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

"Conflict of Interest Statement All the authors declare that they have no conflict of interest regarding this study."

"This project received no external funding."

"The study was designed according to the guidelines in the synthesis of qualitative research (ENTREQ) found on the equatornetwork.org []. Before starting the study, we obtained the approval of the local ethics review board at the University Medical Center in Rostock (A 2019-0213 from 26 November 2019). Furthermore, the study was registered at the German Clinical Trials Register (DKRS 00020406). Formally, this study is a prospective unicentric noninterventional trial. The inclusion criteria were adult patient (aged over 18 years) and RC with IC as urinary diversion due to muscle-invasive bladder cancer. If the inclusion criteria were met and informed consent was obtained from the patient, there were no further exclusion criteria. All relevant patient data like patient history, demographic characteristics, and all relevant clinical data were prospectively collected according to the study protocol, available via DKRS number, on defined timepoints (preoperatively and days 4, 8, and 12 postoperatively). The urine samples were collected by sterile catheterization of the IC, except prior to RC when midstream urine was used. 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. No bowel preparation was done. RC with bilateral pelvic lymphadenectomy was performed according to the established surgical principles and IC was implemented with a 12–15-cm ileal loop taken 20 cm from the ileocecal valve, with end-to-end ileostomy and separate end-to-side anastomoses of the ureters to the IC. Ureteric stents got removed on days 9 and 10 after surgery without prior antibiotic administration. We applied the principles of enhanced recovery after surgery (fast-track surgery). The patients got discharged from the hospital on day 12 following RC, when no complication was obvious or intravenous treatment was necessary."