Safety and Efficacy of a Novel Miniaturized Robotic-Assisted Surgery System in Colectomy: A Prospective, Investigational Device Exemption Clinical Study Using the IDEAL Framework.

BACKGROUND: Robotics has increased rates of minimally invasive surgery, with distinct advantages over open surgery. However, current commercially available robotic platforms have device and system issues that limit robotic-assisted surgery expansion. OBJECTIVE: To demonstrate the safety and efficacy of a novel miniaturized robotic-assisted surgery device in colectomy. DESIGN: Prospective, Investigational Device Exemption clinical study following the idea, development, exploration, assessment, and long-term follow-up framework (stage 2b, exploration). SETTINGS: Three centers with high-volume robotic colorectal cases and surgeons. PATIENTS: Patients scheduled for a right or left colectomy for benign or malignant disease. INTERVENTION: Colectomy with the novel miniaturized robotic-assisted surgery device. MAIN OUTCOME MEASURES: For safety, intraoperative and device-related adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion. RESULTS: Thirty patients (13 women, 17 men) were analyzed. The mean age was 59.4 (SD 13.4) years. Seventy percent of patients (n = 21) were overweight/obese and 53.3% of patients (n = 16) had prior abdominal surgery. Forty percent of patients had malignant and 60% had benign disease. Cases were 15 right and 15 left colectomies. Overall operative time was a median of 146 (range, 80-309) minutes; console time was 70 (range, 34-174) minutes. There were no conversions to open surgery and no intraoperative or device-related adverse events. In 100% of patients (n = 30), the primary dissection was completed, and hemostasis was maintained with the novel miniaturized robotic-assisted surgery device. The morbidity rate was 26.7% minor and 3.3% major. The median length of stay was 2 days. There were no mortalities. LIMITATIONS: Single-arm study, short-term follow-up. CONCLUSIONS: This first clinical study of a novel miniaturized robotic-assisted surgery device along the IDEAL framework demonstrated that it was safe and effective. Given this success, further assessment and long-term follow-up of the miniaturized robotic-assisted surgery device are planned for comparative clinical and economic effectiveness in colorectal surgery. See Video Abstract . SEGURIDAD Y EFICACIA DE UN NOVEDOSO SISTEMA DE CIRUGA ASISTIDA POR ROBOT MINIATURIZADO EN COLECTOMA UN ESTUDIO CLNICO PROSPECTIVO DE INVESTIGACIN DE EXENCIN DE DISPOSITIVO QUE UTILIZA EL MARCO IDEAL: ANTECEDENTES:La robótica ha aumentado las tasas de cirugía mínimamente invasiva, con claras ventajas sobre la cirugía abierta. Sin embargo, las plataformas robóticas actualmente disponibles comercialmente tienen problemas con los dispositivos y sistemas que limitan la expansión de la cirugía asistida por robot.OBJETIVO:Demostrar la seguridad y eficacia de un novedoso dispositivo de cirugía asistida por robot miniaturizado en colectomía.DISEÑO:Estudio clínico prospectivo de investigación de exención de dispositivo siguiendo el marco IDEAL (Etapa 2b, exploración).ESCENARIO:Tres centros con cirujanos y casos colorrectales robóticos de gran volumen.PACIENTES:Pacientes programados para colectomía derecha o izquierda por enfermedad benigna o maligna.INTERVENCIÓN:Colectomía con el nuevo dispositivo de cirugía asistida por robot miniaturizado.PRINCIPALES MEDIDAS DE RESULTADO:Para la seguridad, eventos adversos intraoperatorios y relacionados con el dispositivo y morbilidad a 30 días. Para la evaluación de la eficacia, la finalización exitosa de los pasos predefinidos sin conversión.RESULTADOS:Se analizaron treinta pacientes (13 mujeres, 17 hombres). La edad media fue 59,4 (DE 13,4) años. El 70% (n=21) tenía sobrepeso/obesidad y el 53,3% (n=16) había tenido cirugía abdominal previa. El 40% tenía enfermedad maligna y el 60% benigna. Los casos fueron 15 colectomías derechas y 15 izquierdas. La mediana del tiempo operatorio general fue de 146 (rango, 80-309) minutos; 70 (rango, 34-174) minutos fue el tiempo de consola. No hubo conversiones a cirugía abierta ni eventos adversos intraoperatorios o relacionados con el dispositivo. En el 100% (n=30), se completó la disección primaria y se mantuvo la hemostasia con el novedoso dispositivo de cirugía asistida por robot miniaturizado. La tasa de morbilidad menor fue de un 26,7% y mayor un 3,3%. La mediana de estadía fue de 2 días. No hubo mortalidad.LIMITACIONES:Estudio de un solo brazo, corto plazo de seguimiento.CONCLUSIONES:Este primer estudio clínico de un novedoso dispositivo de cirugía asistida por robot miniaturizado según el marco IDEAL demostró que era seguro y eficaz. Dado este éxito, se planean evaluaciones adicionales y seguimiento a largo plazo del dispositivo de cirugía asistida por robot miniaturizado para comparar la efectividad clínica y económica en la cirugía colorrectal. (Traducción-Dr. Felipe Bellolio ).

One year follow-up of the colon cancer patient cohort treated with a novel miniaturized robotic-assisted surgery device (mRASD).

BACKGROUND: With the proven benefits of minimally invasive surgery, there is steady growth in robotic surgery use and interest in novel robotic platforms. A miniaturized Robotic-Assisted Surgery Device (mRASD) has been in clinical use under a multi-center, investigational device exemption (IDE) study for right and left colectomy. The goal of this work was to report the short-term and 12-month outcomes specifically for the cohort of colon cancer patients that underwent surgery using the mRASD. METHOD: From the IDE study that included both benign and malignant diseases, long-term follow-up was only conducted for patients with colon cancer. The main outcome measures were the oncologic quality metrics (Overall Survival, OS and Disease-free Survival, DFS). Secondary outcomes included incidence of intra-operative, device-related, and procedure-related adverse events. Frequency statistics were performed to assess the measures of central tendency and variability in short (within 30 days) and long-term (1-year) outcomes. RESULTS: Thirty total patients underwent a colectomy with mRASD; 17 (57%) were diagnosed with a malignancy and included in this analysis. The mean patient age was 59.9 ± 13.2 years. There were no intraoperative or device-related adverse events. In 100% of cases (n = 17), the primary dissection was completed and hemostasis maintained using the mRASD, and negative margins were achieved. At 30 days postoperatively, the major complication rate was 6%, and there was one unplanned reoperation for anastomotic leak. At one-year follow-up, the OS and DFS rates were 100 and 94%, respectively. In one patient, omental implants were discovered at the time of surgery, and the patient opted to not undergo additional therapy. CONCLUSIONS: The first experience with mRASD for colectomy in colon cancer demonstrated technical effectiveness and an acceptable surgical safety profile in line with other minimally invasive procedures. The study continues to monitor disease recurrence and survival outcomes in this cohort.

Defining digital surgery: a SAGES white paper.

BACKGROUND: Digital surgery is a new paradigm within the surgical innovation space that is rapidly advancing and encompasses multiple areas. METHODS: This white paper from the SAGES Digital Surgery Working Group outlines the scope of digital surgery, defines key terms, and analyzes the challenges and opportunities surrounding this disruptive technology. RESULTS: In its simplest form, digital surgery inserts a computer interface between surgeon and patient. We divide the digital surgery space into the following elements: advanced visualization, enhanced instrumentation, data capture, data analytics with artificial intelligence/machine learning, connectivity via telepresence, and robotic surgical platforms. We will define each area, describe specific terminology, review current advances as well as discuss limitations and opportunities for future growth. CONCLUSION: Digital Surgery will continue to evolve and has great potential to bring value to all levels of the healthcare system. The surgical community has an essential role in understanding, developing, and guiding this emerging field.

Gender equity in ergonomics: does muscle effort in laparoscopic surgery differ between men and women?

BACKGROUND: Women surgeons may experience more ergonomic challenges while performing surgery. We aimed to assess ergonomics between men and women surgeons. METHODS: Laparoscopic surgeons from a single institution were enrolled. Demographics and intraoperative data were collected. Muscle groups were evaluated objectively using surface electromyography (EMG; TrignoTM, Delsys, Inc., Natick, MA), and comprised upper trapezius (UT), anterior deltoid, flexor carpi radialis (FCR), and extensor digitorum (ED). Comparisons were made between women (W) and men (M) for each muscle group, assessing maximal voluntary contraction (MVC) and median frequency (MDF). The Piper Fatigue Scale-12 (PFS-12) was used to assess self-perceived fatigue. Statistical analyses were performed using SPSS v26.0, α = 0.05. RESULTS: 18 surgeries were recorded (W:8, M:10). Women had higher activation of UT (32% vs 23%, p < 0.001), FCR (33% vs 16%, p < 0.001), and ED (13% vs 10%, p < 0.001), and increased effort of ED (90.4 ± 18.13 Hz vs 99.1 ± 17.82 Hz). Comparisons were made between W and M for each muscle group, assessing MVC and MDF. CONCLUSIONS: After controlling for surgeon's height and duration of surgery, an increase in muscle activation was seen for women laparoscopic surgeons. Since poor ergonomics could be a major cause of work-related injuries, we must understand differences in ergonomics between men and women and evaluate which factors impact these variations.

Minimally invasive approach to hiatal hernia repair is superior to open, even in the emergent setting: a large national database analysis.

BACKGROUND: We aimed to examine the outcomes and utilization of different hiatal hernia repair (HHR) approaches in elective and emergent/urgent settings. METHODS: Vizient 2015-2017 database was queried for adult patients who underwent HHR. Patients were grouped into open (OHHR), laparoscopic (LHHR), or robotic-assisted (RHHR), and further stratified by elective or urgent status and severity of illness at admission. Surgical outcomes and costs were compared across all groups. Statistical analysis were done using SPSS v.25.0. RESULTS: 9171 adults were included (OHHR N = 1534;LHHR N = 6796;RHHR N = 841). LHHR was the most utilized approach (74.1%), followed by OHRR (16.7%) and RHHR (9.2%). OHHR was employed three times as frequently in U settings, compared to elective. Overall, OHHR had longer mean length of stay (LOS; 9.41 vs. < 4 days) and higher postoperative complication rates (8.8% vs < 3.8%), mortality (2.7% vs < 0.5%) and mean direct cost ($27,842 vs < $10,407), when compared to both LHHR and RHHR, all p < 0.05. Analysis of mild to severely ill elective cases demonstrated LHHR and RHHR to be better than OHHR regarding complications (p < 0.05), cost (p < 0.001) and LOS (p < 0.013); there were insufficient extremely ill elective patients for meaningful analysis. In the urgent setting, minimally invasive approaches predominate, overtaken by OHHR only for the extremely ill. Despite the urgent setting, for mild-moderately ill patients, OHHR was statistically inferior to both LHHR and RHHR for LOS (p = 0.002, p < 0.0001) and cost (p = 0.0133, p < 0.001). In severe-extremely ill patients, despite being more utilized, OHHR was not superior to LHHR; in fact, complication, cost, and mortality trends (all p > 0.05) favored LHHR. CONCLUSION: Our analysis demonstrated LHHR to currently be the most employed approach overall. LHHR and RHHR were associated with lower cost, decreased LOS, complications, and mortality compared to OHHR, in all but the sickest of patients. Patients should be offered minimally invasive HHR, even in urgent/emergent settings, if technically feasible.

Surgical and clinical outcomes comparison of mesh usage in laparoscopic hiatal hernia repair.

PURPOSE: Use of absorbable mesh in hiatal hernia (HH) repair has been shown to decrease recurrence rates. Our aim was to compare the efficiency of three meshes in relation to the surgical outcomes of patients undergoing HH repair. METHODS: A single-institution retrospective review was done for adult patients who underwent HH repair with mesh between 2004 and 2016. Demographics, intra-operative, and cost data were collected. Esophageal symptoms and medication use were assessed pre- and postoperatively. Surgical outcomes were evaluated at 6-, 12-months, and long-term follow-up. Three groups were created based on type of mesh: human tissue matrix (HTM), biosynthetic mesh (BIOS), or porcine tissue matrix (PTM). Comparisons were performed between groups using SPSS v.26.0 and PC SAS v9.4, α = 0.05. RESULTS: 292 patients were included (HTM:N = 162, BIOS:N = 83, PTM:N = 47). Majority were male (60.4%), Caucasian (93.2%), median age, and BMI of 59 years [25-90 years] and 29.19 kg/m2 [18.9-58.0 kg/m2], respectively. 69% had a large HH. Median follow-up time was 27 months [1-166 months]. Overall recurrence rate was 39%, being significantly lower in BIOS at long-term (HTM: 31%, BIOS: 17%, PTM: 19%, p = 0.038). All groups had a significant postoperative improvement of esophageal symptoms, all p < 0.001. 65-70% of the cost difference between the groups was incurred by the cost of mesh alone (HTM: $1072, BIOS: $548, PTM: $1295), with the remainder attributable to the surgery itself. CONCLUSION: While outcomes of the three mesh groups were similar in our data, there was a significant difference in mesh cost. Surgeon and hospital preference still play a role in choosing the type of mesh used; however, knowledge of the individual mesh cost will help surgeons make better informed decisions.

How high is too high? Extensive mediastinal dissection in patients with hiatal hernia repair.

BACKGROUND: Approximately 10% of patients receiving anti-reflux procedures present with shortened esophagus. Collis gastroplasty (CG) is the current gold standard for esophageal lengthening, but mediastinal esophageal mobilization without gastroplasty may be an alternative approach. This study assesses preoperative and intraoperative hernia characteristics and mediastinal dissection impact in patients with large hiatal hernia repair (HHR). METHODS: A single-institution, prospectively collected database was reviewed for adults who underwent laparoscopic HHR with mesh and anti-reflux surgery between 2005 and 2016, hernia ≥ 5 cm. Preoperative hernia and follow-up were assessed using upper endoscopy and barium swallow. Intraoperative hernia characteristics were collected from the operative note. Esophageal symptom scores were collected pre- and postoperatively. Analyses were conducted using SPSS v26.0. RESULTS: Among 662 patients who had anti-reflux surgery in this period, a total of 205 patients who underwent HHR with mesh met the inclusion criteria and were included in study. Mean age was 61.7 ± 13.6 years, and majority of patients were female and Caucasian. Mean BMI was 29.9 ± 6.0 kg/m2. Median hernia size was 6.5 cm [5.0-12.0 cm], and intra-thoracic stomach had a prevalence of 21.9%. Analysis of preoperative barium swallow revealed an average of elevated gastroesophageal junction above the diaphragm of 4.10 ± 1.67 cm. Radiographically, average hernia size was 6.34 ± 1.93 cm and 6.38 ± 1.92 cm in the anterior-posterior and obliquus view, respectively. Median follow-up time was 2.7 years [1-9 years]. Esophageal symptoms improved in all patients (p < 0.05). 45% of patients had radiographic recurrence, but only four presented symptomatic or were on PPI. CONCLUSIONS: CG has been the standard for ensuring adequate esophageal length prior to anti-reflux surgery. Our results support that CG is unnecessary in the majority of cases, and extensive mediastinal dissection was successfully used instead of CG with durable, long-term outcomes. Extended mediastinal dissection may mitigate CG risks in patients requiring additional intra-abdominal esophagus.

A comprehensive review of robotic surgery curriculum and training for residents, fellows, and postgraduate surgical education.

BACKGROUND: In 2017, the utilization of robotic-assisted surgery had grown 10-40-fold relative to laparoscopic surgery in common general surgery procedures. The rapid rise in the utilization of robotic-assisted surgery has necessitated a standardized training curriculum. Many curricula are currently being developed and validated. Additionally, advancements in virtual reality simulators have facilitated their integration into robotic-assisted surgery training. This review aims to highlight and discuss the features of existing curricula and robotic-assisted surgery training simulators and to provide updates on their respective validation process. MATERIALS AND METHODS: A literature review was conducted using PubMed from 2000-2019 and commercial websites. Information regarding availability, content, and status of validation was collected for each current robotic-assisted surgery curriculum. This review did not qualify as human subjects research, so institutional review board approval was not required. RESULTS: The daVinci Technology Training Pathway and Fundamentals of Robotic Surgery are purely web-based and self-paced robotic-assisted surgery training. The Society of American Gastrointestinal and Endoscopic Surgeon Robotic Masters Series, Fundamental Skills of Robot-Assisted Surgery training program, and the Robotics Training Network curriculum require trainees to be on site in order to provide expert feedback on surgical techniques and robot maintenance. Currently, there are few virtual reality simulators for robotic-assisted surgical training available on the market. CONCLUSIONS: Didactic courses are available in all of these training programs, but their contents are inconsistent. Furthermore, the availability and nature of hands-on training offered by these curriculums are widely variable.

Outcomes and impact of laparoscopic inguinal hernia repair versus open inguinal hernia repair on healthcare spending and employee absenteeism.

BACKGROUND: This study compares the impact of open (OIHR) versus laparoscopic (LIHR) inguinal hernia repair on healthcare spending and postoperative outcomes. METHODS: The TRUVEN database was queried using ICD9 procedure codes for open, laparoscopic, and robotic-assisted IHR, from 2012 to 2013. Patients > 18 years of age and continuously enrolled for 12 months postoperatively were included. Demographics, patient comorbidities, postoperative complications, pain medication use, length of hospital stay, missed work hours, postoperative visits, and overall expenditure were collected, and assessed at time of surgery and at 30-, 60-, 90-, 180-, and 365-days postoperatively. Statistical analysis was conducted using SAS, with α = 0.05. RESULTS: 66,116 patients were included (LIHR: N = 23,010; OIHR: N = 43,106). Robotic-assisted procedures were excluded due to small sample size (N = 61). The largest demographic was males between 55 and 64 years. LIHR had fewer surgical wound complications than OIHR (LIHR: 0.3%; OIHR: 0.5%, p = 0.007), less utilization of pain medication (LIHR: 23.3%; OIHR: 28.5%; p < 0.001), and fewer outpatient visits. In the 90-day postoperative period, LIHR had significantly fewer missed work hours (LIHR: 12.1 ± 23.2 h; OIHR: 12.9 ± 26.7 h, p = 0.023). LIHR had higher postoperative urinary complications (LIHR: 0.2%; OIHR: 0.1%; p < 0.001), consistent with the current literature. LIHR expenditures ($15,030 ± $25,906) were higher than OIHR ($13,303 ± 32,014), p < 0.001. CONCLUSIONS: The results highlight the benefits of laparoscopic repair with regard to surgical wound complications, postoperative pain, outpatient visits, and missed work hours. These improved outcomes with respect to overall healthcare spending and employee absenteeism support the paradigm shift toward laparoscopic inguinal hernia repairs, in spite of higher overall expenditures.

SAGES masters program: determining the seminal articles for each pathway.

BACKGROUND: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has recently developed and announced its Masters Program that aims to address existing needs of practicing surgeons for lifelong learning and consists of eight clinical pathways each containing three anchoring procedures. The objective of this study was to select the seminal articles for each anchoring procedure of these pathways using a systematic methodology. METHODS: A systematic literature search of Web of Science was conducted for the most cited articles for each of the anchoring procedures of the SAGES Masters pathways. The most relevant identified articles were then reviewed by expert members of the relevant SAGES pathway committees and task forces and the seminal articles chosen for each anchoring procedure using expert consensus. RESULTS: 578 highly cited articles were identified by the original search of the literature and the seminal articles were selected for each anchoring procedure after expert review and consensus. Articles address procedural outcomes, disease pathophysiology, and surgical technique and are presented in this paper. CONCLUSIONS: We have identified seminal articles for each anchoring procedure of the SAGES Masters program pathways using a systematic methodology. These articles provide surgeon participants of this program with a great resource to improve their procedure-specific knowledge and may further benefit the larger surgical community by focusing its attention to must-read impactful work that may inform best practices.

Effects of Varied Surgical Simulation Training Schedules on Motor-Skill Acquisition.

There have been many studies to evaluate the effect of training schedules on retention; however, these usually compare only 2 drastically different schedules, massed and distributed, and they have tended to look at declarative knowledge tasks. This study examined learning on a laparoscopic surgery simulator using a set of procedural or perceptual-motor tasks with some declarative elements. The study used distributed, massed, and 2 hybrid-training schedules that are neither distributed nor massed. To evaluate the training schedules, 23 participants with no previous laparoscopic experience were recruited and randomly assigned to 1 of the 4 training schedules. They performed 3 laparoscopic training tasks in eight 30-minute learning sessions. We compared how task time decreased with each schedule in a between-participants design. We found participants in all groups demonstrated a decrease in task completion time as the number of training sessions increased; however, there were no statistically significant differences in participants' improvement on task completion time between the 4 different training schedule groups, which suggested that time on task is more important for learning these tasks than the training schedule.

Ergonomics Analysis for Subjective and Objective Fatigue Between Laparoscopic and Robotic Surgical Skills Practice Among Surgeons.

Introduction. Our aim was to determine how self-reported and objectively measured fatigue of upper limb differ between laparoscopic and robotic surgical training environments. Methods. Surgeons at the 2016 SAGES Conference Learning Center and at our institution were enrolled. Two standardized surgical tasks (peg transfer [PT] and needle passing [NP]) were performed twice in each surgical skills practical environments: (1) laparoscopic training-box environment (Fundamentals of Laparoscopic Surgery [FLS]) and (2) Mimic dV-trainer (MIMIC). Muscle activation of upper trapezius (UT), anterior deltoid (AD), flexor carpi radialis, and extensor digitorum were recorded using surface electromyography (EMG; Trigno, Delsys, Inc, Natick, MA). Subjective fatigue was self-reported using Piper Fatigue Scale-12. Analysis was done using SPSS v25.0, α = .05. Results. Demographics were similar between FLS (N = 14) and MIMIC (N = 12). For PT, MIMIC had a significant increase in EMGRMS of UT (P < .001) and AD (P < .001). Conversely, FLS led to significant decreased muscle fatigue in UT (P = .015). For NP, MIMIC had a significant increase in EMGRMS for UT (P = .034) and AD (P = .031), but FLS induced more muscle fatigue for AD (P = .004). There was significant decrease in self-reported fatigue after performing FLS tasks (P = .030) but not after MIMIC (P = .663). Conclusion. Our results showed that practice with MIMIC resulted in greater activation of shoulder muscles, while FLS caused more significant muscle fatigue in the same muscles. This could be due to ergonomic disadvantages and nonoptimal ergonomic settings. Further studies are needed to understand the optimal ergonomics and its impact on fatigue and muscle activation during use of both the FLS and MIMIC training systems.

Post-Discharge Services for Different Diagnoses Than Index Hospitalization Predict Decreased 30-Day Readmissions Among Medicare Beneficiaries.

BACKGROUND: Efforts to reduce hospital readmissions include post-discharge interventions related to the illness treated during the index hospitalization (IH). These efforts may be inadequate because readmissions are precipitated by a wide range of health conditions unrelated to the primary diagnosis of the IH. OBJECTIVE: To investigate the relationship between post-discharge health services utilization for the same or a different diagnosis than the IH and unplanned 30-day readmission. DESIGN AND PARTICIPANTS: The study sample included 583,199 all-cause IHs among 2014 Medicare fee-for-service beneficiaries. For all-cause IH, as well as individually for heart failure, myocardial infarction, and pneumonia IH, we used multivariable logistic regressions to investigate the association between post-discharge services utilization and readmission. MAIN MEASURES: The outcome was unplanned 30-day readmission. Primary independent variables were post-discharge services utilization, including institutional outpatient, office-based primary care, office-based specialist, office-based non-physician practitioner, emergency department, home health care, and skilled nursing facility providers. KEY RESULTS: Among all-cause IH, 11.7% resulted in unplanned 30-day readmissions, and only 18.1% of readmissions occurred for the same primary diagnosis as IH. A substantial majority of post-discharge health services were utilized for a primary diagnosis differing from IH. Compared with no visit, institutional outpatient visits for the same primary diagnosis as IH (odds ratio [OR], 0.33; 95% confidence interval [CI], 0.31-0.34) and for a different primary diagnosis than IH (OR, 0.36; 95% CI, 0.35-0.37) were similarly strongly associated with decreased unplanned 30-day readmission. Primary care physician, specialist, non-physician practitioner, and home health care showed similar patterns. IH for heart failure, myocardial infarction, and pneumonia manifested similar patterns to all-cause IH both in terms of post-discharge services utilization and in terms of its impact on readmission. CONCLUSIONS: To reduce unplanned 30-day readmission more effectively, discharge planning should include post-discharge services to address health conditions beyond the primary cause of the IH.

Ergonomics of minimally invasive surgery: an analysis of muscle effort and fatigue in the operating room between laparoscopic and robotic surgery.

BACKGROUND: Our aim was to determine how objectively-measured and self-reported muscle effort and fatigue of the upper-limb differ between surgeons performing laparoscopic (LAP) and robotic-assisted (ROBOT) surgeries. METHODS: Surgeons performing LAP or ROBOT procedures at a single-institution were enrolled. Objective muscle activation and self-reported fatigue were evaluated, and comparisons were made between approaches. Muscle activation of the upper trapezius (UT), anterior deltoid (AD), flexor carpi radialis (FCR), and extensor digitorum (ED) were recorded during the surgical procedure using Trigno wireless surface electromyography (EMG). The maximal voluntary contraction (MVC) was obtained to normalize root-mean-square muscle activation as %MVCRMS. The median frequency (MDF) was calculated to assess muscle fatigue. Each surgeon also completed the validated Piper Fatigue Scale-12 (PFH-12) before and after the procedure for self-perceived fatigue assessment. Statistical analysis was done using SAS/STAT software, with α = 0.05. RESULTS: 28 surgeries were recorded (LAP: N = 18, ROBOT: N = 10). EMG analysis revealed the ROBOT group had a higher muscle activation than LAP for UT (37.7 vs. 25.5, p = 0.003), AD (8.9 vs. 6.3, p = 0.027), and FCR (14.4 vs. 10.9, p = 0.019). Conversely, LAP required more effort for the ED, represented by a significantly lower MDF compared to the ROBOT group (91.2 ± 1.5 Hz vs. 102.8 ± 1.5 Hz, p < 0.001). Survey analysis revealed no differences in self-reported fatigue before and after the surgery between approaches, p = 0.869. CONCLUSIONS: Our analysis revealed surgeons show similar fatigue levels performing the first case of the day using either robotic or LAP surgery. Surgeons performing LAP surgery had more fatigue in the forearm, robotic surgery required more shoulder and neck use, but neither was superior. Neither technique produced significant overall fatigue on survey. Long-term selective use of these different muscles could be correlated with different patterns of injury. Future studies are needed to fully understand long-term implications of prolonged surgery on occupational injury.

Global Surgery: Effective Involvement of US Academic Surgery: Report of the American Surgical Association Working Group on Global Surgery.

: There is an unacceptably high burden of death and disability from conditions that are treatable by surgery, worldwide and especially in low- and middle-income countries (LMICs). The major actions to improve this situation need to be taken by the surgical communities, institutions, and governments of the LMICs. The US surgical community, including the US academic surgical community, has, however, important roles to play in addressing this problem. The American Surgical Association convened a Working Group to address how US academic surgery can most effectively decrease the burden from surgically treatable conditions in LMICs. The Working Group believes that the task will be most successful (1) if the epidemiologic pattern in a given country is taken into account by focusing on those surgically treatable conditions with the highest burdens; (2) if emphasis is placed on those surgical services that are most cost-effective and most feasible to scale up; and (3) if efforts are harmonized with local priorities and with existing global initiatives, such as the World Health Assembly with its 2015 resolution on essential surgery. This consensus statement gives recommendations on how to achieve those goals through the tools of academic surgery: clinical care, training and capacity building, research, and advocacy. Through all of these, the ethical principles of maximally and transparently engaging with and deferring to the interests and needs of local surgeons and their patients are of paramount importance. Notable benefits accrue to US surgeons, trainees, and institutions that engage in global surgical activities.

Growth in robotic-assisted procedures is from conversion of laparoscopic procedures and not from open surgeons' conversion: a study of trends and costs.

BACKGROUND: Utilization of laparoscopy (LAP) has been increasing in general surgery for years, and there is currently a rapid increase in the utilization of robotic-assisted surgeries (RAS). This study evaluates trends in the surgical approach utilized in some commonly performed surgeries, the proportion of each approach within the procedures, and the cost of these surgeries based on the surgical approach. METHODS: This is a retrospective study using the Vizient database. The database was queried using ICD-9 codes for colectomy, cholecystectomy, inguinal and ventral hernia repairs, and bariatric surgeries, either open, LAP, or robotically performed. Utilization trends were evaluated between quarters, over a 7-year period, and direct cost was compared between approaches. IBM SPSS v.23.0.0 was used for data analysis, with α = 0.05. RESULTS: 857,468 patients underwent colectomy, cholecystectomy, inguinal and ventral hernia repairs, and bariatric procedures. A significant decrease in open-approach utilization was seen in colectomy (71.8-61.9%), cholecystectomy (35.7-27.1%), and bariatric surgeries (20.1-10.1%), whereas both LAP and RAS utilization increased (p < 0.001). Significant RAS increase was seen in all five procedures: colectomy (0.4-8.0%), cholecystectomy (0.2-1.8%), IHR (19.9-29.4%), VHR (0.2-2.9%), and bariatric (0.6-5.4%), compared to a decrease in LAP (p < 0.001). Surgery cost was significantly higher for open ($14,364), followed by RAS ($11,376) and LAP ($7945), p < 0.001. CONCLUSIONS: Robotic technology is commonly viewed as enabling open procedures to be converted to minimally invasive, a trend not observed in our study. Our trends analysis revealed significant RAS utilization increase from LAP procedures and not from open procedure conversion, although specific surgeon data were not available. RAS were costlier than LAP for all five procedures. The benefits of rapid robot adoption and the forces that are driving these must be examined against a backdrop of burdening an already expensive healthcare system.

Robotic ventral hernia repair is not superior to laparoscopic: a national database review.

BACKGROUND: Minimally invasive surgery (MIS) use for ventral hernia repair has increased over the last decade. Whether outcomes are improved by robotic assistance remains a subject of debate. The aim of this study is to evaluate outcomes (including cost, complications, length of stay (LOS), and pain medication utilization) in patients who underwent an open (OVHR), laparoscopic (LVHR), or robotic (RVHR) ventral hernia repair (VHR). METHODS: The Vizient database was queried using ICD-9 procedure and diagnosis codes for patients who underwent VHR from January 2013 to September 2015. Complications, 30-day readmission, mortality, LOS, cost, and intra-hospital opiate utilization were analyzed using IBM SPSS v.23.0.0.0. Median tests with post hoc pairwise comparisons, Fischer's exact, and Pearson's chi-squared test with Bonferroni correction were applied where appropriate, with α = 0.05. RESULTS: 46,799 patients (OVHR: N = 39,505, LVHR: N = 6829, RVHR: N = 465) met the criteria and patients in each group had similar demographics (Table 1). OVHR was associated with significant increased overall complications, 30-day readmission, LOS, and postoperative pain use compared to RVHR or LVHR. OVHR had higher mortality and postoperative infection rates than LVHR. RVHR had significantly higher rates of complications and postoperative infections compared to LVHR, although there was no difference in mortality, 30-day readmission, LOS, and postoperative pain medication use. Mean direct cost of surgery was significantly higher for RVHR, followed by OVHR and LVHR. CONCLUSIONS: Overall patient outcomes were improved in the LVHR and RVHR groups compared to the open approach. However, RVHR patients did not have significant improvement compared with the LVHR group in either short-term outcomes or opiate medication used. While RVHR surgery was the most expensive modality, OVHR was also significantly costlier than LVHR, which was the least expensive. Long-term data on recurrence could not be evaluated and should be studied to determine the role of robotic surgery in VHR and recurrence rates.

Review of emerging surgical robotic technology.

BACKGROUND: The use of laparoscopic and robotic procedures has increased in general surgery. Minimally invasive robotic surgery has made tremendous progress in a relatively short period of time, realizing improvements for both the patient and surgeon. This has led to an increase in the use and development of robotic devices and platforms for general surgery. The purpose of this review is to explore current and emerging surgical robotic technologies in a growing and dynamic environment of research and development. METHODS: This review explores medical and surgical robotic endoscopic surgery and peripheral technologies currently available or in development. The devices discussed here are specific to general surgery, including laparoscopy, colonoscopy, esophagogastroduodenoscopy, and thoracoscopy. Benefits and limitations of each technology were identified and applicable future directions were described. RESULTS: A number of FDA-approved devices and platforms for robotic surgery were reviewed, including the da Vinci Surgical System, Sensei X Robotic Catheter System, FreeHand 1.2, invendoscopy E200 system, Flex® Robotic System, Senhance, ARES, the Single-Port Instrument Delivery Extended Research (SPIDER), and the NeoGuide Colonoscope. Additionally, platforms were reviewed which have not yet obtained FDA approval including MiroSurge, ViaCath System, SPORT™ Surgical System, SurgiBot, Versius Robotic System, Master and Slave Transluminal Endoscopic Robot, Verb Surgical, Miniature In Vivo Robot, and the Einstein Surgical Robot. CONCLUSIONS: The use and demand for robotic medical and surgical platforms is increasing and new technologies are continually being developed. New technologies are increasingly implemented to improve on the capabilities of previously established systems. Future studies are needed to further evaluate the strengths and weaknesses of each robotic surgical device and platform in the operating suite.

Increased glycine-amidated hyocholic acid correlates to improved early weight loss after sleeve gastrectomy.

BACKGROUND: Bile acids (BAs) are post-prandial hormones that play an important role in glucose and lipid homeostasis as well as energy expenditure. Total and glycine-amidated BAs increase after sleeve gastrectomy (SG) and correlate to improved metabolic disease. No specific bile acid subtype has been shown conclusively to mediate the weight loss effect. Therefore, the objective of this study was to prospectively evaluate the comprehensive changes in meal-stimulated BAs after SG and determine if a specific change in the BA profile correlates to the early weight loss response. METHODS: Patients were prospectively enrolled at the University of Nebraska Medical Center who were undergoing a SG for treatment of morbid obesity. Primary and secondary plasma bile acids and their amidated (glycine, G-, or taurine, T-) subtypes were measured at fasting, 30 and 60 min after a liquid meal performed pre-op, and at 6 and 12 weeks post-op. Area under the curve (AUC) was calculated for the hour meal test for each bile acid subtype. BAs that were significantly increased post-op were correlated to body mass index (BMI) loss. RESULTS: Total BA AUC was significantly increased at 6 (p < 0.01) and 12 weeks post-op (p < 0.01) compared to pre-operative values. The increase in total BA AUC was due to a statistically significant increase in G-BAs. Nine different BA AUC subtypes were significantly increased at both 6 and 12 weeks post-op. Increased total and G-chenodeoxycholic acid AUC was significantly correlated to the 6 week BMI loss (p = 0.03). Increased G-hyocholic acid was significantly correlated to increased weight loss at both 6 (p = 0.05) and 12 weeks (p = 0.006). CONCLUSIONS: SG induced an early and persistent post-prandial surge in multiple bile acid subtypes. Increased G-hyocholic consistently correlated with greater early BMI loss. This study provides evidence for a role of BAs in the surgical weight loss response after SG.

Performance of a Multifunctional Robot for Natural Orifice Transluminal Endoscopic Surgery.

Natural orifice transluminal endoscopic surgery (NOTES) has gained attention as a revolutionary technique with its potential advantages in eliminating skin incisions, shortening recovery time, and decreasing postoperative complications; however, its practical application is still constrained by the complexity of navigation through the surgical field and paucity of available instruments. Current progress on NOTES focuses on designing flexible articulated robots or fully inserted bimanual robots to address the limitations. However, the lack of multitasking tools, trade-offs between size and power, and lack of sufficient surgical force are too often neglected. The authors designed a bimanual robot with a multifunctional manipulator, which can realize on-site instrument-change according to surgeon needs. An articulated drive mechanism with 2 independent curvature sections was designed to deliver the robot to the surgical site. A corresponding reconfiguration operation sequence was formulated to ease insertion and thereby decrease the design trade-off between size and power. This article presents 3 benchtop and animal tests to evaluate the robotic surgery approach and demonstrate the effectiveness of the robot.