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Advancements in neoadjuvant regimens for esophageal adenocarcinoma have enabled some patients to achieve complete pathologic response at time of esophagectomy. There are currently limited data detailing this trend or the implications of complete pathologic response on survival. The National Cancer Database was used to identify 16,169 patients with esophageal adenocarcinoma that received trimodal therapy including esophagectomy between 2006 and 2020. Of these, 11.4% had complete pathologic response at esophagectomy. Patient factors, staging characteristics, and survival trends were evaluated. In patients diagnosed between 2016 and 2020, the rate of complete pathologic response was 17.5%. Female sex (OR 1.295, 95% CI 1.134-1.481, p = 0.0001), Black race (OR 1.729, 95% CI 1.362-2.196, p = 0.0002), Hispanic ethnicity (OR 1.418, 95% CI 1.073-1.875, p = 0.0141), and later era of diagnosis (2016-2020 OR 2.898, 95% CI 2.508-3.349, p < 0.0001) were independent predictors of complete pathologic response. Clinical stage II disease was associated with an increased probability of complete pathologic response (OR 1.492, 95% CI 1.19-1.871) while clinical stage III disease had a decreased probability of complete pathologic response (OR 0.762, 95% CI 0.621-0.936, p < 0.0001). Complete pathologic response conveyed a strong survival benefit, with a median survival of 86.4 months (95% CI 73.9-102.1) versus 30.7 months (95% CI 29.8-31.7, p < 0.0001) in those without complete pathologic response. Four-year median survival was also higher in those with complete pathologic response (63.3%, 95% CI 60.8-66.0% vs. 39.2%, 95% CI 38.4-40.1%, p < 0.0001). In summary, complete pathologic response is associated with a profound survival advantage in patients with esophageal adenocarcinoma. Such knowledge carries implications for patient counseling, prognostication, and surveillance and demonstrates a need for improved identification of complete clinical response prior to esophagectomy., (© The Author(s) 2024. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The significance of lymphovascular invasion (LVI) in esophageal adenocarcinoma (EAC) has not yet been described. Potential utility as an adjunct to current staging guidelines remains unknown., Methods: The National Cancer Database was queried from 2006 to 2020. Univariate and multivariable models, Kaplan Meier method, and log-rank test were used. Subgroup analyses by pN stage were conducted., Results: Of 9,689 patients, 23.2% had LVI. LVI was an independent prognostic factor (hazard ratio [HR] 1.401, 95% confidence interval [CI] 1.307-1.502, p < 0.0001) with reduction in median survival to 20.0 months (95% CI 18.9-21.4) from 39.7 months (95% CI 37.8-42.3, p < 0.0001). Multivariable survival analysis adjusted on pN and pT stage found that patients with LVI had decreased survival in a given pN stage (p < 0.001). pN0/LVI+ patients had a similar prognosis to the higher staged pN1/LVI- (28.6 months), although pN1/LVI- patients did slightly worse (p = 0.0135). Additionally, patients with pN1/LVI+ had equivalent survival compared with pN2/LVI- (p = 0.178) as did pN2/LVI+ patients compared with pN3/LVI- (p = 0.995)., Conclusions: In these data, LVI is an independent negative prognostic factor in EAC. LVI was associated with a survival reduction similar to an upstaged nodal status irrespective of T stage. Patients with LVI may be better classified at a higher pN stage., (© 2024. The Author(s).)

Secondary amyloidosis (AA) is a disorder of protein conformation associated with inflammatory disorders. Detailed reports of patients diagnosed with AA and inflammatory bowel disease (IBD) are limited. This study reports the cases of eight patients, across three tertiary medical centers, diagnosed with both IBD and AA between 2000 and 2020. Seven patients had a diagnosis of Crohn disease (CD), while one had ulcerative colitis (UC). All patients were diagnosed with AA after being diagnosed with IBD (median: 15 years later). The small bowel (62.5%) and the colon (62.5%) were the most common IBD locations. 4 patients had undergone TNF-alpha inhibitor therapy and all CD patients required surgical treatment of their IBD. A history of fistula or abscess was identified in 5 patients. The most common initial site of AA was the kidney (75%). All 8 patients presented with some form of renal dysfunction and proteinuria (median: 1500 mg/24 h). Hypoalbuminemia was found in most patients. Six patients developed chronic kidney disease and 4 required dialysis. Anti TNF-alpha antibody therapy led to rapid improvement of renal function in one of four patients who received it. Three patients required a renal transplant. Four patients had died upon the latest follow-up (5-year survival: 75%). The presence of proteinuria, fistula, or abscess should serve as indicators for potentially increased AA risk in CD patients., (© 2024. Japanese Society of Gastroenterology.)

In the last two decades, colorectal cancer (CRC) mortality has been decreasing in the United States. However, the mortality trends for the different subtypes of CRC, including different sides of colon, rectosigmoid, and rectal cancer remain unclear. We analyzed the mortality trends of different subtypes of CRC based on Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research data from 1999 to 2020. We calculated age-adjusted mortality rates (AAMR) per 100,000 individuals and examined the trends over time by estimating the average annual percent change (AAPC) using the Joinpoint Regression Program. Our study shows that the overall CRC rates decreased significantly from 26.42 to 15.98 per 100,000 individuals, with an AAPC of -2.41. However, the AAMR of rectosigmoid cancer increased significantly from 0.82 to 1.08 per 100,000 individuals, with the AAPC of +1.10. Men and Black individuals had the highest AAMRs respectively (23.90 vs. 26.93 per 100,000 individuals). The overall AAMR of CRC decreased for those aged ≥50 years but increased significantly from 1.02 to 1.58 per 100,000 individuals for those aged 15-49 years, with an AAPC of +0.75. Rural populations had a higher AAMR than the urban populations (22.40 vs. 19.60 per 100,000 individuals). Although overall CRC mortality declined, rising trends in young-onset CRC and rectosigmoid cancer warrant attention. Disparities persist in terms of sex, race, and geographic region, and urbanization level, emphasizing the need for targeted public health measures., (© 2024 UICC.)

Introduction: Physicians have gravitated toward larger group practice arrangements in recent years. However, consolidation trends in colorectal surgery have yet to be well described. Our objective was to assess current trends in practice consolidation within colorectal surgery and evaluate underlying demographic trends including age, gender, and geography., Methods: We performed a retrospective cross-sectional study using the Center for Medicare Services National Downloadable File from 2015 to 2022. Colorectal surgeons were categorized by practice size and by region, gender, and age., Results: From 2015 to 2022, the number of colorectal surgeons in the United States increased from 1369 to 1621 (+18.4%), while the practices with which they were affiliated remained relatively stable (693-721, +4.0%). The proportion of colorectal surgeons in groups of 1-2 members fell from 18.9% to 10.7%. Conversely, those in groups of 500+ members grew from 26.5% to 45.2% (linear trend P < 0.001). The midwest region demonstrated the highest degree of consolidation. Affiliations with group practices of 500+ members saw large increases from both female and male surgeons (+148.9% and +86.9%, respectively). New surgeons joining the field since 2015 overwhelmingly practice in larger groups (5.3% in groups of 1-2, 50.1% in groups of 500+)., Conclusions: Colorectal surgeons are shifting toward larger practice affiliations. Although this change is happening across all demographic groups, it appears unevenly distributed across geography, gender, and age. New surgeons are preferentially joining large group practices., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Surgical site infections (SSIs) are one of the most common complications following diverting loop ileostomy (DLI) closures. This study assesses SSIs after DLI closure and the temporal trends in skin closure technique., Methods: A retrospective review was conducted using the American College of Surgeons National Surgical Quality Improvement Program database for adult patients who underwent a DLI closure between 2012 and 2021 across a multistate health system. Skin closure technique was categorized as primary, primary ​+ ​drain, or purse-string closure. The primary outcome was SSI at the former DLI site., Results: A SSI was diagnosed in 5.7% of patients; 6.9% for primary closure, 5.7% for primary closure ​+ ​drain, and 2.7% for purse-string closure (p ​= ​0.25). A diagnosis of Crohn's disease, diverticular disease, and increasing operative time were significant risk factors for SSIs. There was a positive trend in the use of purse-string closure over time (p ​< ​0.0001)., Conclusions: This study identified a low SSI rate after DLI closure which did not vary significantly based on skin closure technique. Utilization of purse-string closure increased over time., Competing Interests: Declaration of competing interest Authors declare there is no conflicts of interest. No generative AI or AI-assisted technologies were used in the writing process of this manuscript., (Published by Elsevier Inc.)

Background: Medicare reimbursement rates have decreased across various specialties but have not yet been studied in colorectal surgery., Objective: This study aimed to analyze Medicare reimbursement trends in colorectal surgery., Design: Observational study., Setting: The Centers for Medicare and Medicaid Services' Physician Fee Schedule was evaluated for reimbursement data for the 20 most common colorectal surgery procedures from 2006 to 2020., Main Outcome Measures: Inflation-adjusted annual percentage change, compound annual growth rate, and total percentage change were the outcome measures. A subanalysis was performed comparing the changes in reimbursement between 2006 to 2016 and 2016 to 2020 because of legislative changes that went into effect in 2016., Results: During the study period, the inflation-unadjusted mean Medicare reimbursement rate for the 20 most common colorectal surgery procedures increased by +15.6%. This rise was surpassed by the inflation rate of +31.3%. Consequently, the inflation-adjusted reimbursement rate decreased by -11%. The adjusted reimbursement rates decreased the most at -33.8% for a flexible colonoscopy with biopsy and increased the most at +45.3% for a diagnostic rigid proctosigmoidoscopy. Annual percentage change was -0.79%, and the compound annual growth rate was -0.98%. There was an accelerated decrease in annual reimbursement rates from 2016 to 2020 at -2.23% compared to 2006 to 2016 at -0.22% ( p = 0.03). The only procedure that had an increase in adjusted reimbursement rate from 2016 to 2020 was the injection of sclerosing solution for hemorrhoids., Limitations: Only Medicare reimbursement data were analyzed., Conclusions: Medicare reimbursements for colorectal surgery procedures are decreasing at an accelerating rate. Although this study is limited to Medicare data, it still presents a representation of overall reimbursement changes because Medicare policies have a ripple effect in the commercial insurance market. It is vital to understand the financial trends to be able to structure future patient care teams and to advocate for the sustainability of colorectal surgery practices in the United States. See Video Abstract at http://links.lww.com/DCR/C136 ., Reembolso De Medicare En Ciruga Colorrectal Un Problema Creciente: ANTECEDENTES: Las tasas de reembolso de Medicare han disminuido en varias especialidades, pero aún no han sido estudiado en cirugía colorrectal.OBJETIVO: Analizar las tendencias de reembolso de Medicare en cirugía colorrectal.DISEÑO: Estudio observacional.CONTEXTO: Se evaluó el programa de tarifas médicas de los Centros de Servicios de Medicare y Medicaid para obtener datos de reembolso de los 20 procedimientos más comunes en cirugía colorrectal entre los años 2006 y 2020.PRINCIPALES MEDIDAS DE RESULTADO: Variación porcentual anual ajustada por inflación, tasa de crecimiento anual compuesta y variación porcentual total. Se realizó un subanálisis comparando los cambios en el reembolso entre los años 2006 a 2016 y 2016 a 2020 debido a los cambios legislativos que entraron en vigencia en 2016.RESULTADOS: Durante el período de estudio, la tasa media de reembolso de Medicare sin ajuste por inflación para los 20 procedimientos más comunes en cirugía colorrectal aumentó en +15,6 %. Esta suba fue superada por la tasa de inflación del +31,3%. En consecuencia, la tasa de reembolso ajustada por inflación disminuyó un -11%. Lo máximo que disminuyeron las tasas ajustadas de reembolso fue a -33,8% para una colonoscopia flexible con biopsia y aumentaron más a +45,3% para una proctosigmoidoscopia rígida de diagnóstico. El cambio porcentual anual fue -0,79% y la tasa de crecimiento anual compuesto fue -0,98%. Hubo una disminución acelerada en las tasas de reembolso anual de 2016 a 2020 a -2,23 % en comparación con 2006 a 2016 a -0,22% ( p = 0,03). El único procedimiento que tuvo un aumento en la tasa de reembolso ajustada de 2016 a 2020 fue la inyección de solución esclerosante para las hemorroides.LIMITACIONES: Solo se analizaron los datos de reembolso de Medicare.CONCLUSIONES: Los reembolsos de Medicare por procedimientos en cirugía colorrectal están disminuyendo a un ritmo acelerado. Aunque este estudio se limita a los datos de Medicare, aún presenta una representación de los cambios generales en los reembolsos, ya que las pólizas de Medicare tienen un efecto dominó en el mercado de seguros comerciales. Es fundamental comprender las tendencias financieras para poder estructurar futuros equipos de atención de pacientes y abogar por la sostenibilidad de las prácticas de cirugía colorrectal en los Estados Unidos. Consulte Video Resumen video en https://links.lww.com/DCR/C136 . (Traducción-Dr. Osvaldo Gauto )., (Copyright © The ASCRS 2023.)

Background: There is currently no consensus on surgical management of splenic flexure adenocarcinoma (SFA)., Methods: Patients undergoing surgical resection for SFA between 1993 and 2015 were identified. Postoperative outcomes were compared between patients who underwent segmental (SR) vs. anatomical resection (AR)., Results: One-hundred and thirteen patients underwent SR and 89 underwent AR. More patients in the SR group had open resections, but there were otherwise no differences in demographics or surgical characteristics between the two groups. There were no differences in overall (p = 0.29) or recurrence-free(p = 0.37) survival. On multivariable analysis, increased age (HR 1.04, 1.01-1.07, p = 0.005), higher American Society of Anesthesiology classification (HR 3.1, 1.7-5.71, p < 0.001), and higher tumor stage (HR 8.84, 3.76-20.82, p < 0.001) were predictive of mortality., Conclusions: Short and long-term outcomes after SR and AR for SFA are not different, making SR a viable option for SFA surgical management., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Aim: The National Accreditation Program for Rectal Cancer (NAPRC) was developed to improve rectal cancer patient outcomes in the United States. The NAPRC consists of a set of process and outcome measures that hospitals must meet in order to be accredited. We aimed to assess the potential of the NAPRC by determining whether achievement of the process measures correlates with improved survival., Methods: The National Cancer Database was used to identify patients undergoing curative proctectomy for non-metastatic rectal cancer from 2010 to 2014. NAPRC process measures identified in the National Cancer Database included clinical staging completion, treatment starting <60 days from diagnosis, carcinoembryonic antigen level measured prior to treatment, tumour regression grading and margin assessment., Results: There were 48 669 patients identified with a mean age of 62 ± 12.9 years and 61.3% of patients were men. The process measure completed most often was assessment of proximal and distal margins (98.4%) and the measure completed least often was the serum carcinoembryonic antigen level prior to treatment (63.8%). All six process measures were completed in 23.6% of patients. After controlling for age, gender, comorbidities, annual facility resection volume, race and pathological stage, completion of all process measures was associated with a statistically significant mortality decrease (Cox hazard ratio 0.88, 95% CI 0.81-0.94, P < 0.001)., Conclusion: Participating institutions provided complete datasets for all six process measures in less than a quarter of patients. Compliance with all process measures was associated with a significant mortality reduction. Improved adoption of NAPRC process measures could therefore result in improved survival rates for rectal cancer in the United States., (© 2023 Association of Coloproctology of Great Britain and Ireland.)

Background: General surgery residents may be underprepared for practice, due in part to declining operative autonomy during training. The factors that influence entrustment of autonomy in the operating room are unclear., Objective: To identify and compare the factors that residents and faculty consider influential in entrustment of operative autonomy., Methods: An anonymous survey of 29-item Likert-type scale (1-7, 1 = strongly disagree, 7 = strongly agree), 9 multiple-choice, and 4 open-ended questions was sent to 70 faculty and 45 residents in a large ACGME-approved general surgery residency program comprised of university, county, and VA hospitals in 2018., Results: Sixty (86%) faculty and 38 (84%) residents responded. Faculty were more likely to identify resident-specific factors such as better resident reputation and higher skill level as important in fostering entrustment. Residents were more likely to identify environmental factors such as a focus on efficiency and a litigious malpractice environment as impeding entrustment. Both groups agreed that work hour restrictions do not decrease autonomy and entrustment does not increase risk to patients. More residents considered low faculty confidence level as a barrier to operative autonomy, while more faculty considered lower resident clinical skill as a barrier. Improvement in resident preparation for cases was cited as an important intervention that could enhance entrustment., Conclusions: Differences in perspectives exist between general surgery residents and faculty regarding entrustment of autonomy. Residents cite environmental and attending-related factors, while faculty cite resident-specific factors as most influential. Residents and faculty both agree that entrustment is integral to surgical training., Competing Interests: Conflict of interest: The authors declare they have no competing interests.

Colorectal cancer remains the 3rd most common cancer diagnosed among men and women in the United States. With improved screening, premalignant rectal lesions and rectal cancers are being detected at earlier stages. In addition, the use of neoadjuvant chemo- and radiotherapy has led to downstaging of larger lesions. There is growing interest among colorectal surgeons in local excision with organ preservation for patients with rectal cancer. There are multiple platforms for local excision of rectal cancers, including transanal excision (TAE), transanal endoscopic microsurgery (TEM) and transanal minimally invasive surgery (TAMIS). TAMIS was developed as an affordable platform that uses conventional laparoscopic equipment familiar to many colorectal surgeons. TAMIS allows for full-thickness benign or malignant lesion excision in any quadrant without the need for patient repositioning. The literature has shown that, for appropriately selected patients, TAMIS provides superior excision quality compared to TAE. Furthermore, TAMIS has oncologic outcomes equivalent to TEM at a fraction of the cost. Recently, robotic TAMIS has been introduced, which takes advantage of the articulating instruments of the robotic platform without the need for a skilled assistant. This article will cover multiple technical aspects for TAMIS including patient selection and preparation, technical tips for successful excision and defect closure, and recent advances, including robotic TAMIS.

The number of gene therapies in development continues to increase, as they represent a novel method to treat, and potentially cure, many diseases. Gene therapies can be conducted with an in vivo or ex vivo approach, to cause gene augmentation, gene suppression, or genomic editing. Adeno-associated viruses are commonly used to deliver gene therapies, but their use is associated with several manufacturing, nonclinical and clinical challenges. As these challenges emerge, regulatory agency expectations continue to evolve. Following administration of rAAV-based gene therapies, nonclinical toxicities may occur, which includes immunogenicity, hepatotoxicity, neurotoxicity, and the potential risks for insertional mutagenesis and subsequent tumorgenicity. The mechanism for these findings and translation into the clinical setting are unclear at this time but have influenced the nonclinical studies that regulatory agencies are increasingly requesting to support clinical trials and marketing authorizations. These evolving regulatory expectations and toxicities, as well as future nonclinical considerations, are discussed herein.

Background: The aim of this study was to determine whether patients undergoing thyroidectomy and parathyroidectomy have similar postoperative pain if managed with an opioid-sparing regimen versus an opioid-containing regimen. We hypothesized that an opioid-sparing regimen would provide equivalent analgesia., Methods: We performed a prospective, randomized trial (clinicaltrials.govNCT03640247) comparing non-narcotic and narcotic postoperative pain regimens after discharge. Patients ≥18 y undergoing thyroidectomy or parathyroidectomy were eligible for inclusion. Patients were excluded if they were taking a narcotic. Patients in the nonnarcotic arm of the study received acetaminophen, alternating with ibuprofen, and patients in the narcotic arm received the same medications plus a narcotic., Results: Of 126 patients, 64 patients were in the nonnarcotic group and 62 were in the narcotic group. The mean age was 54 ± 14 y, and 108 (86%) patients were female. Median pain scores were similar on postoperative day #0 (narcotic group 7 versus nonnarcotic group 7.5), postoperative day #1 (narcotic group 6 versus nonnarcotic group 6), postoperative day #2 (narcotic group 5 versus nonnarcotic group 5), postoperative day #3 (narcotic group 4 versus nonnarcotic group 4), postoperative day #4 (narcotic group 3 versus nonnarcotic 3) and postoperative day #5 (narcotic group 2.5 versus nonnarcotic group 2, all P > .1). A total of 31 (50%) patients in the narcotic group did not take a narcotic. A total of 8 (12.5%) patients in the nonnarcotic group and of 31 (50%) patients in the narcotic group took a median total of 2 narcotic tablets., Conclusion: An opioid-sparing pain medication regimen provides effective analgesia for most patients after thyroidectomy and parathyroidectomy., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Twenty-five percent of rectal adenocarcinoma patients achieve pathologic complete response (pCR) to neoadjuvant chemoradiation and could avoid proctectomy. However, pretreatment clinical or imaging markers are lacking in predicting response to chemoradiation. Radiomic texture features from MRI have recently been associated with therapeutic response in other cancers., Purpose: To construct a radiomics texture model based on pretreatment MRI for identifying patients who will achieve pCR to neoadjuvant chemoradiation in rectal cancer, including validation across multiple scanners and sites., Study Type: Retrospective., Subjects: In all, 104 rectal cancer patients staged with MRI prior to long-course chemoradiation followed by proctectomy; curated from three institutions., Field Strength/sequence: 1.5T-3.0T, axial higher resolution T 2 -weighted turbo spin echo sequence., Assessment: Pathologic response was graded on postsurgical specimens. In total, 764 radiomic features were extracted from single-slice sections of rectal tumors on processed pretreatment T 2 -weighted MRI., Statistical Tests: Three feature selection schemes were compared for identifying radiomic texture descriptors associated with pCR via a discovery cohort (one site, N = 60, cross-validation). The top-selected radiomic texture features were used to train and validate a random forest classifier model for pretreatment identification of pCR (two external sites, N = 44). Model performance was evaluated via area under the curve (AUC), accuracy, sensitivity, and specificity., Results: Laws kernel responses and gradient organization features were most associated with pCR (P ≤ 0.01); as well as being commonly identified across all feature selection schemes. The radiomics model yielded a discovery AUC of 0.699 ± 0.076 and a hold-out validation AUC of 0.712 with 70.5% accuracy (70.0% sensitivity, 70.6% specificity) in identifying pCR. Radiomic texture features were resilient to variations in magnetic field strength as well as being consistent between two different expert annotations. Univariate analysis revealed no significant associations of baseline clinicopathologic or MRI findings with pCR (P = 0.07-0.96)., Data Conclusion: Radiomic texture features from pretreatment MRIs may enable early identification of potential pCR to neoadjuvant chemoradiation, as well as generalize across sites., Level of Evidence: 3 TECHNICAL EFFICACY STAGE: 2., (© 2020 International Society for Magnetic Resonance in Medicine.)

(1) Background : The relatively poor expert restaging accuracy of MRI in rectal cancer after neoadjuvant chemoradiation may be due to the difficulties in visual assessment of residual tumor on post-treatment MRI. In order to capture underlying tissue alterations and morphologic changes in rectal structures occurring due to the treatment, we hypothesized that radiomics texture and shape descriptors of the rectal environment (e.g., wall, lumen) on post-chemoradiation T2-weighted (T2w) MRI may be associated with tumor regression after neoadjuvant chemoradiation therapy (nCRT). (2) Methods : A total of 94 rectal cancer patients were retrospectively identified from three collaborating institutions, for whom a 1.5 or 3T T2w MRI was available after nCRT and prior to surgical resection. The rectal wall and the lumen were annotated by an expert radiologist on all MRIs, based on which 191 texture descriptors and 198 shape descriptors were extracted for each patient. (3) Results : Top-ranked features associated with pathologic tumor-stage regression were identified via cross-validation on a discovery set ( n = 52, 1 institution) and evaluated via discriminant analysis in hold-out validation ( n = 42, 2 institutions). The best performing features for distinguishing low (ypT0-2) and high (ypT3-4) pathologic tumor stages after nCRT comprised directional gradient texture expression and morphologic shape differences in the entire rectal wall and lumen. Not only were these radiomic features found to be resilient to variations in magnetic field strength and expert segmentations, a quadratic discriminant model combining them yielded consistent performance across multiple institutions (hold-out AUC of 0.73). (4) Conclusions : Radiomic texture and shape descriptors of the rectal wall from post-treatment T2w MRIs may be associated with low and high pathologic tumor stage after neoadjuvant chemoradiation therapy and generalized across variations between scanners and institutions.

Purpose Minimally invasive rectal cancer (RC) resection has become common, despite recent high-profile trials failing to show non-inferiority to open proctectomy. We hypothesized that at a high-volume center, laparoscopic resection may have superior outcomes compared to those seen in ALaCaRT and ACOSOG Z6051. Methods Retrospective review of patients undergoing laparoscopic proctectomy from 2007 to 2015 for RC was performed at a high-volume center. Primary outcome was successful resection defined by negative circumferential resection margin (CRM) and distal margin (DM), and complete total mesorectal excision (TME). Results A total of 89 patients were included. Of 33 patients with TME grading, 31 (93.9%) had complete/near complete TME, and 29 (87.9%) had a "successful resection" compared with 81.7% in ACOSOG and 82% in ALaCART trials using same criteria. CRM was ≥1 mm in 87 (97.8%) of patients. Mean DM was 3.8 cm; 97.8% of patients had negative DM. Conclusion High-volume centers can achieve similar high quality RC outcomes to those demonstrated in recent trials. Institutional outcomes should determine optimal surgical technique., Competing Interests: The authors have declared financial relationships, which are detailed in the next section., (Copyright © 2020, Ofshteyn et al.)

The EU is a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and therefore adopts the ICH Guidelines, including the ICH M3 Guideline on Nonclinical Safety Studies. Following the 2016 incident in France with BIA 10-2474, and in light of the substantial evolvement of how early clinical development has been undertaken during the last 10 years, for example, conducting integrated (FIH) studies that include multiple parts (eg, single ascending doses, multiple ascending doses, food effect), EMA decided to update the existing 2007 FIH guideline. The key revisions to the 2007 guideline, now titled "Guideline on Strategies to Identify and Mitigate Risks for First-in-Human and Early Clinical Trials With Investigational Medicinal Products," include additional information. The revision reinforces the importance and impact of pharmacologic data, which supports the intended efficacy of the compound, risk assessment, and protocol design. The updates, effective February 2018, are intended to provide additional guidance and clarity for Sponsors developing FIH and early phase clinical research programs, and ultimately support subject safety. At the 2018 DIA Europe Annual Meeting in Basel, Switzerland, European regulators, industry representatives and academics convened a DIAlogue Session on April 17 to discuss how the revised 2017 guideline is being applied, and to establish recommendations for its application. Using two case studies as examples, the session participants discussed the nonclinical and clinical considerations for applying the newly revised recommendations, and interacted with a panel including regulators and industry representatives. The proceedings from this session reflect practical considerations for the implementation of the revised guideline.

Purpose: Most preoperative assessment tools to evaluate risk for postoperative complications require multiple data points to be collected and can be logistically burdensome. This study evaluated if umbilical contamination, a simple bedside assessment, correlated with surgical outcomes., Methods: A 6-point score to measure umbilical contamination was developed and applied prospectively to patients undergoing colorectal surgery at an academic medical center., Results: There were 200 patients enrolled (mean age 58.1 ± 14.8; 56% female). The mean BMI was 28.6 ± 7.4. Indications for surgery included colon cancer (24%), rectal cancer (18%), diverticulitis (13.5%), and Crohn's disease (12.5%). Umbilical contamination scores were 0 (23%, cleanest), 1 (26%), 2 (21%), 3 (24%), 4 (6%), and 5 (0%, dirtiest). Umbilical contamination did not correlate with preoperative functional status (p > 0.2). Umbilical contamination correlated with increased length of stay (rho = 0.19, p = 0.007) and postoperative complications (OR 1.3, 1.02-1.7, p = 0.04), but not readmission (p = 0.3) or discharge disposition (p > 0.2)., Conclusion: Sterile preparation of the abdomen is an important component of proper surgical technique and umbilical contamination correlates with increased postoperative complications.

Background: Mentorship is a key component in preventing burnout and attrition in surgical training, yet many residencies lack a formal program, one method used to establish successful mentor relationships. We aimed to measure the difference in resident perceptions and experience after the implementation of a mentorship program., Methods: An anonymous survey was distributed to all general surgery residents at a single academic institution before and after implementation of a year-long mentorship program that involved assigned mentors, two social events, and recommended mentorship meetings. Responses were recorded on a five-point Likert scale., Results: Half of respondents (n = 17, 53%) attended at least one event, and 66% (n = 21) had at least one mentor meeting. The proportion of residents who identified a faculty mentor increased from 59% to 75%. Residents with two or more mentor meetings (n = 12, 38%) were more likely to report faculty were interested in mentoring and cared about their development (3.5 versus 4.6, 3.6 versus 4.6, P < 0.001). They were more likely to identify faculty approachable for resident performance (3.8 versus 4.6, P < 0.02) and outside of work concerns (3.2 versus 4.3, P < 0.01) and were more likely to be satisfied with the amount of mentorship received (2.8 versus 4.0 P < 0.001)., Conclusions: Implementation of a formal mentorship program resulted in an improvement in resident perception of faculty involvement and support. Meeting with a mentor resulted in a significant improvement in resident perception. Implementation of a mentorship program can improve resident experience, and few interactions are needed to affect the change., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: A large proportion of patients with anorectal complaints are referred to colorectal surgeons with the label of hemorrhoids., Objective: The purpose of this study was to review presenting symptoms and frequency of accurate diagnosis, as well as to analyze determinants of misdiagnosis to guide educational endeavors., Design: This was a retrospective study., Settings: The study was conducted at a tertiary care academic center., Patients: The charts of patients referred to a colorectal clinic with the diagnosis of hemorrhoids from January 1, 2012, to January 1, 2017, were reviewed., Main Outcome Measures: The accuracy of the referring provider's diagnosis of hemorrhoids was measured., Results: Review of charts identified 476 patients with the referral diagnosis of hemorrhoids. The most common presenting symptoms were bleeding (63%; n = 302), pain (48%; n = 228), and protrusion (39%; n = 185). Anal examination (ie, external inspection and/or digital internal examination) was documented in only 48%. The hemorrhoid diagnostic accuracy was 65% (n = 311). Among patients with incorrect hemorrhoid diagnoses (35%; n = 169), actual diagnosis was anal fissure (34%), skin tag (27%), and hypertrophied papilla (6%). One rectal and 2 anal carcinomas were found (0.63%). Compared with general practitioners, gastroenterologists had 86% higher odds of correct diagnosis (OR = 1.86 (95% CI, 1.10-3.10); p = 0.02), whereas the gynecologists had 68% lower odds of correct diagnosis at the time of referral (OR = 0.32 (95% CI, 0.10-0.80); p = 0.02). On multivariable analysis, referring specialty was not predictive of accurate diagnosis. Patients presenting with protrusion had 73% higher odds of accurate diagnosis (OR = 1.7 (95% CI, 1.1-2.7); p = 0.02), whereas patients presenting with pain (OR = 1.6 (95% CI, 1.1-2.5); p = 0.03) or pruritus (OR = 2.5 (95% CI, 1.2-5.0); p = 0.008) were more likely to be misdiagnosed., Limitations: This is a retrospective study. Not all of the charts contained all data points. The number of patients may limit the power of the study to detect some differences., Conclusions: A variety of anorectal complaints are diagnosed as hemorrhoids by providers who have initial contact with the patients. Educational programs directed toward improving physician knowledge can potentially improve diagnostic accuracy and earlier initiation of appropriate care. Presenting symptoms other than protrusion lead to higher rate of misdiagnosis by a referring physician. See Video Abstract at http://links.lww.com/DCR/A847.

Background: As our nation's population ages, operating on older and sicker patients occurs more frequently. Robotic operations have been thought to bridge the gap between a laparoscopic and an open approach, especially in more complex cases like proctectomy., Methods: Our objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All cases were restricted to age 70 years old or greater., Results: We identified 6740 admissions for rectal cancer including: 5879 open, 666 laparoscopic, and 195 robotic procedures. The median age was 77 years old. The incidence of a robotic proctectomy increased by 39%, while the open approach declined by 6% over the time period studied. Median (interquartile range) length of stay was shorter for robotic procedures at 4.3 (3-7) days, compared to laparoscopic 5.8 (4-8) and open at 6.7 (5-10) days (p < 0.01), while median total hospital charges were greater in the robotic group compared to laparoscopic and open cases ($64,743 vs. $55,813 vs. $50,355, respectively, p < 0.01). There was no significant difference in the risk of total complications between the different approaches following multivariate analysis., Conclusion: Robotic proctectomy was associated with a shorter LOS, and this may act as a surrogate marker for an overall improvement in adverse events. These results demonstrate that a robotic approach is a safe and feasible option, and should not be discounted solely based on age or comorbidities.

Background: Postoperative ileus is a significant complication after bowel resection surgeries. Alvimopan is the only US Food and Drug Administration-approved therapy for accelerating the return of bowel function after large- and small-bowel resection., Objective: The purpose of this study was to estimate the healthcare use and in-hospital morbidities associated with on-label use of alvimopan in patients undergoing bowel resection surgeries., Design: A retrospective observational propensity-matched cohort study was conducted using a large hospital administrative database., Setting: The study included inpatient postsurgical patients., Patients: Patients aged ≥18 years undergoing a primary large or small segmental bowel resection with discharge dates between January 2010 and December 2014 were included., Interventions: Patients receiving 2 to 15 doses of alvimopan were defined as the treatment cohort, and those without any alvimopan use were included as control subjects., Main Outcome Measures: The primary outcome was postoperative length of stay. Secondary outcomes included postoperative in-hospital morbidities, inpatient mortality, intensive care unit length of stay, discharge disposition, and 30-day readmission., Results: Each propensity-score matched cohort included 18,559 patients. The mean (±SD) postoperative length of stay was 4.62 ± 2.45 days in alvimopan-treated patients compared with 5.24 ± 3.35 days in control subjects (p < 0.001). Alvimopan-treated patients had lower rates of postoperative GI complication (12.15% vs 16.50%; p < 0.001). The rates of urinary tract infections; other postoperative infections; and cardiovascular, pulmonary, thromboembolic, and cerebrovascular events were also lower compared with the control subjects., Limitations: The study was limited by its inability to generalize to the US population, because the database included a convenience sample of hospital discharges. The identification of patients undergoing bowel resection and their clinical conditions relied on the accuracy and completeness of International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedure coding. There may be a confounding effect by the use of enhanced recovery pathways associated with the use of alvimopan., Conclusions: The use of alvimopan was associated with a reduction of 0.62 days in postsurgery length of stay and lower rates of postoperative GI complications, infections, and other in-hospital morbidities. See Video Abstract at http://links.lww.com/DCR/A703.

Rationale and Objectives: The objective of this study was to develop and quantitatively evaluate a radiology-pathology fusion method for spatially mapping tissue regions corresponding to different chemoradiation therapy-related effects from surgically excised whole-mount rectal cancer histopathology onto preoperative magnetic resonance imaging (MRI)., Materials and Methods: This study included six subjects with rectal cancer treated with chemoradiation therapy who were then imaged with a 3-T T2-weighted MRI sequence, before undergoing mesorectal excision surgery. Excised rectal specimens were sectioned, stained, and digitized as two-dimensional (2D) whole-mount slides. Annotations of residual disease, ulceration, fibrosis, muscularis propria, mucosa, fat, inflammation, and pools of mucin were made by an expert pathologist on digitized slide images. An expert radiologist and pathologist jointly established corresponding 2D sections between MRI and pathology images, as well as identified a total of 10 corresponding landmarks per case (based on visually similar structures) on both modalities (five for driving registration and five for evaluating alignment). We spatially fused the in vivo MRI and ex vivo pathology images using landmark-based registration. This allowed us to spatially map detailed annotations from 2D pathology slides onto corresponding 2D MRI sections., Results: Quantitative assessment of coregistered pathology and MRI sections revealed excellent structural alignment, with an overall deviation of 1.50 ± 0.63 mm across five expert-selected anatomic landmarks (in-plane misalignment of two to three pixels at 0.67- to 1.00-mm spatial resolution). Moreover, the T2-weighted intensity distributions were distinctly different when comparing fibrotic tissue to perirectal fat (as expected), but showed a marked overlap when comparing fibrotic tissue and residual rectal cancer., Conclusions: Our fusion methodology enabled successful and accurate localization of post-treatment effects on in vivo MRI., (Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

Background: Quality is the major driver for both clinical and financial assessment. There remains a need for simple, affordable, quality metric tools to evaluate patient outcomes, which led us to develop the HospitAl length of stay, Readmission and Mortality (HARM) score. We hypothesized that the HARM score would be a reliable tool to assess patient outcomes across various surgical specialties., Methods: From 2011 to 2015, we identified colorectal, hepatobiliary, upper gastrointestinal, and hernia surgery admissions using the Vizient Clinical Database. Individual and hospital HARM scores were calculated from length of stay, 30-day readmission, and mortality rates. We evaluated the correlation of HARM scores with complication rates using the Clavien-Dindo classification., Results: We identified 525,083 surgical patients: 206,981 colorectal, 164,691 hepatobiliary, 97,157 hernia, and 56,254 upper gastrointestinal. Overall, 53.8% of patients were admitted electively with a mean HARM score of 2.24; 46.2% were admitted emergently with a mean HARM score of 1.45 (p < 0.0001). All HARM components correlated with patient complications on logistic regression (p < 0.0001). The mean length of stay increased from 3.2 ± 1.8 days for a HARM score < 2 to 15.1 ± 12.2 days for a HARM score > 4 (p < 0.001). In elective admissions, for HARM categories of < 2, 2-< 3, 3-4, and > 4, complication rates were 9.3, 23.2, 38.8, and 71.6%, respectively. There was a similar trend for increasing HARM score in emergent admissions as well. For all surgical procedure categories, increasing HARM score, with and without risk adjustment, correlated with increasing severity of complications by Clavien-Dindo classification., Conclusions: The HARM score is an easy-to-use quality metric that correlates with increasing complication rates and complication severity across multiple surgical disciplines when evaluated on a large administrative database. This inexpensive tool could be adopted across multiple institutions to compare the quality of surgical care.

Background: In an effort to improve the quality of rectal cancer care in the US, the American College of Surgeons Commission on Cancer has developed the National Accreditation Program for Rectal Cancer (NAPRC). We aimed to describe the current status of rectal cancer care before implementation of the NAPRC., Study Design: The 2011-2014 National Cancer Database was queried for non-metastatic rectal cancer patients who underwent proctectomy. The NAPRC process measures evaluated included clinical staging completion, treatment starting fewer than 60 days from diagnosis, CEA level drawn before treatment, tumor regression grading, and margin assessment. The NAPRC performance measures included negative proximal, distal, and circumferential margins, and ≥12 lymph nodes harvested during resection., Results: There were 39,068 patients identified (mean age 62 years, 61.6% male sex). In >85% of patients, clinical staging was completed, treatment was started within 60 days, and all tumor margins were assessed. Pretreatment CEA level (64.6% complete) was the process measure most often omitted. However, completion of all included process measures occurred in only 28.1% of patients. All pathologic margins were negative in 79.8% of patients and 73.2% of specimens reported ≥12 lymph nodes. Overall, 56.3% of patients achieved all performance measures. Patients treated at high-volume centers (>30 cases/year) had higher odds of meeting all performance measures (odds ratio 1.42; p < 0.001)., Conclusions: Overall, very few patients achieved all of the proposed quality measures for rectal cancer care. It will be important to re-evaluate these data after the implementation of the NAPRC., (Copyright © 2018. Published by Elsevier Inc.)

Background: Increasingly, patients with multiple co-morbidities undergo surgery for rectal cancer. We aimed to evaluate if decreased psoas muscle area and volume, as measures for sarcopenia, were associated with postoperative morbidity., Methods: Retrospective review of patients undergoing rectal cancer resection at a tertiary medical center (2007-2015). Variables included demographics, co-morbidities, preoperative psoas muscle area and volume, and postoperative complications., Results: Among 180 patients (58% male, mean age 62.7 years), 44% experienced complications (n = 79), of which 38% (n = 30) were major complications. Malnourished patients had smaller height-adjusted total psoas area than non-malnourished patients (6.4 vs. 9.5 cm 2 /m 2 , p = 0.004). Among patients with imaging obtained within 90 days of surgery, major morbidity was associated with smaller total psoas area (6.7 vs. 10.5 cm 2 /m 2 , p = 0.04) and total psoas volume (26.7 vs. 42.2 cm 3 /m 2 , p = 0.04) compared to those with minor complications., Conclusion: Preoperative cross-sectional imaging may help surgeons anticipate postoperative complications following rectal cancer surgery., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The feasibility of a laparoscopic approach in patients who have had a prior laparotomy (PL) remains controversial. We hypothesized that laparoscopic colorectal resection was safe and feasible in patients with previous open abdominal surgery., Methods: A retrospective review (2007-2015) of all patients undergoing laparoscopic resection for sigmoid and rectal adenocarcinoma with or without prior midline laparotomy (NPL) was performed. Primary endpoints included conversion and perioperative morbidity. Secondary endpoints included length of stay and perioperative outcomes. Demographics, surgical history, oncologic staging, and short-term outcomes were reviewed., Results: We identified 211 patients, of whom 33 (15.6%) had a prior laparotomy. Significantly more patients in the PL group were female (76.2 vs. 52.8%, p = 0.004). Patients with PL were of similar age to NPL patients (69.3 vs. 62.5, p = 0.09), and comorbidities, tumor staging, and neoadjuvant therapy were comparable between groups (all p > 0.05). Additional trocar placement was significantly higher in PL group (33.3 vs. 17.4%, p = 0.03), while conversion rate did not reach statistical significance (24.2 vs. 12.9%, p = 0.08). The postoperative complication rate was comparable between PL and NPL patients (33.3 vs. 25.3%, respectively, p = 0.2)., Conclusions: Prior laparotomy should not be a contraindication to patients undergoing laparoscopic colorectal surgery, though surgeons should anticipate a higher likelihood of conversion to open.

Background: Disparities in access to colorectal cancer care are multifactorial and are affected by socioeconomic elements. Uninsured and Medicaid patients present with advanced stage disease and have worse outcomes compared with similar privately insured patients. Safety net hospitals are a major care provider to this vulnerable population. Few studies have evaluated outcomes for safety net hospitals compared with private institutions in colorectal cancer., Objective: The purpose of this study was to compare demographics, screening rates, presentation stage, and survival rates between a safety net hospital and a tertiary care center., Design: Comparative review of patients at 2 institutions in the same metropolitan area were conducted., Settings: The study included colorectal cancer care delivered either at 1 safety net hospital or 1 private tertiary care center in the same city from 2010 to 2016., Patients: A total of 350 patients with colorectal cancer from each hospital were evaluated., Main Outcome Measures: Overall survival across hospital systems was measured., Results: The safety net hospital had significantly more uninsured and Medicaid patients (46% vs 13%; p < 0.001) and a significantly lower median household income than the tertiary care center ($39,299 vs $49,741; p < 0.0001). At initial presentation, a similar percentage of patients at each hospital presented with stage IV disease (26% vs 20%; p = 0.06). For those undergoing resection, final pathologic stage distribution was similar across groups (p = 0.10). After a comparable median follow-up period (26.6 mo for safety net hospital vs 29.2 mo for tertiary care center), log-rank test for overall survival favored the safety net hospital (p = 0.05); disease-free survival was similar between hospitals (p = 0.40)., Limitations: This was a retrospective review, reporting from medical charts., Conclusions: Our results support the value of safety net hospitals for providing quality colorectal cancer care, with survival and recurrence outcomes equivalent or improved compared with a local tertiary care center. Because safety net hospitals can provide equivalent outcomes despite socioeconomic inequalities and financial constraints, emphasis should be focused on ensuring that adequate funding for these institutions continues. See Video Abstract at http://links.lww.com/DCR/A454.

Background: Recent data suggest that treatment of acute, uncomplicated appendicitis (AUA) with antibiotics is as effective as surgery. A 2015 study indicated that more than 50% of patients would choose antibiotic therapy. Medical students represent a unique population of potential patients with greater medical knowledge than the general public and possibly less bias than practicing physicians. Therefore, we aimed to evaluate what the MEDICAL STUDENT'S treatment choice for AUA would be and what factors influence these decisions., Methods: We conducted a survey of current medical students at a single institution. Survey data included demographics, interest in surgery or a procedure-related specialty, knowledge of and experience with surgery and antibiotics, and concerns about treatments. A summary of the literature regarding the efficacy and safety of antibiotics and surgery was presented. Each participant was asked which treatment he or she would choose if affected by AUA., Results: A series of 255 medical students completed the survey (mean age 24.8 ± 2.4 y; 51.5% female). The largest number of respondents (41.2%) were second-year students, and more than half (54.2%) reported an interest in a procedure-related specialty. Nearly all (93%) reported prior antibiotic use (19% reporting adverse effects), and 50% had prior surgery (20% reporting adverse events). When asked to identify concerns about each treatment choice, "surgical complications" was selected most frequently (82%) for surgery, and "adverse events and side effects" was selected most frequently for antibiotics (57%). When asked how they would treat their own AUA, 66.3% selected surgery, 24.3% selected antibiotics, and 9.4% were unsure. Race, gender, specialty of interest, year of training, and history of adverse effects related to antibiotics or surgery were not significantly related to treatment choice (all p > 0.1)., Conclusion: When informed of the benefits and risks of surgery and antibiotics to treat AUA, medical students in our study were more likely to choose surgery.

Background: Surgeons often approach anal fissure with chemical denervation (Botulinum toxin, BT) instead of initial lateral internal sphincterotomy (LIS) due to concerns for long-term incontinence. We evaluated the characteristics and outcomes of patients who received BT or LIS., Methods: We performed a retrospective chart review of patients undergoing LIS and BT for anal fissure between 2009 and 2015. In 2015, a telephone survey was performed to evaluate durability, long-term incontinence and patient satisfaction., Results: Ninety-four patients met criteria: 73 LIS and 21 BT. Age (BT 49 vs. LIS 52) was similar between groups (p = 1.0). Cleveland Clinic Fecal Incontinence (CCFI) score pre-intervention was higher in BT than LIS patients (2.1 vs. 0.4, p = 0.007) with fewer BT patients with perfect continence (50% vs. 88%). Telephone survey response was 61%. Fissure recurrence was significantly higher for BT than LIS patients (36% vs. 9%, p = 0.03)., Conclusion: Patients undergoing LIS were less likely to recur. Both LIS and BT patients had some durable changes in continence raising the question of whether there is a safe technique., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose: Previous studies have demonstrated that obese patients (BMI >30) undergoing laparoscopic colectomy have longer operative times and increased complications when compared to non-obese cohorts. However, there is little data that specifically evaluates the outcomes of obese patients based on the degree of their obesity. The aim of this study was to evaluate the impact of increasing severity of obesity on patients undergoing laparoscopic colectomy., Methods: A retrospective review was performed of all patients undergoing laparoscopic colectomy between 1996 and 2013. Patients were classified according to their BMI as obese (BMI 30.0-39.9), morbidly obese (BMI 40.0-49.9), and super obese (BMI >50). Main outcome measures included conversion rate, operative time, estimated blood loss, post-operative complications, and length of stay., Results: There were 923 patients who met inclusion criteria. Overall, 604 (65.4%), 257 (27.9%), and 62 (6.7%) were classified as obese (O), morbidly obese (MO), and super obese (SO), respectively. Clinicopathologic characteristics were similar among the three groups. The SO group had significantly higher conversion rates (17.7 vs. 7 vs. 4.8%; P = 0.031), longer average hospital stays (7.1 days vs. 4.9 vs. 3.4; P = 0.001), higher morbidity (40.3 vs. 16.3 vs. 12.4%; P = 0.001), and longer operative times (206 min vs. 184 vs. 163; P = 0.04) compared to the MO and O groups, respectively. The anastomotic leak rate in the SO (4.8%; P = 0.027) and MO males (4.1%; P = 0.033) was significantly higher than MO females (2.2%) and all obese patients (1.8%)., Conclusion: Increasing severity of obesity is associated with worse perioperative outcomes following laparoscopic colectomy.

Background: Our goal was to evaluate presentation and outcomes for colorectal cancer across gender in a safety net hospital (SNH)., Methods: An institutional Tumor Registry was reviewed for colorectal cancer resections 12/2009-2/2016. Patients were stratified into male and female cohorts. The main outcome measures were stage at presentation and oncologic outcomes across gender., Results: 170 women (48.6%) and 180 men (51.4%) were evaluated; 129 (84.1%) females and 143 (79.4%) males underwent curative resection. There were no significant differences in prior colorectal cancer screening. On presentation, there were similar rates of stage IV disease across genders (p = 0.3). After median follow-up of 26.5 months (female) and 29.9 months (male), there were no significant differences in overall survival, survival by stage, or disease-free survival by gender (all p = 0.7). The local (1.4% females vs. 2.6% males, p = 0.7) and distant recurrence (16.6% females vs. 14.9% males, p = 0.7) were similar across gender., Conclusion: With equal access to treatment, there were no significant differences in overall survival, survival by stage, or local or distant recurrence rates by gender. These findings stress the importance of the SNH system, and need for continued support., (Copyright © 2017. Published by Elsevier Inc.)

Introduction: Abdominoperineal Resection (APR) remains an important option for patients with advanced rectal cancer though some may require multivisceral resection (MVR) in addition to APR. We hypothesized that oncological outcomes would be worse with MVR., Methods: A retrospective review from 2006 to 2015 of 161 patients undergoing APR or MVR for rectal cancer, of whom 118 underwent curative APR or APR with MVR. Perioperative, oncologic and survival metrics were evaluated., Results: There were 82 patients who underwent APR and 36 who underwent MVR. Surgical approach and incidence of complications were similar (All P > 0.05). There was 1 local recurrence in each of the APR and MVR groups at a mean follow-up of 34 and 32 months, respectively. Distant recurrences occurred in 3 APR patients and 4 MVR patients., Conclusions: APR and APR with MVR can be performed with comparable morbidity and oncologic outcomes., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Postoperative ileus (POI) is a major cause of morbidity, increased length of stay (LOS) and hospital cost after colorectal surgery. Alvimopan is a µ-opioid antagonist used to accelerate upper and lower gastrointestinal function after bowel resection. We hypothesized that alvimopan would reduce LOS in patients undergoing colorectal resection with stoma, a situation that has not been evaluated., Methods: A retrospective review (2010-2015) identified 58 patients who underwent colorectal resection for benign or malignant disease with stoma creation and received alvimopan. They were case-matched to 58 non-alvimopan patients based on age, BMI, baseline comorbidities, stoma type created and surgical approach. We compared overall LOS, incidence of POI and other postoperative complications., Results: There were equal numbers of laparoscopic (N = 18) and open resections (N = 40) in the alvimopan group and non-alvimopan group. There were also equal numbers of patients with an ileostomy (N = 37) or colostomy (N = 21) in each group. Overall, 41 patients underwent resection for malignant disease in the alvimopan group compared to 37 in the non-alvimopan group. There was a significant reduction in median LOS overall (alvimopan 5 (4-7) versus control 6 (4.75-9.25) days, P = 0.03). While the 6-day median LOS was similar for patients undergoing ileostomy creation (P = 0.25), alvimopan patients had a 3-day decreased median LOS that approached statistical significance (P = 0.06). The overall 30-day complication rate was higher in the control group (41.4 vs. 51.7%, P = 0.26), but the readmission rate within 30 days was higher in the alvimopan group (19 vs. 13.8%, P = 0.45). Neither of these differences reached statistically significance., Conclusion: The use of alvimopan in patients undergoing colorectal resection with stoma is associated with a significantly shorter LOS, but the increased readmission rate warrants further study. Based on these data, alvimopan should be evaluated in a controlled setting for patients undergoing colorectal resection with colostomy creation.

Social media is a source of news and information for an increasing portion of the general public and physicians. The recent political election was a vivid example of how social media can be used for the rapid spread of "fake news" and that posts on social media are not subject to fact-checking or editorial review. The medical field is susceptible to propagation of misinformation, with poor differentiation between authenticated and erroneous information. Due to the presence of social "bubbles," surgeons may not be aware of the misinformation that patients are reading, and thus, it may be difficult to counteract the false information that is seen by the general public. Medical professionals may also be prone to unrecognized spread of misinformation and must be diligent to ensure the information they share is accurate.

Background: Reprocessed (re-sterilized) bipolar energy devices represent one effort to reduce operative costs., Methods: Between January 2014 to October 2015, 76 patients underwent laparoscopic colectomy using a reprocessed bipolar energy device and were case-matched to 76 patients from a prospectively-maintained database from November 2012 to December 2013 when an identical, new device was used. Outcomes included reprocessed device safety, efficiency and hospital costs., Results: There was no difference in patient demographics, operative times or failed pedicle ligation requiring intervention between groups (all P > 0.05). In 19.7% of reprocessed cases, the surgeon opened an additional new device after dissatisfaction with the reprocessed instrument. Operating room costs and total costs were less for the reprocessed device group (all P < 0.05)., Conclusion: Reprocessed bipolar energy devices were associated with savings in operative expenses, however, larger studies are warranted due to the high surgeon dissatisfaction regarding safety concerns with the reprocessed equipment., (Copyright © 2017. Published by Elsevier Inc.)

Background: The lack of consensus for performance assessment of laparoscopic colorectal resection is a major impediment to quality improvement., Objective: The purpose of this study was to develop and assess the validity of an evaluation tool for laparoscopic colectomy that is feasible for wide implementation., Design: During the pilot phase, a small group of experts modified previous assessment tools by watching videos for laparoscopic right colectomy with the following categories of experience: novice (less than 20 cases), intermediate (50-100 cases), and expert (more than 500 cases). After achieving sufficient reliability (κ > 0.8), a user-friendly tool was validated among a large group of blinded, trained experts., Setting: The study was conducted through the American Society of Colon and Rectal Surgeons Operative Competency Evaluation Committee., Patients: Raters were from the Operative Competency Evaluation Committee of the American Society of Colon and Rectal Surgeons., Main Outcome Measures: Assessment tool reliability and internal consistency were measured., Results: From October 2014 through February 2015, 4 groups of 5 raters blinded to surgeon skill level evaluated 6 different laparoscopic right colectomy videos (novice = 2, intermediate = 2, expert = 2). The overall Cronbach α was 0.98 (>0.9 = excellent internal consistency). The intraclass correlation for the overall assessment was 0.93 (range, 0.77-0.93) and was >0.74 (excellent) for each step. The average scores (scale, 1-5) for experts were significantly better than those in the intermediate category, with a mean (SD) of 4.51 (0.56) versus 2.94 (0.56; p = 0.003). Videos in the intermediate group scored more favorably than beginner videos for each individual step and overall performance (mean (SD) = 3.00 (0.32) vs 1.78 (0.42); p = 0.006)., Limitations: The study was limited by rater bias to technique and style., Conclusions: The unique and robust methodology in this trial produced an assessment tool that was feasible for raters to use when assessing videotaped laparoscopic right hemicolectomies. The potential applications for this new tool are widespread, including both training and evaluation of competence at the attending level. See Video Abstract at http://links.lww.com/DCR/A369, http://links.lww.com/DCR/A370, http://links.lww.com/DCR/A371.

Background: The HospitAl length of stay, Readmissions and Mortality (HARM) score is a simple, inexpensive quality tool, linked directly to patient outcomes. We assess the HARM score for measuring surgical quality across multiple surgical populations., Methods: Upper gastrointestinal, hepatobiliary, and colorectal surgery cases between 2005 and 2009 were identified from the Healthcare Cost and Utilization Project California State Inpatient Database. Composite and individual HARM scores were calculated from length of stay, 30-day readmission and mortality, correlated to complication rates for each hospital and stratified by operative type., Results: 71,419 admissions were analyzed. Higher HARM scores correlated with higher complication rates for all cases after risk adjustment and stratification by operation type, elective or emergent status., Conclusions: The HARM score is a simple and valid quality measurement for upper gastrointestinal, hepatobiliary and colorectal surgery. The HARM score could facilitate benchmarking to improve patient outcomes and resource utilization, and may facilitate outcome improvement., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Intraoperative radiation therapy (IORT) has been proposed as a tool to improve local control in patients with locally advanced primary or recurrent colorectal cancer., Methods: A retrospective review (1999-2015) of all patients undergoing IORT for locally advanced or recurrent colorectal cancer at a single academic center was performed. Patient demographics, oncologic staging, short-term and long-term outcomes were reviewed., Results: There were 77 patients (mean age 63 ± 11 years) identified, of whom 19 had colon cancer, 57 had rectal cancer, and 2 had appendiceal cancers. R0 resection was performed in 53 patients (69%), R1 in 19 (25%) and R2 in 5 (6%). Ten (13%) patients had a local recurrence at 18 ± 14 months and 34 (44%) had a distant recurrence at 18 ± 18 months. Mean survival was 47 ± 41 months., Conclusion: IORT resulted in low local failure rates and should be considered for patients with locally advanced or recurrent colorectal cancers., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Colovaginal fistula is a rare condition associated with significant morbidity. The literature characterizing colovaginal fistula repair is sparse. We present our institution's experience treating colovaginal fistulas., Methods: A retrospective review of all patients surgically treated for colovaginal fistula between 2005 and 2015 was performed. Patient demographics, intra-operative details, and post-operative outcomes were reviewed., Results: We identified 27 patients with a mean age of 71 (±13) and BMI of 30 (±9). The most common etiology for fistula was diverticulitis (n = 24, 89%). A laparoscopic approach was initiated in 19 patients (70%) and an open approach for 8 (30%) with 8 patients converted from laparoscopy to open (42%). At a mean follow-up of 18 months (±21), there were no recurrences., Conclusion: We present one of the largest series of the surgical management of colovaginal fistulas. Although our conversion rate was high, we recommend a laparoscopic approach be utilized when feasible., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Enhanced recovery pathways allow for safe discharge and optimal outcomes within 48 hours after ileostomy closure. Unfortunately, some patients undergoing ileostomy closure have prolonged hospital stays. We have shown previously that the Modified Frailty Index can help predict patients who will fail early discharge after laparoscopic colorectal surgery., Objective: The purpose of this study was to use the Modified Frailty Index to identify patients who were safe for early discharge after ileostomy closure., Design: This was a retrospective review., Settings: The study was conducted at a tertiary referral center., Patients: Patients who underwent ileostomy closure (2006-2015) were stratified into early (≤48 hours) and late discharge groups., Main Outcome Measures: The Modified Frailty Index, morbidity, and readmission rates were measured., Results: A total of 272 patients undergoing ileostomy closure were evaluated. Overall length of stay was 3.64 days (±3.23 days), with 114 patients (42%) discharged within 48 hours. Sex, age, and ASA scores were similar between early and later discharge groups (p > 0.2). Univariate logistic regression demonstrated that a Modified Frailty Index score of 0 was associated with early discharge (p = 0.03), whereas a Modified Frailty Index score ≤1 and ≤2 were not. There was no significant association between the Modified Frailty Index and complication or readmission rates. Postoperative complications occurred in 39 patients (14.3%), and 1 patient died secondary to an anastomotic leak. Fifteen patients (5.5%) were readmitted within 30 days. Readmission rate within 30 days was 3.2%, with a Modified Frailty Index score of 0, 6.1% for a Modified Frailty Index score of <1, and 5.9% for a Modified Frailty Index score of <2, for which there was not an association based on univariate logistic regression (Modified Frailty Index = 0, p = 0.13; <1, p = 0.55; <2, p = 0.53)., Limitations: The study was limited by nature of being a retrospective review., Conclusions: Patients undergoing ileostomy closure with a Modified Frailty Index score of 0 are associated with higher rates of discharge within 48 hours of ileostomy closure surgery than those with a higher Modified Frailty Index, without higher readmission rates. This information can be helpful to better manage patient and resource use expectations for the duration of inpatient recovery.

Three orally administered metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulators caused skin lesions consistent with delayed type-IV hypersensitivity in cynomolgus macaques in 2- and 12-week toxicity studies. Several monkeys developed macroscopic skin lesions in multiple locations after 8 to 9 days of dosing; the most prominent effects involved the genital region of males and generalized erythema occurred in both sexes. Microscopic lesions occurred in both clinically affected and unaffected areas and were characterized by lymphocytic interface inflammation, subepidermal bullae, and individual keratinocyte vacuolation/necrosis. In the 12-week study, clinical effects in 2 animals resolved with continued dosing, whereas in others the inflammatory process progressed with 1 female exhibiting systemic lymphocytic inflammation in multiple tissues. The inflammatory infiltrate consisted of CD3 and CD4 positive T lymphocytes with minimal CD68 positive macrophages and only rare CD8 positive T lymphocytes. A subset of animals given a dosing holiday was subsequently rechallenged with similar lesions developing but with a more rapid clinical onset. These skin lesions were consistent with type-IV delayed hypersensitivity with some features comparable to bullous drug eruptions in humans. A relationship between these findings and the intended mode of action for these compounds could not be ruled out, given the occurrence across different chemotypes., (© 2015 by The Author(s).)

Transient ileus is a normal physiologic process after surgery. When prolonged, it is an important contributor to postoperative complications, increased length of stay and increased healthcare costs. Efforts have been made to prevent and manage postoperative ileus; alvimopan is an oral, peripheral μ-opioid receptor antagonist, and the only currently US FDA-approved medication to accelerate the return of gastrointestinal function postoperatively.