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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02467959
Other study ID # AntalyaTRH04
Secondary ID
Status Recruiting
Phase N/A
First received June 4, 2015
Last updated June 9, 2015
Start date January 2015
Est. completion date December 2015

Study information

Verified date June 2015
Source Antalya Training and Research Hospital
Contact faruk güngör, md
Email drfarukgungor@gmail.com
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient presented with the complaint of right lower abdominal pain

- Suspected acute appendicitis

Exclusion Criteria:

- Flank pain

- Previous appendectomy

- Pregnancy

- Unstable vital signs

- Frank peritonitis

- US performed before EP's examination

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Turkey Antalya Training and Research Hospital, Department of Emergency Antalya

Sponsors (1)

Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Lam 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of emergency physician performed bedside ultrasound in diagnosing of acute appendicitis 1 year No
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