Clinical trial NCT05392634: Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery
Official title: Рrospective Multicenter Randomized 3 Phase Study Evaluating the Role of Prolonged Antibiotic Prophylaxis as a Measure to Reduce the Incidence of Postoperative Complications After Radical Cystectomy With ERAS Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: radical cystectomy
antibiotic prophylaxis
ERAS protocol
muscle-invasive bladder cancer
urinary diversion
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
Collaborators: name: The Foundation for Cancer Research Support (RakFond)
First posted: 2022-05-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Event rate
timeFrame: 90 days after Radical cystectomy
measure: Event-free survival
timeFrame: 90 days after Radical cystectomy
Secondary outcomes:
measure: Emergence of resistant
timeFrame: 30-90 days after Radical cystectomy
measure: All-cause mortality
timeFrame: 90 days after Radical cystectomy
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
state: Санкт-Петербург
Study officials:
affiliation: FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
name: Mariya Berkut, PhD
role: PRINCIPAL_INVESTIGATOR
References: