EP performed ultrasound is not well established. The diagnosis of a patient presented to emergency department with right lower abdominal pain is generally problematic and physician has to exclude acute surgical reasons such as acute appendicitis.
In this study, patients who are suspicious to have acute appendicitis base on their clinical findings will be included. EP will record his diagnosis and then patient will undergo emergency physician performed ultrasound. After ultrasound EP will fill the study form according to US findings and record his diagnosis once again.
At the end of the study the investigators evaluate and compare the radiology performed US reports and if there is operational biopsy results with the EP's pre- and post ultrasound diagnosis to estimate the diagnostic yield and accuracy of bedside emergency physician performed ultrasound in the diagnosis of acute appendicitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | –Ultrasound evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 18 years of age presented to emergency department with the complaint of right lower abdominal pain
Key inclusion criteria (2 listed)
- Patient presented with the complaint of right lower abdominal pain
- Suspected acute appendicitis
Key exclusion criteria (6 listed)
- Flank pain
- Previous appendectomy
- Pregnancy
- Unstable vital signs
- Frank peritonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of emergency physician performed bedside ultrasound in diagnosing of acute appendicitis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- Background: PubMed 25358207Hussain S, Rahman A, Abbasi T, Aziz T. Diagnostic accuracy of ultrasonography in acute appendicitis. J Ayub Med Coll Abbottabad. 2014 Jan-Mar;26(1):12-7.
- Results publication: PubMed 25493122Lam SH, Grippo A, Kerwin C, Konicki PJ, Goodwine D, Lambert MJ. Bedside ultrasonography as an adjunct to routine evaluation of acute appendicitis in the emergency department. West J Emerg Med. 2014 Nov;15(7):808-15. doi: 10.5811/westjem.2014.9.21491. Epub 2014 Sep 18.
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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.
faruk güngör, md contact
faruk güngör, md contact
faruk güngör, md study chair
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Abdomen and Acute Appendicitis, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 10 Jun 2015. 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 Turkey (Türkiye). 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 faruk güngör, md (drfarukgungor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of emergency physician performed bedside ultrasound in diagnosing of acute appendicitis (time frame: 1 year). 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 NCT02467959, which also lists 2 linked publications.
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 10 Jun 2015.