Evaluating a diagnostic strategy for acute appendicitis in children with abdominal pain
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
NA · University Medical Center Groningen · NCT06762275
This study is testing a new way for doctors to figure out if kids with belly pain have appendicitis to see if it helps reduce unnecessary trips to the hospital while still catching any serious cases.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 566 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Trial ID | NCT06762275 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a diagnostic strategy for acute appendicitis in children presenting with acute abdominal pain in primary care settings. It involves a cluster randomized controlled trial where general practitioners (GPs) in the intervention group will utilize a clinical prediction rule (cPR) and a C-reactive protein point-of-care test (CRP POCT) for medium-risk patients. The goal is to improve referral efficiency by reducing unnecessary referrals while ensuring that cases of acute appendicitis are not missed. The study compares this approach to the usual care provided by GPs.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 18 years who present with acute abdominal pain of less than 7 days duration.
Not a fit: Patients who have a history of appendectomy, are currently pregnant, or have a traumatic cause of abdominal pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this strategy could lead to more accurate diagnoses and fewer unnecessary referrals for children with abdominal pain.
How similar studies have performed: Other studies have shown promise in using clinical prediction rules and point-of-care tests for improving diagnostic accuracy in similar contexts, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Groningen, Provincie Groningen
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Gea A. Holtman, Dr. — University Medical Center Groningen
- Study coordinator: Gea A. Holtman, Dr.
- Email: g.a.holtman@umcg.nl
- Phone: +31642637125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Appendicitis Acute, Acute Abdomen in Children, General practitioner, Appendicitis, Clinical prediction rule, C-reactive protein, Children