Randomised controlled trialindependent cross-checkabstract only checked★ key study I-BAR-05 in-depth review

Swiss trial: sleeve vs bypass

Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial.

Overview

Peterli R et al.. JAMA 2018 · PMID 29340679 · DOI 10.1001/jama.2017.20897

Reflux got worse in about 32% after sleeve vs 6% after bypass.

Does the study support the specific claim? Partly · Methodological quality: high

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Compare procedures

How was the study done?

RCT

How many people, animals or samples were studied?

217

What was actually found?

More reflux after sleeve

How large was the observed effect?

31.8% vs 6.3%

What do the results mean in everyday life?

Reflux is common but not universal

What are the study's limitations?

Exploratory reflux outcome

What does it say about Elawady's specific claim?

Supports increase, refutes 'inevitable'

Do the results apply to Germany and Europe?

European

What can explicitly not be concluded from this study?

Long-term BE

Scientific in-depth review

1. Full reference

Authors
Peterli R et al.
Journal
JAMA
Year
2018
Identifier
PMID 29340679 DOI 10.1001/jama.2017.20897
Verification
verified – PubMed efetch 2026-10-25
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

SG vs RYGB at 5 years

3. Study design and population

Study design
Randomised controlled trial – Multicentre RCT
Population

Morbid obesity, mean BMI 43.9

Country

Switzerland

Period

2007-2017

Sample size

217 (205 completed)

4. Methods and endpoints

Exposure / intervention

SG

Comparator

RYGB

Endpoints

Excess BMI loss; comorbidities; adverse events

5. Actual results

Results

Excess BMI loss 61.1% vs 68.3% (NS after adjustment). Reflux remission 25.0% SG vs 60.4% RYGB; reflux worsened 31.8% SG vs 6.3% RYGB. Reoperations 15.8% vs 22.1%.

Absolute risks

Reflux worsened in 31.8% after SG

Authors' conclusion

No significant difference in excess BMI loss at 5 years.

6. Strengths

  • Randomized, 94.5% completion

7. Weaknesses

  • Reflux exploratory endpoint

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

9. Assessment of the statistical interpretation

10. Relevance to the specific claim

Supports C-BAR-02 (more reflux after SG) and contradicts C-BAR-03 (reflux not inevitable: about one third worsened).

11. Independent contrary findings

12. Transferability to Germany and Europe

Directly European.

13. Overall methodological judgement

Strong RCT evidence, consistent with SLEEVEPASS.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualityhigh
Risk of biassome concerns
Precision of resultsmoderate
Directnessdirect
Reproducibilityreplicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

15. Linked fact checks