Alexander Beulens

199 A prospective observational multicentre study concerning non-technical skills in robot assisted radical cystectomy versus open radical cystectomy. apy, prior local treatment, prior radiation therapy in the surgical field, diagnosis, prior abdominal and/or pelvic surgery, the indication of surgery, per-operative complications, postoperative complications according to the Clavien-Dindo system22, length of hospital stay, ICU stay, blood loss, PREMS, PROMS, method of surgery, and oncological outcome (Surgical margins and number of resected lymph nodes, and pathology results) will be registered prospectively. Patient follow-up will be at least 30 days. Surgeon specific data will be recorded (i.e. Age of the surgeon, Gender, right or left handedness, gaming experience and prior surgical and robot assisted surgery experience) Regulation statement As this is a prospective observational non-invasive study, participants will not be subject to any study treatments or actions. Even though, the Medical Research Involving Human Subjects Act (in Dutch: Wet Medisch-wetenschappelijk Onderzoek met Mensen) does not apply informed consent will be obtained. This study will be conducted in accordance to the “Code Goed Gebruik” (January 2002). Formal ethical approval has been provided by Medical research Ethics Committees United (MEC-U), Nieuwegein, reference number W19.048. The study protocol is registered at the Netherlands Trail Registry under reference number NL8537. Privacy Observations will be performed during surgery by two members of the urology inhouse staff (Medically trained researchers with training in both Non-Technical Skills and Technical skills analysis) none of the observers have a hierarchical relationship with any of the team members. As discussion of planned surgeries are part of daily staff meetings there are no additional privacy concerns. The observations do not contain the name of the patient, nor the date and time of surgery. This is in accordance with the General Data Protection Regulation, GDPR. Handling and storage of data and documents Data will be handled strictly confidential and will be coded during the extraction of patient characteristics and video analysis. It will be stored in a secure and encrypted database (research manager) and code lists will exclusively be stored at the hospital of consultation or treatment until video analysis results and patient characteristics have been matched. The data will be stored for a maximum period of 6 months. Afterwards they will be destroyed