BACKGROUND: Current recommendations for treating acute calculus cholecystitis include the use of intravenous antibiotics, although these recommendations were never tested scientifically. The aim of this study was to evaluate the role of intravenous antibiotic therapy in patients with mild acute calculus cholecystitis. METHODS: In this prospective, randomized controlled trial, 84 patients with a diagnosis of mild acute calculus cholecystitis were randomly assigned to supportive treatment only or supportive treatment with intravenous antibiotic treatment (42 patients in each arm). Patients were followed through their index admission and until delayed laparoscopic cholecystectomy was performed. RESULTS: The two study groups did not differ in their demographic data or in the clinical presentation and disease severity. Analysis was conducted on the intent-to-treat basis. Patients in the intravenous antibiotics arm resumed a liquid diet earlier (1.7 vs. 2.2 days, p = 0.02) but did not significantly differ in resumption of regular diet (2.8 vs. 3.2 days, p = 0.16) or hospital length of stay (LOS) (3.9 vs. 3.8 days, p = 0.89). Patients in the intravenous antibiotics arm had rates of percutaneous cholecystostomy tube placement (12 vs. 5 %, p = 0.43), readmissions (19 vs. 13 %, p = 0.73), and perioperative course similar to those not receiving antibiotics. The overall hospital LOS, including initial hospitalization and subsequent cholecystectomy, was similar for both groups (5.6 vs. 5.1 days, p = 0.29). Eight (19 %) patients in the supportive arm were crossed over to the intravenous antibiotic arm during the index admission. CONCLUSIONS:Intravenous antibiotic treatment does not improve the hospital course or early outcome in most of the patients with mild acute calculus cholecystitis.
RCT Entities:
BACKGROUND: Current recommendations for treating acute calculus cholecystitis include the use of intravenous antibiotics, although these recommendations were never tested scientifically. The aim of this study was to evaluate the role of intravenous antibiotic therapy in patients with mild acute calculus cholecystitis. METHODS: In this prospective, randomized controlled trial, 84 patients with a diagnosis of mild acute calculus cholecystitis were randomly assigned to supportive treatment only or supportive treatment with intravenous antibiotic treatment (42 patients in each arm). Patients were followed through their index admission and until delayed laparoscopic cholecystectomy was performed. RESULTS: The two study groups did not differ in their demographic data or in the clinical presentation and disease severity. Analysis was conducted on the intent-to-treat basis. Patients in the intravenous antibiotics arm resumed a liquid diet earlier (1.7 vs. 2.2 days, p = 0.02) but did not significantly differ in resumption of regular diet (2.8 vs. 3.2 days, p = 0.16) or hospital length of stay (LOS) (3.9 vs. 3.8 days, p = 0.89). Patients in the intravenous antibiotics arm had rates of percutaneous cholecystostomy tube placement (12 vs. 5 %, p = 0.43), readmissions (19 vs. 13 %, p = 0.73), and perioperative course similar to those not receiving antibiotics. The overall hospital LOS, including initial hospitalization and subsequent cholecystectomy, was similar for both groups (5.6 vs. 5.1 days, p = 0.29). Eight (19 %) patients in the supportive arm were crossed over to the intravenous antibiotic arm during the index admission. CONCLUSIONS: Intravenous antibiotic treatment does not improve the hospital course or early outcome in most of the patients with mild acute calculus cholecystitis.
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