Clinical Characteristics and Outcomes of Colorectal Cancer in the ColoCare Study: Differences by Age of Onset.

Early-onset colorectal cancer has been on the rise in Western populations. Here, we compare patient characteristics between those with early- (<50 years) vs. late-onset (≥50 years) disease in a large multinational cohort of colorectal cancer patients (n = 2193). We calculated descriptive statistics and assessed associations of clinicodemographic factors with age of onset using mutually-adjusted logistic regression models. Patients were on average 60 years old, with BMI of 29 kg/m2, 52% colon cancers, 21% early-onset, and presented with stage II or III (60%) disease. Early-onset patients presented with more advanced disease (stages III-IV: 63% vs. 51%, respectively), and received more neo and adjuvant treatment compared to late-onset patients, after controlling for stage (odds ratio (OR) (95% confidence interval (CI)) = 2.30 (1.82-3.83) and 2.00 (1.43-2.81), respectively). Early-onset rectal cancer patients across all stages more commonly received neoadjuvant treatment, even when not indicated as the standard of care, e.g., during stage I disease. The odds of early-onset disease were higher among never smokers and lower among overweight patients (1.55 (1.21-1.98) and 0.56 (0.41-0.76), respectively). Patients with early-onset colorectal cancer were more likely to be diagnosed with advanced stage disease, to have received systemic treatments regardless of stage at diagnosis, and were less likely to be ever smokers or overweight.

Evaluation of Secure Messaging Applications for a Health Care System: A Case Study.

OBJECTIVE: The use of text messaging in clinical care has become ubiquitous. Due to security and privacy concerns, many hospital systems are evaluating secure text messaging applications. This paper highlights our evaluation process, and offers an overview of secure messaging functionalities, as well as a framework for how to evaluate such applications. METHODS: Application functionalities were gathered through literature review, Web sites, speaking with representatives, demonstrations, and use cases. Based on similar levels of functionalities, vendors were grouped into three tiers. Essential and secondary functionalities for our health system were defined to help narrow our vendor choices. RESULTS: We stratified 19 secure messaging vendors into three tiers: basic secure communication, secure communication within an existing clinical application, and dedicated communication and collaboration systems. Our essential requirements revolved around functionalities to enhance security and communication, while advanced functionalities were mostly considered secondary. We then narrowed our list of 19 vendors to four, then created clinical use cases to rank the final vendors. DISCUSSION: When evaluating a secure messaging application, numerous factors must be considered in parallel. These include: what clinical processes to improve, archiving text messages, mobile device management, bring your own device policy, and Wi-Fi architecture. CONCLUSION: Secure messaging applications provide a Health Insurance Portability and Accountability Act (HIPAA) compliant communication platform, and also include functionality to improve clinical collaboration and workflow. We hope that our evaluation framework can be used by other health systems to find a secure messaging application that meets their needs.

Outcomes and Quality of Life Among Men After Anal Sphincter-Sparing Transperineal Rectourethral Fistula Repair.

OBJECTIVE: To describe long-term quality of life (QOL) outcomes after rectourethral fistula (RUF) repair. RUF is a debilitating diagnosis and complex surgical dilemma with limited data regarding QOL after repair. METHODS: Patients at a tertiary referral center undergoing transperineal RUF repair 1/2009-5/2016 were analyzed. Patients were contacted by telephone to assess QOL following repair. Descriptive analysis performed of short-term surgical data (success and complications) and long-term QOL data (novel questionnaire). RESULTS: Twenty one men underwent RUF surgery with 95% success after initial repair. Fifty two percent had a history of radiation and/or ablation. Four individuals (19%) experienced a Clavien-Dindo complication within 30 days, with 3 of those being grade III+. Fifteen had postoperative urinary incontinence, of whom 73% underwent artificial urinary sphincter placement. Three previously radiated individuals underwent subsequent urethral stricture surgery. At long-term follow-up (mean 45.6 ± 27.1 months), 53% reported perineal pain, 43% reported problems related to the gracilis flap, and 80% reported urinary incontinence (primarily occasional mild leakage). Twenty one percent were unable to do the things they wanted in their daily lives, while 80% reported that surgery positively impacted their life. None would have opted for complete urinary diversion. CONCLUSION: RUF repair leads to patient satisfaction and improved QOL, despite possible residual issues such as perineal pain and urinary incontinence. Definitive RUF repair should be offered to suitable radiated and nonradiated patients.

Dynamic plasma microRNAs are biomarkers for prognosis and early detection of recurrence in colorectal cancer.

BACKGROUND: Plasma microRNAs (miRNAs) are promising non-invasive biomarkers for colorectal cancer (CRC) prognosis. However, the published studies to date have yielded conflicting and inconsistent results for specific plasma miRNAs. METHODS: We have conducted a study using robust assays to assess a panel of nine miRNAs for CRC prognosis and early detection of recurrence. Plasma samples from 144 patients in a prospective CRC cohort study were collected at diagnosis, 6, 12, and 24 months after diagnosis. miRNAs were assayed by Taqman qRT-PCR to generate miRNA normalised copy numbers. RESULTS: Preoperative high plasma miRNA levels were associated with increased recurrence risk for miR-200b (HR [95% CI]=2.04 [1.00, 4.16], P=0.05), miR-203 (HR=4.2 [1.48, 11.93], P=0.007), miR-29a (HR=2.61 [1.34,5.07], P=0.005), and miR-31 (HR=4.03 [1.76, 9.24], P=0.001). Both plasma miR-31 (AUC: 0.717) and miR-29a (AUC: 0.703) could discriminate recurrence from these patients without recurrence. In addition, high levels of miR-31 during surveillance was associated with a three-fold increased risk of recurrence across all time points. Dynamic postoperative plasma miR-141 and 16 levels correlated with recurrence in the surveillance samples. CONCLUSIONS: Pre-operative plasma miR-29a, 200b, 203, and 31 are potential CRC prognosis biomarkers. In addition, dynamic postoperative miR-31, 141 and 16 levels are potential biomarkers for the early detection of recurrence during CRC surveillance.

Preoperative Use of Methotrexate and the Risk of Early Postoperative Complications in Patients with Inflammatory Bowel Disease.

BACKGROUND: Preoperative immunosuppressive use among patients with Crohn's disease or ulcerative colitis may lead to an increased risk of postoperative complications. There is limited information on the preoperative safety profile of methotrexate (MTX) in inflammatory bowel disease (IBD). METHODS: A retrospective study of patients who underwent abdominal surgery for IBD between 1993 and 2012 was performed and records abstracted, including preoperative use of MTX, azathioprine/6-mercaptopurine, antitumor necrosis factor, and corticosteroids. Early postoperative complications, including death, septic, and nonseptic complications were identified. A meta-analysis was also performed on the use of preoperative MTX in patients with IBD or rheumatoid arthritis. RESULTS: A total of 180 patients with IBD underwent abdominal surgery. A total of 15 patients received MTX either monotherapy or in combination therapy. Total early postoperative complications were identified in 71 (39%) patients, specifically 5 patients on oral MTX. A total of 51 cases (28%) of septic complications and 20 (11%) nonseptic. No significant association between the use of MTX and early postoperative complications was found. The odds ratio (OR) of complications versus no complications associated with MTX was 0.75 (95% CI, 0.25-2.29) and with azathioprine/6-mercaptopurine, OR 1.48 (95% CI, 0.77-2.84). The odds of a septic complication associated with MTX were 0.58 (95% CI, 0.09-3.73), and higher in azathioprine/6-mercaptopurine, OR 3.97 (95% CI, 1.03-15.3). Our meta-analysis also did not reveal an increased risk of postoperative complications in IBD or rheumatoid arthritis on preoperative MTX (OR 0.62, 95% CI, 0.34-1.15). CONCLUSIONS: Preoperative MTX use does not seem to be associated with early postoperative complications in IBD.

Beyond task time: automated measurement augments fundamentals of laparoscopic skills methodology.

BACKGROUND: Laparoscopic psychomotor skills are challenging to learn and objectively evaluate. The Fundamentals of Laparoscopic Skills (FLS) program provides a popular, inexpensive, widely-studied, and reported method for evaluating basic laparoscopic skills. With an emphasis on training safety before efficiency, we present data that explore the metrics in the FLS curriculum. MATERIALS AND METHODS: A multi-institutional (n = 3) cross-sectional study enrolled subjects (n = 98) of all laparoscopic skill levels to perform FLS tasks in an instrumented box trainer. Recorded task videos were postevaluated by faculty reviewers (n = 2) blinded to subject identity using a modified Objective Structured Assessment of Technical Skills (OSATS) protocol. FLS scores were computed for each completed task and compared with demographically established skill levels (training level and number of procedures), video review scoring, and objective performance metrics including path length, economy of motion, and peak grasping force. RESULTS: Three criteria used to determine expert skill, training and experience level, blinded review of performance by faculty via OSATS, and FLS scores, disagree in establishing concurrent validity for determining "true experts" in FLS tasks. FLS-scoring exhibited near-perfect correlation with task time for all three tasks (Pearson r = 0.99, 1.00, 1.00 with P <0.00000001). FLS error penalties had negligible effect on FLS scores. Peak grasping force did not correlate with task time or FLS scores. CONCLUSIONS: FLS technical skills scores presented negligible benefit beyond the measurement of task time. FLS scoring is weighted more toward speed than precision and may not significantly address poor tissue handling skills, especially regarding excessive grasping force. Categories of experience or training level may not form a suitable basis for establishing proficiency thresholds or for construct validity studies for technical skills.

Increased body mass index is associated with earlier time to loss of response to infliximab in patients with inflammatory bowel disease.

BACKGROUND: Obesity is an emerging problem in the care of inflammatory bowel disease (IBD) patients and has been associated with a diminished response to adalimumab. Whether obesity influences the response to infliximab (IFX) is not known. METHODS: A retrospective cohort of 124 subjects with IBD initiating IFX, naive to biologic therapy, was identified. Subjects were stratified according to their weight and body mass index (BMI). The primary outcome was the first occurrence of an IBD flare defined as dose escalation of IFX, corticosteroid use, discontinuation of IFX, hospitalization, or surgery. Multivariable logistic regression was performed considering body mass and BMI as categorical and continuous variables. RESULTS: Obese (BMI > 30 kg/m) patients with Crohn's disease were more likely to have an IBD flare than nonobese patients (adjusted hazard ratio [HR]: 3.03, P < 0.001); overweight (BMI > 25 kg/m) patients with ulcerative colitis trended toward a similar observation (HR: 9.68, P = 0.06). When considered as continuous variables, increasing mass and BMI were associated with earlier IBD flare in both Crohn's disease (adjusted HR: 1.06 per unit increase in BMI [P = 0.02] and 1.02 per kg increase in body mass [P = 0.02]) and ulcerative colitis (adjusted HR: 1.3 per unit increase in BMI [P = 0.01] and 1.11 per kg increase in body mass [P = 0.004]). CONCLUSIONS: Increased body weight is associated with an earlier time to loss of response to IFX in Crohn's disease and ulcerative colitis, a novel finding given that IFX is the only antitumor necrosis factor agent whose dosing reflects increased body weight.

A collaborative, systems-level approach to eliminating healthcare-associated MRSA, central-line-associated bloodstream infections, ventilator-associated pneumonia, and respiratory virus infections.

To achieve sustainable reductions in healthcare-associated infections (HAIs), the University of Washington Medical Center (UWMC) deployed a collaborative, systems-level initiative. With the sponsorship of senior leadership, multidisciplinary teams were established to address healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA), central-line-associated bloodstream infections (CLABSI), ventilator-associated pneumonia (VAP), and respiratory virus infections. The goal of the initiative was to eliminate these four HAIs among medical center inpatients by 2012. In the first 24 months of the project, the number of healthcare-associated MRSA cases decreased 58%; CLABSI cases decreased 54%. Staff and provider compliance with infection prevention measures improved and remained strong, for example, 96% compliance with hand hygiene, 98% compliance with the recommended influenza vaccination program, and 100% compliance with the VAP bundle. Achieving these results required an array of coordinated, systems-level interventions. Critical project success factors were believed to include creating organizational alignment by declaring eliminating HAIs as an organizational breakthrough goal, having the organization's executive leadership highly engaged in the project, coordination by an experienced and effective project leader and manager, collaboration by multidisciplinary project teams, and promoting transparency of results across the organization.

Safety and efficacy of video-assisted retroperitoneal debridement for infected pancreatic collections: a multicenter, prospective, single-arm phase 2 study.

BACKGROUND: The feasibility of video-assisted retroperitoneal debridement (VARD) for infected pancreatic walled-off necrosis is established. We provide prospective data on the safety and efficacy of VARD. DESIGN: Multicenter, prospective, single-arm phase 2 study. SETTING: Six academic medical centers. PATIENTS: We evaluated 40 patients with pancreatic necrosis who had infection determined using Gram stain or culture. INTERVENTIONS: Percutaneous drains were placed at enrollment, and computed tomographic scans were repeated at 10 days. Patients who had more than a 75% reduction in collection size were treated with drains. Other patients were treated with VARD. Crossover to open surgery was performed for technical reasons and/or according to surgeon judgment. MAIN OUTCOME MEASURES: Efficacy (ie, successful VARD treatment without crossover to open surgery or death) and safety (based on mortality and complication rates). Patients received follow-up care for 6 months. RESULTS: We enrolled 40 patients (24 men and 16 women) during a 51-month period. Median age was 53 years (range, 32-82 years). Mean (SD) Acute Physiology and Chronic Health Evaluation II score at enrollment was 8.0 (5.1), and median computed tomography severity index score was 8. Of the 40 patients, 24 (60%) were treated with minimally invasive intervention (drains with or without VARD). Nine patients (23%) did not require surgery (drains only). For 31 surgical patients, VARD was possible in 60% of patients. Most patients (81%) required 1 operation. In-hospital 30-day mortality was 2.5% (intent-to-treat). Bleeding complications occurred in 7.5% of patients; enteric fistulas occurred in 17.5%. CONCLUSIONS: This prospective cohort study supports the safety and efficacy of VARD for infected pancreatic walled-off necrosis. Of the patients, 85% were eligible for a minimally invasive approach. We were able to use VARD in 60% of surgical patients. The low mortality and complication rates compare favorably with open debridement. An unexpected finding was that a reduction in collection size of 75% according to the results of computed tomographic scans at 10 to 14 days predicted the success of percutaneous drainage alone.

Teleoperation in surgical robotics--network latency effects on surgical performance.

A teleoperated surgical robotic system allows surgical procedures to be conducted across long distances while utilizing wired and wireless communication with a wide spectrum of performance that may affect the outcome. An open architecture portable surgical robotic system (Raven) was developed for both open and minimally invasive surgery. The system has been the subject of an intensive telesurgical experimental protocol aimed at exploring the boundaries of the system and surgeon performance during a series of field experiments in extreme environments (desert and underwater) teleportation between US, Europe, and Japan as well as lab experiments under synthetic fixed time delay. One standard task (block transfer emulating tissue manipulation) of the Fundamentals of Laparoscopic Surgery (FLS) training kit was used for the experimental protocol. Network characterization indicated a typical time delay in the range of 16-172 ms in field experiments. The results of the lab experiments showed that the completion time of the task as well as the length of the tool tip trajectory significantly increased (alpha< 0.02) as time delay increased in the range of 0-0.5 sec increased. For teleoperation with a time delay of 0.25s and 0.5s the task completion time was lengthened by a factor of 1.45 and 2.04 with respect to no time delay, whereas the length of the tools' trajectory was increased by a factor of 1.28 and 1.53 with respect to no time delay. There were no statistical differences between experienced surgeons and non-surgeons in the number of errors (block drooping) as well as the completion time and the tool tip path length at different time delays.

Objective assessment of telesurgical robot systems: Telerobotic FLS.

The Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Fundamentals of Laparoscopic Surgery (FLS) program contains curriculum that includes both a cognitive and psychomotor skills. In this research the use of FLS Block Transfer task is used to evaluate the performance of surgeons' teleoperating the University of Washington Surgical robot. The use of the FLS Trainer Box and accessories kit provides a well-defined series of tasks that can be repeated by any researchers working in the field of surgical robotics so that systems can be evaluated using a common method.

Biomechanical properties of abdominal organs in vivo and postmortem under compression loads.

Accurate knowledge of biomechanical characteristics of tissues is essential for developing realistic computer-based surgical simulators incorporating haptic feedback, as well as for the design of surgical robots and tools. As simulation technologies continue to be capable of modeling more complex behavior, an in vivo tissue property database is needed. Most past and current biomechanical research is focused on soft and hard anatomical structures that are subject to physiological loading, testing the organs in situ. Internal organs are different in that respect since they are not subject to extensive loads as part of their regular physiological function. However, during surgery, a different set of loading conditions are imposed on these organs as a result of the interaction with the surgical tools. Following previous research studying the kinematics and dynamics of tool/tissue interaction in real surgical procedures, the focus of the current study was to obtain the structural biomechanical properties (engineering stress-strain and stress relaxation) of seven abdominal organs, including bladder, gallbladder, large and small intestines, liver, spleen, and stomach, using a porcine animal model. The organs were tested in vivo, in situ, and ex corpus (the latter two conditions being postmortem) under cyclical and step strain compressions using a motorized endoscopic grasper and a universal-testing machine. The tissues were tested with the same loading conditions commonly applied by surgeons during minimally invasive surgical procedures. Phenomenological models were developed for the various organs, testing conditions, and experimental devices. A property database-unique to the literature-has been created that contains the average elastic and relaxation model parameters measured for these tissues in vivo and postmortem. The results quantitatively indicate the significant differences between tissue properties measured in vivo and postmortem. A quantitative understanding of how the unconditioned tissue properties and model parameters are influenced by time postmortem and loading condition has been obtained. The results provide the material property foundations for developing science-based haptic surgical simulators, as well as surgical tools for manual and robotic systems.

TeleRobotic fundamentals of laparoscopic surgery (FLS): effects of time delay--pilot study.

Within the area of telerobotic surgery no standardized means of surgically relevant performance evaluation has been established. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Fundamentals of Laparoscopic Surgery (FLS) program provides a set of standardized tasks that are considered the 'gold standard' in surgical skill assessment. We present a methodology for using one of the SAGES FLS tasks for surgical robotic performance evaluation. The TeleRobotic FLS methodology is extendable to two other FLS tasks. Time delay in teleoperation in general and telesurgery in particular is one of the fundamental effects that limits performance in telerobotic surgery. In this pilot study the effect of time delay on the Block Transfer task performance was investigated. The RAVEN Surgical Robot was used in a master/slave configuration in which time delays of 0, 250, 500, and 1000 ms were introduced by a network emulator between the master (Surgeon Site) and the slave (Patient Site). The study included three subjects, each of whom was presented with three of the four conditions. The results show that one subject had a lower error rate with increasing time delay, whereas the other subjects had a higher error rate with increased delay. The subject with the longest average completion time suffered the least performance decrease under time delay.

Reliable assessment of laparoscopic performance in the operating room using videotape analysis.

The Global Operative Assessment of Laparoscopic Skills (GOALS) is a valid assessment tool for objectively evaluating the technical performance of laparoscopic skills in surgery residents. We hypothesized that GOALS would reliably differentiate between an experienced (expert) and an inexperienced (novice) laparoscopic surgeon (construct validity) based on a blinded videotape review of a laparoscopic cholecystectomy procedure. Ten board-certified surgeons actively engaged in the practice and teaching of laparoscopy reviewed and evaluated the videotaped operative performance of one novice and one expert laparoscopic surgeon using GOALS. Each reviewer recorded a score for both the expert and the novice videotape reviews in each of the 5 domains in GOALS (depth perception, bimanual dexterity, efficiency, tissue handling, and overall competence). The scores for the expert and the novice were compared and statistically analyzed using single-factor analysis of variance (ANOVA). The expert scored significantly higher than the novice did in the domains of depth perception (p = .005), bimanual dexterity (p = .001), efficiency (p = .001), and overall competence ( p = .001). Interrater reliability for the reviewers of the novice tape was Cronbach alpha = .93 and the expert tape was Cronbach alpha = .87. There was no difference between the two for tissue handling. The Global Operative Assessment of Laparoscopic Skills is a valid, objective assessment tool for evaluating technical surgical performance when used to blindly evaluate an intraoperative videotape recording of a laparoscopic procedure.

CIELab and sRGB color values of in vivo normal and grasped porcine liver.

Surgical simulators are excellent training tools for minimally invasive procedures but are currently lacking in realistic tissue rendering and tissue responses to manipulation. Accurate color representation of tissues may add realism to simulators and provide medically relevant information. The goal of this study was to determine feasible methods for measuring color of in vivo tissue, specifically liver, in a standardized color space. Several compressions were applied to in vivo porcine liver. Three methods were then used to determine the CIELab and/or sRGB colors of normal and damaged liver. Results suggest that there are significant differences between normal and damaged liver color.

The red DRAGON: a multi-modality system for simulation and training in minimally invasive surgery.

With the development of new technologies in surgery, minimally invasive surgery (MIS) has drastically improved the way conventional medical procedures are performed. However, a new learning curve has resulted requiring an expertise in integrating visual information with the kinematics and dynamics of the surgical tools. The Red DRAGON is a multi-modal simulator for teaching and training MIS procedures allowing one to use it with several modalities including: simulator (physical objects and virtual objects) and an animal model. The Red DRAGON system is based on a serial spherical mechanism in which all the rotation axes intersect at a single point (remote center) allowing the endoscopic tools to pivot around the MIS port. The system includes two mechanisms that incorporate two interchangeable MIS tools. Sensors are incorporated into the mechanism and the tools measure the positions and orientations of the surgical tools as well as forces and torques applied on the tools by the surgeon. The design is based on a mechanism optimization to maximize the manipulability of the mechanism in the MIS workspace. As part of a preliminary experimental protocol, five expert level surgeons performed three laparoscopic tasks--a subset of the Fundamental Laparoscopic Skill (FLS) set as a baseline for skill assessment protocols. The results provide an insight into the kinematics and dynamics of the endoscopic tools, as the underlying measures for objectively assessing MIS skills.