[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054028":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":64,"collaborators":66,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diagnostic strategy","EXPERIMENTAL","GPs in the intervention group will use a diagnostic strategy for AA referral, consisting of an externally validated cPR based on seven signs and symptoms, selectively followed by CRP-POCT in children in the medium risk group according to the cPR.",[13],"Diagnostic Test: Diagnostic strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","GPs in the control group provide care as usual, i.e. according to the Dutch College of GPs (NHG) guideline 'Abdominal pain in children', which does not include specific recommendations for AA referral and in which CRP POCT is not recommended. See for details: Detailed description - Usual care.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","GPs' use of an externally validated cPR followed by CRP-POCT in the medium risk group. See for details: Detailed description - Intervention.",[9],[25,26],"Clinical prediction rule","C-reactive protein point-of-care test",[28],{"name":29,"affiliation":5,"role":30},"Gea A. Holtman, Dr.","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","+31642637125","g.a.holtman@umcg.nl",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Huibert Burger, Dr.","+31612582356","h.burger@umcg.nl",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Groningen","Provincie Groningen","9700AD","Netherlands","NL",{"type":49,"coordinates":50},"Point",[51,52],6.56667,53.21917,{"lat":52,"lon":51},[55,59,61],{"name":56,"role":33,"phone":57,"phoneExt":18,"email":58},"Esmee M Hogervorst, Drs.","+31657600112","e.m.hogervorst@umcg.nl",{"name":60,"role":33,"phone":34,"phoneExt":18,"email":35},"Gea A Holtman, Dr.",{"name":62,"role":63,"phone":18,"phoneExt":18,"email":18},"Eline JAQ Naber, Bsc","SUB_INVESTIGATOR",{"type":65,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[67,69,71],{"name":68,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":70,"class":6},"Leiden University Medical Center",{"name":72,"class":6},"UMC Utrecht","100054028","the-impact-of-a-diagnostic-strategy-for-acute-appendicitis-in-children-with-acute-abdominal-pain-in-primary-care-100054028",false,"NCT06762275","The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care","Optimizing Management of Children Presenting With Acute Abdominal Pain in Primary Care: a Cluster Randomized Controlled Trial Evaluating the Impact of a Clinical Prediction Rule Including C-reactive Protein for Appendicitis","ISAAK","Inclusion criteria:\n\n\\- Children aged 4 to 18 years with acute abdominal pain (onset ≤ 7 days) who present at the GP.\n\nExclusion criteria:\n\n* A history of appendectomy\n* Current pregnancy\n* Traumatic cause of abdominal pain","ALL","4 Years","18 Years",{"count":85,"type":86},566,"ESTIMATED","INTERVENTIONAL",[89],"NA","BACKGROUND Acute appendicitis (AA) in an early stage is difficult to distinguish from other (self-limiting) causes of acute abdominal pain (e.g. constipation and gastroenteritis), resulting in missing 19% of children with AA at first presentation in primary care and 70% of non-AA cases among referrals.\n\nOBJECTIVE To evaluate the impact of the use of a diagnostic strategy for acute appendicitis (AA), which consists of a clinical prediction rule (cPR) including C-reactive protein point-of-care test (CRP POCT), on referral efficiency in children with acute abdominal pain in primary care, as compared to usual care.\n\nSTUDY DESIGN This is a cluster randomized controlled trial in primary care with a process evaluation. GPs in the intervention group will use an externally validated cPR based on symptoms and signs selectively followed by a CRP POCT in the medium risk group. GPs from general practices allocated to the control group will provide care and diagnosis as usual, i.e. following recommendations of the Dutch College of GPs guideline 'abdominal pain in children'.\n\nSTUDY POPULATION Children aged 4 to 18 years presenting to their general practitioner (GP) with acute abdominal pain.\n\nOUTCOME MEASURES Primary outcome: referral efficiency (proportion non-referrals in non-AA patients during 30 days follow-up).\n\nSecondary outcomes: safety (proportion of referrals in AA patients during the first consultation or planned reassessment), proportion of children with CRP-POCT, proportion of children with planned reassessment, child anxiety, parent or child satisfaction, quality of life, and costs.",[92,93],"Appendicitis Acute","Acute Abdomen in Children",[95,96,25,97,98],"General practitioner","Appendicitis","C-reactive protein","Children","2026-07-09",{"date":101,"type":102},"2026-07-13","ACTUAL",{"date":104,"type":102},"2025-03-06",{"date":106,"type":86},"2029-03-01",{"name":5,"class":6},1]