Search

ObjectiveTo determine the effect of introducing prospective monitoring of outcomes using control charts and regular feedback on indicators to surgical teams on major adverse events in patients.DesignNational, parallel, cluster randomised trial embedding a difference-in-differences analysis.Setting40 surgical departments of hospitals across France.Participants155 362 adults who underwent digestive tract surgery. 20 of the surgical departments were randomised to prospective monitoring of outcomes using control charts with regular feedback on indicators (intervention group) and 20 to usual care only (control group).InterventionsProspective monitoring of outcomes using control charts, provided in sets quarterly, with regular feedback on indicators (intervention hospitals). To facilitate implementation of the programme, study champion partnerships were established at each site, comprising a surgeon and another member of the surgical team (surgeon, anaesthetist, or nurse), and were trained to conduct team meetings, display posters in operating rooms, maintain a logbook, and devise an improvement plan.Main outcome measuresThe primary outcome was a composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications) within 30 days after surgery. Changes in surgical outcomes were compared before and after implementation of the programme between intervention and control hospitals, with adjustment for patient mix and clustering.Results75 047 patients were analysed in the intervention hospitals (37 579 before and 37 468 after programme implementation) versus 80 315 in the control hospitals (41 548 and 38 767). After introduction of the control chart, the absolute risk of a major adverse event was reduced by 0.9% (95% confidence interval 0.4% to 1.4%) in intervention compared with control hospitals, corresponding to 114 patients (70 to 280) who needed to receive the intervention to prevent one major adverse event. A significant decrease in major adverse events (adjusted ratio of odds ratios 0.89, 95% confidence interval 0.83 to 0.96), patient death (0.84, 0.71 to 0.99), and intensive care stay (0.85, 0.76 to 0.94) was found in intervention compared with control hospitals. The same trend was observed for reoperation (0.91, 0.82 to 1.00), whereas severe complications remained unchanged (0.96, 0.87 to 1.07). Among the intervention hospitals, the effect size was proportional to the degree of control chart implementation witnessed. Highly compliant hospitals experienced a more important reduction in major adverse events (0.84, 0.77 to 0.92), patient death (0.78, 0.63 to 0.97), intensive care stay (0.76, 0.67 to 0.87), and reoperation (0.84, 0.74 to 0.96).ConclusionsThe implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients. Understanding variations in surgical outcomes and how to provide safe surgery is imperative for improvements.Trial registrationClinicalTrials.gov NCT02569450.

International audience; BACKGROUND/AIMS: Pancreaticoduodenectomy (PD) is indicated in benign or malignant pancreatic head diseases. It is a difficult operation with high morbidity especially in elderly patients. The aim of our study was to determine whether pancreaticoduodenectomy is associated with higher morbidity and mortality in patients ≥ 70 years old.METHODOLOGY: During 17 years, 173 patients were operated by Whipple intervention, whatever the disease. From a prospective database, patients were divided in 2 groups (Group A ≥ 70 years old, Group B RESULTS: Postoperative mortality was not significantly higher in elderly (12% vs. 4.1%; p=0.06). However, re-intervention and morbidity were more important in univariate analysis (p=0.03 and p=0.002 respectively). In multivariate analysis, age ≥ 70 years old was not an independent prognostic factor of mortality (p=0.27) and re-intervention (p=0.07). Whereas age (p=0.04) and preoperative morbidity (p=0.02) were independent prognostic factors of morbidity.CONCLUSIONS: PD requires careful patient selection. However, age should not be a limiting factor.