Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis (FAST) pilot trial.

Abstract

Background: Timing to surgery for acute cholecystitis remains variable, ranging from early (< 7 d) to delayed surgery (> 7 d). Accelerated surgery may result in better outcomes owing to reduced exposure to hypercoagulable and inflammatory states. We sought to determine the feasibility of a trial comparing accelerated surgery with standard care among patients with calculous acute cholecystitis.

Methods: We conducted a multicentre pilot randomized controlled trial. We randomly assigned adult patients with acute cholecystitis to receive accelerated surgery (i.e., goal of surgery within 6 hours of diagnosis) or standard care. The primary feasibility outcome included recruitment of 60 patients, randomly assigning the equivalent of 1 patient per site per month, and 95% follow-up at 90 days.

Results: Sixty patients (mean age 61.7, standard deviation [SD] 13.5, yr; 27 [45%] female) were randomly assigned to accelerated surgery (n = 31) or standard care (n = 29) from December 2019 to December 2021, with 2 recruitment pauses due to the COVID-19 pandemic. The median time from diagnosis to surgery was 5.8 (interquartile range [IQR] 4.4-11.1) hours in the accelerated care arm and 20.3 (IQR 6.8-26.8) hours in the standard care arm. Across 4 sites, 4.6 patients per month were randomly assigned. All patients completed the 90-day follow up.

Conclusion: In our pilot trial, we found that accelerated cholecystectomy was achievable. These results show the feasibility of a trial comparing accelerated and standard care among patients requiring surgery for acute cholecystitis and support a definitive trial.

Trial registration: ClinicalTrials.gov, no. NCT04033822.