Appendicitis in children with acute abdominal pain in primary care, a retrospective cohort study.
Guus C G H Blok, Laura M M Veenstra, Johan van der Lei...
https://pubmed.ncbi.nlm.nih.gov/34278425Actively Recruiting
Led by University Medical Center Groningen · Updated on 2025-11-26
566
Participants Needed
1
Research Sites
47 weeks
Total Duration
U
University Medical Center Groningen
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
Researchers are studying children aged 4 to 18 years who visit their general practitioner with acute abdominal pain to evaluate a new diagnostic strategy for acute appendicitis (AA). This strategy combines a clinical prediction rule (cPR) based on seven signs and symptoms with a C-reactive protein point-of-care test (CRP POCT) for those at medium risk. The study aims to improve referral efficiency by reducing unnecessary referrals while ensuring children with AA receive timely care. This is a cluster randomized controlled trial comparing this diagnostic approach with usual care in primary care settings. In this trial, general practitioners in the intervention group will apply the cPR and selectively use the CRP POCT for children classified as medium risk. The cPR score guides whether children are given safety advice, referred immediately, or tested with CRP POCT to decide further action. The control group will provide standard care according to Dutch guidelines, which rely on symptoms and signs without CRP testing. The study will recruit children over two years from different GP practices to compare the outcomes of these approaches. Participants will be followed for 30 days to assess referral efficiency, safety, and other outcomes such as anxiety, satisfaction, quality of life, and healthcare costs. Data will be collected on the use of CRP POCT, planned reassessments, and complications. Questionnaires and health assessments will be used to monitor children's well-being and parental satisfaction. The study includes a process evaluation to understand how the diagnostic strategy is used and its impact on care, with follow-up extending to three months for some measures.
CONDITIONS
The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days from symptom onset
Participants undergo evaluation using a clinical prediction rule (cPR) based on seven signs and symptoms, and children in the medium risk group receive a CRP point-of-care test (CRP-POCT) to guide referral decisions for acute appendicitis.
1 visit (in-person)
Duration - 30 days
Participants are followed for 30 days to assess referral efficiency, safety, anxiety, satisfaction with management, quality of life, and healthcare costs.
Follow-up assessments occurring during this period
Duration - 3 months
Participants continue to be monitored for 3 months to assess longer-term anxiety, quality of life, and healthcare costs.
Follow-up assessments occurring during this period
Total: 1 location
1
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9700AD
Actively Recruiting
G
Gea A. Holtman, Dr.
H
Huibert Burger, Dr.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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