Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
NCT06762275

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

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

566

Participants Needed

1

Research Sites

208 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

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.

CONDITIONS

Official 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 the last 7 days who see their GP
Not Eligible

You will not qualify if you...

  • History of appendectomy
  • Current pregnancy
  • Abdominal pain caused by trauma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands, 9700AD

Actively Recruiting

Loading map...

Research Team

G

Gea A. Holtman, Dr.

CONTACT

H

Huibert Burger, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here