Russian Randomized Trial to Select Optimal Antibiotic Prophylaxis in Radical Cystectomy: Initial Results of MACS-TRIAL (NCT05392634)

Abstract

Introduction. The key treatment for high-risk non-invasive bladder tumor or invasive urothelial cancer remains radical cystectomy (RCE), which provides the best survival rates. At the same time, the incidence of infectious complications in a number of studies reaches 33%, which in most cases causes repeated hospitalizations and disrupts the Enhanced Recovery After Surgery (ERAS) guidelines. Therefore, research into effective alternations of antibiotic prophylaxis remains relevant.Materials and methods. The MACS trial is a Russian Phase 3 study with a prospective randomized set of participants to assess the incidence of infectious complications after RCE in the context of the ERAS guidelines (intermediate data snapshot after including 39% of the data). Detailed inclusion and exclusion criteria are published on ClinicalTrials. gov, ID – NCT05392634. The study has been approved by the Local Ethics Committee, No. 1/129 of April 28, 2022. Statistical data processing was performed with StatPlus:Mac LE.Results and discussion. 36 patients were included in the study (39% of the expected sample). For the period from May 30, 2022 to February 01, 2023. A heterotopic Bricker reservoir was formed intracorporeally in 83.3% of cases (30/36), an orthotopic J-pouch reservoir was created in 13.8% of cases (5/36) and in 2.9% of cases (1/36) the urodereating stage was completed with ureteral clipping. No significant differences were revealed in urine bacterial contamination before surgery. However, in group A, the incidence of positive bacterial cultures, when the ureteric intubators were removed, was 2-fold higher than in the prolonged antibiotic therapy group: 7/14 cases (50.0%) and 3/12 cases (25.0%), respectively. In group B, the risk of complications in the prolonged antibiotic therapy group reduced by 47% within 30 days after RCE (HR 0.53 (95CI %: 0.21-1.32).Conclusion. An intermediate data snapshot in MACS study revealed that RCE was associated with a high risk of early postoperative infectious complications. The prognostic significance of systemic inflammation indices as predictors of infectious complications subject to further evaluation in the remaining 61% of cases.