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

NCT06762275 | Recruiting

• 2 other identifiers: METc 2022/39910390022210064
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute; Acute Abdomen in Children

Keywords

General practitioner; Appendicitis; Clinical prediction rule; C-reactive protein; Children

Outcome Measures

Primary Outcomes (1)

• Referral efficiency

  The referral efficiency is defined as the proportion of non-referrals in patients without AA during 30 days follow-up (development of appendicitis beyond this period is extremely unlikely). This corresponds with the specificity of the diagnostic strategy. Medical records of the participating children in the GPs registry, including discharge letters (hospital data), will be screened by the researchers, in order to assess whether children were referred and whether they were or were not diagnosed with AA.

  30 days follow-up from baseline

Secondary Outcomes (7)

• Safety

  30 days follow-up from baseline

• Proportion of children with CRP-POCT

  Baseline

• Proportion of children with planned reassessment

  Baseline

• Anxiety of child ≥8 years according to the Dutch version of the State-Trait Anxiety Inventory for Children

  30 days and 3 months follow-up from baseline

• Parent or child satisfaction with management according to the Parental Medical Interview Scale (P-MISS)

  30 days follow-up from baseline

Study Arms (2)

Diagnostic strategy

EXPERIMENTAL

GPs in the intervention group will use a diagnostic strategy for AA referral, consisting of an externally validated cPR based on seven signs and symptoms, selectively followed by CRP-POCT in children in the medium risk group according to the cPR.

Diagnostic Test: Diagnostic strategy

Control

NO INTERVENTION

GPs in the control group provide care as usual, i.e. according to the Dutch College of GPs (NHG) guideline 'Abdominal pain in children', which does not include specific recommendations for AA referral and in which CRP POCT is not recommended. See for details: Detailed description - Usual care.

Interventions

Diagnostic strategy DIAGNOSTIC_TEST

GPs' use of an externally validated cPR followed by CRP-POCT in the medium risk group. See for details: Detailed description - Intervention.

Also known as: Clinical prediction rule, C-reactive protein point-of-care test

Diagnostic strategy

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Children aged 4 to 18 years with acute abdominal pain (onset ≤ 7 days) who present at the GP.

You may not qualify if:

• A history of appendectomy
• Current pregnancy
• Traumatic cause of abdominal pain

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Leiden University Medical Center: collaborator
• UMC Utrecht: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700AD, Netherlands

RECRUITING

Related Publications (15)

• Blok GCGH, Veenstra LMM, van der Lei J, Berger MY, Holtman GA. Appendicitis in children with acute abdominal pain in primary care, a retrospective cohort study. Fam Pract. 2021 Nov 24;38(6):758-765. doi: 10.1093/fampra/cmab039.

  PMID: 34278425 BACKGROUND

• Gorter RR, Eker HH, Gorter-Stam MA, Abis GS, Acharya A, Ankersmit M, Antoniou SA, Arolfo S, Babic B, Boni L, Bruntink M, van Dam DA, Defoort B, Deijen CL, DeLacy FB, Go PM, Harmsen AM, van den Helder RS, Iordache F, Ket JC, Muysoms FE, Ozmen MM, Papoulas M, Rhodes M, Straatman J, Tenhagen M, Turrado V, Vereczkei A, Vilallonga R, Deelder JD, Bonjer J. Diagnosis and management of acute appendicitis. EAES consensus development conference 2015. Surg Endosc. 2016 Nov;30(11):4668-4690. doi: 10.1007/s00464-016-5245-7. Epub 2016 Sep 22.

  PMID: 27660247 BACKGROUND

• Blok G, Burger H, van der Lei J, Berger M, Holtman G. Development and validation of a clinical prediction rule for acute appendicitis in children in primary care. Eur J Gen Pract. 2023 Dec;29(1):2233053. doi: 10.1080/13814788.2023.2233053.

  PMID: 37578416 BACKGROUND

• Blok GCGH, Nikkels ED, van der Lei J, Berger MY, Holtman GA. Added value of CRP to clinical features when assessing appendicitis in children. Eur J Gen Pract. 2022 Dec;28(1):95-101. doi: 10.1080/13814788.2022.2067142.

  PMID: 35535699 BACKGROUND

• Kharbanda AB, Vazquez-Benitez G, Ballard DW, Vinson DR, Chettipally UK, Dehmer SP, Ekstrom H, Rauchwerger AS, McMichael B, Cotton DM, Kene MV, Simon LE, Zhu J, Warton EM, O'Connor PJ, Kharbanda EO; Clinical Research on Emergency Services and Treatments Network (CREST) and the Critical Care Research Center, HealthPartners Institute. Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2036344. doi: 10.1001/jamanetworkopen.2020.36344.

  PMID: 33560426 BACKGROUND

• Lintula H, Kokki H, Kettunen R, Eskelinen M. Appendicitis score for children with suspected appendicitis. A randomized clinical trial. Langenbecks Arch Surg. 2009 Nov;394(6):999-1004. doi: 10.1007/s00423-008-0425-0. Epub 2008 Oct 8.

  PMID: 18841382 BACKGROUND

• Ansems S, Berger M, Rheenen PV, Vermeulen K, Beugel G, Couwenberg M, Holtman G. Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial. BMJ Open. 2021 Jul 23;11(7):e045444. doi: 10.1136/bmjopen-2020-045444.

  PMID: 34301652 BACKGROUND

• Kappen TH, van Loon K, Kappen MA, van Wolfswinkel L, Vergouwe Y, van Klei WA, Moons KG, Kalkman CJ. Barriers and facilitators perceived by physicians when using prediction models in practice. J Clin Epidemiol. 2016 Feb;70:136-45. doi: 10.1016/j.jclinepi.2015.09.008. Epub 2015 Sep 21.

  PMID: 26399905 BACKGROUND

• van der Wouden JC, Blankenstein AH, Huibers MJ, van der Windt DA, Stalman WA, Verhagen AP. Survey among 78 studies showed that Lasagna's law holds in Dutch primary care research. J Clin Epidemiol. 2007 Aug;60(8):819-24. doi: 10.1016/j.jclinepi.2006.11.010. Epub 2007 Mar 26.

  PMID: 17606178 BACKGROUND

• Bjarnason NH, Kampmann JP. Selection bias introduced by the informed consent process. Lancet. 2003 Jun 7;361(9373):1990. doi: 10.1016/S0140-6736(03)13568-4. No abstract available.

  PMID: 12801770 BACKGROUND

• Van den Bruel A, Jones C, Thompson M, Mant D. C-reactive protein point-of-care testing in acutely ill children: a mixed methods study in primary care. Arch Dis Child. 2016 Apr;101(4):382-5. doi: 10.1136/archdischild-2015-309228. Epub 2016 Jan 12.

  PMID: 26757989 BACKGROUND

• Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013.

  PMID: 15485730 BACKGROUND

• Schols AM, Dinant GJ, Cals JW. Point-of-care testing in general practice: just what the doctor ordered? Br J Gen Pract. 2018 Aug;68(673):362-363. doi: 10.3399/bjgp18X698033. No abstract available.

  PMID: 30049755 BACKGROUND

• Schunemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, Williams JW Jr, Kunz R, Craig J, Montori VM, Bossuyt P, Guyatt GH; GRADE Working Group. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008 May 17;336(7653):1106-10. doi: 10.1136/bmj.39500.677199.AE.

  PMID: 18483053 BACKGROUND

• RIFT Study Group on behalf of the West Midlands Research Collaborative. Appendicitis risk prediction models in children presenting with right iliac fossa pain (RIFT study): a prospective, multicentre validation study. Lancet Child Adolesc Health. 2020 Apr;4(4):271-280. doi: 10.1016/S2352-4642(20)30006-7. Epub 2020 Feb 13.

  PMID: 32200936 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Gea A. Holtman, Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gea A. Holtman, Dr.

CONTACT

+31642637125; g.a.holtman@umcg.nl

Huibert Burger, Dr.

CONTACT

+31612582356; h.burger@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Even though the GP's and children can not be blinded to the allocation, researchers performing the analyses will be blinded to the assigned group.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 7, 2025
• Study Start: March 6, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After all publications concerning the study are published.
• Access Criteria: Data will be made available upon reasonable request. In addition, processed and pseudonymized data will be made available upon restricted access (DataverseNL). Meta data will be presented in the UMCG Research Data Catalogue. DOI (Digital Object Identifier) will be shared via publications to make the data more findable.

Locations

NL (1)