Randomised controlled trialindependent cross-checkabstract checked★ key study I-BAR-136 in-depth review

Egyptian trial: gallstones after obesity surgery

Cholelithiasis after bariatric surgery, incidence, and prophylaxis: randomized controlled trial.

Overview

Talha et al.. Surg Endosc 2020 · PMID 31858245 · DOI 10.1007/s00464-019-07323-7

Without preventive medicine, about 22 in 100 patients formed gallstones within a year; a bile-acid medicine lowered this to about 6 in 100.

Does the study support the specific claim? Yes · Methodological quality: moderate

Study explained simply

What did the researchers want to find out?: Gallstones and UDCA
How was the study done?: RCT
How many people, animals or samples were studied?: 1,432
What was actually found?: 22% vs 6.5%
How large was the observed effect?: NNT 6
What do the results mean in everyday life?: Gallstones are common after rapid weight loss and largely preventable
What are the study's limitations?: Inconsistent numbers in abstract
What does it say about Elawady's specific claim?: Supports the claim
Do the results apply to Germany and Europe?: Egypt
What can explicitly not be concluded from this study?: Exact sleeve rate

How often do gallstones form after bariatric surgery and does 6 months of UDCA prevent them?

Study design: Randomised controlled trial – Randomised placebo-controlled trial of UDCA prophylaxis (Alexandria, Egypt)
Population: Morbidly obese patients undergoing OAGB, SG or greater curve plication
Country: Egypt
Period: not stated in abstract
Sample size: 1,530 enrolled, 1,432 analysed
Inclusion and exclusion criteria: Excluded prior/concomitant cholecystectomy and missed follow-up

Results: Overall cholelithiasis 9.7%. Incidence 22% with placebo vs 6.5% with UDCA; NNT 6. Of those with gallstones, 64.7% had SG vs 28.1% OAGB and 7.2% GCP. Higher %EWL in those who formed stones.
Absolute risks: Placebo arm: 22 in 100 formed gallstones within about a year.
Authors' conclusion: Cholelithiasis after SG and OAGB was higher than GCP; rapid weight loss predicts gallstones; 6 months UDCA is effective prophylaxis.

Abstract numbers internally inconsistent (overall 9.7% vs 22%/6.5%; "RR is 3.4%")
Procedure shares among stone formers do not give procedure-specific incidence
Short follow-up

Orienting tool: RoB 2
Type of assessment: simplified assessment (abstract only)
Full formal assessment: no
Overall risk of bias: some concerns
Rationale: Reporting inconsistencies in abstract; randomisation details not in abstract.

NNT 6.5 reproduced; overall incidence inconsistent with arm-specific rates unless groups were very unequal (stats/I-BAR-136_talha_2020.py).

Egyptian randomised data showing gallstones are common after sleeve-dominated bariatric surgery and largely preventable.

Not everyone forms stones; UDCA prevents most.

Egyptian setting; biology universal.

Supports C-BAR-11 in an Egyptian population, with reporting caveats.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	moderate
Risk of bias	some concerns
Precision of results	moderate
Directness	direct
Reproducibility	replicated
Consistency with the overall evidence	consistent
Regional transferability	high
Adequacy of the interpretation (by the archive)	not applicable

Sleeve-specific incidence.