Randomised controlled trialindependent cross-checkabstract checked I-ORG-108 standard review
Antibiotic strategy for simple appendicitis in Dutch children
Non-operative treatment strategy versus surgery for children with simple appendicitis: non-inferiority randomised controlled trial.
Overview
van Amstel P et al.. BMJ Med 2026 · PMID 42157906 · DOI 10.1136/bmjmed-2025-002466
About 70% of children treated with antibiotics avoided an operation, with similar complication rates, but non-inferiority was not proven.
Does the study support the specific claim? Partly · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Compare a non-operative strategy with surgery
- How was the study done?
Randomised trial
- How many people, animals or samples were studied?
302 children aged 7-17
- What was actually found?
Complications 9.3% vs 8.6%; 69.5% avoided surgery
- How large was the observed effect?
Risk difference 0.7%
- What do the results mean in everyday life?
Antibiotics are a possible option for selected children
- What are the study's limitations?
Unblinded, moderate size
- What does it say about Elawady's specific claim?
Partly supports avoiding some operations; appendicitis still needs treatment
- Do the results apply to Germany and Europe?
Directly applicable
- What can explicitly not be concluded from this study?
Cannot show equivalence
Scientific in-depth review
1. Full reference
- Authors
- van Amstel P et al.
- Journal
- BMJ Med
- Year
- 2026
- Identifier
- PMID 42157906 DOI 10.1136/bmjmed-2025-002466
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Not stated in abstract.
2. Research question
Is a non-operative strategy non-inferior to appendectomy for complications in children with imaging-confirmed simple appendicitis?
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre randomised non-inferiority trial (margin 5%), 1-year follow-up
- Population
Children 7-17 years with imaging-confirmed simple appendicitis without faecolith
- Country
Netherlands (15 hospitals)
- Period
2017-2023
- Sample size
302 (151 per arm)
- Inclusion and exclusion criteria
Imaging-confirmed simple appendicitis; faecolith excluded
4. Methods and endpoints
- Exposure / intervention
IV amoxicillin-clavulanate + gentamicin 48 h, then oral 5 days
- Comparator
Appendectomy
- Endpoints
Complications within 1 year (primary); appendectomy avoided; HRQoL; costs; satisfaction
- Statistical methods
Absolute risk difference with 95% CI
5. Actual results
- Results
Complications 14/151 (9.3%) vs 13/151 (8.6%) (absolute difference 0.7%, upper 95% limit 7.1%; non-inferiority not proven). Appendectomy avoided in 105/151 (69.5%). HRQoL similar. Costs lower with non-operative strategy; longer hospital stay (3.3 vs 1.9 days) and lower satisfaction (Net Promoter Score 18.9 vs 48.0).
- Absolute risks
Complications 9.3% vs 8.6%; 69.5% avoided surgery.
- Authors' conclusion
Non-inferiority not proven, though most of the CI lay within the margin; about 70% avoided surgery; similar HRQoL, lower costs, longer stay and lower satisfaction.
6. Strengths
- Multicentre RCT
- Imaging-confirmed diagnosis
7. Weaknesses
- Moderate size
- Unblinded
- Non-inferiority not shown
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Open-label trial; objective complication outcome.
9. Assessment of the statistical interpretation
Risk difference reproduced (stats/C-ORG-17_appendicitis.py); CI -5.8% to 7.1% crosses the 5% margin.
10. Relevance to the specific claim
Shows that most children with simple appendicitis can avoid surgery with antibiotics.
11. Independent contrary findings
St Peter 2025 found inferiority with a different failure definition.
12. Transferability to Germany and Europe
Dutch; directly applicable.
13. Overall methodological judgement
Partly supports the claim that many appendectomies in children could be avoided, but within a supervised antibiotic treatment strategy.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | mixed |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Long-term recurrence.
15. Linked fact checks
- The appendix (like tonsils and adenoids) is removed far too readily from early childhood onward. – Studies with mixed or unclear results