Update on Transanal NOTES for Rectal Cancer: Transitioning to Human Trials

The feasibility of natural orifice translumenal endoscopic surgery (NOTES) resection for rectal cancer has been demonstrated in both survival swine and fresh human cadaveric models. In preparation for transitioning to human application, our group has performed transanal NOTES rectal resection in a large series of human cadavers. This experience both solidified the feasibility of resection and allowed optimization of technique prior to clinical application. Improvement in specimen length and operative time was demonstrated with increased experience and newer platforms. This extensive laboratory experience has paved the way for successful clinical translation resulting in an ongoing clinical trial. To date, based on published reports, 4 human subjects have undergone successful hybrid transanal NOTES resection of rectal cancer. While promising, instrument limitations continue to hinder a pure transanal approach. Careful patient selection and continued development of new endoscopic and flexible-tip instruments are imperative prior to pure NOTES clinical application

Venous thromboembolism after inpatient surgery in administrative data vs NSQIP: a multi-institutional study

Previous studies have documented significant differences between administrative data and registry data in the determination of postoperative venous thromboembolism (VTE). The goal of this study was to characterize the discordance between administrative and registry data in the determination of postoperative VTE.This study was performed using data from the American College of Surgeons NSQIP merged with administrative data from 8 different hospitals (5 different medical centers) between 2013 and 2015. Occurrences of postoperative vein thrombosis (VT) and pulmonary embolism (PE) as ascertained by administrative data and NSQIP data were compared. In each situation where the 2 sources disagreed (discordance), a 2-clinician chart review was performed to characterize the reasons for discordance.The cohort used for analysis included 43,336 patients, of which 53.3% were female and the mean age was 59.5 years. Concordance between administrative and NSQIP data was worse for VT (κ 0.57; 95% CI 0.51 to 0.62) than for PE (κ 0.83; 95% CI 0.78 to 0.89). A total of 136 cases of discordance were noted in the assessment of VT; of these, 50 (37%) were explained by differences in the criteria used by administrative vs NSQIP systems. In the assessment of postoperative PE, administrative data had a higher accuracy than NSQIP data (odds ratio for accuracy 2.86; 95% CI 1.11 to 7.14) when compared with the 2-clinician chart review.This study identifies significant problems in ability of both NSQIP and administrative data to assess postoperative VT/PE. Administrative data functioned more accurately than NSQIP data in the identification of postoperative PE. The mechanisms used to translate VTE measurement into quality improvement should be standardized and improved

International consensus definition of low anterior resection syndrome

BACKGROUND: Low anterior resection syndrome is pragmatically defined as disordered bowel function after rectal resection leading to a detriment in quality of life. This broad characterization does not allow for precise estimates of prevalence. The low anterior resection syndrome score was designed as a simple tool for clinical evaluation of low anterior resection syndrome. Although the low anterior resection syndrome score has good clinical utility, it may not capture all important aspects that patients may experience. OBJECTIVE: The aim of this collaboration was to develop an international consensus definition of low anterior resection syndrome that encompasses all aspects of the condition and is informed by all stakeholders. DESIGN: This international patient-provider initiative used an online Delphi survey, regional patient consultation meetings, and an international consensus meeting. PARTICIPANTS: Three expert groups participated: patients, surgeons, and other health professionals from 5 regions (Australasia, Denmark, Spain, Great Britain and Ireland, and North America) and in 3 languages (English, Spanish, and Danish). MAIN OUTCOME MEASURE: The primary outcome measured was the priorities for the definition of low anterior resection syndrome. RESULTS: Three hundred twenty-five participants (156 patients) registered. The response rates for successive rounds of the Delphi survey were 86%, 96%, and 99%. Eighteen priorities emerged from the Delphi survey. Patient consultation and consensus meetings refined these priorities to 8 symptoms and 8 consequences that capture essential aspects of the syndrome. LIMITATIONS: Sampling bias may have been present, in particular, in the patient panel because social media was used extensively in recruitment. There was also dominance of the surgical panel at the final consensus meeting despite attempts to mitigate this. CONCLUSIONS: This is the first definition of low anterior resection syndrome developed with direct input from a large international patient panel. The involvement of patients in all phases has ensured that the definition presented encompasses the vital aspects of the patient experience of low anterior resection syndrome. The novel separation of symptoms and consequences may enable greater sensitivity to detect changes in low anterior resection syndrome over time and with intervention

Risk Stratification in Patients with Stage II Colon Cancer

The decision to receive adjuvant chemotherapy is far from evident and remains controversial in patients with American Joint Committee on Cancer stage II colon cancer. This study analyzes several pathological characteristics in order to assess their (combined) predictive value for outcomes in stage II colon cancer. All stage II patients treated surgically for colon cancer at our tertiary care center (2004-2011) were extracted from a prospectively maintained, Institutional Review Board-approved data repository (n = 313). Mortality and metastasis were compared, including multivariable Cox regression adjusted for stage subdivisions (IIA/IIB/IIC) and potential confounders. Colon cancer-specific mortality was substage independently increased in patients with baseline carcinoembryonic antigen (CEA) > 5 ng/L [hazard ratio (HR) 2.88; p = 0.022], large vessel invasion (LVI; HR 4.59; p 5 ng/L (HR 2.37; p = 0.046), LVI (HR 3.07; p = 0.001), perineural invasion (HR 2.57; p = 0.010), and EMVI (HR 2.83; p = 0.002). The number of high-risk features (0, 1, 2-3, 4+) was associated with a clear incremental increase in overall and disease-specific mortality and recurrence (p aecurrency sign 0.001). The major inflection point is at two high-risk characteristics or more, whereas 5-year survival is almost halved from 77.4 % to 31.7 % (p < 0.001). The risk score introduced provides a prognostic tool based on readily available data extracted from baseline pathology and preoperative CEA, which provides an easy method to stratify risks of mortality and recurrence and may therefore help in treatment decisions after surgery in stage II patients

Gender and ethnic disparities in colon cancer presentation and outcomes in a US universal health care setting

Objective Access to care is a pillar of U.S. healthcare reform and could potentially challenge existing ethnic and gender disparities in care. We present a snapshot of these disparities in surgical colon cancer patients in the largest public hospital in Massachusetts, a state leading in providing universal healthcare, to indicate potential changes that might result from universal care access. Methods All surgical colon cancer patients at Massachusetts General Hospital (2004-2011) were included. Baseline characteristics, perioperative, and long-term outcomes were compared. Results Among 1,071 patients, the 110 (10.3%) minority patients presented with more comorbid (mean Charlson score 0.84 vs. 0.71; P=0.039), metastatic (21.8% vs. 14%; P=0.026), and node-positive disease (50% vs. 38.8%; P=0.014). Women (n=521; 48.6%) had less screening diagnoses (overall: 17.8% vs. 22.6%; P=0.049, screening age: 26.4% vs. 32.7%; P=0.036) with subsequently higher rates of metastatic disease on pathology (11.3% vs. 7.1%, P=0.02). Multivariate adjustment for baseline staging makes outcome disparities no longer statistically significant. Conclusions Significant gender and ethnic disparities subsist at baseline despite long-standing low-threshold healthcare access, although seemingly mitigated by enrollment into high-level care, empowering equal chances for underprivileged groups. The outcomes are also a reminder that universal healthcare will not be a panacea for the deeply rooted and dynamic causes of presentation inequalities. J. Surg. Oncol 2014; 109:645-651. (c) 2014 Wiley Periodicals, In

Postoperative Myocardial Infarction in Administrative Data vs Clinical Registry: A Multi-Institutional Study

Previous studies have documented significant differences between administrative data and registry data in the determination of postoperative MI. The goal of this study was to characterize discordance between administrative and registry data in the determination of postoperative myocardial infarction (MI).This study was performed using data from the American College of Surgeons NSQIP merged with administrative data from 8 different hospitals, between 2013 and 2015. From each of these sources, the occurrence of a postoperative MI, as ascertained by administrative data and NSQIP data, were compared. In each situation in which the 2 sources disagreed (discordance), a 2-clinician chart review was performed to generate a "gold standard" determination as to the occurrence of postoperative MI.A total of 43,289 operations met our inclusion criteria for analysis. Within this cohort a total of 230 cases of MI were identified by administrative data and/or NSQIP data (administrative rate 0.41%, NSQIP rate 0.42%). A total of 89 discordant ascertainments were identified, of which 42 were admin+/NSQIP- and 47 were admin-/NSQIP+. Accuracy (99.9% for both) and concordance (kappa\ua0= 0.89 [95% CI 0.86 to 0.92] for administrative data, kappa\ua0= 0.87 [95% CI 0.84 to 0.91] for NSQIP data) of the 2 systems were similar when compared against our gold standard (chart review). The majority of errors were related to false negatives, with sensitivity rates of 81% in both data sources.In this multi-institutional study, administrative data and NSQIP demonstrated a similar ability to determine the occurrence of postoperative MI. These findings do not demonstrate an advantage of registry data over administrative data in the determination of postoperative MI