The current usage of antibiotic prophylaxis (AP) in radical cystectomy (RC) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. There are a huge number of different AP protocols according to Urological Associations. However, there is no convincing evidence to support variations and duration of AP which requires a randomized clinical trial on AP when performing variants of RC with uroderivation. Research hypothesis: The use of prolonged antibiotic prophylaxis (5 days), depending on the glomerular filtration rate, does not affect the incidence of postoperative complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
98
Group B: prolonged antibiotic prophylaxis \>72 hours (5 days) from the moment of the skin incision in accordance with the selected clinic drug + correction of the appointment based on clinical events after 5 days.
Group A: antibiotic prophylaxis within 24 hours from the moment of skin incision according to local clinical practice;
FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
Saint Petersburg, Sankt-Peterburg, Russia
RECRUITINGEvent rate
Determine the frequency of events of clinical interest in the period 30-90 days after RC in a surgical hospital working according to the protocol for early postoperative recovery of the patient
Time frame: 90 days after Radical cystectomy
Event-free survival
Estimate the time to development of events of clinical interest in the period 30-90 days after RC in a surgical hospital
Time frame: 90 days after Radical cystectomy
Emergence of resistant
To assess the probability of occurrence of acquired carbapenemase against the background of prolonged antibiotic prophylaxis
Time frame: 30-90 days after Radical cystectomy
All-cause mortality
Establish the frequency of 30-day, 90-day all-cause mortality after RC in a surgical hospital working according to the protocol for early postoperative patient recovery
Time frame: 90 days after Radical cystectomy
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