Safety and equity in scaling minimally invasive surgery worldwide in 109 countries using cholecystectomy as a tracer procedure: a prospective cohort stud

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Résumé

Summary
Background Minimally invasive surgery is rapidly expanding globally, yet there is insufficient knowledge of how to
scale this technology safely and equitably across diverse health systems. We aimed to identify health-system factors
associated with safe implementation of minimally invasive surgery globally, using minimally invasive cholecystectomy
as a tracer procedure.
Methods We conducted a multicentre, prospective cohort study of consecutive adults undergoing cholecystectomy
between July 31 and Nov 19, 2023, in 1218 hospitals across 109 countries. Data were collected by more than
10 000 health-care workers using a core measurement set mapped to the WHO Health System Building Blocks and
the Global Patient Safety Action Plan. The primary outcome was 30-day procedure-specific complications, with
multilevel logistic regression used to examine associations between health-system features and patient outcomes.
This study is registered on ClinicalTrials.gov (NCT06223061).
Findings Among 52 187 included patients, the adjusted procedure-specific complication rate varied 40-fold between
hospitals, from 0·3% in the lowest risk quintile to 12·1% in the highest risk quintile. Despite large structural
differences across income groups in access to minimally invasive surgery, diagnostics, and emergency services,
country income level was not independently associated with complication rates (adjusted odds ratio [OR] 0·81 [95% CI
0·59–1·10] for upper-middle income vs high income and 0·99 [0·70–1·39] for lower-middle income or low income
vs high income). Three modifiable hospital-level factors were strongly associated with safer outcomes: establishment
of local simulation-based training facilities (adjusted OR 0·78 [0·71–0·86]; p<0·0001), adoption of intraoperative
safety and communication strategies (0·87 [0·79–0·96]; p=0·0046), and on-site CT diagnostics (0·79 [0·65–0·97];
p=0·0220). Training facilities showed the greatest benefit in hospitals with limited infrastructure and an inexperienced
workforce: the number needed to treat to prevent a procedure-specific complication was 21 (95% CI 14–35; p<0·0001).
Interpretation Safe implementation of minimally invasive surgery varies widely worldwide but is not defined by
national income level; differences in outcomes reflect the ability of health systems to adopt and safely deploy new
surgical techniques. We identified for the first time that the presence of local simulation-based training facilities is
independently associated with improved patient outcomes. Simulation appears to be fundamental to the safe delivery
of minimally invasive surgery, particularly in resource-constrained settings. Together with safety systems and
diagnostic capacity, these findings offer actionable targets for health systems seeking to equitably scale up essential
surgical technologies.

Mots-clés

safety, equity,minimally, invasive, surgery