Bladder Cancer
Conditions
Keywords
radical cystectomy, antibiotic prophylaxis, ERAS protocol, muscle-invasive bladder cancer, urinary diversion
Brief summary
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.
Interventions
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.
DRUGAmoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg
Group A: antibiotic prophylaxis within 24 hours from the moment of skin incision according to local clinical practice;
Sponsors
The Foundation for Cancer Research Support (RakFond)
N.N. Petrov National Medical Research Center of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* histologically confirmed diagnosis of very high risk non muscle-invasive bladder carcinoma (cT1NoMo) or muscle-invasive bladder carcinoma (cT2-T4NxM0) with or without neoadjuvant therapy (chemotherapy or immunotherapy are both possible); * patient should be eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy or hysterectomy if applicable) according to surgeon opinion; * pelvic lymph node dissection is engaged in two possible variants: extended level to intersection of ureter and iliac vessels; superextended level - up to aortic bifurcation; * urinary diversion is engaged in two possible variants: orthotopic diversion (J- or U-pouch reservoirs), heterotopic diversion in the Mainz-I modification, Bricker; * male or female is at least 18 years old at the time of signing the informed consent form; * female patient is eligible to participate if she is not pregnant, not breastfeeding; * ECOG performance status of 0 or 1; * adequate organ function (in accordance with laboratory standards); * used valid protocol for Enhanced Recovery After Surgery (ERAS protocol) at Hospital (oncourological department);
Exclusion criteria
* known additional non-urothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions; * diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug; * replacement doses of corticosteroids are permitted for participants with adrenal insufficiency; * evidences of uncontrolled diseases (diabetes mellites, noninfectious pneumonitis that required steroids, et.) or any conditions which interfere with the conduct of the research procedures according to doctor opinion; * presence of 2 or more criteria for systemic inflammatory response syndrome (SIRS) at the time of the patient's admission to the hospital (assessment of these factors 3-7 days before randomization): * temperature ≥ 38˚С or ≤ 36˚С; * heart rate (HR) ≥ 90 / min; * respiratory rate \< 20/min or hyperventilation (Pa CO2 ≤ 32 mm Hg); * blood leukocytes \>12 ∙ 109 / l or \< 4 ∙ 109 / l, or immature forms \> 10% * prohibited urinary diversion when planning surgery and signing voluntary consent: diversion into continuous intestine (ureterosigmostomy, Mainz-pouch II operation); * inadequate organ function: * Neutrophils \<1.5 x 10 \^ 9 / l * Platelets \<100 x 10 \^ 9 / l * ALT\> 3 x VGN * AST\> 3 x VGN * Bilirubin\> 1.5 x ULN * GFR level \<35 ml / min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event rate | 90 days after Radical cystectomy | 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 |
| Event-free survival | 90 days after Radical cystectomy | Estimate the time to development of events of clinical interest in the period 30-90 days after RC in a surgical hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergence of resistant | 30-90 days after Radical cystectomy | To assess the probability of occurrence of acquired carbapenemase against the background of prolonged antibiotic prophylaxis |
| All-cause mortality | 90 days after Radical cystectomy | 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 |
Countries
Russia
Contacts
Primary ContactMariya Berkut, PhD
Outcome results
None listed