Laparoscopic surgery offers significant benefits to patients in low-resource settings compared to open surgery such as faster recovery, less pain, and lower infection rate. However, there exist significant barriers to the safe introduction of laparoscopy such as high costs and limited availability of trained staff. Low- and middle-income country (LMIC) hospitals suffer from higher post-surgical infection which might be due to the limited facilities for the sterile reprocessing of laparoscopic instruments. To design a solution to this issue, a detailed understanding of local settings was needed. Therefore, this research applied a context-driven design approach, based on the Roadmap for Design of Surgical Equipment for Safe Surgery Worldwide. Over several design phases, the need for a reprocessing device was established. An analysis of the sterile reprocessing of laparoscopic instruments led to a list of context-specific design requirements. These were translated to a final conceptual design of a laparoscopic instrument cleaner using a waterfall design method. Finally, a usability study of the loading system of the device was conducted with nurses in four Indian hospitals. A root-cause analysis of the usability study showed that the device was not intuitive enough to use for Indian nurses. A redesign of the loading system was made to improve its ease of use. The design process used in this study can be used as an example for designers wanting to address the critical issue of context-specific medical devices worldwide, or more specifically, the sterile supply of surgical instruments in resource-constrained environments.

Introduction: There has been a wide uptake in the use of Minimal Invasive Surgery (MIS) globally across different surgical specialties. Whilst evidence exists for a structured training curriculum for basic laparoscopic surgery, there is little agreement on a complete framework for an advanced MIS training curriculum, defining the essential elements of the curriculum including the optimal assessment methods. The aim of this study is to obtain a consensus on the essential elements of a training curriculum for advanced MIS. Materials and Methods: A Delphi study was carried out involving 57 international experts in advanced MIS across different surgical specialties. A three round survey was conducted to reach consensus on the essential domains of a curriculum. This included defining the learners, trainers and training centres; curriculum content and competency based assessment. Results: Unanimous agreement was reached for the completion of basic laparoscopic training before entry into advanced training. A trainer should have reached competency in advanced MIS and attended a ‘Train the trainer’ course. The curriculum should be delivered as modular training, including a multi-modal approach with a structured clinical proctorship programme. Formative assessment was considered as an integral part of learning and should be performed using objective work based assessment tools such as global assessment scale (GAS) forms. Accreditation in advanced MIS can be achieved by objective assessment of technical performance of unedited videos in addition to key clinical performance outcomes. Conclusion: A consensus on the framework of an advanced MIS training curriculum has been achieved defining the essential elements of entry criteria, selection of trainers and training units and curriculum content. Multimodal learning, clinical proctorship programme and competency based assessment are integral parts of the curriculum.

Objective Laparoscopic skills can be improved effectively through laparoscopic simulation. The purpose of this study was to verify the face and content validity of a new portable Ergonomic Laparoscopic Skills simulator (Ergo-Lap simulator) and assess the construct validity of the Ergo-Lap simulator in 4 basic skills tasks. Design Four tasks were evaluated: 2 different translocation exercises (a basic bimanual exercise and a challenging single-handed exercise), an exercise involving tissue manipulation under tension, and a needle-handling exercise. Task performance was analyzed according to speed and accuracy. The participants rated the usability and didactic value of each task and the Ergo-Lap simulator along a 5-point Likert scale. Setting Institutional academic medical center with its affiliated general surgery residency. Participants Forty-six participants were allotted into 2 groups: a Novice group (n = 26, <10 clinical laparoscopic procedures) and an Experienced group (n = 20, >50 clinical laparoscopic procedures). Results The Experienced group completed all tasks in less time than the Novice group did (p < 0.001, Mann-Whitney U test). The Experienced group also completed tasks 1, 2, and 4 with fewer errors than the Novice group did (p < 0.05). Of the Novice participants, 96% considered that the present Ergo-Lap simulator could encourage more frequent practice of laparoscopic skills. In addition, 92% would like to purchase this simulator. All of the experienced participants confirmed that the Ergo-Lap simulator was easy to use and useful for practicing basic laparoscopic skills in an ergonomic manner. Most (95%) of these respondents would recommend this simulator to other surgical trainees. Conclusions This Ergo-Lap simulator with multiple tasks was rated as a useful training tool that can distinguish between various levels of laparoscopic expertise. The Ergo-Lap simulator is also an inexpensive alternative, which surgical trainees could use to update their skills in the skills laboratory, at home, or in the office.

In recent years, many efforts have been made to reduce the trauma of surgical access further by the use of single-incision laparoscopic surgery (SILS). The Ergo-Lap (ergonomic laparoscopic) simulator was taken to the 20th International Congress of the European Association for Endoscopic Surgery (EAES) in 2012 in Brussels, Belgium. During the congress, the simulator was assessed by 13 general surgeons with different SILS experience using a standardized questionnaire to determine the usability of the Ergo-Lap simulator training for basic SILS skills. Eleven of the 13 participants rated the simulator as an attractive simulator (attractive here means arousing interest of the trainees). For the aspects of training in an ergonomic way, 12 of 13 participants rated it as good to excellent because the work space and task panel location can be adjusted according to the length of instruments. Also, 92% (12 of 13) thought the Ergo-Lap simulator was useful for practicing basic SPLS skills. And 85% (11 of 13) thought it was very easy to use. For SILS skills training, this in~xpensive and portable Ergo-Lap simulator offers a feasible training opportunity to help trainees practice their SILS skills under ergonomic conditions.

For patients less invasive image-based procedures (IBP) such as laparoscopy have many benefits in comparison to traditional open surgery, such as less pain, faster recovery, and fewer scars. However, to perform IBP effectively, efficiently, and above all safely, the surgical team is highly dependent on technology. The interaction with the surgical instruments and equipment requires extensive training. The proficiency level of the physician and the interaction with the instruments and equipment are key factors in ensuring quality of surgical performance in IBP and patient safety. During surgery, the surgeon should be able to concentrate on the therapeutic tasks. To achieve this, the gap between the preferred and actual level of proficiency of the physician should first of all be minimised by means of preclinical training using simulation tools. In this thesis, the validity of virtual reality simulators for training and assessment of basic psychomotor skills for laparoscopic surgery and flexible lower gastrointestinal endoscopy (colonoscopy) is established. The relation between different IBP skills was also investigated. The performance on two basic laparoscopy tasks (bimanual tissue manipulation and angled laparoscope navigation) proves to be not related; clinically-based expertise in laparoscopic tissue manipulation does not infer skilfulness in angled laparoscope navigation. Training in basic laparoscopy tasks does not affect performance of basic colonoscopy tasks (and vice versa). Training and assessment of basic IBP skills should thus focus on each IBP skill type independently. The influence of specific characteristics of the simulator interface on the efficacy of preclinical training on simulators was also studied. The angled laparoscope navigation task is performed better in an abstract virtual environment than in a virtual environment with simulated anatomic landmarks of the abdomen. And, for training of laparoscopic suturing tasks haptic feedback is a prerequisite. Furthermore, the quality of performance and patient safety should be better safeguarded by improving the interaction with the instruments and equipment in the operating room. Using an integrated operating room system together with the prototype of Pro/cheQ (a digital integrated procedural checklist tool) reduces the number of equipment and instrument related risk sensitive events further than using only an integrated operating room system