DUGi

Evaluation of ureteral stents in bricker urinary diversion after radical cystectomy; randomized clinical trial

http://dugi.udg.edu/item/http:@@@@hdl.handle.net@@10256@@28671

Background: Radical cystectomy followed by Bricker-type ileal conduit urinary diversion is the standard treatment for muscle-invasive bladder cancer. Currently, the placement of ureteral stents is the gold standard to protect the uretero-ileal anastomosis. However, these devices are associated with significant morbidity, including urinary tract infections (UTIs), hematuria, and physical discomfort. Objective: The primary aim of this study is to evaluate and compare the incidence of early, mid-term, and long-term postoperative complications between patients undergoing radical cystectomy with Bricker diversion without ureteral stents (stentless) versus the standard procedure with stents. Methods: This is a multicenter, prospective, randomized, open-label, noninferiority trial involving nine hospitals in Catalonia. A total of 404 patients will be randomized 1:1 into two groups: the experimental group (stentless) and the control group (standard 6-7 Fr Mono-J stents). The primary endpoint is the incidence of complications within 12 months, measured by the Clavien-Dindo Classification System. Secondary variables include UTI rates, length of hospital stay, renal function evolution (eGFR and creatinine), and patient-reported pain using the Visual Analogue Scale (VAS). Expected Impact: If the stentless approach proves non-inferior, it could transform the standard of care by reducing stent-associated morbidity, enhancing patient physical comfort, and optimizing healthcare resources within the public health system

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