Safe implementation of hand held steerable laparoscopic instruments: a survey among EAES surgeons.

The complexity of handheld steerable laparoscopic instruments (SLI) may impair the learning curve compared to conventional instruments when first utilized. This study aimed to provide the current state of interest in the use of SLI, the current use of these in daily practice and the type of training which is conducted before using SLI in the operating room (OR) on real patients. An online survey was distributed by European Association of Endoscopic Surgery (EAES) Executive Office to all active members, between January 4th and February 3rd, 2020. The survey consisted of 14 questions regarding the usage and training of steerable laparoscopic instruments. A total of 83 members responded, coming from 33 different countries. Twenty three percent of the respondents using SLI, were using the instruments routinely and of these 21% had not received any formal training in advance of using the instruments in real patients. Of all responding EAES members, 41% considered the instruments to potentially compromise patient safety due to their complexity, learning curve and the inexperience of the surgeons. The respondents reported the three most important aspects of a possible steerable laparoscopic instruments training curriculum to be: hands-on training, safe tissue handling and suturing practice. Finally, a major part of the respondents consider force/pressure feedback data to be of significant importance for implementation of training and assessment of safe laparoscopic and robotic surgery. Training and assessment of skills regarding safe implementation of steerable laparoscopic instruments is lacking. The respondents stressed the need for specific hands-on training during which feedback and assessment of skills should be guaranteed before operating on real patients.

SATA-LRS: A modular and novel steerable hand-held laparoscopic instrument platform for low-resource settings☆.

BACKGROUND: Hospitals in low resource settings (LRS) can benefit from modern laparoscopic methodologies. However, cleaning, maintenance and costs requirements play a stronger role while training and technology are less available. Steerable laparoscopic instruments have additional requirements in these settings and need extra identified adaptations in their design. METHOD: Several modular detachability and tip steerability features were applied to the SATA-LRS instrument platform designed specifically for LRS. Ten subjects participated a dis- and reassembly experiment to validate the modularity, and in a steering experiment using a custom made set-up to validate steering. RESULTS: A new steerable SATA-LRS instrument was developed with the ability to exchange end-effectors through a disassembly of the shafts. Experiments showed an average 34 and 90 s for complete dis- and reassembly, respectively. Participants were able to handle the instrument independently after a single demonstration and 4 rounds of repetitions. Precise tip-target alignment in the box set-up showed a very short learning-curve of 6 repetitions. CONCLUSION: A novel instrument platform with articulating and rotating end-effector was designed for LRS. Within a minute the SATA-LRS can be disassembled to component level for inspection, cleaning, maintenance and repair, and can be autonomously reassembled by novices after a minimal training. The modular buildup is expected to reduce purchasing and repair costs. The instrument has been shown intuitive by use without extensive training.

Robotic-assisted cholecystectomy is superior to laparoscopic cholecystectomy in the initial training for surgical novices in an ex vivo porcine model: a randomized crossover study.

BACKGROUND: Robotic-assisted surgery (RAS) potentially reduces workload and shortens the surgical learning curve compared to conventional laparoscopy (CL). The present study aimed to compare robotic-assisted cholecystectomy (RAC) to laparoscopic cholecystectomy (LC) in the initial learning phase for novices. METHODS: In a randomized crossover study, medical students (n = 40) in their clinical years performed both LC and RAC on a cadaveric porcine model. After standardized instructions and basic skill training, group 1 started with RAC and then performed LC, while group 2 started with LC and then performed RAC. The primary endpoint was surgical performance measured with Objective Structured Assessment of Technical Skills (OSATS) score, secondary endpoints included operating time, complications (liver damage, gallbladder perforations, vessel damage), force applied to tissue, and subjective workload assessment. RESULTS: Surgical performance was better for RAC than for LC for total OSATS (RAC = 77.4 ± 7.9 vs. LC = 73.8 ± 9.4; p = 0.025, global OSATS (RAC = 27.2 ± 1.0 vs. LC = 26.5 ± 1.6; p = 0.012, and task specific OSATS score (RAC = 50.5 ± 7.5 vs. LC = 47.1 ± 8.5; p = 0.037). There were less complications with RAC than with LC (10 (25.6%) vs. 26 (65.0%), p = 0.006) but no difference in operating times (RAC = 77.0 ± 15.3 vs. LC = 75.5 ± 15.3 min; p = 0.517). Force applied to tissue was similar. Students found RAC less physical demanding and less frustrating than LC. CONCLUSIONS: Novices performed their first cholecystectomies with better performance and less complications with RAS than with CL, while operating time showed no differences. Students perceived less subjective workload for RAS than for CL. Unlike our expectations, the lack of haptic feedback on the robotic system did not lead to higher force application during RAC than LC and did not increase tissue damage. These results show potential advantages for RAS over CL for surgical novices while performing their first RAC and LC using an ex vivo cadaveric porcine model. REGISTRATION NUMBER: researchregistry6029.

A life cycle assessment of reprocessing face masks during the Covid-19 pandemic.

The Covid-19 pandemic led to threatening shortages in healthcare of medical products such as face masks. Due to this major impact on our healthcare society an initiative was conducted between March and July 2020 for reprocessing of face masks from 19 different hospitals. This exceptional opportunity was used to study the costs impact and the carbon footprint of reprocessed face masks relative to new disposable face masks. The aim of this study is to conduct a Life Cycle Assessment (LCA) to assess and compare the climate change impact of disposed versus reprocessed face masks. In total 18.166 high quality medical FFP2 face masks were reprocessed through steam sterilization between March and July 2020. Greenhouse gas emissions during production, transport, sterilization and end-of-life processes were assessed. The background life cycle inventory data were retrieved from the ecoinvent database. The life cycle impact assessment method ReCiPe was used to translate emissions into climate change impact. The cost analysis is based on actual sterilization as well as associated costs compared to the prices of new disposable face masks. A Monte Carlo sampling was used to propagate the uncertainty of different inputs to the LCA results. The carbon footprint appears to be 58% lower for face masks which were reused for five times compared to new face masks which were used for one time only. The sensitivity analysis indicated that the loading capacity of the autoclave and rejection rate of face masks has a large influence on the carbon footprint. The estimated cost price of a reprocessed mask was €1.40 against €1.55. The Life Cycle Assessment demonstrates that reprocessed FFP2 face masks from a circular economy perspective have a lower climate change impact on the carbon footprint than new face masks. For policymakers it is important to realize that the carbon footprint of medical products such as face masks may be reduced by means of circular economy strategies. This study demonstrated a lower climate change impact and lower costs when reprocessing and reusing disposable face masks for five times. Therefore, this study may serve as an inspiration for investigating reprocessing of other medical products that may become scarce. Finally, this study advocates that circular design engineering principles should be taken into account when designing medical devices. This will lead to more sustainable products that have a lower carbon footprint and may be manufactured at lower costs.

Can sterilization of disposable face masks be an alternative for imported face masks? A nationwide field study including 19 sterilization departments and 471 imported brand types during COVID-19 shortages.

BACKGROUND: Face masks, also referred to as half masks, are essential to protect healthcare professionals working in close contact with patients with COVID-19-related symptoms. Because of the Corona material shortages, healthcare institutions sought an approach to reuse face masks or to purchase new, imported masks. The filter quality of these masks remained unclear. Therefore, the aim of this study was to assess the quality of sterilized and imported FFP2/KN95 face masks. METHODS: A 48-minute steam sterilization process of single-use FFP2/KN95 face masks with a 15 minute holding time at 121°C was developed, validated and implemented in the Central Sterilization Departments (CSSD) of 19 different hospitals. Masks sterilized by steam and H2O2 plasma as well as new, imported masks were tested for particle filtration efficiency (PFE) and pressure drop in a custom-made test setup. RESULTS: The results of 84 masks tested on the PFE dry particle test setup showed differences of 2.3±2% (mean±SD). Test data showed that the mean PFE values of 444 sterilized FFP2 face masks from the 19 CSSDs were 90±11% (mean±SD), and those of 474 new, imported KN95/FFP2 face masks were 83±16% (mean±SD). Differences in PFE of masks received from different sterilization departments were found. CONCLUSION: Face masks can be reprocessed with 121 °C steam or H2O2 plasma sterilization with a minimal reduction in PFE. PFE comparison between filter material of sterilized masks and new, imported masks indicates that the filter material of most reprocessed masks of high quality brands can outperform new, imported face masks of unknown brands. Although the PFE of tested face masks from different sterilization departments remained efficient, using different types of sterilization equipment, can result in different PFE outcomes.

The value of force and torque measurements in transanal total mesorectal excision (TaTME).

BACKGROUND: Transanal total mesorectal excision (TaTME) is associated with a relatively long learning curve. Force, motion, and time parameters are increasingly used for objective assessment of skills to enhance laparoscopic training efficacy. The aim of this study was to identify relevant metrics for accurate skill assessment in more complex transanal purse-string suturing. METHODS: A box trainer was designed for TaTME and equipped with two custom made multi-DOF force/torque sensors. These sensors measured the applied forces in the axial direction of the instruments (Fz), instrument load orientation expressed in torque (Mx and My) on the entrance port, and the full tissue interaction force (Fft) at the intestine fixation point. In a construct validity study, novices for TaTME performed a purse-string suture to investigate which parameters can be used best to identify meaningful events during tissue manipulation and instrument handling. RESULTS: Significant differences exist between pre- and post-training assessment for the mean axial force at the entrance port Fz (p = 0.01), mean torque in the entrance port Mx (p = 0.03) and mean force on the intestine during suturing Fft (p = 0.05). Furthermore, force levels during suturing exceed safety threshold values, potentially leading to dangerous complications such as rupture of the rectum. CONCLUSIONS: Forces and torque measured at the entrance port, and the tissue interaction force signatures provide detailed insight into instrument handling, instrument loading, and tissue handling during purse-string suturing in a TaTME training setup. This newly developed training setup for single-port laparoscopy that enables objective feedback has the potential to enhance surgical training in TaTME.

In-Vitro Detection of Small Isolated Cartilage Defects: Intravascular Ultrasound Vs. Optical Coherence Tomography.

This experimental work focused on the sensor selection for the development of a needle-like instrument to treat small isolated cartilage defects with hydrogels. The aim was to identify the most accurate and sensitive imaging method to determine the location and size of defects compared to a gold standard (µCT). Only intravascular ultrasound imaging (IVUS) vs. optical coherent tomography (OCT) were looked at, as they fulfilled the criteria for integration in the needle design. An in-vitro study was conducted on six human cadaveric tali that were dissected and submerged in saline. To simulate the natural appearance of cartilage defects, three types of defects were created via a standardised protocol: osteochondral defects (OCD), chondral defects (CD) and cartilage surface fibrillation (CSF), all sized between 0.1 and 3 mm in diameter. The detection rate by two observers for all diameters of OCD were 80, 92 and 100% with IVUS, OCT and µCT, for CD these were 60, 83 and 97%, and for CSF 0, 29 and 24%. Both IVUS and OCT can detect the presence of OCD and CD accurately if they are larger than 2 mm in diameter, and OCT can detect fibrillated cartilage defects larger than 3 mm in diameter. A significant difference between OCT-µCT and IVUS-µCT was found for the diameter error (p = 0.004) and insertion depth error (p = 0.002), indicating that OCT gives values closer to reference µCT. The OCT imaging technique is more sensitive to various types and sizes of defects and has a smaller diameter, and is therefore preferred for the intended application.

Validation of the PASSPORT V2 training environment for arthroscopic skills.

PURPOSE: Virtual reality simulators used in the education of orthopaedic residents often lack realistic haptic feedback. To solve this, the (Practice Arthroscopic Surgical Skills for Perfect Operative Real-life Treatment) PASSPORT simulator was developed, which was subjected to fundamental changes: improved realism and user interface. The purpose was to demonstrate its face and construct validity. METHODS: Thirty-one participants were divided into three groups having different levels of arthroscopic experience. Participants answered questions regarding general information and the outer appearance of the simulator for face validity. Construct validity was assessed with one standardized navigation task, which was timed. Face validity, educational value and user-friendliness were determined with two representative exercises and by asking participants to fill out the questionnaire. A value of 7 or greater was considered sufficient. RESULTS: Construct validity was demonstrated between experts and novices. Median task time for the fifth trial was 55 s (range 17-139 s) for the novices, 33 s (range 17-59 s) for the intermediates, and 26 s (range 14-52 s) for the experts. Median task times of three trials were not significantly different between the novices and intermediates, and none of the trials between intermediates and experts. Face validity, educational value and user-friendliness were perceived as sufficient (median >7). The presence of realistic tactile feedback was considered the biggest asset of the simulator. CONCLUSION: Proper preparation for arthroscopic operations will increase the quality of real-life surgery and patients' safety. The PASSPORT simulator can assist in achieving this, as it showed construct and face validity, and its physical nature offered adequate haptic feedback during training. This indicates that PASSPORT has potential to evolve as a valuable training modality.

Laparoscopic suturing learning curve in an open versus closed box trainer.

BACKGROUND: The aim of this study was to examine the influence of training under direct vision prior to training with indirect vision on the learning curve of the laparoscopic suture task. METHODS: Novices were randomized in two groups. Group 1 performed three suturing tasks in a transparent laparoscopic box trainer under direct vision followed by three suturing tasks in a standard non-transparent laparoscopic box trainer equipped with a 0° laparoscope. Group 2 performed six suturing tasks in a standard laparoscopic box trainer. Performance time, motion analysis parameters (economy of movements) and interaction force parameters (tissue handling) were measured. Participants completed a questionnaire assessing: self-perceived dexterity before and after the training, their experienced frustration and the difficulty of the training. RESULTS: A total of 34 participants were included, one was excluded because of incomplete training. Group 1 used significantly less time to complete the total of six tasks (27 %). At the end of the training, there were no differences in motion or force parameters between the two groups. Group 2 rated their self-perceived dexterity after the training significantly lower than before the training and also reported significantly higher levels of frustration compared to group 1. Both groups rated the difficulty of the training similar. CONCLUSION: Novices benefit from starting their training of difficult basic laparoscopic skills, e.g., suturing, in a transparent box trainer without camera. It takes less time to complete the tasks, and they get less frustrated by the training with the same results on their economy of movements and tissue handling skills.

Tying different knots: what forces do we use?

BACKGROUND: A study was performed to determine differences in applied interaction force between conventional open surgery and laparoscopic surgery during suturing in a non-clinical setting. METHODS: In a laparoscopic box trainer set-up, experts performed two intracorporeal and two extracorporeal sutures on an artificial skin model. They also performed two instrument-tie knots and two one-hand square knots in a similar conventional training set-up. The force exerted on the artificial tissue (mean force, mean non-zero, maximum, and volume) and the time to complete a task were measured. For analysis purposes, sutures are divided in a needle driving phase (Phase 1) and knot-tying phase (Phase 2). RESULTS: Phase 1: Force values in laparoscopic suturing are significantly higher than in conventional suturing, except for the force volume during extracorporeal suturing versus the one-hand square knot. Phase 2: The mean force non-zero and maximum force during the intracorporeal knot are significantly higher than during the instrument-tie knot. The mean and maximum force during the extracorporeal knot are significantly higher than during the one-hand square knot. Furthermore, laparoscopic suturing takes longer time than conventional suturing. CONCLUSION: Expert surgeons apply significantly higher force during laparoscopic surgery compared to conventional surgery even though the same strategy is used. Aspects such as the limited visual and haptic feedback, and movement possibilities hamper surgeons' ability to assess the applied interaction force. Therefore it can be useful to provide additional force feedback about the applied interaction force during training in non-clinical settings.

Influence of visual force feedback on tissue handling in minimally invasive surgery.

BACKGROUND: Force feedback might improve surgical performance during minimally invasive surgery. This study sought to determine whether training with force feedback shortened the tissue-handling learning curve, and examined the influence of real-time visual feedback compared with postprocessing feedback. METHODS: Medical students without experience of minimally invasive surgery were randomized into three groups: real-time force feedback, postprocessing force feedback and no force feedback (control). All performed eight suturing tasks consecutively, of which the first and eighth were the premeasurement and postmeasurement tasks respectively (no feedback). Depending on randomization, either form of feedback was given during the second to seventh task. Time, mean force non-zero and maximum force were measured with a force sensor. Results of the groups were compared with one-way ANOVA, and intragroup improvement using a paired-samples t test. RESULTS: A total of 72 students took part. Both intervention groups used significantly lower interaction forces than the control group during the knot-tying phase of the postmeasurement task and improved their interaction forces significantly during the knot-tying phase. The form of feedback did not influence its effectiveness. CONCLUSION: The tissue-handling skills of medical students improved significantly when they were given force feedback of their performance. This effect was seen mainly during the knot-tying phase of the suturing task.

Force Parameters for Skills Assessment in Laparoscopy.

When equipped with motion and force sensors, box-trainers can be good alternatives for relatively expensive Virtual Reality (VR) trainers. As in VR trainers, the sensors in a box trainer could provide the trainee with objective information about his performance. Recently, multiple tracking systems were developed for classification of participants based on motion and time parameters. The aim of this study is the development of force parameters that reflect the trainee's performance in a suture task. Our second goal is to investigate if the level of the participant's skills can be classified as experts or novice level. In the experiment, experts (n = 11) and novices (n = 21) performed a two-handed needle driving and knot tying task on artificial tissue inside a box trainer. The tissue was mounted on the Force platform that was used to measure the force, which the subject applied on the tissue in three directions. We evaluated the potential of 16 different performance parameters, related to the magnitude, direction, and variability of applied forces, to distinguish between different levels of surgical expertise. Nine of the parameters showed significant differences between experts and novices. Principal Component Analysis was used to convert these nine partly correlating parameters, such as peak force, mean force, and main direction of force, into two uncorrelated variables. By performing a Leave-One-Out-Cross Validation with Linear Discriminant Analysis on each participants' score on these two variables, it was possible to correctly classify 84 percent of all participants as an expert or novice. We conclude that force measurements in a box trainer can be used to classify the level of performance of trainees and can contribute to objective assessment of suture skills.