The EasyFlex apparatus was developed and manufactured to improve the ergonomics and surgical comfort during particularly long-lasting endoscopic procedures in stone surgery. A well planned and conducted validation study by expert urologists across three clinics and five distinct endoscopic surgeries effectively established the significance and success of the surgical procedure.
Literature data reveal that the prevalence of orthopedic complaints among endourologists is 64.2%, which includes issues such as back problems (38.1%), neck problems (27.6%), hand problems (17.2%) along with hip and knee problems (14.2%). This risk is significantly higher among particularly older endourologists (> 40 yrs), those of African ancestry, individuals with longer practice tenure (> 10 yrs) and those conducting a higher number of annual procedures [11]. The ergonomic principles particular to endourological procedures, as well as the overall lack of ergonomic knowledge among endourologists, remain to be well elucidated. Outcomes of some recently published studies have shown the importance of ergonomics during fURS procedures [2, 10] and musculoskeletal ergonomics scores tailored for laparoscopy–endoscopy surgeries were used for evaluation [12]. Five independent endourologists performed a trial to compare the conventional fURS method and the EasyFlex based on the surgeons ergonomics and demonstrated a considerable improvement in ergonomics scores in favor of newly developed system. The study demonstrated that performance of the procedures with EasyFlex can improve the musculoskeletal system symptom scores in five distinct groups. The EasyFlex device has been shown to reduce foot and eye-related symptoms by addressing ergonomic challenges. Although mild hand–arm–shoulder symptoms persist, they have been found to be significantly less than those associated with the traditional surgical procedure. Unfortunately, studies comparing robotic fURS with traditional methods have found that the traditional approach produces higher ergonomic symptom scores [13, 15].
Performing these procedures in an consistent and intensive manner in the field of endourological surgery with the concern of chronic musculoskeletal-eye symptoms poses not only a significant challenge for urological surgeons but also increases the risk of developing chronic health issues in the future [16]. The EasyFlex validation study aims to raise ergonomic awareness and propose solutions for these challenges.
The EasyFlex system allows physicians to perform endoscopic procedures with reduced arm strain by including two distinct rotating mechanisms for improved endoscope manipulation capabilities. Physicians can delegate control of the endoscope's optical section to the carrier system, which allows for increased dexterity while performing additional manipulations. This feature maintains the endoscope's last position, reducing procedural delays and increasing success rates. The options offered by EasyFlex, which differ from other devices, are shown in Table 4.
Table 4
Easy Flex: Specific features |
} The height adjustment of the endoscope carrier arm is made with the bluetooth connection. } The height of the surgical chair can be adjusted with the foot pedal. Memory system, surgeon-specific personalized surgical chair and holder system height adjustment are provided |
} Easy Flex has been used by urologists in flexible Ureterorenoscopy surgeries and features have been added according to the feedback of gastroenterologists. } Easy Flex device, by keeping the flexible endoscope fixed, relieves the surgeon in ECRIS operations and provides protection from scopy. |
} Surgeon performs safe surgery with full knowledge of everything ◦ Patient monitor, Flexible URS, laser, guide application, stone removal with basket, irrigation, bleeding, sheet deplation can be observed by himself. |
} The Easy Flex device has features that can be used in all endoscopy clinics with slight modifications. } This situation has been taken into consideration while designing the endoscope holder. } The feature of the holder to be movable with a gradual slide is included in the specification. |
Additionally, as another advantage the system's light tube and sheath guiding apparatus increases physicians' flexibility and reduces the shoulder pain and stiffness associated with traditional approaches [17, 18].
Having the endoscopy sheath secured in place during the procedure, physicians may not face sheath displacement issues. A height-adjustable operating room step makes it easier to operate auxiliary units such as laser and/or fluoroscopy device pedals. It has been well sated that surgeon’s ergonomics, surgical team composition, appropriate instrumentation, and operating room layout are important factors to consider for successful fURS procedures [19].
While robotic fURS systems have been developed and clinically introduced over the last decade to solve such challenges, their effective use remained limited due to certain underlying reasons. These systems do not perform true robotic surgical procedures but rather provide software-assisted flexible URS handling and manipulation capabilities [8, 13, 14]. In comparison, EasyFlex is adaptable and may be used in various endoscopy procedures, with potential use in dental, and ophthalmic settings. The operational differences between robotic fURS devices and the EasyFlex system are shown in Table 5 [13, 14, 20, 21].
Table 5
Robotic Device | EasyFlex |
Set up time is long and tedious | Set up time is very short and easy |
As the fURS is folded, one staff member at the head of the patient and 2 staff at the surgical assistant. | Can perform the most difficult operations with an assistant. |
Spacious space in the operating room is an important handicap. | It takes up very little space to be noticed, it is specially designed in two parts. |
It does not have the ability to go forward with the endoscope + double rotation maneuver at the same time (it is frequently needed and used in fURS operation). | It allows the surgeon to perform every possible movement in the spatial plane simultaneously. |
Adaptation of the surgeon is difficult. Reduces preference by surgeons | Even new assistants can use it very easily. It increases the number of cases. |
Special and difficult to produce The cost is expensive | Production technology is available in different sectors, does not require new technological investment Low production cost |
It has a complex structure. Technical support is needed. | A simple structure of the device; ⎫ No technical support is needed ⎫ Does not require specially trained personnel |
Related with this issue again, while several endoscope holder systems have been introduced so far, many failed to meet the specific requirements of physicians performing fURS surgeries in an extensive manner [3, 22]. Given the common use and preference for flexible endoscopy systems and surgeries among physicians, technological advancements in this field continue to influence the clinical utility of endourological management options [23].
As an important parameter not only for the operating surgeon but also for the patients operated, no statistically significant difference was noted regarding the operational duration values between traditional and EasyFlex fURS procedures for the management of kidney stones in all locations. At present there is no patent addressing the specific requirement provided by the developed doctor's endoscopy chair and endoscope carrying/manipulation apparatus. Although there are several surgical stools, chairs, and armchairs available in the market, they are designed for general use rather than focusing on the specific surgical procedures. Taking the recent advancements in commonly performed fURS procedures, an increasing demand for such facilitating systems is become increasingly important more than ever [7, 23].