INTRODUCTION: 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. MATERIAL AND METHODS: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). RESULTS: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. CONCLUSION: The oral application of an antibiotic (gyrase inhibitor) was feasible and safe for perioperative antibiotic prophylaxis in laparoscopic cholecystectomy in this exploratory trial.
RCT Entities:
INTRODUCTION: 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. MATERIAL AND METHODS: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). RESULTS: 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. CONCLUSION: The oral application of an antibiotic (gyrase inhibitor) was feasible and safe for perioperative antibiotic prophylaxis in laparoscopic cholecystectomy in this exploratory trial.
Authors: J A Shea; M J Healey; J A Berlin; J R Clarke; P F Malet; R N Staroscik; J S Schwartz; S V Williams Journal: Ann Surg Date: 1996-11 Impact factor: 12.969
Authors: J A Shea; J A Berlin; D R Bachwich; R N Staroscik; P F Malet; M McGuckin; J S Schwartz; J J Escarce Journal: Ann Surg Date: 1998-03 Impact factor: 12.969
Authors: Abhishek Choudhary; Matthew L Bechtold; Srinivas R Puli; Mohamed O Othman; Praveen K Roy Journal: J Gastrointest Surg Date: 2008-09-09 Impact factor: 3.452