Oral vs intravenous antibiotic prophylaxis in elective laparoscopic cholecystectomy: an exploratory trial

The application of perioperative intravenous antibiotic prophylaxis is often considered a necessary routine procedure. The only way to decide whether an antibiotic prophylaxis is necessary in elective gallbladder surgery is to conduct a multicenter randomized trial. The aim of this exploratory trial was to clarify whether an oral application of an antibiotic prophylaxis is a feasible and safe procedure compared to intravenous application. This exploratory trial was conducted prospective randomized, using a double-dummy design. The main target criteria included tolerance, adverse effects, pharmacokinetics, and cost of treatment.

Patients undergoing elective laparoscopic cholecystectomy were randomized double-blinded to an oral or intravenous application group of one antibiotic (gyrase inhibitor) using a double-dummy design. Exclusion criteria were acute cholecystitis, icterus, and choledocholithiasis. In addition to a tolerance analysis, the antibiotic concentration was determined in serum and bile by high-pressure liquid chromatography (HPLC).

One hundred fifty one patients (75 patients with oral and 76 with intravenous prophylaxis) were evaluated for the tolerance analysis. Four patients (1 p.o., 3 i.v.) had adverse reactions to the antibiotics. The antibiotic serum concentration was 0.83 mg/l (p.o.) vs 8.44 mg/l (i.v.) before surgery, 0.81 mg/l (p.o.) vs 4.43 mg/l (i.v.) during surgery, and 0.69 mg/l (p.o.) vs 2.77 mg/l (i.v.) after surgery. The bile concentration was higher after oral administration with 9.20 mg/l than after intravenous application with 5.79 mg/l. The costs of medication for intravenous application were 20 times higher than those for oral application.

The oral application of an antibiotic (gyrase inhibitor) was feasible and safe for perioperative antibiotic prophylaxis in laparoscopic cholecystectomy in this exploratory trial.