Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-03-01 @ 3:22 AM
Study NCT ID:
NCT02467959
Status:
UNKNOWN
Last Update Posted:
2015-06-10
First Post:
2015-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of Emergency Physician Performed Bedside Ultrasound in Suspected Acute Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000006', 'term': 'Abdomen, Acute'}, {'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of emergency physician performed bedside ultrasound in diagnosing of acute appendicitis', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['emergency ultrasound', 'acute appendicitis', 'bedside ultrasound'], 'conditions': ['Acute Abdomen', 'Acute Appendicitis']}, 'referencesModule': {'references': [{'pmid': '25358207', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25493122', 'type': 'RESULT', '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 2014 Sep 18.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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.\n\nAt 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 18 years of age presented to emergency department with the complaint of right lower abdominal pain', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient presented with the complaint of right lower abdominal pain\n* Suspected acute appendicitis\n\nExclusion Criteria:\n\n* Flank pain\n* Previous appendectomy\n* Pregnancy\n* Unstable vital signs\n* Frank peritonitis\n* US performed before EP's examination"}, 'identificationModule': {'nctId': 'NCT02467959', 'briefTitle': 'Diagnostic Accuracy of Emergency Physician Performed Bedside Ultrasound in Suspected Acute Appendicitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'Diagnostic Accuracy and Clinic Utility of Bedside Ultrasonography Performed by Emergency Physicians in Suspected Acute Appendicitis', 'orgStudyIdInfo': {'id': 'AntalyaTRH04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound', 'description': 'Ultrasound evaluation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Antalya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'faruk güngör, MD', 'role': 'CONTACT', 'email': 'drfarukgungor@gmail.com', 'phone': '+902422494400', 'phoneExt': '3273'}, {'name': 'faruk güngör, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'can akyol, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'mehmet akçimen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'taylan kılıç, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'gizem ayaz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'umut cengiz çakır, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'mustafa keşaplı, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Antalya Training and Research Hospital, Department of Emergency', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'centralContacts': [{'name': 'faruk güngör, md', 'role': 'CONTACT', 'email': 'drfarukgungor@gmail.com'}, {'name': 'faruk güngör, md', 'role': 'CONTACT', 'email': 'drfarukgungor@gamail.com'}], 'overallOfficials': [{'name': 'faruk güngör, md', 'role': 'STUDY_CHAIR', 'affiliation': 'Antalya Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'faruk güngör', 'investigatorAffiliation': 'Antalya Training and Research Hospital'}}}}