Randomized Double-Blind Clinical Trial of Extended Antibiotic Therapy versus Placebo After Laparoscopic Cholecystectomy for Mild and Moderate Acute Calculous Cholecystitis (CHART Study, NCT02057679)

Objective: To determine the effect of extended antibiotic therapy on infectious complications in patients with mild and moderate acute calculous cholecystitis undergoing laparoscopic cholecystectomy. Background: Acute calculous cholecystitis is the most common complication of cholelithiasis. Laparoscopic cholecystectomy is the gold standard treatment in mild and moderate forms. Currently there is consensus for the use of antibiotics in the preoperative phase of acute cholecystitis. However, the need for antibiotic therapy after surgery remains undefined with a low level of scientific evidence. Methods: The CHART (Cholecystectomy Antibiotic Randomised Trial) study is a single-center, prospective, double blind, and randomized trial. Patients with mild to moderate acute cholecystitis operated by laparoscopic cholecystectomy were randomly assigned to receive antibiotic (amoxicillin/clavulanic acid) or placebo treatment for 5 consecutive days. Primary endpoint was postoperative infectious complications. Secondary endpoints were as follows: (1) length of hospital stay, (2) readmissions, (3) reintervention and (4) overall mortality. Results: In the per-protocol analysis, 6 of 104 patients (5.8%) in the placebo arm and 6 of 91 patients (6.6%) in the antibiotic arm developed postoperative infectious complications, absolute difference 0.82 (95% CI, -5.96 to 7.61, p= 0.81). The median hospital stay was 3 days, without significant difference between groups (p= 0.3). There was no mortality. There were no differences regarding readmissions and reoperations between the two groups. Conclusions: The use of antibiotics in the postoperative period of laparoscopic cholecystectomy for mild and moderate acute calculous cholecystitis is not justified, since it was not associated with a decrease in the incidence of infectious and other types of morbidity in the present study.