NCT06762275 The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care
| NCT ID | NCT06762275 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Appendicitis Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 566 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 566 participants in total. It began in 2025-03-06 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. OBJECTIVE 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. STUDY 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'. STUDY POPULATION Children aged 4 to 18 years presenting to their general practitioner (GP) with acute abdominal pain. OUTCOME MEASURES Primary outcome: referral efficiency (proportion non-referrals in non-AA patients during 30 days follow-up). Secondary outcomes: safety (proportion of referrals in AA patients during the first consultation), proportion of children with CRP-POCT, proportion of children with planned reassessment, child anxiety, parent or child satisfaction, quality of life, and costs.
Eligibility Criteria
Inclusion criteria: \- Children aged 4 to 18 years with acute abdominal pain (onset ≤ 7 days) who present at the GP. Exclusion criteria: * A history of appendectomy * Current pregnancy * Traumatic cause of abdominal pain
Contact & Investigator
Gea A. Holtman, Dr.
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT06762275 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Appendicitis Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06762275 currently recruiting?
Yes, NCT06762275 is actively recruiting participants. Contact the research team at g.a.holtman@umcg.nl for enrollment information.
Where is the NCT06762275 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06762275 clinical trial?
NCT06762275 is sponsored by University Medical Center Groningen. The principal investigator is Gea A. Holtman, Dr. at University Medical Center Groningen. The trial plans to enroll 566 participants.