Oral vs intravenous antibiotic prophylaxis in elective laparoscopic cholecystectomy—an exploratory trial View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2008-07

AUTHORS

Urte Zurbuchen, Joerg-P. Ritz, Kai S. Lehmann, Joern Groene, Majid Heidari, Heinz J. Buhr, Christoph-T. Germer

ABSTRACT

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. More... »

PAGES

479

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00423-007-0256-4

DOI

http://dx.doi.org/10.1007/s00423-007-0256-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1013731274

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/18094990


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52 schema:description 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.
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