Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT03522233
Status:
UNKNOWN
Last Update Posted:
2018-05-11
First Post:
2018-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'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': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2018-04-18', 'studyFirstSubmitQcDate': '2018-05-10', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Equivocal Appendix Ultrasound', 'timeFrame': 'September 2017-October 2018', 'description': 'To determine the rate of equivocal appendix US among children with pARC \\<25%.'}, {'measure': 'Rate of Appendicitis', 'timeFrame': 'September 2017-October 2018', 'description': 'To determine rate of appendicitis among children with pARC \\<25% who had an appendix ultrasound.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '29535251', 'type': 'BACKGROUND', 'citation': "Kharbanda AB, Vazquez-Benitez G, Ballard DW, Vinson DR, Chettipally UK, Kene MV, Dehmer SP, Bachur RG, Dayan PS, Kuppermann N, O'Connor PJ, Kharbanda EO. Development and Validation of a Novel Pediatric Appendicitis Risk Calculator (pARC). Pediatrics. 2018 Apr;141(4):e20172699. doi: 10.1542/peds.2017-2699. Epub 2018 Mar 13."}, {'pmid': '10469767', 'type': 'BACKGROUND', 'citation': 'Pena BM, Taylor GA, Lund DP, Mandl KD. Effect of computed tomography on patient management and costs in children with suspected appendicitis. Pediatrics. 1999 Sep;104(3 Pt 1):440-6. doi: 10.1542/peds.104.3.440.'}, {'pmid': '12037754', 'type': 'BACKGROUND', 'citation': 'Samuel M. Pediatric appendicitis score. J Pediatr Surg. 2002 Jun;37(6):877-81. doi: 10.1053/jpsu.2002.32893.'}, {'pmid': '17383771', 'type': 'BACKGROUND', 'citation': 'Schneider C, Kharbanda A, Bachur R. Evaluating appendicitis scoring systems using a prospective pediatric cohort. Ann Emerg Med. 2007 Jun;49(6):778-84, 784.e1. doi: 10.1016/j.annemergmed.2006.12.016. Epub 2007 Mar 26.'}, {'pmid': '24731432', 'type': 'BACKGROUND', 'citation': 'Ebell MH, Shinholser J. What are the most clinically useful cutoffs for the Alvarado and Pediatric Appendicitis Scores? A systematic review. Ann Emerg Med. 2014 Oct;64(4):365-372.e2. doi: 10.1016/j.annemergmed.2014.02.025. Epub 2014 Apr 14.'}, {'pmid': '25364964', 'type': 'BACKGROUND', 'citation': 'Smith MP, Katz DS, Lalani T, Carucci LR, Cash BD, Kim DH, Piorkowski RJ, Small WC, Spottswood SE, Tulchinsky M, Yaghmai V, Yee J, Rosen MP. ACR Appropriateness Criteria(R) Right Lower Quadrant Pain--Suspected Appendicitis. Ultrasound Q. 2015 Jun;31(2):85-91. doi: 10.1097/RUQ.0000000000000118.'}, {'pmid': '20116016', 'type': 'BACKGROUND', 'citation': 'Howell JM, Eddy OL, Lukens TW, Thiessen ME, Weingart SD, Decker WW; American College of Emergency Physicians. Clinical policy: Critical issues in the evaluation and management of emergency department patients with suspected appendicitis. Ann Emerg Med. 2010 Jan;55(1):71-116. doi: 10.1016/j.annemergmed.2009.10.004.'}, {'pmid': '24842505', 'type': 'BACKGROUND', 'citation': 'Ross MJ, Liu H, Netherton SJ, Eccles R, Chen PW, Boag G, Morrison E, Thompson GC. Outcomes of children with suspected appendicitis and incompletely visualized appendix on ultrasound. Acad Emerg Med. 2014 May;21(5):538-42. doi: 10.1111/acem.12377.'}, {'pmid': '11015507', 'type': 'BACKGROUND', 'citation': 'Pena BM, Taylor GA, Fishman SJ, Mandl KD. Costs and effectiveness of ultrasonography and limited computed tomography for diagnosing appendicitis in children. Pediatrics. 2000 Oct;106(4):672-6. doi: 10.1542/peds.106.4.672.'}, {'pmid': '26797233', 'type': 'BACKGROUND', 'citation': 'Gregory S, Kuntz K, Sainfort F, Kharbanda A. Cost-Effectiveness of Integrating a Clinical Decision Rule and Staged Imaging Protocol for Diagnosis of Appendicitis. Value Health. 2016 Jan;19(1):28-35. doi: 10.1016/j.jval.2015.10.007. Epub 2015 Dec 2.'}, {'pmid': '25708690', 'type': 'BACKGROUND', 'citation': 'Bachur RG, Callahan MJ, Monuteaux MC, Rangel SJ. Integration of ultrasound findings and a clinical score in the diagnostic evaluation of pediatric appendicitis. J Pediatr. 2015 May;166(5):1134-9. doi: 10.1016/j.jpeds.2015.01.034. Epub 2015 Feb 21.'}, {'pmid': '27939802', 'type': 'BACKGROUND', 'citation': 'Partain KN, Patel AU, Travers C, Short HL, Braithwaite K, Loewen J, Heiss KF, Raval MV. Improving ultrasound for appendicitis through standardized reporting of secondary signs. J Pediatr Surg. 2017 Aug;52(8):1273-1279. doi: 10.1016/j.jpedsurg.2016.11.045. Epub 2016 Dec 5.'}]}, 'descriptionModule': {'briefSummary': "Acute appendicitis (AA) is the most common condition requiring emergency surgery in children. At a network of institutions nationwide, a tool called the pediatric appendicitis risk calculator (pARC)1 is being studied to assess patient's true risk of appendicitis and provide guidance for clinical management to ER physicians. Preliminary studies have found the pARC to be more accurate at predicting risk of appendicitis in children when compared to other scoring systems. The study objective is to assess acute care charges and clinical outcomes among children with an appendix ultrasound and a pARC score of less than \\< 25% risk.", 'detailedDescription': "Background Acute appendicitis (AA) is the most common condition requiring emergency surgery in children. The potential for morbidity and mortality from perforation of the appendix necessitates prompt diagnosis.2 Acute appendicitis scoring systems such as pediatric appendicitis score (PAS) use elements of history, exam findings, and lab tests to identify patients at high risk of having acute appendicitis.3 Despite having limited use for this intent 4,5 these scores are often used to stratify patients by risk for continued observation, imaging or operative care. 6 While CT scans may have higher diagnostic yield, its use is not without risk. CT- related radiation exposure has been shown to increase cancer risk. There have been US first strategies published by the American College of Radiology7 and the American College of Emergency Physicians.8 However, nearly 50% of appendix US examinations are equivocal, which poses a dilemma for EM physicians and results in variation in clinical care.\n\nVarious strategies exist for the diagnostic approach to the patient after equivocal US with symptoms of AA. While select patients may be safely discharged based on clinical judgment,9 emergency providers often obtain CT or admit patients for clinical observation. In a study conducted by Garcia et al., they concluded that a protocol of US followed by CT in children with negative or equivocal US exam results in beneficial management as well as cost savings.10 In a study by Gregory et al., they concluded that a clinical decision rule followed by staged imaging was found to be the most cost-effective approach for diagnosis of AA in children.11 Bachur et al. integrated PAS score with US findings and concluded that patients with high risk (PAS 7-10) but negative US or low risk (PAS 0-3) benefit from serial exam or further work up. 12 The addition of US to the strategy reduced CT utilization.11 Standardized radiology reports have also been shown to reduce CT scans and admissions for observation.13 At a network of institutions nationwide a tool called the pediatric appendicitis risk calculator (pARC)1 is being studied to assess patient's true risk of appendicitis and provide guidance for clinical management to ER physicians. Preliminary studies have found the pARC to be more accurate at predicting risk of appendicitis in children when compared to PAS score.\n\nThe study objective is to assess acute care charges and clinical outcomes among children with appendix US and pARC \\< 25%. To the investigator's knowledge, this is the first study to do so in a tertiary care pediatric hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "We will collect data on all patients presenting to the emergency departments of Children's Minnesota between the ages of 5-18 years old who have a US of the appendix performed in the ED over 12 month period from September 23, 2017 to October 1, 2018.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 5-18 years\n* Patients who had an appendix ultrasound in one of our EDs\n\nExclusion Criteria:\n\n* Outside appendix ultrasound or abdominal CT obtained\n* Previous significant abdominal surgery (for example appendectomy, short gut, ileostomy, Hirschsprungs with pull through)\n* No CBC obtained (i.e. cannot determine pARC)\n* Developmental or cognitive delay that impedes communication\n* If there is suspected abuse'}, 'identificationModule': {'nctId': 'NCT03522233', 'briefTitle': 'Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospitals and Clinics of Minnesota"}, 'officialTitle': 'Clinical Outcomes and Charges After Risk Stratification by Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds at a Tertiary Care Pediatric Hospital', 'orgStudyIdInfo': {'id': '1708-113'}}, 'contactsLocationsModule': {'locations': [{'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brianna McMichael, MPH', 'role': 'CONTACT'}], 'facility': "Children's Minnesota", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brianna McMichael, MPH', 'role': 'CONTACT'}], 'facility': "Children's Minnesota", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'centralContacts': [{'name': 'Brianna S McMichael, MPH', 'role': 'CONTACT', 'email': 'Brianna.McMichael@Childrensmn.org', 'phone': '612-813-7104'}, {'name': 'Heidi Vander Velden, MS', 'role': 'CONTACT', 'email': 'heidi.vandervelden@childrensmn.org', 'phone': '(612) 813-7892'}], 'overallOfficials': [{'name': 'Callie Becker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Minnesota"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospitals and Clinics of Minnesota", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}