Safely Introducing New Surgical Devices in Minimally Invasive Gynecologic Surgery: An Argument for Use of the IDEAL Framework.

OBJECTIVE: To review the Food and Drug Administration (FDA) premarket regulatory and postmarket surveillance processes for 2 minimally invasive gynecologic surgery case studies-the laparoscopic power morcellator and the Essure permanent birth control device-and to introduce the IDEAL (Idea, Development, Exploration, Assessment, Long-term) framework for safely introducing and monitoring minimally invasive gynecologic surgery devices. DATA SOURCES: News media publications, agency websites, legal articles, and scientific papers. METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications. TABULATION, INTEGRATION, AND RESULTS: Based on current FDA premarket regulatory processes, 67% of devices do not currently require premarket review and only 1% are subject to clinical trial requirements. The IDEAL framework delineates 5 phases for safe introduction of medical devices: idea, development, exploration, assessment, and long-term study. CONCLUSION: The laparoscopic power morcellator and Essure cases illustrate possible shortcomings in our device approval system that could be improved upon using the IDEAL framework, which limits device use until safety and efficacy data have been established and recommends postmarket surveillance.

First experiences of a hospital-based 3D printing facility - an analytical observational study.

PURPOSE: To identify the clinical impact and potential benefits of in-house 3D-printed objects through a questionnaire, focusing on three principal areas: patient education; interdisciplinary cooperation; preoperative planning and perioperative execution. MATERIALS AND METHODS: Questionnaires were sent from January 2021 to August 2022. Participants were directed to rate on a scale from 1 to 10. RESULTS: The response rate was 43%. The results of the rated questions are averages. 84% reported using 3D-printed objects in informing the patient about their condition/procedure. Clinician-reported improvement in patient understanding of their procedure/disease was 8.1. The importance of in-house placement was rated 9.2. 96% reported using the 3D model to confer with colleagues. Delay in treatment due to 3D printing lead-time was 1.8. The degree with which preoperative planning was altered was 6.9. The improvement in clinician perceived preoperative confidence was 8.3. The degree with which the scope of the procedure was affected, in regard to invasiveness, was 5.6, wherein a score of 5 is taken to mean unchanged. Reduction in surgical duration was rated 5.7. CONCLUSION: Clinicians report the utilization of 3D printing in surgical specialties improves procedures pre- and intraoperatively, has a potential for increasing patient engagement and insight, and in-house location of a 3D printing center results in improved interdisciplinary cooperation and allows broader access with only minimal delay in treatment due to lead-time.

Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5-7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial.

BACKGROUND: The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5-7 mm blood vessels in thoracic surgery. METHODS: This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed. DISCUSSION: This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5-7 mm blood vessels in thoracic surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www. CLINICALTRIALS: gov/study/NCT06002737 .

Gender equity in surgical instruments: ergonomics of ring-handled forceps.

INTRODUCTION: Female surgeons have ergonomic issues with commercialized instruments tailored for male surgeons. The purpose of this study was to identify satisfaction levels and ergonomic problems of female surgeons while using laparoscopic forceps with ring-handles and suggest improvement measures. MATERIAL AND METHODS: A questionnaire was sent to 19,405 members of the Japanese Society of Gastroenterological Surgery via email between 1 August 2022 and 30 September 2022. It included demographic information and specific questions regarding the use of laparoscopic forceps with ring- handles (ergonomic evaluation, influence of the negative aspects of laparoscopic forceps during surgery, physical discomfort in the hands and fingers, degree of satisfaction, and handle size). RESULTS: Valid responses were received from 1,030 respondents (131 female and 899 male surgeons). The ergonomics of the laparoscopic forceps with ring-handles were rated lower by female surgeons in all ten categories (all p value < 0.05). They also reported a negative impact on surgical manipulation and discomfort to their hands and fingers. CONCLUSIONS: Female surgeons had a wide variety of ergonomic problems when using laparoscopic forceps with ring-handles, and showed lower levels of satisfaction. Developing a different model tailored to female surgeons with smaller hands and a weaker grip could be a viable solution.

An alternative method to evaluate lumbar interbody fusion status focusing on position change of screw-rod constructs.

OBJECTIVES: The evaluation of lumbar interbody fusion status is generally subjective and may differ among raters. The authors examined whether the assessment of position change of screw-rod constructs could be an alternative method for the evaluation of fusion status. METHODS: Sixty-three patients undergoing lumbar interbody single-level fusion were retrospectively reviewed. Three-dimensional images of screw-rod constructs were created from baseline CT examination on the day after surgery and follow-up CT examinations (3-5 months, 6-11 months, and ≥ 12 months) and superposed, with position change of screw-rod constructs being evaluated by the distance between the 3-dimensional images at baseline and follow-up. The evaluation was repeated twice to confirm the reproducibility. Fusion status on follow-up CT examinations was assessed by three raters, where inter-rater reliability was evaluated with Fleiss' kappa. The results of the fusion status were classified into fusion and incomplete fusion groups in each timing of follow-up CT examinations, where the amount of position change was compared between the two groups. RESULTS: The evaluation of position change was completely reproducible. The Fleiss' kappa (agreements) was 0.481 (69.4%). The medians of the amount of position change in fusion and incomplete fusion groups were 0.134 mm and 0.158 mm at 3-5 months (p = 0.21), 0.160 mm and 0.190 mm at 6-11 months (p = 0.02), and 0.156 mm and 0.314 mm at ≥ 12 months (p = 0.004). CONCLUSIONS: The assessment of position change of screw-rod constructs at 6 months or more after surgery can be an alternative method for evaluating lumbar interbody fusion status. KEY POINTS: • Lumbar interbody fusion status (satisfactory, incomplete, or failed) is associated with the quantification of position change of screw-rod in this study. • Reference values for the evaluation of position change in identifying interbody fusion status are provided. • Position change of screw-rod could be a supportive method for evaluating interbody fusion status.

Continuous suture technique increases the complete closure rate of colorectal mucosal defects after endoscopic resection: a single-blind, randomized controlled trial.

BACKGROUND: Complete closure of mucosal defects after colorectal endoscopic submucosal dissection (ESD)/piecemeal endoscopic mucosal resection (p-EMR) procedures reduces postoperative adverse events, but the complete closure rate of the traditional method using only hemostatic clips is not satisfactory. Therefore, we invented a continuous suture technique using a barbed suture and clips to increase the complete closure rate of colorectal mucosal defects. METHODS: Patients with a single large (≥ 2 cm) colorectal lesion were recruited. After completion of the ESD/p-EMR procedures, they were randomly allocated to the treatment group or control group. The mucosal defects of the treatment group were closed using barbed suture and clips, while the control group was closed using only clips. RESULTS: From January 18, 2022 to April 13, 2022, a total of 62 patients with colorectal lesions were enrolled, with 31 patients in each group. Complete closure was achieved in 29 patients (93.5%) in the treatment group and 18 patients (58.1%) in the control group (P = 0.001). The median closure time was 13 min in the treatment group and 19 min in the control group (P < 0.001). The median closure speed was 6.4 cm2/10 min in the treatment group and 3.5 cm2/10 min in the control group (P = 0.008). CONCLUSIONS: This study provided a clinically feasible continuous suture technique that was safe and effective for the complete closure of colorectal mucosal defects after endoscopic resection.

Thunderbeat®: a new step forward in transoral surgery-systematic review of literature and our experience.

INTRODUCTION: Minimally invasive surgery is today the main challenge of ENT surgeons who aim to achieve oncological radicality with less aesthetic and functional impact. This is the basis for the widespread transoral surgical techniques, as the Thunderbeat®. OBJECTIVE: To date, the use of Thunderbeat® in transoral surgery is still little known and widespread. So, this study analyzes, with a systematic review, current literature about the transoral use of Thunderbeat® and shows our case studies. METHODS: The research was carried out on Pubmed, Scopus, Web of Science and Cochrane databases using specific keywords. Then, a retrospective study was carried out on 10 patients who underwent transoral surgery by Thunderbeat® in our ENT Clinic. Both in our cases and in the systematic review the following parameters have been evaluated: treated anatomical site and subsite, histological diagnosis, type of surgery, duration of nasogastric tube and hospitalization, post-operative complications, tracheostomy, resection margin status. RESULTS: The review included 3 articles that described transoral use of Thunderbeat® for a total of 31 patients suffering from oropharyngeal, hypopharyngeal and/or laryngeal carcinoma. Nasogastric tube was removed after 21.5 days on average, temporary tracheostomy was performed in 6 patients. The main complications were: bleeding (12.90%) and pharyngocutaneous fistula (29.03%). Thunderbeat® shaft was 35 cm long and 5 mm large. Our case studies included 5 males and 5 females, mean age 64.4 ± 10.28, with oropharyngeal or supraglottic carcinoma, parapharyngeal pleomorphic adenoma and cavernous hemangioma of the tongue base. Temporary tracheostomy was performed in 8 patients. Free resection margins were achieved in all cases (100%). No peri-operative complications occurred. Nasogastric tube was removed after 5.3 ± 2 days on average. All patients were discharged without tracheal tube and NGT after 18.2 ± 4.72 days on average. CONCLUSION: This study demonstrated that Thunderbeat® has several advantages over other transoral surgical approaches, such as CO2 laser and robotic surgery, in terms of best combination of oncological and functional success, less post-operative complications and costs. So, it could represent a step forward in transoral surgery.

[Individual traceability to the instrument: Evolution of laser and micropercussion markings over the sterilisation cycles]. / Traçabilité individuelle à l'instrument : évolution des marquages laser et micropercussion au fil des cycles de stérilisation.

In order to implement individual instrument traceability, the evolution of laser and micropercussion markings was evaluated over 250 sterilisation cycles. A datamatrix associated with its alphanumeric code was applied on three types of instruments by laser or micropercussion. All instruments had a unique identifier affixed by the manufacturer. The sterilisation cycles corresponded to the usual cycles performed in our sterilisation unit. The laser markings had very good visibility but were quickly affected by corrosion: 12% of the markings were corroded after the 5th sterilisation cycle. Similar results were observed for unique identifiers applied by the manufacturer but with visibility attenuated by sterilisation cycles: 33% of identifiers were poorly visible after the 125th sterilisation cycle. Finally, micropercussion markings were less susceptible to corrosion but initially showed poorer contrast.

[Evaluation of Muscle Fatigue in Spinal Surgery Instruments Based on sEMG-JASA].

Based on the joint analysis of EMG spectrum and amplitude method (JASA), a study on muscle fatigue assessment of spinal surgical instruments based on surface EMG signals was carried out, and a comparative evaluation of the operating comfort before and after the optimization of spinal surgical instruments was completed. A total of 17 subjects were recruited to collect the surface EMG signals of their brachioradialis and biceps. Five surgical instruments before and after optimization were selected for data comparison, and the operating fatigue time proportion of each group of instruments under the same task was calculated based on the RMS and MF eigenvalues. The results showed that when completing the same operation task, the operation fatigue time of the surgical instruments before optimization was significantly higher than that after optimization (P<0.05); there was no significant difference in the fatigue status of brachioradialis and biceps when operating the same instrument (P>0.05). These results provide objective data and reference for the ergonomic design of surgical instruments and fatigue damage protection.

The Low Submuscular Reservoir Placement With Transfascial Fixation for Inflatable Penile Prostheses.

BACKGROUND: Several techniques have been described for placement of inflatable penile prostheses (IPP) reservoirs, with variable satisfaction. Standard placement in the Space of Retzius can present with several complications and may be technically difficult in patients with a violated space. Concerns with ectopic reservoir placement have included reservoir herniation and lack of reservoir concealability. AIM: To present a novel technique to achieve reservoir concealment with decreased postoperative complications as an alternative to standard approaches of ectopic reservoir placement. METHODS: We describe our novel low submuscular reservoir (LSM) placement with transfascial fixation (TFF) for inflatable penile prostheses. OUTCOMES: Patient satisfaction with reservoir concealment, complication rate or need for additional surgeries. RESULTS: A total of 31 cases successfully underwent our technique. The low submuscular placement with TFF of the IPP reservoir offers an optimal approach for reservoir placement with a high degree of patient satisfaction with significant ease of placement compared to alternative methods. CLINICAL IMPLICATIONS: Penile prosthetic surgeons should be familiar with several techniques for concealment of reservoir as an option to improve patient satisfaction. STRENGTHS AND LIMITATIONS: Given the small sample size of patients who have undergone this novel technique, current literature regarding the topic is limited. CONCLUSION: Low submuscular reservoir placement with transfascial fixation for IPPs is a technically feasible approach that can be employed to achieve patient satisfaction and decrease the risk of reservoir herniation. Khoei A, Racik N, Bansal U, et al. The Low Submuscular Reservoir Placement With Transfascial Fixation for Inflatable Penile Prostheses. J Sex Med 2022;19:1309-1312.

Utility of a Device Briefing Tool to Improve Surgical Safety.

INTRODUCTION: Clear communication around surgical device use is crucial to patient safety. We evaluated the utility of the Device Briefing Tool (DBT) as an adjunct to the Surgical Safety Checklist. METHODS: A nonrandomized, controlled pilot of the DBT was conducted with surgical teams at an academic referral center. Intervention departments used the DBT in all cases involving a surgical device for 10 wk. Utility, relative advantage, and implementation effectiveness were evaluated via surveys. Trained observers assessed adherence and team performance using the Oxford NOTECHS system. RESULTS: Of 113 individuals surveyed, 91 responded. Most respondents rated the DBT as moderately to extremely useful. Utility was greatest for complex devices (89%) and new devices (88%). Advantages included insight into the team's familiarity with devices (70%) and improved teamwork and communication (68%). Users found it unrealistic to review all device instructional materials (54%). Free text responses suggested that the DBT heightened awareness of deficiencies in device familiarity and training but lacked a clear mechanism to correct them. DBT adherence was 82%. NOTECHS scores in intervention departments improved over the course of the study but did not significantly differ from comparator departments. CONCLUSIONS: The DBT was rated highly by both surgeons and nurses. Adherence was high and we found no evidence of "checklist fatigue." Centers interested in implementing the DBT should focus on devices that are complex or new to any surgical team member. Guidance for correcting deficiencies identified by the DBT will be provided in future iterations of the tool.

Breast Surgery Cost Savings Through Surgical Tray Instrument Reduction.

INTRODUCTION: Removing unnecessary instruments from surgical trays used in the operating room conserves resources and time. We aimed to assess the cost savings impact of breast surgical tray instrument reduction. METHODS: Breast surgeons at a single institution reviewed the standard surgical tray used for lumpectomies and mastectomies and removed underutilized instruments to create a breast-specific tray. This tray was used for all breast surgeries performed throughout the 2019 calendar year. Data for breast-specific tray usage, instrument reprocessing costs, and instrument maintenance costs for inspection, sharpening, aligning, and lubricating were retrospectively obtained. RESULTS: The breast-specific tray was reduced from 82 to 65 instruments. The cost of reprocessing each instrument is $1.69. After 30 tray sterilizations, each tray was sent for maintenance at a cost of $2.00 per instrument. With 10 breast-specific trays in circulation, the trays were used a total of 656 times during the calendar year. Each tray was sent for maintenance an average of two times during this time period. Thus, instrument reduction resulted in $18,847 in instrument reprocessing and $680.00 in maintenance savings, with total annual cost savings of $19,527. CONCLUSIONS: Optimizing surgical trays by removing unused instruments yields significant cost savings and contributes to improved efficiency in the sterile processing department. As efforts to eliminate wasteful practices and reduce costs within the health care system continue, opportunities remain for standardization of trays across all surgical departments and institutions.

Preliminary design and evaluation of a remote tele-mentoring system for minimally invasive surgery.

BACKGROUND: Tele-mentoring during surgery facilitates the transfer of surgical knowledge from a mentor (specialist surgeon) to a mentee (operating surgeon). The aim of this work is to develop a tele-mentoring system tailored for minimally invasive surgery (MIS) where the mentor can remotely demonstrate to the mentee the required motion of the surgical instruments. METHODS: A remote tele-mentoring system is implemented that generates visual cues in the form of virtual surgical instrument motion overlaid onto the live view of the operative field. The technical performance of the system is evaluated in a simulated environment, where the operating room and the central location of the mentor were physically located in different countries and connected over the internet. In addition, a user study was performed to assess the system as a mentoring tool. RESULTS: On average, it took 260 ms to send a view of the operative field of 1920 × 1080 resolution from the operating room to the central location of the mentor and an average of 132 ms to receive the motion of virtual surgical instruments from the central location to the operating room. The user study showed that it is feasible for the mentor to demonstrate and for the mentee to understand and replicate the motion of surgical instruments. CONCLUSION: The work demonstrates the feasibility of transferring information over the internet from a mentor to a mentee in the form of virtual surgical instruments. Their motion is overlaid onto the live view of the operative field enabling real-time interactions between both the surgeons.

Ergonomic Assessment of Surgeon Characteristics and Laparoscopic Device Strain in Gynecologic Surgery.

STUDY OBJECTIVE: To evaluate whether surgeon characteristics, including sex and hand size, were associated with grip strength decline with laparoscopic advanced energy devices. DESIGN: Prospective cohort study. SETTING: Ergonomic simulation at an academic tertiary care site and the Society of Gynecologic Surgeons 47th Annual Meeting. PATIENTS: Thirty-eight participants (19 women and 19 men) were recruited. INTERVENTIONS: Surgeon anthropometric measurements were collected. Each participant completed a 120-second trial of maximum voluntary effort with 3 laparoscopic advanced energy devices (LigaSure, HALO PKS, and ENSEAL). Grip strength was measured using a handheld dynamometer. Subjects completed the NASA Raw Task Load Index scale after each device trial. Grip strengths and ergonomic workload scores were compared using Student t tests and Wilcoxon rank sum tests where appropriate. Univariate and multivariate models analyzed hand size and ergonomic workload. MEASUREMENTS AND MAIN RESULTS: Women had lower baseline grip strength (288 vs 451 N) than men, as did participants with glove size <7 compared with ≥7 (231 vs 397 N). Normalized grip strength was not associated with surgeon sex (p = .08), whereas it was significantly associated with surgeon glove size (p <.01). Grip strength decline was significantly greater for smaller compared to larger handed surgeons for LigaSure (p = .02) and HALO PKS devices (p <.01). The ergonomic workload of device use was significantly greater for smaller compared to larger handed surgeons (p <.01). Surgeon handspan significantly predicted grip strength decline with device use, even after accounting for potential confounders (R2 = .23, ß = .8, p <.01). CONCLUSION: Surgeons with smaller hand size experienced a greater grip strength decline and greater ergonomic workload during repetitive laparoscopic device use. No relationship was found between surgeon sex and grip strength decline or ergonomic workload. Laparoscopic device type was also identified as a significant main effect contributing to grip strength decline. These findings point toward ergonomic strain stemming from an improper fit between the laparoscopic device and the surgeon's hand during device use.

Investigation of the Association between Surgeon Sex and Laparoscopic Device Ergonomic Strain in Gynecologic Surgery.

STUDY OBJECTIVE: To assess whether female compared with male sex is associated with greater ergonomic strain with the use of 4 advanced energy laparoscopic devices (LigaSure, HALO PKS, ENSEAL, and Harmonic scalpel). DESIGN: Online survey distributed by e-mail using the REDCap platform (Vanderbilt University). All responses were anonymous. SETTING: Nationwide survey in the United States. PARTICIPANTS: Gynecologic surgeons were surveyed through the Society of Gynecologic Surgeons listserv and 4 obstetrics and gynecology departmental listservs. INTERVENTIONS: The survey was distributed between May 1, 2020, and November 1, 2020. The primary outcome was the presence of physical complaints owing to laparoscopic devices. Descriptive statistics compared surgeon characteristics and ergonomic symptoms. Logistic regression was performed, adjusted for surgeon characteristics. MEASUREMENTS AND MAIN RESULTS: The response rate was 39%, comprising 149 women (78%) and 41 men (22%). Women compared with men had a significantly younger age (mean, 34 vs 44 years; p <.01), had smaller glove size (mean, 6.5 vs 7.5; p <.01), had shorter height (median, 66 vs 71 inches; p <.01), and were less frequently in practice for >10 years (19% vs 49%; p <.01). Women significantly more often reported physical complaints related to the use of laparoscopic devices (79% vs 41%; p <.01). Women reported that all devices had too large a fit for appropriate use (p <.01). Women were found to have 5.37 times the odds of physical complaints attributed to the use of laparoscopic instruments (crude oods ratio, 5.37; 95% confidence interval, 2.56-11.25); with adjustment for glove size, age, and laparoscopic case volume and duration, this was no longer significant (adjusted odds ratio, 2.02; 95% confidence interval, 0.59-6.93). CONCLUSION: Women significantly more often report physical complaints and inappropriate fit of the LigaSure, HALO PKS, ENSEAL, and Harmonic scalpel. Female sex is associated with 5-fold greater odds of physical complaints with laparoscopic device use. Further investigation of the surgeon factors underlying device-related strain is a critical next step to understanding and reducing surgeon ergonomic injury.

Factors associated with deficiencies in packaging of surgical instrument by staff at a single center in China.

BACKGROUND: Surgical instrument packaging quality directly affects the safety and performance of surgery. We aimed to investigate the factors causing defects in surgical instrument packaging and recommend strategies to prevent defects in surgical instrument packaging. METHODS: We collected surgical instrument packaging data regarding age, gender, length of service, educational background, number of staff dealing with packaging, time period of packaging, instrument specification, where the wrap was intact, whether the wrap reached the required quality of cleaning, and whether the instruments were satisfactorily cleaned in compliance with guidelines from 5000 surgical instrument packages during June-December 2018 at Central Sterile Supply Department of the West China Second University Hospital, Sichuan University. Meanwhile, a questionnaire survey completed by the operating room staff using surgical instruments was used to measure the level of their satisfaction with the instruments in the packages. We utilized single-factor analysis to investigate possible factors that might cause defects in surgical instrument packaging, and conducted multivariate logistic regression analysis of the factors associated with defects in packaging. RESULTS: Length of service, educational background, number of staff dealing with packaging, time period of packaging, instrument structure, whether the wrap was intact, whether the wrap reached the required quality of cleaning, and whether the surgical instruments were satisfactorily cleaned in compliance with guidelines were the factors significantly (P < 0.05) associated with defects in surgical instrument packaging. CONCLUSION: This study reveals that various factors are associated with defects in surgical instrument packaging. Recommendations for reducing incidences of defects include improved scheduling of packaging workload, greater provision of training in packaging skills, and standardization of packaging procedure.

Randomised controlled trial on robot-assisted versus manual surgery for pucker peeling.

BACKGROUND: The aim was to explore the feasibility and safety of performing common surgical steps in epiretinal membrane (ERM) peeling using the Preceyes Surgical System (PSS). METHODS: In a tertiary centre, 15 pseudophakic patients with an idiopathic ERM were randomised to robot-assistance or manual surgery in a 2:1 ratio. In the robot-assisted group, the following steps were performed using PSS: (1) staining the internal limiting membrane (ILM), (2) removal of the dye, (3) creating an ILM flap, (4) completing the peeling, (5) holding a light pipe and (6) fluid-air exchange. Primary outcome measures were feasibility and safety. Secondary outcome measures were duration, best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Moreover, the distance travelled by the instrument during peeling was assessed using motion tracking software. RESULTS: All steps performed with PSS were feasible with no clinical adverse events or complications. The surgical time was longer in the robot-assisted group (mean 56 min, SD = 12 vs. 24 min, SD = 5). During the study, the duration of robot-assisted surgeries decreased from 72 to 46 min. The distance travelled by the forceps was shorter in the robot-assisted group (mean 403 mm, SD = 186 vs. 550 mm, SD = 134). BCVA and CRT improved equally in both groups. CONCLUSIONS: This is the world's first randomised controlled trial on robotic surgery for ERM. Although more time-consuming, we found that several surgical steps were feasible with assistance of the PSS.

Comparison of the effects of virtual training by serious game and lecture on operating room novices' knowledge and performance about surgical instruments setup: a multi-center, two-arm study.

BACKGROUND: Game-based training is increasingly implemented in different nursing fields, as it allows students to learn experientially, with the flexibility to regulate their training based on their personal progresses and abilities. This study aimed to compare the effects of virtual training by the "Playing with Surgical Instruments (PlaSurIn)" game and the lecture on the surgical instruments setup knowledge and performance of Operating Room (OR) novices. METHODS: This study was conducted on 51 s-semester undergraduate OR technology students taking the course "An Introduction to Surgical Instruments and Equipment." An additional virtual training session was held via a learning management system using two different methods. The students of the Game Training Group (GTG, n = 27) played individually with the "PlaSurIn" game during a week, while the students of the Lecture Training Group (LTG, n = 24) received the lecture-based training during a week. To measure knowledge, all the students participated in a theoretical test with 10 multiple-choice questions before and immediately after the training. They also participated in an Objective Structured Clinical Examination (OSCE) after the training, and their performance was evaluated by the remained time for setup completion and the scores, errors, and bonuses. RESULTS: The mean score of the theoretical test was significantly higher in the GTG than in the LTG after the training (p = 0.040). Additionally, the GTG participants had higher scores (p = 0.016), fewer errors (p = 0.001), and higher bonuses (p = 0.011) compared to the LTG ones. The remained time for setup completion was also significantly longer in the GTG than in the LTG (p < 0.001). CONCLUSION: Virtual training by "PlaSurIn" was superior to the lecture-based method for the enhancement of surgical instruments setup knowledge and performance amongst OR novices.

Steerable Surgical Instrument for Conventional and Single-Site Minimally Invasive Surgery.

Background. This article aims to present an innovative design of a steerable surgical instrument for conventional and single-site minimally invasive surgery (MIS), which improves the dexterity and maneuverability of the surgeon while offering a solution to the limitations of current tools. Methods. The steerable MIS instrument consists of a deflection structure with a curved sliding joints design that articulates the distal tip in two additional degrees of freedom (DoFs), relative to the instrument shaft, using transmission by cables. A passive ball-joint mechanism articulates the handle relative to the instrument shaft, improves wrist posture, and prevents collision of instrument handles during single-site MIS procedures. The two additional DoFs of the articulating tip are activated by a thumb-controlled device, using a joystick design mounted on the handle. This steerable MIS instrument was developed by additive manufacturing in a 3D printer using PLA polymer. Results. Prototype testing showed a maximum tip deflection of 60° in the left and right directions, with a total deflection of 120°. With the passive ball-joint fully offset, the steerable tip achieved a deflection of 90° for the right and 40° for the left direction, with a total deflection of 130°. Furthermore, the passive ball-joint mechanism in the handle obtained a maximum range of motion of 60°. Conclusions. This steerable MIS instrument concept offers an alternative to enhance the application fields of conventional and single-site MIS, increasing manual dexterity of the surgeon and the ability to reach narrow anatomies from other directions.

Deviation from the Protocol of a Randomized Clinical Trial Comparing On-Clamp versus Off-Clamp Laparoscopic Partial Nephrectomy (CLOCK II Laparoscopic Study): A Real-Life Analysis.

PURPOSE: We assess factors/additional morbidities related to the conversion of clamping approach during off-clamp vs on-clamp laparoscopic partial nephrectomy in the setting of a randomized study. MATERIALS AND METHODS: Consecutive candidates for laparoscopic partial nephrectomy from 6 institutions were randomized to on-clamp or off-clamp surgery. The present study analyzed 1) off-clamp arm patients, comparing the procedures finalized per protocol without artery clamping (off-clamp) to those needing renal artery clamping (shift-on-clamp) and 2) on-clamp arm patients, comparing the procedures finalized with artery clamping (on-clamp) to those completed without clamping (shift-off-clamp). RESULTS: A total of 123 patients were randomized to on-clamp and 126 to off-clamp surgery. Of the off-clamp patients 41 (32.5%) converted to on-clamp. Of the on-clamp patients 70 (56.9%) completed surgery without clamping the renal artery due to subjective intraoperative decision of the surgeon. Tumor size was greater in shift-on-clamp vs off-clamp cases (4 vs 3, p=0.002). Conversely, tumor size (3.7 vs 3 cm, p=0.002) and R.E.N.A.L. nephrometry score (6 vs 5, p=0.038) were lower in shift-off-clamp cases. Shift-on-clamp cases had longer operative times and greater changes in estimated glomerular filtration rate on postoperative day 1. Shift-off-clamp cases had shorter operative times. A higher proportion of patients who completed on-clamp surgery per protocol had a greater than 25% drop in estimated glomerular filtration rate on postoperative day 1 (29.4%) compared to smaller changes (10.3%, p=0.009) in estimated glomerular filtration rate. Increasing tumor size and complete endophytic growth pattern predicted shift-on-clamp while preventing shift-off-clamp. Body mass index above 28 predicted shift-off-clamp. CONCLUSIONS: The likelihood of shift-on/off-clamp relies on tumor size/complexity. The intraoperative need to convert the planned strategy seemed harmless on postoperative course. An advantage in terms of early functional outcomes does exist when avoiding artery clamping.