Laparoscopic cholecystectomy versus antibiotic therapy for acute cholecystitis in patients over 75 years: Randomized clinical trial and retrospective cohort study

Background and objective: The prevalence of acute cholecystitis among elderly patients is increasing. The aim of this study was to compare laparoscopic cholecystectomy (LC) to antibiotics in elderly patients with acute cholecystitis. Methods: A randomized multicenter clinical trial including patients over 75 years with acute calculous cholecystitis was conducted in four hospitals in Finland between January 2017 and December 2019. Patients were randomized to undergo LC or antibiotic therapy. Due to patient enrollment challenges, the trial was prematurely terminated in December 2019. To assess all eligible patients, we performed a retrospective cohort study including all patients over 75 years with acute cholecystitis during the study period. The primary outcome was morbidity. Predefined secondary outcomes included mortality, readmission rate, and length of hospital stay. Results: Among 42 randomized patients (LC n = 24, antibiotics n = 18, mean age 82 years, 43% women), the complication rate was 17% (n = 4/24) after cholecystectomy and 33% (n = 6/18, 5/6 patients underwent cholecystectomy due to antibiotic treatment failure) after antibiotics (p = 0.209). In the retrospective cohort (n = 630, mean age 83 years, 49% women), 37% (236/630) of the patients were treated with cholecystectomy and 63% (394/630) with antibiotics. Readmissions were less common after surgical treatment compared with antibiotics in both randomized and retrospective cohort patients (8% vs 44%, p < 0.001% and 11 vs 32%, p < 0.001, respectively). There was no 30-day mortality within the randomized trial. In the retrospective patient cohort, overall mortality was 6% (35/630). Conclusions: LC may be superior to antibiotic therapy for acute cholecystitis in the selected group of elderly patients with acute cholecystitis.