Randomised controlled trialindependent cross-checkfull text checked★ key study I-ORG-104 in-depth review
Fewer gallbladder operations by stricter selection
Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones: 5-Year Follow-Up of the SECURE Randomized Clinical Trial.
Overview
Comes DJ et al.. JAMA Surg 2024 · PMID 39167382 · DOI 10.1001/jamasurg.2024.3080
A stricter selection avoided about 8 in 100 operations without more complications, but about a third of patients still had pain after surgery in both groups.
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 whether stricter selection for gallbladder surgery is safe in the long term
- How was the study done?
Randomised trial with 5-year follow-up
- How many people, animals or samples were studied?
1067 Dutch adults with gallstones and abdominal pain
- What was actually found?
Fewer operations, no more complications; only about two thirds pain free in both groups
- How large was the observed effect?
Operation rate 73.2% vs 81.5%
- What do the results mean in everyday life?
Gallstones are not always the cause of pain; surgery should be well indicated
- What are the study's limitations?
Protocol deviations and missing survey data
- What does it say about Elawady's specific claim?
Partly supports caution, not a ban on surgery
- Do the results apply to Germany and Europe?
Directly applicable
- What can explicitly not be concluded from this study?
Cannot say that untreated symptomatic gallstones are harmless
Scientific in-depth review
1. Full reference
- Authors
- Comes DJ et al.
- Journal
- JAMA Surg
- Year
- 2024
- Identifier
- PMID 39167382 DOI 10.1001/jamasurg.2024.3080
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- full text
- Conflicts of interest and funding
Full text: initial trial funded by the Netherlands Organization for Health Research and Development and CZ Healthcare Insurance; follow-up not funded; funders had no role; no conflicts reported.
2. Research question
Long-term pain, operation rate and complications with a restrictive selection strategy versus usual care for cholecystectomy in uncomplicated symptomatic gallstones.
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre randomised non-inferiority trial (SECURE), 5-year follow-up
- Population
Adults 18-95 with abdominal pain and ultrasound-proven uncomplicated gallstones referred to surgical outpatient clinics
- Country
Netherlands (24 hospitals)
- Period
Inclusion 2014-2017; 5-year follow-up data collected 2019-2023
- Sample size
1067 randomised (537 usual care, 530 restrictive); 716 with primary outcome
- Inclusion and exclusion criteria
Uncomplicated cholelithiasis; excluded biliary pancreatitis, cholangitis, CBD stones, cholecystitis
4. Methods and endpoints
- Exposure / intervention
Restrictive stepwise selection for cholecystectomy (triage instrument)
- Comparator
Usual care
- Endpoints
Pain-free (Izbicki) at 5 years (non-inferiority, 5% margin); cholecystectomy rate; biliary/surgical complications; satisfaction
- Statistical methods
Non-inferiority, 1-sided 95% lower confidence limit
5. Actual results
- Results
Pain-free at 5 years 228/363 (62.8%) usual care vs 216/353 (61.2%) restrictive (difference 1.6%; 1-sided 95% lower limit -7.6%; non-inferiority P = .18). After cholecystectomy 63.6% and 63.0% pain-free. Cholecystectomy 387/529 (73.2%) restrictive vs 437/536 (81.5%) usual care (difference 8.3%, P = .001). No differences in biliary or surgical complications or satisfaction.
- Absolute risks
Operation rate 73.2% vs 81.5%; about 36-37% still had pain after cholecystectomy.
- Authors' conclusion
A restrictive strategy causes a small reduction in operations without more complications; regardless of strategy only two-thirds were pain free, so better patient selection and rethinking cholecystectomy as treatment are needed.
6. Strengths
- Large pragmatic multicentre RCT
- 5-year follow-up
- Patient-reported outcomes
7. Weaknesses
- About 30% protocol deviation in restrictive arm (full text)
- Only about 70% completed the pain survey
- No correction for multiple comparisons (full text)
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; substantial non-adherence and missing patient-reported outcome data at 5 years.
9. Assessment of the statistical interpretation
Non-inferiority for being pain free was not demonstrated (lower limit -7.6% beyond the -5% margin), so the restrictive strategy cannot be called equivalent; the operation rate reduction (NNT about 12) is robust.
10. Relevance to the specific claim
Shows that many abdominal pains in people with gallstones persist after the gallbladder is removed, and that a more selective approach to surgery is safe.
11. Independent contrary findings
C-GALL (I-ORG-09) found better gallstone-specific QoL with surgery; NICE (I-ORG-141) recommends offering cholecystectomy for symptomatic stones.
12. Transferability to Germany and Europe
Dutch trial; directly applicable to European care.
13. Overall methodological judgement
Supports the part of the claim that gallstones are not always the cause of abdominal pain and that cholecystectomy is sometimes done without benefit; does not show that the gallbladder should never be removed.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Better selection criteria for surgery.
15. Linked fact checks
- Gallstones cause no symptoms and no harm, have nothing to do with pain after eating, and the gallbladder should not be removed. – Studies with mixed or unclear results
- Adenoids, tonsils and the gallbladder are organs that should not be removed; correcting the diet should be the foundation of treatment. – Studies with mixed or unclear results