September's Paper of the Month looks at early recognition and management of postoperative complications, before they become clinically relevant, using algorithm-based care and usual care.
Lancet, vol 399 May 14, 2022, P1867-1875
This stepped-wedge cluster randomised trial was carried out in 17 major surgical centres across Holland. The investigators demonstrate the value of this trial design for complex interventions, and the potential for rapid implementation of practice change and the importance of team building. ESCP studies like EAGLE are using similar methodology and have the potential to change practice across hundreds of hospitals across the world implementing rapid practice change at a global level. This approach must have wide applications for improving surgical care across the world and ESCP can be a leading force in driving a revolution in surgical research.
During 2022, 17 hospitals in Holland introduced a new protocol for early detection of post-operative complications, notably pancreatic leaks, following Whipple’s resection. The intervention was an algorithm that advised on when escalation in investigations (CT scan) and intervention (antibiotics/drainage) might be required.
The primary endpoint was a composite of bleeding, organ failure and mortality.
They recruited 1,805 consecutive patients into the study over 22 months and found a reduction from 14% to 8% in the primary endpoint. This comprised a small reduction in bleeding and mortality with a larger absolute reduction in organ failure.
This study gave a clear demonstration that early recognition of post-operative complications can improve recovery and potentially save lives. As in any study there are some limitations. The intervention was unblinded (unavoidably) and the intervention (if implemented) would obviously prevent much organ failure. For those considering such studies, it is worth noting they saw a rise in detection of pancreatic and bile leaks (not a reduction). This makes the occurrence of such adverse events not appropriate a primary endpoint. The use of a smart phone app, to maximise uptake is also worth noting.
Because of sepsis, colorectal surgery actually carries a higher morbidity and mortality than Whipple’s procedures. Implementation of such early warning algorithms warrants investigation in our patients. Wider application of this methodology will also be seen in the forthcoming ESCP abdominal wall closure study.
