Assessing the long-term priorities of pancreaticoduodenectomy survivors.

BACKGROUND: This study assessed the long-term quality of life (QOL) and priorities of pancreaticoduodenectomy (PD) survivors. METHODS: Survivors were surveyed via internet-based support groups. The relative importance of longevity, experience, costs, and QOL were assessed. RESULTS: The PD cohort (n = 247, 35%) was 60 ± 12 years, 71% female, and 93% white. With moderate agreement, patients ranked survival most important, followed by functional and emotional well-being; costs and experience were least important (W = 35.7%, p < 0.001). Well-being improved throughout survivorship (P-QOL: 39 ± 12 at ≤3 mo vs 43 ± 12 at >10 y, p = 0.170; M-QOL: 38 ± 13 at ≤3 mo vs 44 ± 16 at >10 y; p = 0.015) but remained below the general population (p < 0.001). PD patients with benign diagnoses ranked functional independence as most important (2.00 ± 1.13 vs 2.63 ± 1.19, p < 0.001, W = 41.1%); PD patients with malignant diagnoses regarded overall survival most important (2.10 ± 1.20 vs 1.82 ± 1.22, p < 0.16, W = 35.1%). The mean rank order of priorities remained concordant between short-term (<1 year) and long-term (>5 years) survivors. CONCLUSION: PD survivors experience long-term mental and physical health impairments, underscoring the importance of functional and emotional support. Survivors place paramount importance on overall survival, functional independence, and emotional well-being. Cancer survivors prioritize longevity, while survivors of chronic benign conditions prioritize functional independence.

Elastomeric half-mask respirator disinfection practices among healthcare personnel.

BACKGROUND: Disposable N95 respirator shortages during the COVID-19 and 2009 H1N1 influenza pandemics highlighted the need for reusable alternatives, such as elastomeric half-mask respirators (EHMRs). Two US medical organizations deployed reusable EHMRs during the COVID-19 response. In addition to wipe-based disinfection following patient care episodes expected per local policies at both organizations, postshift centralized cleaning and disinfection (C&D) was expected at one site (A), permitting shared-pool EHMR use, and optional at the other (Site B), where EHMRs were issued to individuals. Using a survey, we evaluated disinfection practices reported by EHMR users and predictors of disinfection behaviors and perceptions. METHODS: Surveys assessed EHMR disinfection practices, occupational characteristics, EHMR use frequency, training, and individual-issue versus shared-pool EHMR use. RESULTS: Of 1080 EHMR users completing the survey, 76% reported that they disinfect the EHMR after each patient encounter, which was the expected practice at both sites. Increasing EHMR use, recall of disinfection training, and work in intensive care or emergency settings significantly influenced higher reporting of this practice. 36% of respondents reported using centralized C&D, although reporting was higher at the site (A) where this was expected (53%). Confidence in cleanliness of the EHMR following centralized C&D was not influenced by individual versus shared-pool EHMR issue. CONCLUSIONS: Most EHMR users reported adherence with expected post-care individual-based disinfection of EHMRs but did not necessarily use standardized, centralized C&D. Future efforts to limit reliance on behavior related to respirator disinfection may improve EHMR implementation in healthcare to avert dependence on single-use, disposable N95 respirators.

Neoadjuvant chemoradiation is associated with decreased lymph node ratio in borderline resectable pancreatic cancer: A propensity score matched analysis.

BACKGROUND: Lymph node ratio (LNR) and margin status have prognostic significance in pancreatic cancer. Herein we examined the pathologic and clinical outcomes in patients with borderline resectable pancreatic cancer (BRPC) following neoadjuvant therapy (NAT) and pancreaticoduodenectomy. METHODS: Patients who underwent treatment between January 1, 2012 and June 30, 2017 were included. Sequential patients in the BRPC group were compared to a propensity score matched cohort of patients with radiographically resectable pancreatic cancer who underwent upfront surgical resection. The BRPC group was also compared to sequential patients with radiographically resectable pancreatic cancer who required vein resection (VR) during upfront surgery. RESULTS: There were 50 patients in the BRPC group, 50 patients in the matched control group, and 38 patients in the VR group. Negative margins (R0) were seen in 72%, 64%, and 34% of the BRPC, control, and VR groups, respectively (P = 0.521 for BRPC vs. control; P = 0.002 for BRPC vs. VR), with 24% of the BRPC group requiring a vascular resection. Nodal stage was N0 in 64%, 20%, and 18% of the BRPC, control, and VR groups, respectively (P < 0.001 for BRPC vs. control or VR). When nodal status was stratified into four groups (N0, or LNR ≤ 0.2, 0.2-0.4, ≥ 0.4), the BRPC group had a more favorable distribution (P < 0.001). The median overall survival were 28.8, 38.6, and 19.0 months for the BRPC, control, and VR groups, respectively (log-rank P = 0.096). CONCLUSIONS: NAT in BRPC was associated with more R0 and N0 resections and lower LNR compared to patients undergoing upfront resection for resectable disease.

Pathologic tumor response to neoadjuvant therapy in borderline resectable pancreatic cancer.

BACKGROUND: Previous studies have demonstrated the prognostic significance of pathologic tumor response in pancreatic adenocarcinoma following neoadjuvant therapy (NAT). The aim of this study was to determine the incidence of significant pathologic response to NAT in borderline resectable pancreatic cancer (BRPC), and association of NAT regimen and other clinico-pathologic characteristics with pathologic response. METHODS: Patients with BRPC who underwent NAT and pancreatic resection between January 2012 and June 2017 were included. Pathologic response was assessed on a qualitative scale based on the College of American Pathologists grading system. Demographics and baseline characteristics, oncologic treatment, pathology, and survival outcomes were compared. RESULTS: Seventy-one patients were included for analysis. Four patients had complete pathologic responses (tumor regression score 0), 12 patients had marked responses (score 1), 42 had moderate responses (score 2), and 13 had minimal responses (score 3). Patients with complete or marked responses were more likely to have received neoadjuvant gemcitabine chemoradiation (62.5%, 38.1%, and 23.1% of the complete/marked, moderate, and minimal response groups, respectively; P = 0.04). Of the complete/marked, moderate, and minimal response groups, margins were negative in 75.0%, 78.6%, and 46.2% (P = 0.16); node negative disease was observed in 87.5%, 54.8%, and 15.4% (P < 0.01); and median overall survival was 50.0 months, 31.7 months, and 23.2 months (P = 0.563). Of the four patients with pathologic complete responses, three were disease-free at 66.1, 41.7 and 31.4 months, and one was deceased with metastatic liver disease at 16.9 months. CONCLUSIONS: A more pronounced pathologic tumor response to NAT in BRPC is correlated with node negative disease, but was not associated with a statistically significant survival benefit in this study.

Time Attributable to Obesity in Surgery: A Multi-specialty Report on Day-of-Surgery Resource Utilization from 189,264 Cases.

BACKGROUND: Obesity presents a unique challenge in caring for surgical patients and has been shown to adversely affect outcomes for several operative procedures. However, quantitative data on surgical resource utilization attributable to obesity are scarce. The aim of this study was to quantify day-of-surgery resource utilization by degree of obesity. METHODS: Patients undergoing one of 14 common surgical procedures at our multicenter institution between 2008 and 2017 were identified from our operating room management databank. Multiple-variable regression analysis (MVRA) was performed to quantify the independent effect of body mass index (BMI) category on day-of-surgery resource utilization variables including procedure time, non-operative OR time, PACU time, number of unique staff and number of supplies used. Trends in mean BMI were examined for each procedure studied. RESULTS: MVRA of the 189,264 cases in the database revealed consistently significant (p < 0.05) stepwise increase in procedure time by BMI category for all procedures studied. Non-operative OR time was also significantly prolonged, though to a lesser degree. There was no significant impact on number of unique staff, supplies utilized or PACU time by BMI category. Procedures most impacted by BMI category in terms of resource utilization were ventral hernia repair, laminectomy and hysterectomy. CONCLUSION: Our study quantified day-of-surgery resource utilization for 14 major surgical procedures by BMI category. The need for additional resources to accommodate patients in higher BMI groups was consistent across all procedures studied and was primarily reflected by lengthened operative times.

A Multi-institutional Comparison of Perioperative Outcomes of Robotic and Open Pancreaticoduodenectomy.

OBJECTIVES: Limited data exist comparing robotic and open approaches to pancreaticoduodenectomy (PD). We performed a multicenter comparison of perioperative outcomes of robotic PD (RPD) and open PD (OPD). METHODS: Perioperative data for patients who underwent postlearning curve PD at 8 centers (8/2011-1/2015) were assessed. Univariate analyses of clinicopathologic and treatment factors were performed, and multivariable models were constructed to determine associations of operative approach (RPD or OPD) with perioperative outcomes. RESULTS: Of the 1028 patients, 211 (20.5%) underwent RPD (4.7% conversions) and 817 (79.5%) underwent OPD. As compared with OPD, RPD patients had higher body mass index, rates of prior abdominal surgery, and softer pancreatic remnants, whereas OPD patients had a higher percentage of pancreatic ductal adenocarcinoma cases, and greater proportion of nondilated (<3 mm) pancreatic ducts. On multivariable analysis, as compared with OPD, RPD was associated with longer operative times [mean difference = 75.4 minutes, 95% confidence interval (CI) 17.5-133.3, P = 0.01], reduced blood loss (mean difference = -181 mL, 95% CI -355-(-7.7), P = 0.04) and reductions in major complications (odds ratio = 0.64, 95% CI 0.47-0.85, P = 0.003). No associations were demonstrated between operative approach and 90-day mortality, clinically relevant postoperative pancreatic fistula and wound infection, length of stay, or 90-day readmission. In the subset of 522 (51%) pancreatic ductal adenocarcinomas, operative approach was not a significant independent predictor of margin status or suboptimal lymphadenectomy (<12 lymph nodes harvested). CONCLUSIONS: Postlearning curve RPD can be performed with similar perioperative outcomes achieved with OPD. Further studies of cost, quality of life, and long-term oncologic outcomes are needed.

Predicting early mortality in resectable pancreatic adenocarcinoma: A cohort study.

BACKGROUND: Survival after surgical resection for pancreatic cancer remains poor. A subgroup of patients die early (<6 months), and understanding factors associated with early mortality may help to identify high-risk patients. The Khorana score has been shown to be associated with early mortality for patients with solid tumors. In the current study, the authors evaluated the role of this score and other prognostic variables in this setting. METHODS: The current study was a cohort study of patients who underwent surgical resection for pancreatic cancer from January 2006 through June 2013. Baseline (diagnosis ±30 days) parameters were used to define patients as high risk (Khorana score ≥3). Statistically significant univariable associations and a priori prognostic variables were tested in multivariable models; adjusted hazard ratios (HR) were calculated. RESULTS: The study population comprised 334 patients. The median age was 67 years, 50% of the study population was female, and 86% of the patients were white. The pancreatic head was the primary tumor site for 73% of patients; 67% of tumors were T3 and 63% were N1. The median Khorana score was 2; 152 patients (47%) were determined to be high risk. Adjunctive treatment included chemotherapy (70%) and radiotherapy (40%). The postoperative (30-day) mortality rate was 0.9%. The 6-month mortality rate for the entire cohort was 9.4%, with significantly higher rates observed for high-risk patients (13.4% vs 5.6%; P = .02). On multivariable analyses (examining a total of 326 patients), the Khorana score (HR for high risk, 2.31; P = .039) and elevated blood urea nitrogen (HR, 4.34; P<.001) were associated with early mortality. CONCLUSIONS: Patients at high risk of early mortality after surgical resection of pancreatic adenocarcinoma can be identified using simple baseline clinical and laboratory parameters. Future studies should address preoperative interventions in these patients at high risk of early mortality.

Treatment of 200 locally advanced (stage III) pancreatic adenocarcinoma patients with irreversible electroporation: safety and efficacy.

OBJECTIVES: Ablative therapies have been increasingly utilized in the treatment of locally advanced pancreatic cancer (LAPC). Irreversible electroporation (IRE) is an energy delivery system, effective in ablating tumors by inducing irreversible membrane destruction of cells. We aimed to demonstrate efficacy of treatment with IRE as part of multimodal treatment of LAPC. METHODS: From July 2010 to October 2014, patients with radiographic stage III LAPC were treated with IRE and monitored under a multicenter, prospective institutional review board-approved registry. Perioperative 90-day outcomes, local failure, and overall survival were recorded. RESULTS: A total of 200 patients with LAPC underwent IRE alone (n = 150) or pancreatic resection plus IRE for margin enhancement (n = 50). All patients underwent induction chemotherapy, and 52% received chemoradiation therapy as well for a median of 6 months (range, 5-13 months) before IRE. IRE was successfully performed in all patients. Thirty-seven percent of patients sustained complications, with a median grade of 2 (range, 1-5). Median length of stay was 6 days (range, 4-36 days). With a median follow-up of 29 months, 6 patients (3%) have experienced local recurrence. Median overall survival was 24.9 months (range: 4.9-85 months). CONCLUSIONS: For patients with LAPC (stage III), the addition of IRE to conventional chemotherapy and radiation therapy results in substantially prolonged survival compared with historical controls. These results suggest that ablative control of the primary tumor may prolong survival.

Minimally invasive duodenojejunostomy for superior mesenteric artery syndrome: a case series and review of the literature.

BACKGROUND: Superior mesenteric artery syndrome (SMAS) is a disorder characterized by vascular compression of the duodenum leading to mechanical obstruction. Surgical intervention is indicated in patients who fail standard non-operative management, in which duodenojejunostomy is favored based on previous small series. Given the rarity of the condition, knowledge of the optimal indications for surgery, risk of postoperative complications, and prognosis of SMAS after minimally invasive duodenojejunostomy is limited. METHODS: A retrospective chart review was performed on patients who underwent minimally invasive duodenojejunostomy for SMAS from March 2005 to December 2013 at our "healthcare system". We analyzed patients' presentations, work-up, surgical therapy, and outcomes. RESULTS: A series of 14 patients with SMAS underwent minimally invasive duodenojejunostomy. All of these patients met clinical criteria of SMAS with radiological confirmation. Average weight loss before surgery was 10.7 kg. Depression and eating disorders were comorbid in 6/14 patients. The mean age was 39 years (19-91 years). Twelve operations were completed laparoscopically and two were performed with robotic assistance. Mean operation duration was 119 min and average length of hospital stay was 5.5 days. There were no immediate postoperative complications. One patient developed a delayed anastomotic stricture that improved with single endoscopic balloon dilation. Initial symptom improvement occurred in all patients and the improvement occurred in 11 patients (79%) during the follow-up. At a mean follow-up of 20 months, two patients experienced complications, including one infection at a simultaneously placed J-tube site and one patient with dumping syndrome. Mean weight gain was 3.8 kg (p < 0.01). CONCLUSION: SMAS should be considered a potential diagnosis in patients who present with a history of persistent postprandial vomiting, epigastric pain, and weight loss and confirmatory radiographic findings. In well-selected patients, minimally invasive duodenojejunostomy is a safe and effective treatment for SMAS with excellent short-term outcomes.

Estimating the need for hepato-pancreatico-biliary surgeons in the USA.

BACKGROUND: Hepato-pancreatico-biliary (HPB) fellowship training has risen in popularity in recent years and hence large numbers of graduating fellows enter the workforce each year. Studies have proposed that the increase in HPB-trained surgeons will outgrow demand in the USA. This study shows that the need for HPB-trained surgeons refers not to the meeting of demand in terms of case volume, but to improving patient access to care. METHODS: The National Inpatient Sample (NIS) database for the years 2005-2011 was queried for CPT codes relating to pancreatic, liver and biliary surgical cases. These numbered 6627 in 2005 and increased to 8515 in 2011. Cases were then mapped to corresponding states. The number of procedures in an individual state was divided by the total number of procedures to give a ratio for each state. A similar ratio was calculated for the population of each state to the national population. These ratios were combined to give a ratio by state of observed to expected HPB surgical cases. RESULTS: Of the 46 states that participate in the NIS, only 18 achieved ratios of observed to expected cases of >1. In the remaining 28 states, the number of procedures was lower than that expected according to each state's population. CONCLUSIONS: The majority of the USA is underserved in terms of HPB surgery. Given the growing number of HPB-trained physicians entering the job market, this sector should focus on bringing understanding and management of complex disease to areas of the country that are currently in need.

Prognostic value of the lymph node ratio after resection of periampullary carcinomas.

BACKGROUND: Data have indicated that the lymph node ratio (LNR) may be a better prognostic indicator than lymph node status in pancreatic cancer. OBJECTIVES: To analyse the value of the LNR in patients undergoing resection for periampullary carcinomas. METHODS: A cut off value of 0.2 was assigned to the LNR in accordance with published studies. The impact of histopathological factors including a LNR was analysed using Kaplan-Meier and Cox regression methods. RESULTS: In total, 551 patients undergoing a resection (January 2000 to December 2010) were analysed. The median lymph node yield was 15, and 198 (34%) patients had a LNR > 0.2. In patients with a LNR of > 0.2, the median overall survival (OS) was 18 versus 33 months in patients with an LNR < 0.2 (P < 0.001). Univariate analysis demonstrated a LNR > 0.2, T and N stage, vascular or perineural invasion, grade and resection margin status to be significantly associated with OS. On multivariate analysis, only a LNR > 0.2, vascular or perineural invasion and margin positivity remained significant. In N1 disease, a LNR was able to distinguish survival in patients with a similar lymph node burden, and correlated with more aggressive tumour pathological variables. CONCLUSION: A LNR > 0.2, and not lymph note status, is an independent prognostic factor for OS indicating the LNR should be utilized in outcome stratification.

Comprehensive value implications of surgeon volume for lung cancer surgery: Use of an analytic framework within a regional health system.

Objective: We used a framework to assess the value implications of thoracic surgeon operative volume within an 8-hospital health system. Methods: Surgical cases for non-small cell lung cancer were assessed from March 2015 to March 2021. High-volume (HV) surgeons performed >25 pulmonary resections annually. Metrics include length of stay, infection rates, 30-day readmission, in-hospital mortality, median 30-day charges and direct costs, and 3-year recurrence-free and overall survival. Multivariate regression-based propensity scores matched patients between groups. Metrics were graphed on radar charts to conceptualize total value. Results: All 638 lung resections were performed by 12 surgeons across 6 hospitals. Two HV surgeons performed 51% (n = 324) of operations, and 10 low-volume surgeons performed 49% (n = 314). Median follow-up was 28.8 months (14.0-42.3 months). Lobectomy was performed in 71% (n = 450) of cases. HV surgeons performed more segmentectomies (33% [n = 107] vs 3% [n = 8]; P < .001). Patients of HV surgeons had a lower length of stay (3 [2-4] vs 5 [3-7]; P < .001) and infection rates (0.6% [n = 1] vs 4% [n = 7]; P = .03). Low-volume and HV surgeons had similar 30-day readmission rates (14% [n = 23] vs 7% [n = 12]; P = .12), in-hospital mortality (0% [n = 0] vs 0.6% [n = 1]; P = .33), and oncologic outcomes; 3-year recurrence-free survival was 95% versus 91%; P = .44, and 3-year overall survival was 94% versus 90%; P = 0. Charges were reduced by 28%, and direct costs were reduced by 23% (both P < .001) in the HV cohort. Conclusions: HV surgeons provide comprehensive value across a health system. This multidomain framework can be used to help drive oncologic care decisions within a health system.

Laparoscopic completion cholecystectomy and common bile duct exploration for retained gallbladder after single-incision cholecystectomy.

BACKGROUND: Recent enthusiasm in the surgical community for less invasive surgical approaches has resulted in widespread application of single-incision techniques. This has been most commonly applied in laparoscopic cholecystectomy in general surgery. Cosmesis appears to be improved, but other advantages remain to be seen. Feasibility has been demonstrated, but there is little description in the current literature regarding complications. PATIENT AND METHODS: We report the case of a patient who previously underwent single-incision laparoscopic cholecystectomy for symptomatic gallstone disease. After a brief symptom-free interval, she developed acute pancreatitis. At evaluation, imaging results of ultrasonography and magnetic resonance cholangiopancreatography demonstrated a retained gallbladder with cholelithiasis. The patient was subsequently referred to our hospital, where she underwent further evaluation and surgical intervention. RESULTS: Our patient underwent 4-port laparoscopic remnant cholecystectomy with transcystic common bile duct exploration. Operative exploration demonstrated a large remnant gallbladder and a partially obstructed cystic duct with many stones. Transcystic exploration with balloon extraction resulted in duct clearance. The procedure took 75 minutes, with minimal blood loss. The patient's postoperative course was uneventful. Final pathology results demonstrated a remnant gallbladder with cholelithiasis and cholecystitis. CONCLUSION: This report is the first in the literature to describe successful laparoscopic remnant cholecystectomy and transcystic common bile duct exploration after previous single-port cholecystectomy. Although inadvertent partial cholecystectomy is not unique to this technique, single-port laparoscopic procedures may result in different and significant complications.

Natural history of asymptomatic pancreatic cystic neoplasms.

BACKGROUND: The management of asymptomatic pancreatic cysts is controversial and indications for excision are based on pathology and natural history. OBJECTIVES: This study aimed to examine outcomes of asymptomatic lesions using a protocol based on size and cyst fluid analysis. METHODS: Asymptomatic cysts were identified from a prospectively maintained database. Sequential cross-sectional imaging studies were assessed, and results of endoscopic ultrasound-guided aspiration were co-analysed. RESULTS: A total of 338 asymptomatic patients underwent evaluation. Overall, 84 cysts were <1.5 cm and 254 were ≥1.5 cm in diameter. Median patient follow-up was 5.1 years [interquartile range (IQR): 4.1-6.9 years]. In the group in which cysts measured <1.5 cm in diameter, median cyst size was 1.0 cm (IQR: 0.6-1.2 cm) at presentation and increased to 1.2 cm (IQR: 0.7-1.6 cm) during follow-up. Five (6.0%) patients underwent resection, all within 2 months of presentation. In the group in which cysts measured ≥1.5 cm in diameter, median cyst size was 2.5 cm (IQR: 2.0-3.4 cm) at presentation and increased to 2.7 cm (IQR: 3.0-4.2 cm). A total of 63 (24.8%) patients underwent resection. Surgery was performed with 2 months in 53 (84.1%) patients, within 12 months in four (6.3%) patients and at >12 months post-presentation in six (9.5%) patients. A total of 70.6% of resected specimens were identified as malignancies or mucinous lesions. CONCLUSIONS: Asymptomatic cysts of <1.5 cm in diameter can safely be followed by imaging and are expected to undergo little change. A quarter of all asymptomatic cysts measuring ≥1.5 cm are appropriately resected based on imaging and cyst fluid analysis.

Comprehensive Cost Implications of Commercially Available Noninvasive Colorectal Cancer Screening Modalities.

BACKGROUND: There is an increasing usage of noninvasive screening modalities for colorectal cancer (CRC), primarily the fecal immunochemical test (FIT) and multi-target stool DNA test (Cologuard [CG]). The aim of this study was to determine the comprehensive, long-term cost implications of these noninvasive screening modalities. STUDY DESIGN: Using a national insurer-based administrative dataset, patients screened for CRC from January 1, 2019 to December 31, 2019 were analyzed. A hierarchical logic system was used to determine the primary screening modality for each patient. The total annual costs in US dollars ($) were extrapolated using number of patients screened, costs per test, screening intervals, and costs incurred from false results. Patients within our tumor registry diagnosed with CRC were matched to their claims data, and cancer stage distribution was compared. RESULTS: Of 119,334 members who underwent noninvasive screening, 38.1% underwent screening with FIT and 40.0% with CG. The combined annual cost for these 2 screening modalities was $13.7 million. By transitioning to FIT alone for all noninvasive screening, the total annual cost would decrease to $7.9 million, resulting in a savings of approximately $5.8 million per year. Additionally, by combining data from the network cancer registry and insurer-based claims dataset, we were able to match 533 individuals who underwent screening and were later diagnosed with CRC. The rate of early-stage (stage 0 to II) disease was found to be similar between those screened with FIT and CG (59.5% FIT vs 63.2% CG; p = 0.77). CONCLUSIONS: The adoption of FIT as the primary noninvasive CRC screening method has the potential to generate significant cost savings, and therefore, carries significant value implications for a large population health system.

Examining the Impact of Elastomeric Half Mask Respirator Knowledge and User Barriers on Safety Climate Perceptions in Health Care Settings.

BACKGROUND: Availability of personal protective equipment (PPE) and its effective use may influence safety climate perceptions among health care personnel (HCP). It is unclear how health care organizations can leverage the effective use of respiratory protection to engage in continuous improvement of their safety climate, which can inform opportunities for employee education and engagement. METHODS: After using an elastomeric half mask respirator (EHMR) as their primary form of respiratory protection for several months, 1,080 HCP provided feedback in an electronic survey about respiratory protection training, confidence in EHMR use, barriers during use, and perceived safety climate. Ordinal logistic regressions were used as nonlinear models to test relationships between these variables. FINDINGS: We observed that an increase in user confidence (p < .013), training content (p < .001), training formats (p < .001), and a decrease in EHMR barriers (p < .001) were associated with a statistically significant increase in proactive safety climate. In the second model, an increase in user confidence (p < .006) and training content (p < .001), and a decrease in barriers (p < .001), was associated with a statistically significant increase in compliant safety climate. CONCLUSIONS/APPLICATION TO PRACTICE: HCP EHMR confidence was positively associated with safety climate perceptions, underscoring the value of competency building by respiratory protection leaders prior to implementation. Because fewer barriers experienced while using an EHMR were associated with a more positive perception of safety climate, it is important to first communicate with end users about potential barriers and, second, to continue research with end users and manufacturers to improve the design of EHMRs moving forward.

Malfunction and failure of robotic systems during general surgical procedures.

BACKGROUND: There has been recent interest in using robots for general surgical procedures. This shift in technique raises the issue of patient safety with automated instrumentation. Although the safety of robotics has been established for urologic procedures, there are scant data on its use in general surgical procedures. The aim of this study is to analyze the incidence of robotic malfunction and its consequences for general surgical procedures. METHODS: All robotic general surgical procedures performed at a tertiary center between 2008 and 2011 were reviewed from institutional review board (IRB)-approved prospective databases. RESULTS: A total of 223 cases were done robotically, including 102 endocrine, 83 hepatopancreaticobiliary, 17 upper gastrointestinal, and 21 lower gastrointestinal colorectal procedures. There were 10 cases of robotic malfunction (4.5%). These failures were related to robotic instruments (n = 4), optical system (n = 3), robotic arms (n = 2), and robotic console (n = 1). None of these failures led to adverse patient consequences or conversion to open. Six (2.7%) cases were converted to open due to bleeding (n = 3), difficult dissection plane (n = 1), invasion of tumor to surrounding structures (n = 1), and intolerance of pneumoperitoneum due to CO(2) retention (n = 1). There was no mortality, and morbidity was 1% (n = 2). CONCLUSION: To our knowledge, this is the largest North American report to date on robotic general surgical procedures. Our results show that robotic malfunction occurs in a minority of cases, with no adverse consequences. We believe that awareness of these failures and knowing how to troubleshoot are important to maintain the efficiency of these procedures.

First human surgery with a novel single-port robotic system: cholecystectomy using the da Vinci Single-Site platform.

BACKGROUND: Interest in single-incision laparoscopic techniques continues to grow. A learning curve certainly exists, and although the techniques have improved, technical considerations including external clashes, poor visualization of critical structures, and surgeon fatigue remain. Applications of robotics to these newer techniques are evolving. The da Vinci Single-Site robotic surgery platform is a new semi-rigid robotic operative system designed to work with the Intuitive Surgical da Vinci Si operative system. The authors present the first human experience with this new device used to perform single-incision laparoscopic cholecystectomy. This study aimed to present the first human experience performing cholecystectomy with a novel robotic single-port platform. METHODS: After Cleveland Clinic Institutional Review Board approval, patients with symptomatic biliary disease fitting standard criteria for cholecystectomy were enrolled in the study. A total of 13 consecutive single-port, robotic cholecystectomy operations were performed. Patient demographics and operative results were evaluated. RESULTS: All 13 operations were completed successfully with the Single-Site platform. A critical view of safety as determined by the operative surgeon was obtained in all cases. One patient required placement of an additional extra-umbilical trocar for appropriate visualization secondary to gallbladder necrosis, and this incision also was used for eventual drain placement. For two patients, an intraoperative choloangiogram was performed. The mean operative time was 107 ± 54 min, and the mean docking time was 15 ± 9 min. Discharge for 11 patients was within 24 h. No significant complications occurred. CONCLUSION: Cholecystectomy using the da Vinci Single-Site system is feasible. Availability of this new semi-rigid, robotic surgery platform may increase access to the potential advantages of single-site surgery. Additional advantages of single-site surgery may be elucidated with further studies.

Single-port surgery: laboratory experience with the daVinci single-site platform.

BACKGROUND AND OBJECTIVES: The purpose of this study was to evaluate the feasibility and validity of a dedicated da Vinci single-port platform in the porcine model in the performance of gynecologic surgery. METHODS: This pilot study was conducted in 4 female pigs. All pigs had a general anesthetic and were placed in the supine and flank position. A 2-cm umbilical incision was made, through which a robotic single-port device was placed and pneumoperitoneum obtained. A data set was collected for each procedure and included port placement time, docking time, operative time, blood loss, and complications. Operative times were compared between cases and procedures by use of the Student t test. RESULTS: A total of 28 surgical procedures (8 oophorectomies, 4 hysterectomies, 8 pelvic lymph node dissections, 4 aorto-caval nodal dissections, 2 bladder repairs, 1 uterine horn anastomosis, and 1 radical cystectomy) were performed. There was no statistically significant difference in operating times for symmetrical procedures among animals (P=0.3215). CONCLUSIONS: This animal study demonstrates that singleport robotic surgery using a dedicated single-site platform allows performing technically challenging procedures within acceptable operative times and without complications or insertion of additional trocars.