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

Original publication

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
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualitymoderate
Risk of biassome concerns
Precision of resultsmoderate
Directnessdirect
Reproducibilitypartly replicated
Consistency with the overall evidencemixed
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

Long-term recurrence.

15. Linked fact checks