Alexander Beulens

64 Chapter 3 experience consisted of completion of surgical rotation, experience with laparoscopy, and experience with RAS. The Participant satisfaction questionnaire was used to have a feedback and ensure a high quality of the training programme. The Kirkpatrick’s (KP) model was used to assess participant’s satisfaction and it was filled at the end of the training by all the participants. Informed consent Although participants were not subjected to any study actions, the Medical Ethics Committee deemed the Medical Research Involving Human Subjects Act did not apply since no physically and psychological invasive interventions were performed. Informed consent was obtained from all participants and the study was granted approval from the institutional medical committee. Procedure Design This prospective non-blinded 3-arm randomised controlled trial investigated different methods of teaching RAS using simulation. After a basic skill and an un-guided procedural simulator training the participants were randomly divided into three different intervention groups (proctored guided, simulator-generated guidance and no guided). During this phase the participants received a different training and at the end were asked to perform again the same task (vesicourethral anastomosis) autonomously. All parts of the training were the same for all the trainees with the exception of the intervention phase. During the training all participants were asked to complete multiple questionnaires. Training program The training program is displayed in figure 2. The training was given in timeslots of three hours and a maximum two participants per timeslot were included. A minimum of one trainer was present during the training. The proctor guided group received individual guidance by one of the two trainers. All the participants started with the completion of the baseline questionnaire and with the signature of the consent form. The randomization was performed using a simple randomization, prior to the start of the study a sequence of 72 random numbers ranging 1-3 was created using www. The numbers in this sequence automatically received a place marker (1-72), this place marker corresponded to a study number (1-72). The study numbers were assigned to the participants in numerical sequence once the participant com-