S.N. Paus-Buzink
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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.
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.
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.