The effect of implementing a transanal minimally invasive surgical programme for the local excision of early rectal neoplasia on outcomes in a tertiary referral rectal cancer centre.

Transanal minimally invasive surgery (TAMIS) is a surgical alternative to proctectomy in the management of complex rectal polyps and early rectal cancers. In 2016, our institution introduced a TAMIS programme. The purpose of this study was to evaluate changes in practice and outcomes in our institution in the 3 years before and after the implementation of TAMIS. We conducted a retrospective analysis of a prospective database of patients who underwent proctectomy or TAMIS for the management of complex rectal polyps or early rectal cancers at our institution between 2013 and 2018. 96 patients were included in this study (41 proctectomy vs 55 TAMIS). A significant reduction was noted in the number of proctectomies performed in the 3 years after the implementation of TAMIS as compared to the 3 years before (13 vs 28) ( P  < 0.001); 43% of patients ( n  = 12) who underwent proctectomy in the period prior to implementation of TAMIS were American Society of Anaesthesiologists grade III, as compared to only 15% ( n  = 2) of patients during the period following TAMIS implementation ( P  = 0.02). TAMIS was associated with a significant reduction in length of inpatient stay ( P  < 0.001). Oncological outcomes were comparable between groups (log rank P  = 0.83). Our findings support TAMIS as a safe and effective alternative to radical resection. The availability of TAMIS has resulted in a significant reduction in the number of comorbid patients undergoing proctectomy at our institution. Consequently, we have observed a significant reduction in postoperative complications over this time period.

Evaluation of different approaches to define expert benchmark scores for new robotic training simulators based on the Medtronic HUGO™ RAS surgical robot experience.

New robot-assisted surgery platforms being developed will be required to have proficiency-based simulation training available. Scoring methodologies and performance feedback for trainees are currently not consistent across all robotic simulator platforms. Also, there are virtually no prior publications on how VR simulation passing benchmarks have been established. This paper compares methods evaluated to determine the proficiency-based scoring thresholds (a.k.a. benchmarks) for the new Medtronic Hugo™ RAS robotic simulator. Nine experienced robotic surgeons from multiple disciplines performed the 49 skills exercises 5 times each. The data were analyzed in 3 different ways: (1) include all data collected, (2) exclude first sessions, (3) exclude outliers. Eliminating the first session discounts becoming familiar with the exercise. Discounting outliers allows removal of potentially erroneous data that may be due to technical issues, unexpected distractions, etc. Outliers were identified using a common statistical technique involving the interquartile range of the data. Using each method above, mean and standard deviations were calculated, and the benchmark was set at a value of 1 standard deviation above the mean. In comparison to including all the data, when outliers are excluded, fewer data points are removed than just excluding first sessions, and the metric benchmarks are made more difficult by an average of 11%. When first sessions are excluded, the metric benchmarks are made easier by an average of about 2%. In comparison with benchmarks calculated using all data points, excluding outliers resulted in the biggest change making the benchmarks more challenging. We determined that this method provided the best representation of the data. These benchmarks should be validated with future clinical training studies.

The role of radiotherapy in the management of nodal disease in breast cancer.

The management of nodal disease in breast cancer has evolved over the last two decades. With minimalist surgical approaches for early breast cancers becoming commonplace, the question of whether radiation can replace surgery to reduce morbidity is an important question in this population, as decision making has become more complex. In more advanced disease, and in patients with significant high-risk clinical and/or pathological features, the dilemma of who should receive regional nodal irradiation has been addressed in large studies but remains controversial. In this article, we summarise and discuss the recent trials which guide modern clinical practice, as well as some of the ongoing studies which aim to address outstanding questions within the field.

Evaluation of a novel universal robotic surgery virtual reality simulation proficiency index that will allow comparisons of users across any virtual reality simulation curriculum.

STUDY OBJECTIVE: Evaluate a universal proficiency metric for Robotic Surgery Virtual Reality (VR) simulation that will allow comparison of all users across any VR curriculum. DESIGN: Retrospective analysis of VR Simulation metrics. SETTING: Two training institutions. PATIENTS OR PARTICIPANTS: Residents, fellows and practicing surgeons. INTERVENTIONS: Analysis of the Mimic robotic Virtual Reality (VR)-Simulation database of over 600,000 sessions was utilized to calculate Mean scores for each exercise. Those Mean scores were then normalized to 100. Subject's scores were also averaged and normalized to 100. We called this Index score the MScore Proficiency Index (MPI©). Scores above 100 were better than average; Less than 100 were worse than average. MEASUREMENTS AND MAIN RESULTS: Seventeen thousand six hundred and forty eight sessions were analyzed (2017-2020) comparing 77 students (residents to practicing surgeons) working in 7 different curriculums. On average, each student spent 8 h and 24 min on simulation, attempted 26.5 different exercises, and became proficient in 20.6 exercises per user. The MPI© mean score for all participants in all curricula was an MPI© of 104.9 (SD: 15.5). Thirteen students were 1 standard deviation below the norm with an average MPI© of 80.15. This group averaged 9 h 27 min each on the simulator attempting 23.46 exercises but becoming proficient in only 10.38 (47%) of them in 224 sessions. Twelve students were 1 standard deviation above the norm with an average MPI© of 127.05. This group averaged 6 h 31 min each on the simulator attempting 29.08 exercises but becoming proficient in 27.5 (95%) of them in 196 sessions. CONCLUSION: A universal skill-based performance index (MPI©) was calculated and found to be a reliable tool that could be used to identify relative proficiency among students in different robotic surgery VR Simulation curriculums. An individual user's proficiency can be utilized to identify a student's progress in a given curriculum. Future studies of MPI© will determine if machine learning can provide timely personalized feedback to the user.

A Randomized Multicenter Study Assessing the Educational Impact of a Computerized Interactive Hysterectomy Trainer on Gynecology Residents.

STUDY OBJECTIVE: To assess the improvement of cognitive surgical knowledge of laparoscopic hysterectomy in postgraduate year (PGY) 1 and 2 gynecology residents who used an interactive computer-based Laparoscopic Hysterectomy Trainer (Red Llama, Inc., Seattle, WA). DESIGN: A multicenter, randomized, controlled study (Canadian Task Force classification I). SETTING: Five departments of obstetrics and gynecology: Keck School of Medicine of the University of Southern California, Los Angeles, CA; University of California, Los Angeles, Los Angeles, CA; University of Washington, Seattle, WA; University of British Columbia, Vancouver, British Columbia, Canada; and University of Toronto, Toronto, Ontario, Canada. PARTICIPANTS: Gynecology residents, fellows, faculty, and minimally invasive surgeons. INTERVENTIONS: The use of an interactive computer-based Laparoscopic Hysterectomy Trainer. MEASUREMENTS AND MAIN RESULTS: In phase 1 of this 3-phase multicenter study, 2 hysterectomy knowledge assessment tests (A and B) were developed using a modified Delphi technique. Phase 2 administered these 2 online tests to PGY 3 and 4 gynecology residents, gynecology surgical fellows, faculty, and minimally invasive surgeons (n = 60). In phase 3, PGY 1 and 2 gynecology residents (n = 128) were recruited, and 101 chose to participate, were pretested (test A), and then randomized to the control or intervention group. Both groups continued site-specific training while the intervention group additionally used the Laparoscopic Hysterectomy Trainer. Participant residents were subsequently posttested (test B). Phase 2 results showed no differences between cognitive tests A and B when assessed for equivalence, internal consistency, and reliability. Construct validity was shown for both tests (p < .001). In phase 3, the pretest mean score for the control group was 242 (standard deviation [SD] = 56.5), and for the intervention group it was 217 (SD = 57.6) (nonsignificant difference, p = .089). The t test comparing the posttest control group (mean = 297, SD = 53.6) and the posttest intervention group (mean = 343, SD = 50.9) yielded a significant difference (p < .001, 95% confidence interval, 48.4-108.8). Posttest scores for the intervention group were significantly better than for the control group (p < .001). CONCLUSION: Using the Laparoscopic Hysterectomy Trainer significantly increased knowledge of the hysterectomy procedure in PGY 1 and 2 gynecology residents.

How to set up a robotic-assisted laparoscopic surgery center and training of staff.

The use of computers to assist surgeons in the operating room has been an inevitable evolution in the modern practice of surgery. Robotic-assisted surgery has been evolving now for over two decades and has finally matured into a technology that has caused a monumental shift in the way gynecologic surgeries are performed. Prior to robotics, the only minimally invasive options for most Gynecologic (GYN) procedures including hysterectomies were either vaginal or laparoscopic approaches. However, even with over 100 years of vaginal surgery experience and more than 20 years of laparoscopic advancements, most gynecologic surgeries in the United States were still performed through an open incision. However, this changed in 2005 when the FDA approved the da Vinci Surgical Robotic Systemtm for use in gynecologic surgery. Over the last decade, the trend for gynecologic surgeries has now dramatically shifted to less open and more minimally invasive procedures. Robotic-assisted surgeries now include not only hysterectomy but also most all other commonly performed gynecologic procedures including myomectomies, pelvic support procedures, and reproductive surgeries. This success, however, has not been without controversies, particularly around costs and complications. The evolution of computers to assist surgeons and make minimally invasive procedures more common is clearly a trend that is not going away. It is now incumbent on surgeons, hospitals, and medical societies to determine the most cost-efficient and productive use for this technology. This process is best accomplished by developing a Robotics Program in each hospital that utilizes robotic surgery.

Web-connected surgery: using the internet for teaching and proctoring of live robotic surgeries.

The purpose of this study was to assess the feasibility of using live teleconferencing for teaching of new robotic-assisted surgical techniques. This was a prospective study with review of outcomes (Canadian Task Force classification II-3) in a community hospital. In 2009, our community hospital acquired the da Vinci Connect™ System, a technology which allows for live surgeon-to-surgeon interaction during robotic surgery via a secure internet connection. We utilized this technology from March 2009 through March 2011 to perform 28 live robotic surgeries that were observed by surgeons and hospital staff in 14 different US states as well as in France. We also had 14 episodes where new robotic surgeons in our facilities were mentored by experienced robotic surgeons in other geographic locations live through the da Vinci Connect internet connection. We performed two live surgeries for continuing medical education courses with live interactions between the course attendees and the console surgeon. Finally, one surgeon in our hospital proctored new surgeons remotely in distant sites on challenging cases. Utilizing computers that allow an experienced mentor surgeon to interact with less experienced surgeons on a live case is invaluable and presages the way we will train surgeons in the future. This feasibility study validates the need to pursue this technology for future education and training as well as for real-time collaboration.

Navigating credentialing, privileging, and learning curves in robotics with an evidence and experienced-based approach.

The rapid growth of robot-assisted surgery has created new challenges for hospitals to establish credentialing guidelines for new surgeons. Developing and maintaining these skills requires frequent practice. Borrowing from the aviation model that requires maintaining currency and demonstrating proficiency, robotic credentialing guidelines are being developed that will enable hospitals to insure patient safety and optimal outcomes. The utilization of computerized robotic simulators will, like flight simulators, also help surgeons to maintain and improve skills.

What is the learning curve for robotic assisted gynecologic surgery?

STUDY OBJECTIVE: The purpose of this study was to estimate the learning curve when using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA) in benign gynecologic cases by a team of 2 gynecologic laparoscopists. DESIGN: Retrospective case series (Canadian Task Force classification II-1). SETTING: A private practice obstetrics/gynecology clinic. PATIENTS: Patients requiring major benign gynecologic surgery who were candidates for a laparoscopic approach. INTERVENTION: All patients who would have otherwise been offered a transabdominal or conventional laparoscopic procedure were offered the option of having their procedure performed laparoscopically with robotic assistance. Data that were collected included robot set-up times by the operative room staff, operative times for use of robot, total operative times, and perioperative outcome. We analyzed the learning curve defined as the number of cases required to stabilize operative time to perform the various procedures. MEASUREMENTS AND MAIN RESULTS: One hundred thirteen patients were treated over a 22-month period with the da Vinci Surgical System. Most procedures were hysterectomies, whereas other gynecologic procedures included supracervical hysterectomy, laparoscopic vaginal assisted hysterectomy, myomectomy, sacrocolpopexy, and oophorectomy. Total operative times for hysterectomies studied sequentially stabilized at approximately 95 minutes after 50 cases. The decrease in robotic time did not depend on uterine size. The mean length of hospital stay was 24 hours, and return to normal activities averaged 2.8 weeks. CONCLUSIONS: Robotic assisted surgery is an enabling technology that allows gynecologic surgeons the ability to offer laparoscopic procedures to most of their patients. In the hands of surgeons with advanced laparoscopic skills, the learning curve to stabilize operative times for the various surgical procedures in women requiring benign gynecolologic interventions is 50 cases.

Oral and local anesthesia in the nonsurgical radiofrequency-energy treatment of stress urinary incontinence.

STUDY OBJECTIVE: To demonstrate the feasibility, safety, and patient comfort associated with nonsurgical radiofrequency-energy (RF) tissue micro-remodeling in women with stress urinary incontinence (SUI) given oral and local anesthesia. DESIGN: Prospective, open-label pilot clinical trial (Canadian Task Force classification II-2). SETTING: Department of urology in a major academic teaching hospital in Mexico City, Mexico. PATIENTS: Sixteen women with SUI and hypermobility (based on history and physical examination) with no history of previous definitive incontinence therapy. INTERVENTIONS: Nonsurgical, transurethral, outpatient RF tissue micro-remodeling with women given oral plus local anesthesia. MEASUREMENTS AND MAIN RESULTS: The women had a mean age of 49.7 years (range 30-76 years) and a mean duration of incontinence of 7.6 years (range 1-30 years). The nonsurgical RF micro-remodeling treatment, which was previously demonstrated to be of significant benefit when administered under intravenous (IV) sedation in an outpatient surgicenter setting, was successfully completed in all 16 women. Either the treating physician or the patient had the option to convert to IV sedation during the procedure if there was too much discomfort; however, this did not occur in any of the 16 patients. Thus neither the treating physician nor any patient determined that conversion to IV conscious sedation was required for treatment completion. The first six patients received an oral sedative and oral analgesic as well as a local periurethral anesthetic block with 10 mL of 2% lidocaine. The final 10 patients (63%) received only one oral sedative or analgesic and a total of 10mL lidocaine local anesthetic. Two women who received the maximum oral regimen (both oral sedation and analgesics) experienced nausea and emesis when drinking immediately after treatment, and one of these women also experienced urinary retention, which resolved after 24 hours of catheterization. Immediately before discharge, subjects classified their pain on a scale from zero ("no pain") to 10 ("terrible pain"). Mean score was 1.8, and 38% of subjects selected "zero." CONCLUSION: This pilot trial demonstrated the feasibility, safety, and patient comfort associated with performing a novel new successful technique of nonsurgical RF of the urethra for treatment of SUI, which was previously studied under IV sedation in an outpatient surgery center, on women in an office-based setting using oral plus local anesthesia.

Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence.

OBJECTIVE: This study was undertaken to determine the effect of menopause and hormone replacement therapy (HRT) on incontinence quality of life (I-QOL) score improvement in women with moderate-to-severe stress urinary incontinence (SUI) after nonsurgical, transurethral radiofrequency energy (RF) tissue micro-remodeling. STUDY DESIGN: Retrospective review of prospective, randomized, controlled clinical trial. Women with moderate-to-severe SUI were analyzed by menopausal status and HRT use for 10-point or greater I-QOL score improvement (an increase associated with subjective and objective SUI improvement). RESULTS: RF micro-remodeling resulted in 81% of subjects achieving 10-point or greater I-QOL score improvement versus 49% of sham subjects at 12 months ( P = .04). Outcomes did not differ statistically when premenopausal (85%), postmenopausal using HRT (70%), and postmenopausal not using HRT (71%) groups were compared. CONCLUSION: Menopausal status and HRT demonstrated no impact on the quality of life improvement experienced by women with moderate-to-severe SUI who underwent RF tissue micro-remodeling.

Comparison of laparoscopic-assisted vaginal hysterectomy with traditional hysterectomy for cost-effectiveness to employers.

OBJECTIVE: The purpose of this study was to compare the cost-effectiveness of laparoscopic-assisted vaginal hysterectomy to traditional total abdominal hysterectomy and total vaginal hysterectomy with regard not only to direct hospital costs but also to indirect costs. STUDY DESIGN: This was a combined retrospective cohort study (Canadian Task Force classification II-2) that was conducted in a suburban private practice. The cases of 268 patients who underwent hysterectomies over a 27-month period were analyzed to include clinical outcomes, direct hospital costs, and indirect costs (time to return to normal function, time to return to work, and time away from work required by other family members). RESULTS: For all patients, length of hospital stay and time of return to normal function were shorter for laparoscopic-assisted vaginal hysterectomy than for total abdominal hysterectomy and total vaginal hysterectomy. For working patients, time to return to work and time off for working family members were all significantly shorter after laparoscopic-assisted vaginal hysterectomy when compared with both total abdominal hysterectomy and total vaginal hysterectomy. Operating times were similar for total abdominal hysterectomy and laparoscopic-assisted vaginal hysterectomy, and complications were greater for total abdominal hysterectomy. In a comparison of all procedures, direct hospital costs were greatest for laparoscopic-assisted vaginal hysterectomy and least for total vaginal hysterectomy. CONCLUSION: For most patients, laparoscopic-assisted vaginal hysterectomy provides a minimally invasive way to accomplish a hysterectomy with a lower cost to employers (payers) on the basis of lost work hours.