urothelial cell carcinoma of the bladder
Conditions
Interventions
An Open Radical Cystectomy (control) or Robot Assisted Radical Cystectomy (Intervention)
Sponsors
Investigator initiated study
Eligibility
Inclusion criteria
Inclusion criteria: Patients who will undergo either an Open Radical Cystectomy (ORC) or Robot Assisted Radical Cystectomy (RARC) in Catharina Hospital Eindhoven or Antoni van Leeuwenhoek hospital are eligible for this study. The choice of treatment is at the discretion of the patient and the surgeon. For study inclusion, the following criteria must be met: - Patients must be at least 18 years of age. - patients must be able to understand and sign an informed consent. - Patients who will undergo either an Open Radical Cystectomy (ORC) or Robot Assisted Radical Cystectomy (RARC) in Catharina Hospital Eindhoven or Antoni van Leeuwenhoek hospital. - indication for the radical cystectomy must be urothelial cell carcinoma of the bladder. - Informed consent of the patient to gather data and perform observations during surgery.
Exclusion criteria
Exclusion criteria: No exclusion criteria will be used for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following outcomes will be reported. Non-technical skills will be observed using five different methods. 1. NOTSS: Non-Technical Skills for Surgeons16 The focus of the NOTSS assessment method lies on the following aspects of NTS: -Situation Awareness: Developing and maintaining a dynamic awareness of the situation in operating theatre based on assembling data from the environment, understanding what they mean, and thinking ahead about what may happen next. -Decision Making: Skills for diagnosing the situation and reaching a judgement in order to choose an appropriate course of action. -Communication and Teamwork: Skills for working in a team context to ensure that the team has an acceptable shared overview of the situation and can complete tasks effectively. -Leadership: Leading the team and providing direction, demonstrating high standards of clinical practice and care, and being considerate about the needs of individual team members. 2. Oxford NOTECHS II: A Modified Theatre Team Non-Technical Skills Scoring System11,12 The focus of the NOTECHS II assessment method lies on the following aspects of NTS: -leadership and management -teamwork and co-operation -problem-solving and decision-making -situation awareness 3. OTAS: Observational Teamwork Assessment for Surgery20 The focus of the OTAS assessment method lies on the following aspects of NTS: -communication -coordination -cooperation and back up behaviour -leadership -team monitoring and situational awareness 4. ICARS: non-technical skills evaluation in robotic surgery17 The focus of the ICARS assessment method lies on the following aspects of NTS: -checklist and equipment -interpersonal skills (communication and team skills & leadership) -cognitive skills (decision-making & situational awareness) -resource skills (stress and distractors) 5. Human factors analysis21 Human factors analysis consists of 4 levels of system failure: unsafe acts, preconditions for unsafe acts, unsafe supervision, and org | — |
Secondary
| Measure | Time frame |
|---|---|
| Age, WHO performance status, Charlson comorbidity index, neoadjuvant chemotherapy, 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. | — |
Contacts
Public ContactAlexander Beulens
Catharina hospital Eindhoven
Outcome results
None listed