FAST TRACK PATHWAY TO ACCELERATED CHOLECYSTECTOMY VERSUS STANDARD OF CARE FOR ACUTE CHOLECYSTITIS (FAST) PILOT TRIAL
Lily J. Park*1,2, Flavia K. Borges1,2, Rahima Nenshi1,2, Pablo E. Serrano1, Paul Engels1, Kelly Vogt3, Emily Di Sante2, Jessica Vincent2, Kate Tsiplova2, PJ Devereaux1,2
1McMaster University, Hamilton, ON, Canada; 2Population Health Research Institute, Hamilton, ON, Canada; 3Western University Schulich School of Medicine & Dentistry, London, ON, Canada
Background
The timing to surgery for acute cholecystitis (AC) remains variable, ranging anywhere from early (<7 days) to delayed surgery (>7 days). Accelerated surgery for AC may result in better outcomes by reducing patient exposure to inflammatory, hypercoagulable, and stress states. We undertook a pilot trial to determine the feasibility of providing accelerated care (i.e., surgery within 6 hours of diagnosis) compared to standard care among patients with calculus AC.
Methods
Adult patients with AC requiring surgery were randomized to receive accelerated surgery or standard care. The primary feasibility outcome included recruitment of 1 patient per site per month, ≥95% follow-up at 90 days, and determining timelines of accelerated surgery. The secondary outcome was a composite of major perioperative complications (all-cause mortality, reinterventions and reoperations, various intra- and post-operative complications, cardiovascular events, venous thromboembolism, bleeding) within 90 days of randomization. Other outcomes included individual components of the composite, length of hospital stay, readmissions, surgery duration, and feasibility of drawing preoperative point-of-care N-terminal-pro hormone BNP (NT-proBNP) in ≥90% of patients. Analysis included descriptive statistics and cox proportional hazards models to calculate hazard ratios (HR) and 95% confidence interval (CI) for outcomes with time to event data.
Results
Sixty patients were randomly assigned to accelerated surgery (N=31) and standard care (N=29) across 4 Canadian hospitals. There was ≥1 patient recruited per site per month. All patients completed 90 day follow up. The median time and interquartile range (IQR) from diagnosis to surgery in the accelerated arm was 5.8 [4.4-11.1] hours versus 20.3 [6.8-26.8] hours in the standard care arm. A major perioperative complication occurred in 9/31 (29.0%) patients in the accelerated and 4/29 (13.8%) patients in the standard care arm (HR 2.42, 95% CI 0.74-7.91). The main contribution was from 5/31 (16.1%) versus 1/29 (3.4%) post-operative endoscopic retrograde cholangiopancreatography performed in the accelerated versus standard care arm, respectively (HR 5.11, 95% CI 0.60-43.9). Of note, 4/31 and 3/29 patients in the accelerated and standard care groups underwent intraoperative cholangiogram. Between both groups, there were no differences in surgery duration (mean (standard deviation): 86.8 (30.0) vs. 86.4(32.3) minutes), length of hospital stay (median [IQR]: 2.0 [1.0-3.0] vs. 2.0 [2.0-3.0] days), readmissions (2/31 vs. 4/29), or cardiovascular events (2/31 vs. 1/29). Preoperative NT-proBNP was drawn in 57/60 (95.0%) patients.
Conclusion
These results demonstrate the feasibility of a trial comparing accelerated and standard care among patients requiring surgery for AC and supports a definitive trial.
Back to 2023 Abstracts