Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery (MACS)

This is an interventional prevention trial for Bladder Cancer focused on measuring radical cystectomy, antibiotic prophylaxis, ERAS protocol, muscle-invasive bladder cancer, urinary diversion Read More

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