SUMMARY A randomised controlled trial has been performed in 150 patients undergoing biliary operations to determine whether an antibiotic which is excreted almost entirely in bile (rifamide) is to be preferred to one having satisfactory serum levels only (gentamicin). Patients were allocated to one of three groups: 50 received gentamicin, 50 received rifamide, and there were 50 controls who received no antibiotic cover. In the absence of duct obstruction, rifamide achieved extremely high bile levels but low serum concentrations. However, in jaundiced patients, both the bile and the serum concentrations of rifamide were too low to be of therapeutic value. The incidence of postoperative sepsis was not reduced by rifamide compared with controls. In contrast, gentamicin achieved adequate serum concentrations in 88 % of patients. Despite poor bile levels, gentamicin was associated with a significant reduction of wound infection from 22 % to 6 % and septicaemia from 14 % to 2 % compared with controls. To reduce the septic complications of biliary operations, adequate serum levels of an effective antimicrobial are more important than an antibiotic, which is excreted almost entirely into the bile.Organisms can be isolated from the bile in approximately a third of patients having operations on the biliary tract (Edlund et al., 1958). If the bile duct contains stones and the patient is jaundiced at operation, bacteria are present in 90 % of cases (Flemma et al., 1967). After biliary operations, most of the clinical infections in the wound and in the bloodstream are associated with the presence of bacteria in the bile (Mason, 1968;Keighley et al., 1974). Therefore, it is those patients with calculous obstructive jaundice who are most likely to develop wound sepsis or septicaemia after elective operation.Prophylactic antibiotics have been shown to minimise the incidence of sepsis after biliary surgery (Bevan and Williams, 1971), and it has been suggested that an antibiotic that achieves high concentrations in the bile should be used (Acocella et al., 1968). Concentrations of antibiotic in the bile in patients having operations for biliary disease are inadequate if the biliary tract is obstructed, even if the antibiotic is normally excreted in high concentrations into the bile (Zaslow et al., 1947;Zaslow et al., 1950;Zaslow and Rosenthal, 1954;Khan and Scott, 1967;Mortimer et al., 1969; Sales et al., 1972)."Reprint requests to Mr J. Alexander-Williams.Received for publication 7 April 1976 The purpose of this study is to compare the results of prophylaxis with an antibiotic almost entirely excreted in the bile (rifamide) with one having adequate concentrations only in the serum (gentamicin).
Methods CLINICAL STUDYOne hundred and fifty patients undergoing operations on the biliary tract were allocated at random to one of three groups. Fifty received gentamicin, 50 were given rifamide, and there were 50 control patients who received no antibiotic cover. Randomisation was stratified to provide equal numbers of jaundiced patie...