2.1. Study Design
bladder carcinoma, a malignant neoplasm of the urinary bladder
AORTIC STENOSIS, BLADDER CARCINOMA, RECRUITMENT
Patients with a malignant neoplasm of the urinary bladder, who underwent radical cystectomy at Marien Hospital Herne, University Hospital of the Ruhr-University Bochum, Germany, were included in this prospective, controlled, randomized, partially blinded study after detailed information and written informed consent. The study was approved by the Ethics Committee of the Ruhr-University Bochum (Registration No.: 20-7027-NIS) on 11 September 2020, and the study was registered in the German Registry for Clinical Studies (DRKS-ID: DRKS00023682) on 25 November 2020. After checking for eligibility block-wise (10 patients per block, 6:4 randomization), randomization was performed in a standardized manner using consecutively numbered envelopes during the anesthesiological informed consent interview by physicians and data were collected and stored using REDCap (Research Electronic Data Capture), which is a secure, web-based software platform designed to support data capture for research studies [Recruitment was based on defined inclusion and exclusion criteria. All patients had a pathologically histologically confirmed bladder carcinoma and were about to undergo radical cystectomy with urinary diversion. A minimum age of 18 years, adherence to the Enhanced Recovery After Surgery (ERAS) protocol and assignment to the American Society of Anesthesiologists (ASA) anesthesiologic risk score of classes II/III and epidural anesthesia in combination with standard anesthesia were considered as inclusion criteria. Exclusion criteria were being under the minimum age of 18 years, a language barrier and clinically relevant aortic stenosis. A total of 60 patients were randomized and a total of 51 patients were included in the final analysis, whereas all patients are listed according to the consolidated standards of reporting trials (CONSORT) requirements [