Introduction: Radical cystectomy (RC) is associated with a high risk of infectious complications. This risk does not only apply for the perioperative phase, but also for the long-term. Despite significant morbidity, these complications are inadequately investigated. This is the first prospective study that systematically assesses infectious complications after RC. Methods: Patients undergoing RC because of oncological and non-oncological indications are prospectively enrolled in this ongoing observational study. Perioperative parameters are assessed at standardized time points and include infectious laboratory parameters (leukocytes, CRP, IL-6, Procalcitonin) as well as microbiological analyses (wound drainage, urine samples). Follow-up examinations are performed 3, 6, and 12 months after surgery and include questionnaires, blood tests, and urosonography. An Ethical Committee approval has been obtained and the study has been registered on ClinicalTrials.gov (NCT05153694). Results: We performed an interim analysis of 50 patients. The median age was 69 years (84% male, 16% female). 40.0% received an ileal conduit (IC) and 60.0% a neobladder (NB). 50.0% of patients presented with a urinary tract infection preoperatively, but only 25.0% reported dysuria. The hospital antibiotic (AB) prophylaxis standard of cefuroxime (5d) and metronidazole (3d) was extended in 97.6% of patients. Microbiological analysis of the wound drainage on the 1st postoperative day (POD) showed bacterial growth in 18.2%. The urine culture on the 8th POD was positive in 65.9%. 40.0% had at least one episode of fever (=38°C) during the inpatient stay. The incidence of fever between IC and NB was not significantly different (OR 0.88; p=0.24). Also, there was no significant association between the level of IL-6 on the 1 st POD or the results of the microbiological analyses (wound drainage and urine samples) and the occurrence of fever (p=0.82; p=0.83; p=0.93, respectively). 50.0% reported the intake of at least one AB drug and 31.4% reported an emergency consultation due to RC-associated fever in the first 3 months after surgery, respectively. There was no significant difference between IC and NB for these follow-up results (p=0.17; p=0.55, respectively). Conclusions: This is the first systematic and comprehensive prospective study assessing infectious complications after RC. Importantly, our preliminary results indicate that these complications are severely underestimated both during the inpatient stay, but also in the long-term. SOURCE OF Funding: No funding
