Publicatie datum

A Prospective, Observational, Multicentre Study Concerning Nontechnical Skills in Robot-assisted Radical Cystectomy Versus Open Radical Cystectomy.

Beulens, A.J.W., Brinkman, W.M., Koldewijn, E.L., Hendrikx, A.J.M., Basten, J.P.A. van, Merriënboer, J.J.G. van, Poel, H.G. van der, Bangma, C.H., Wagner, C. A Prospective, Observational, Multicentre Study Concerning Nontechnical Skills in Robot-assisted Radical Cystectomy Versus Open Radical Cystectomy. European Urology Open Science: 2020, 19, p. 37-44.
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Introduction and hypotheses
valuation of surgical skills, both technical and nontechnical, is possible through observations and video analysis. Besides technical failures, adverse outcomes in surgery can also be related to hampered communication, moderate teamwork, lack of leadership, and loss of situational awareness. Even though some surgeons are convinced about nontechnical skills being an important part of their professionalisation, there is paucity of data about a possible relationship between nontechnical skills and surgical outcome. In robot-assisted surgery, the surgeon sits behind the console and is at a remote position from the surgical field and team, making communication more important than in open surgery and conventional laparoscopy. A lack of structured research makes it difficult to assess the value of the different analysis methods for nontechnical skills, particularly in robot-assisted surgery. Our hypothesis includes the following: (1) introduction of robot-assisted surgery leads to an initial decay in nontechnical skills behaviour during the learning curve of the team, (2) nontechnical skills behaviour is more explicitly expressed in experienced robot-assisted surgery teams than in experienced open surgery teams, and (3) introduction of robot-assisted surgery leads to the development of different forms of nontechnical skills behaviour compared with open surgery.

This study is a prospective, observational, multicentre, nonrandomised, case-control study including bladder cancer patients undergoing either an open radical cystectomy or a robot-assisted radical cystectomy at the Catharina Hospital Eindhoven, the Netherlands, or at the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital Amsterdam. All patients are eligible for inclusion; there are no exclusion criteria. The Catharina Hospital Eindhoven, the Netherlands, performs on average 35 radical cystectomies a year. The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital Amsterdam, performs on average 100 radical cystectomies a year.

Protocol overview
The choice of treatment is at the discretion of the patient and the surgeon. Patient results will be obtained prospectively. Pathology results as well as complications occurring within 90 d following surgery will be registered. Surgical complications will be registered according to the Clavien-Dindo system.

Nontechnical skills will be observed using five different methods: (1) NOTSS: Nontechnical Skills for Surgeons; (2) Oxford NOTECHS II: a modified theatre team nontechnical skills scoring system; (3) OTAS: Observational Teamwork Assessment for Surgery; (4) Interpersonal and Cognitive Assessment for Robotic Surgery (ICARS): evaluation of nontechnical skills in robotic surgery; and (5) analysis of human factors. Technical skills in robot-assisted radical cystectomy will be analysed using two different methods: (1) GEARS: Global Evaluative Assessment of Robotic Skill and (2) GERT: Generic Error Rating Tool.

Safety criteria and reporting
Formal ethical approval has been provided by Medical research Ethics Committees United (MEC-U), The Netherlands (reference number W19.048). We hope to present the results of this study to the scientific community at conferences and in peer-reviewed journals.

Statistical analysis
Frequency statistics will be calculated for patient demographical data, and a Shapiro-Wilk test with p > 0.05 will be used to define normal distribution. Univariate analysis will be conducted to test for statistically significant differences in observation scores between open radical cystectomy and robot-assisted radical cystectomy cohorts across all variables, using independent sample t tests and Mann-Whitney U testing, as appropriate. A variable-selection strategy will be used to create multivariate models. Binary logistic regression will be conducted to calculate odds ratios and 95% confidence intervals for significant predictors on univariate analysis and clinically relevant covariates. Statistical significance is set at p < 0.05 based on a two-tailed comparison.

This study uses a structured approach to the analysis of nontechnical skills using extracorporeal videos of both open radical cystectomy and robot-assisted radical cystectomy surgeries, in order to obtain detailed data on nontechnical skills during open and minimally invasive surgeries. The results of this study could possibly be used to develop team-training programmes, specifically for the introduction of the surgical robot in relation to changes in nontechnical skills. Additional analysis of technical skills using the intracorporeal footage of the surgical robot will be used to elucidate the role of surgical skills and surgical events in nontechnical skills.