Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
ID06762275

Optimizing Management of Children Presenting With Acute Abdominal Pain in Primary Care Using Clinical Prediction Rule and C-reactive Protein Testing for Appendicitis

Led by University Medical Center Groningen · Updated on 2025-11-26

566

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

Sponsors

U

University Medical Center Groningen

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 4 to 18 years with acute abdominal pain starting within 7 days who see their general practitioner
Not Eligible

You will not qualify if you...

  • History of appendix removal (appendectomy)
  • Current pregnancy
  • Abdominal pain caused by injury or trauma

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Short-term Follow-up

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

Extended Follow-up

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

Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands, 9700AD

Actively Recruiting

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Research Team

G

Gea A. Holtman, Dr.

H

Huibert Burger, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial.

Anupam B Kharbanda, Gabriela Vazquez-Benitez, Dustin W Ballard...

https://pubmed.ncbi.nlm.nih.gov/33560426

Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial.

Sophie Ansems, Marjolein Berger, Patrick van Rheenen...

https://pubmed.ncbi.nlm.nih.gov/34301652