Randomised controlled trialindependent cross-checkabstract checked★ key study I-ORG-107 in-depth review
Antibiotics versus surgery for appendicitis in children
Appendicectomy versus antibiotics for acute uncomplicated appendicitis in children: an open-label, international, multicentre, randomised, non-inferiority trial.
Overview
St Peter SD et al.. Lancet 2025 · PMID 39826968 · DOI 10.1016/S0140-6736(24)02420-6
Antibiotics failed in 34% of children versus 7% with surgery, but about two thirds of antibiotic-treated children kept their appendix for a year.
Does the study support the specific claim? Partly · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Test antibiotics against surgery for uncomplicated appendicitis in children
- How was the study done?
International randomised trial
- How many people, animals or samples were studied?
936 children aged 5-16
- What was actually found?
Antibiotics inferior by the trial margin; no deaths or serious harms
- How large was the observed effect?
Failure 34% vs 7%
- What do the results mean in everyday life?
Surgery remains the more reliable treatment in children; antibiotics are an option with a high failure rate
- What are the study's limitations?
Unblinded; different failure definitions
- What does it say about Elawady's specific claim?
Limits the claim that appendices are removed far too readily
- Do the results apply to Germany and Europe?
Directly applicable
- What can explicitly not be concluded from this study?
Not about diet or untreated appendicitis
Scientific in-depth review
1. Full reference
- Authors
- St Peter SD et al.
- Journal
- Lancet
- Year
- 2025
- Identifier
- PMID 39826968 DOI 10.1016/S0140-6736(24)02420-6
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
- Retracted
- no
- Corrections
ErratumIn: Lancet. 2025 Feb 8;405(10477):468. doi: 10.1016/S0140-6736(25)00206-5.
- Extent checked
- abstract only
- Conflicts of interest and funding
Abstract: Funding 'None'. Erratum published (Lancet 2025;405:468).
2. Research question
Is antibiotic treatment of uncomplicated appendicitis in children non-inferior to appendicectomy for 1-year treatment failure?
3. Study design and population
- Study design
- Randomised controlled trial – Pragmatic international multicentre randomised non-inferiority trial (margin 20%)
- Population
Children 5-16 years with suspected non-perforated appendicitis
- Country
Canada, USA, Finland, Sweden, Singapore (11 children's hospitals)
- Period
January 2016 - December 2021; 12-month follow-up
- Sample size
936 randomised (477 antibiotics, 459 appendicectomy); 846 with 12-month data
- Inclusion and exclusion criteria
Clinical (with or without radiological) diagnosis of non-perforated appendicitis
4. Methods and endpoints
- Exposure / intervention
Antibiotics
- Comparator
Appendicectomy
- Endpoints
Treatment failure within 1 year (antibiotics: appendix removal or further procedure; surgery: negative appendix or further procedure)
- Statistical methods
Non-inferiority with 90% CI; RR for adverse events
5. Actual results
- Results
Failure 153/452 (34%) antibiotics vs 28/394 (7%) appendicectomy (difference 26.7%, 90% CI 22.4-30.9) - inferiority by the 20% margin. All but one failure in the surgery group were negative appendicectomies. 13 (8%) of appendicectomies in the antibiotic group had normal pathology. No deaths or serious adverse events. Mild-moderate adverse events RR 4.3 (2.1-8.7) with antibiotics.
- Absolute risks
34% vs 7% treatment failure at 1 year; about 66% of antibiotic-treated children kept their appendix for a year.
- Authors' conclusion
Based on cumulative failure rates and a 20% margin, antibiotic management of non-perforated appendicitis in children was inferior to appendicectomy.
6. Strengths
- Large international pragmatic RCT
- Children-specific
- Low loss to follow-up (10%)
7. Weaknesses
- Unblinded
- Composite failure definitions differ between arms
- Clinical diagnosis without mandatory imaging
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; asymmetric failure definitions.
9. Assessment of the statistical interpretation
Absolute difference 26.7 points reproduced (stats/C-ORG-17_appendicitis.py). The negative appendicectomy rate of about 7% in the surgery arm shows that some appendices removed are normal.
10. Relevance to the specific claim
Direct test in children of whether appendicectomy can be avoided.
11. Independent contrary findings
van Amstel 2026 (I-ORG-108): complications similar; 70% avoided surgery.
12. Transferability to Germany and Europe
Includes Finnish and Swedish centres; directly applicable.
13. Overall methodological judgement
Limits the claim: in children, antibiotics failed in a third and were formally inferior; yet two thirds avoided surgery and about 7% of operations removed a normal appendix, which partly supports concern about unnecessary removal.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | high |
| 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 outcomes beyond 1 year in children.
15. Linked fact checks
- The appendix (like tonsils and adenoids) is removed far too readily from early childhood onward. – Studies contradicting or limiting the claim