Reduction of Perioperative Antibiotic Prophylaxis in Open Radical Cystectomy with Ileal Conduit Is Feasible: Results of a Prospective Clinical Trial

Abstract

Introduction: The aim of this study is to perform a prospective clinical trial in antibiotic prophylaxis, infectious complication, and colonization of ileal conduit (IC) following radical cystectomy (RC) since urinary tract infections (UTIs) and surgical site infections (SSIs) contribute significantly to the morbidity associated with RC and IC. Moreover, an optimal regimen of antibiotic prophylaxis has not been established, yet. Material and Methods: After a positive vote of ethical review committee and the registration at the German Clinical Trials Register (DKRS 00020406), we started a prospective clinical unicentric not interventional study. The urine samples were collected by sterile catheterization of the IC. All patients received an antibiotic prophylaxis with 3 × 500 mg metronidazole and 3 × 1.5 g cefuroxime intravenously for 3 days starting on the day before RC. Ureteral stents got removed on days 9 and 10 after surgery without prior antibiotic administration. The student t test and the χ2 test or the Fisher exact test were used. For risk factor assessment, the univariate Cox regression method was applied. Results: Nineteen male (63.3%) and 11 female patients (36.7%) with a median age of 70.5 years were included. Three patients developed complicated UTI (10%) on day 12 after RC with E. faecium and needed antibiotic treatment with meropenem (Clavien-Dindo II). Two patients (6.7%) developed SSI with E. faecium and needed surgery (Clavien-Dindo IIIb). Palliative RC (p < 0.0001), prior radiation therapy (p < 0.0001), and timeframe >3 months from diagnosis to RC (p = 0.036) are significantly associated with the development of complicated UTI. Interestingly, the IC got colonized with Staph. haemolyticus at day 12 after RC (n = 12; 40.0%). We must assume that our data have some limitations like a unicentric study population. Conclusion: Further evaluation of reduction to single-shot antibiotic prophylaxis in nonpalliative RC with IC could be feasible.