Early discharge after enhanced recovery rectal resection does not increase emergency department visits and readmissions: a single institution analysis.

BACKGROUND: Same-day discharge after colectomy in enhanced recovery pathways has been shown to be feasible. It is not clear how early patients with rectal resections may be safely discharged. The study aim was to determine if patients discharged ≤ 3 days after rectal resections are associated with increased rates of emergency department (ED) visits and hospital readmissions. METHODS: Retrospective analysis of enhanced recovery low anterior resection, abdominoperineal resection, and proctocolectomy patients in a prospectively maintained single institution colorectal surgery database from 01/01/2018 to 07/15/2022. Clinic visits were scheduled within 4-7 days and at 30 days after discharge, and every 1-2 weeks for stoma patients until no longer needed. Logistic regression models were used to analyze the association of discharge on postoperative days (POD)-1-3, POD-4-5, and POD ≥ 6 days with incidence of ED visits and readmissions. RESULTS: A total of 118 patients met inclusion criteria, 76 with stomas. Median postoperative length of stay was 5 [IQR 6.5] days. Mean age was 58.6 years; 59.3% were ASA-3; and 69.5% had a minimally invasive surgical approach. ED visits were not significantly different between discharge-day groups (p = 0.096). No patients were discharged same-day, one without a stoma was discharged on POD-1, ten patients (2 with stomas) on POD-2, and twenty-four patients (13 with stomas) on POD-3. ED visits were lowest for the POD-1-3 group (14.3%) but not significantly different than later discharge groups (p = 0.166). Readmission rate was also lowest for the POD-1-3 group (11.4%) and also not significantly different than later discharge groups (p = 0.261) and this was confirmed with logistic regression. Complication rate was lowest in the POD-1-3 group (p < 0.001). CONCLUSION: Early discharge after enhanced recovery partial or complete proctectomy is not associated with increased ED visits and readmissions. Follow up studies should identify post-discharge resources that allow safe early discharge and that may be standardized and generalizable.

The Fur-like regulatory protein MAP3773c modulates key metabolic pathways in Mycobacterium avium subsp. paratuberculosis under in-vitro iron starvation.

Johne's disease (JD) is a chronic enteric infection of dairy cattle worldwide. Mycobacterium avium subsp. paratuberculosis (MAP), the causative agent of JD, is fastidious often requiring eight to sixteen weeks to produce colonies in culture-a major hurdle in the diagnosis and therefore in implementation of optimal JD control measures. A significant gap in knowledge is the comprehensive understanding of the metabolic networks deployed by MAP to regulate iron both in-vitro and in-vivo. The genome of MAP carries MAP3773c, a putative metal regulator, which is absent in all other mycobacteria. The role of MAP3773c in intracellular iron regulation is poorly understood. In the current study, a field isolate (K-10) and an in-frame MAP3773c deletion mutant (ΔMAP3773c) derived from K-10, were exposed to iron starvation for 5, 30, 60, and 90 min and RNA-Seq was performed. A comparison of transcriptional profiles between K-10 and ΔMAP3773c showed 425 differentially expressed genes (DEGs) at 30 min time post-iron restriction. Functional analysis of DEGs in ΔMAP3773c revealed that pantothenate (Pan) biosynthesis, polysaccharide biosynthesis and sugar metabolism genes were downregulated at 30 min post-iron starvation whereas ATP-binding cassette (ABC) type metal transporters, putative siderophore biosynthesis, PPE and PE family genes were upregulated. Pathway analysis revealed that the MAP3773c knockout has an impairment in Pan and Coenzyme A (CoA) biosynthesis pathways suggesting that the absence of those pathways likely affect overall metabolic processes and cellular functions, which have consequences on MAP survival and pathogenesis.

Early Discharge after Enhanced Recovery Colectomy Does Not Increase Emergency Department Visits and Readmissions: A Single Institution Analysis.

BACKGROUND: Same-day discharge after colorectal surgery in enhanced recovery pathways is increasing. This study aimed to determine if discharge on postoperative days (POD) one or two is associated with increased rates of emergency department (ED) visits and hospital readmissions after left and right colectomy. METHODS: Single institution retrospective analysis of prospective institutional colorectal surgery database between 07/01/2018 and 07/15/2022. Primary outcomes were ED visit and readmission rates for enhanced recovery open and minimally invasive right and left colectomy using logistic regressions models. RESULTS: 820 patients met inclusion criteria. There were significant differences in discharge-day by diagnosis-58.5% of patients with Crohn's disease were discharged on POD ≥4 and 21.6% with benign colon neoplasia were discharged on POD-0-1 (P < .001). ED visits occurred in 12.9% of the study population and were not significantly different between discharge-day groups (P = .096). Overall readmission rate was 8.5% and significantly different between discharge-day groups (0% POD-0 vs 8.3% POD-1 vs 5.8% POD-2 vs 6.9% POD-3 vs 12.9% POD ≥4, P = .041). Logistic regression showed that ED visits and readmissions for longer discharge-days (POD-2, POD-3, POD ≥4) were not significantly different than POD-0-1. Readmission diagnoses for the study population were higher for ileus (17.1%) and surgical site infection (SSI) type-III (22.9%) than for acute kidney injury (1.4%) and SSI type-I/II (1.4%). CONCLUSION: Early discharge after left and right colectomy is not associated with increased rates of ED visits and readmissions. Same-day discharge may be feasible in selected enhanced recovery patients. Standardized post-discharge resources that safely allow same-day discharge require further investigation.

Operative trends following the adoption of nonoperative management of rectal cancer.

BACKGROUND: Differentiating clinical near-complete and complete responses (cCR) after neoadjuvant therapy (NT) is challenging in rectal cancer patients. We hypothesized that magnetic resonance imaging staging limitations for low rectal cancers may increase the proportion of abdominoperineal resection (APR) with permanent colostomy for those without a cCR. METHODS: Single institution retrospective analysis of rectal cancer cases before and after adoption of nonoperative "watch and wait" (W&W) pathway. APR as a percentage of rectal resections was the primary outcome. RESULTS: There were 76 total mesorectal excisions (TME) in the pre-W&W group and 98 in the post-W&W group. NT was significantly more common in the post-W&W group. There was no significant difference in the APR primary outcome (pre-W&W APR 33.3% vs. post-W&W APR 26.5%, p = 0.482). APR patients had fewer complete TME grades (69.2% vs. 46.2%) and more pathologic complete responses (0% vs. 26.9%) in the post-W&W period. The cCR rate for patients with nonoperative management was 51.4% (n = 37) and 13.5% (n = 5) had regrowths, all of whom underwent salvage surgery. CONCLUSION: APR for those without a cCR to NT has not increased in the nonoperative management era. Balancing the pathologic complete response rate may require restaging some patients with clinical near-complete responses.

Structured reporting to improve transparency of analyses in prognostic marker studies.

BACKGROUND: Factors contributing to the lack of understanding of research studies include poor reporting practices, such as selective reporting of statistically significant findings or insufficient methodological details. Systematic reviews have shown that prognostic factor studies continue to be poorly reported, even for important aspects, such as the effective sample size. The REMARK reporting guidelines support researchers in reporting key aspects of tumor marker prognostic studies. The REMARK profile was proposed to augment these guidelines to aid in structured reporting with an emphasis on including all aspects of analyses conducted. METHODS: A systematic search of prognostic factor studies was conducted, and fifteen studies published in 2015 were selected, three from each of five oncology journals. A paper was eligible for selection if it included survival outcomes and multivariable models were used in the statistical analyses. For each study, we summarized the key information in a REMARK profile consisting of details about the patient population with available variables and follow-up data, and a list of all analyses conducted. RESULTS: Structured profiles allow an easy assessment if reporting of a study only has weaknesses or if it is poor because many relevant details are missing. Studies had incomplete reporting of exclusion of patients, missing information about the number of events, or lacked details about statistical analyses, e.g., subgroup analyses in small populations without any information about the number of events. Profiles exhibit severe weaknesses in the reporting of more than 50% of the studies. The quality of analyses was not assessed, but some profiles exhibit several deficits at a glance. CONCLUSIONS: A substantial part of prognostic factor studies is poorly reported and analyzed, with severe consequences for related systematic reviews and meta-analyses. We consider inadequate reporting of single studies as one of the most important reasons that the clinical relevance of most markers is still unclear after years of research and dozens of publications. We conclude that structured reporting is an important step to improve the quality of prognostic marker research and discuss its role in the context of selective reporting, meta-analysis, study registration, predefined statistical analysis plans, and improvement of marker research.

Association of circulating leptin, adiponectin, and resistin concentrations with long-term breast cancer prognosis in a German patient cohort.

Adipokines including leptin, adiponectin and resistin have been linked to risk of obesity-related cancers potentially through low-grade chronic inflammation pathways. We aimed to assess the role of post-diagnosis circulating adipokines on long-term prognosis in a prospective breast cancer cohort. Adipokines were measured in blood collected at baseline shortly after diagnosis (2002-2005) and at follow-up (2009) from 3112 breast cancer patients enrolled in the population-based MARIE study. Half of the patients had measurements at both time-points. All-cause mortality, breast cancer specific mortality and recurrences were ascertained up to June 2015 (11 years median follow-up). Associations with time-varying adipokine concentrations overall and stratified by estrogen and progesterone receptor (ERPR) were evaluated using adjusted proportional hazard regression. At baseline (n = 2700) and follow-up (n = 2027), median concentrations for leptin, adiponectin and resistin were 4.6 and 2.7 ng/ml, 24.4 and 30.0 mg/l, 15.4 and 26.2 ng/ml, respectively. After adjustment, there was no evidence for associations between adipokines and any outcome overall. In ERPR negative tumors, highest vs. lowest quintile of adiponectin was significantly associated with increased breast cancer specific mortality (HR 2.51, 95%CI 1.07-5.92). Overall, post-diagnosis adipokines were not associated with long-term outcomes after breast cancer. In patients with ERPR negative tumors, higher concentrations of adiponectin may be associated with increased breast cancer specific mortality and warrant further investigation.

The taxonomy of two uncultivated fungal mammalian pathogens is revealed through phylogeny and population genetic analyses.

Ever since the uncultivated South American fungal pathogen Lacazia loboi was first described 90 years ago, its etiology and evolutionary traits have been at the center of endless controversies. This pathogen infects the skin of humans and as long believed, dolphin skin. However, recent DNA analyses of infected dolphins placed its DNA sequences within Paracoccidioides species. This came as a surprise and suggested the human and dolphin pathogens may be different species. In this study, population genetic analyses of DNA from four infected dolphins grouped this pathogen in a monophyletic cluster sister to P. americana and to the other Paracoccidioides species. Based on the results we have emended the taxonomy of the dolphin pathogen as Paracoccidioides cetii and P. loboi the one infecting human. Our data warn that phylogenetic analysis of available taxa without the inclusion of unusual members may provide incomplete information for the accurate classification of anomalous species.

Genetic Variation and Cardiovascular Risk Factors: A Cohort Study on Migrants from the Former Soviet Union and a Native German Population.

Resettlers are a large migrant group of more than 2 million people in Germany who migrated mainly from the former Soviet Union to Germany after 1989. We sought to compare the distribution of the major risk factors for cardiovascular disease (CVD) and to investigate the overall genetic differences in a study population which consisted of resettlers and native (autochthone) Germans. This was a joint analysis of two cohort studies which were performed in the region of Augsburg, Bavaria, Germany, with 3363 native Germans and 363 resettlers. Data from questionnaires and physical examinations were used to compare the risk factors for cardiovascular diseases between the resettlers and native Germans. A population-based genome-wide association analysis was performed in order to identify the genetic differences between the two groups. The distribution of the major risk factors for CVD differed between the two groups. The resettlers lead a less active lifestyle. While female resettlers smoked less than their German counterparts, the men showed similar smoking behavior. SNPs from three genes (BTNL2, DGKB, TGFBR3) indicated a difference in the two populations. In other studies, these genes have been shown to be associated with CVD, rheumatoid arthritis and osteoporosis, respectively.

Quantification of Brucella abortus population structure in a natural host.

Cattle are natural hosts of the intracellular pathogen Brucella abortus, which inflicts a significant burden on the health and reproduction of these important livestock. The primary routes of infection in field settings have been described, but it is not known how the bovine host shapes the structure of B. abortus populations during infection. We utilized a library of uniquely barcoded B. abortus strains to temporally and spatially quantify population structure during colonization of cattle through a natural route of infection. Introducing 108 bacteria from this barcoded library to the conjunctival mucosa resulted in expected levels of local lymph node colonization at a 1-wk time point. We leveraged variance in strain abundance in the library to demonstrate that only 1 in 10,000 brucellae introduced at the site of infection reached a parotid lymph node. Thus, cattle restrict the overwhelming majority of B. abortus introduced via the ocular conjunctiva at this dose. Individual strains were spatially restricted within the host tissue, and the total B. abortus census was dominated by a small number of distinct strains in each lymph node. These results define a bottleneck that B. abortus must traverse to colonize local lymph nodes from the conjunctival mucosa. The data further support a model in which a small number of spatially isolated granulomas founded by unique strains are present at 1 wk postinfection. These experiments demonstrate the power of barcoded transposon tools to quantify infection bottlenecks and to define pathogen population structure in host tissues.

Temporal patterns of hospital readmissions according to disease category for patients after elective colorectal surgery.

RATIONALE: The aim of this study was to identify temporal readmission patterns according to baseline disease categories to provide opportunities for targeted interventions. METHODS: Retrospective analysis of consecutive adult (≥18 years) patients who underwent elective colorectal resections (2011-2017) at Mayo Clinic Rochester, MN. A prospective administrative database including patient demographics, procedure characteristics, discharge information and specifics on 30-day readmissions (to index facility) including timing and reasons was utilized. The ICD-9 codes were regrouped into the main pathologies Cancer, Crohn's disease (CD)/chronic ulcerative colitis (CUC), and diverticular disease. RESULTS: In total, 521 (7.2%) out of 7245 patients undergoing inpatient colorectal surgery were readmitted. In all increments of time from discharge (0-2 days: 31.3% of all readmissions, 3-7 days: 32.4% of all readmissions, 8-14 days: 18% of all readmissions, and 15-30 days: 18.3% of all readmissions), reasons for readmission differed significantly (all P < 0.001). Across all disease categories, early readmissions (within 2 days of discharge) were most likely due to ileus/obstruction (53.4% of early readmissions), whereas with 42.5%, infection was the most common cause for late readmissions (>7 days). Patients with home discharge were more likely to be readmitted earlier within the 30-day observation period (P = 0.099), whereas patients with a longer length of index hospital stay (>7 days) were readmitted later (P = 0.080). CONCLUSIONS: Reasons for readmission appear to be universal across different disease categories. Targeted educational and collaborative measures may help to mitigate the burden of hospital readmissions to index facilities.

Prognostic associations of circulating phytoestrogens and biomarker changes in long-term survivors of postmenopausal breast cancer.

Lignans are associated with improved postmenopausal breast cancer (BC) survival, but whether these associations, particularly with enterolactone (major lignan metabolite), persist over time is unclear. Little is known about other phytoestrogens on prognosis in long-term survivors. The study examines associations of prognosis with 1) circulating postdiagnosis enterolactone, 2) eight circulating phytoestrogen metabolites, and 3) changes in enterolactone and genistein. In a German cohort of 2,105 postmenopausal BC patients with blood samples collected at recruitment 2002-2005 (baseline) and re-interview in 2009 (follow-up), delay-entry Cox proportional hazards regression was used. Landmark analysis showed that circulating enterolactone (log2) associations with 5-year survival changed over time, with strongest hazard ratios of 0.89 (95% CI, 0.80-0.99) at blood draw (BD) and 0.86 (0.77-0.97) at 2 years post-BD for BC mortality, and 0.87 (0.80-0.95) at BD and 0.84 (0.76-0.92) at 3 years post-BD for all-cause mortality, which attenuated thereafter. In long-term survivors, increasing concentrations of genistein (1.17, 1.01-1.36), resveratrol (1.19, 1.02-1.40), and luteolin (1.96, 1.07-3.58) measured in follow-up blood samples were associated with poorer subsequent prognosis. Neither enterolactone at follow-up nor changes in enterolactone/genistein were associated with prognosis. Large long-term longitudinal studies with multiple phytoestrogen measurements are required to understand long-term effects of phytoestrogens after BC.

The effects of tranexamic acid on blood loss and transfusion rate in colorectal surgery.

BACKGROUND: The present study aimed to evaluate safety of tranexamic acid (TA) administration and to assess bleeding risk in colorectal surgery (CRS). METHODS: Retrospective cohort study including consecutive patients undergoing elective CRS by a single surgeon between August 2014 and May 2015. All patients received 1 g of TA intravenously at induction and at closure. Demographics, operative and postoperative details were prospectively assessed and compared to a historical control cohort. RESULTS: 213 patients were evaluated. TA did not increase complications, readmissions, or reoperation rates. Significant postoperative hemoglobin (Hgb) drop (≥3 g/dL) (TA: n = 6, 7.4%, Control: n = 22, 16.6%; p = 0.193) and transfusion rates (intraoperative: TA: n = 2, 2.5%, Control: n = 2, 1.5%; p = 0.586, postoperative: TA: n = 1, 1.2%, Control: 9, 6.8%; p = 0.065) were not statistically different. CONCLUSIONS: Postoperative hemoglobin drop and transfusion rates were not decreased statistically. Further study is warranted given the large clinical differences in favor of TA.

Predictors of 2010-2011 Michigan Medicaid Beneficiary Adverse E-Code Health Care Encounters.

To inform Medicaid medication management and public health policymaking, the authors analyzed the major predictive factors influencing program-approved therapeutic use or poisoning E-coded encounters leading to emergency department visits and hospital admission for the totality of Michigan Medicaid beneficiaries during a 12-month 2010-2011 period. The analytic cohort was composed of 26,134 approved E-code encounters submitted for 19,865 discrete Michigan Medicaid beneficiaries.More than 1% of all beneficiaries experienced at least one adverse medication/agent-related E-code encounter during the period. More such encounters and costlier approved encounters were recorded female subjects, African Americans, dually eligible adults, urban elderly, those with fee-for-service Medicaid coverage, and those residing in urban-density counties.Especially notably for patient safety policymakers, more than 9% of total E-coded encounters for children and adults were primarily attributed by providers to likely preventable poisoning causes such as exposure to household cleaning agents/gases, cosmetic products, illicit drug/alcohol, or secondary tobacco smoke. Encounter costs for the total sample totaled $37 million but ranged considerably up to more than a quarter million dollars.In view of the future expanding Medicaid-covered beneficiary cohorts, the authors propose several key patient safety/public health policy implications for researchers and policymakers striving to serve lower-income health care consumer groups.

Post-Discharge Opioid Prescribing Patterns and Risk Factors in Patients Undergoing Elective Colon and Rectal Surgery Without Complications.

BACKGROUND: Few studies have examined opioid usage in the post-discharge period. The primary aim of this study was to evaluate the need for post-discharge opioids in a unique set of patients: those undergoing colorectal operations and experiencing no surgical complications. The secondary aim was to examine the accuracy of the Opioid Risk Tool (ORT) to predict the need for additional opioid prescriptions. Our hypotheses were that few patients would require post-discharge opioids and that the ORT would predict patients requiring post-discharge opioids. METHODS: All patients undergoing elective colorectal surgery between January 2012 and December 2014 that did not experience NSQIP complications within 30 days or receive an opioid prescription in the 2 weeks prior to operation were reviewed. ORT score was calculated for all patients. Patients requiring post-discharge opioids within 1 year were compared to those not receiving additional opioids after discharge. RESULTS: There were 367 patients that met inclusion criteria and 56 (15%) received post-discharge opioids. Opioid use in the year prior to surgery was the only significant risk factor to receive post-discharge opioids. Opioids were prescribed for three distinct reasons by three groups of prescribers. The ORT did not accurately predict need for post-discharge opioids. CONCLUSIONS: Even among patients without complications, 15% received post-discharge opioid prescriptions. Previous opioid use within the year prior to surgery was a major risk factor for additional prescriptions. The timing and prescriber's specialty are impacted by the indication for post-discharge opioids. The ORT did not predict which patients would receive post-discharge opioids.

Post-surgical opioid prescribing patterns and risk factors for additional opioid prescriptions within one year after non-emergent colorectal surgery.

BACKGROUND: National opioid concerns resulted in review of prescribing patterns following colorectal surgery. METHODS: This retrospective cohort study examined prescribing patterns in elective colorectal surgery at a tertiary academic medical center from January 2012 through December 2014. RESULTS: Forty percent of 4286 patients received additional opioid prescriptions within the year following colorectal surgery. Multivariable analysis demonstrated that a pre-operative opioid prescriptions within 1 year of surgery (OR 2.91; 95% CI, 1.83-4.60), increasing operative time (OR 1.02; 95% CI, 1.00-1.04), or complications (OR 2.18; 95% CI, 1.38-3.43) was associated with additional opioid prescriptions. The median opioid prescription upon discharge was 225 mg morphine milligram equivalents. Discharge opioid amount was not a risk factor. CONCLUSIONS: Additional opioid prescriptions after surgery occurred in 40% of patients. Pre-operative prescriptions, increasing operative time and complications were associated with additional opioid prescriptions while opioid amount at discharge was not a risk factor.

Efficacy and Outcomes of Intrathecal Analgesia as Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients.

PURPOSE: Multimodal analgesia is an essential component of an enhanced recovery pathway (ERP). An ERP that includes the use of single-injection intrathecal analgesia (IA) has been shown to decrease morbidity and cost and shorten length of stay (LOS). Limited data exist on safety, feasibility, and the optimal IA regimen. Our objective was to characterize the efficacy, safety, and feasibility of IA within an ERP in a cohort of colorectal surgical patients. METHODS: We performed a retrospective review of all consecutive patients aged ≥ 18 years who underwent open or minimally invasive colorectal surgery from October 2012 to December 2013. All patients were enrolled in an institutional ERP that included the use of single-injection IA. Demographics, anesthetic management, efficacy (pain scores and opiate consumption), postoperative ileus (POI), adverse effects, and LOS are reported. RESULTS: 601 patients were identified. The majority received opioid-only IA (91%) rather than a multimodal regimen. Median LOS was 3 days. Overall rate of ileus was 16%. Median pain scores at 4, 8, 16, 24, and 48 hours were 3, 2, 3, 4, and 3, respectively. There was no difference in postoperative pain scores, LOS, or POI based on intrathecal medication or dose received. Overall, development of respiratory depression (0.2%) or pruritus (1.2%) was rare. One patient required blood patch for postdural headache. CONCLUSION: Intrathecal analgesia is safe, feasible, and efficacious in the setting of ERP for colorectal surgery. All regimens and doses achieved a short LOS, low pain scores, and a low incidence of POI. This trial is registered with Clinicaltrails.gov NCT03411109.

Leveraging electronic health records for predictive modeling of post-surgical complications.

Hospital-specific electronic health record systems are used to inform clinical practice about best practices and quality improvements. Many surgical centers have developed deterministic clinical decision rules to discover adverse events (e.g. postoperative complications) using electronic health record data. However, these data provide opportunities to use probabilistic methods for early prediction of adverse health events, which may be more informative than deterministic algorithms. Electronic health record data from a set of 9598 colorectal surgery cases from 2010 to 2014 were used to predict the occurrence of selected complications including surgical site infection, ileus, and bleeding. Consistent with previous studies, we find a high rate of missing values for both covariates and complication information (4-90%). Several machine learning classification methods are trained on an 80% random sample of cases and tested on a remaining holdout set. Predictive performance varies by complication, although an area under the receiver operating characteristic curve as high as 0.86 on testing data was achieved for bleeding complications, and accuracy for all complications compares favorably to existing clinical decision rules. Our results confirm that electronic health records provide opportunities for improved risk prediction of surgical complications; however, consideration of data quality and consistency standards is an important step in predictive modeling with such data.

The MIDA Mortality Risk Score: development and external validation of a prognostic model for early and late death in degenerative mitral regurgitation.

Aims: In degenerative mitral regurgitation (DMR), lack of mortality scores predicting death favours misperception of individual patients' risk and inappropriate decision-making. Methods and results: The Mitral Regurgitation International Database (MIDA) registries include 3666 patients (age 66 ± 14 years; 70% males; follow-up 7.8 ± 5.0 years) with pure, isolated, DMR consecutively diagnosed by echocardiography at tertiary (European/North/South-American) centres. The MIDA Score was derived from the MIDA-Flail-Registry (2472 patients with DMR and flail leaflet-Derivation Cohort) by weighting all guideline-provided prognostic markers, and externally validated in the MIDA-BNP-Registry (1194 patients with DMR and flail leaflet/prolapse-Validation Cohort). The MIDA Score ranged from 0 to 12 depending on accumulating risk factors. In predicting total mortality post-diagnosis, the MIDA Score showed excellent concordance both in Derivation Cohort (c = 0.78) and Validation Cohort (c = 0.81). In the whole MIDA population (n = 3666 patients), 1-year mortality with Scores 0, 7-8, and 11-12 was 0.4, 17, and 48% under medical management and 1, 7, and 14% after surgery, respectively (P < 0.001). Five-year survival with Scores 0, 7-8, and 11-12 was 98 ± 1, 57 ± 4, and 21 ± 10% under medical management and 99 ± 1, 82 ± 2, and 57 ± 9% after surgery (P < 0.001). In models including all guideline-provided prognostic markers and the EuroScoreII, the MIDA Score provided incremental prognostic information (P ≤ 0.002). Conclusion: The MIDA Score may represent an innovative tool for DMR management, being able to position a given patient within a continuous spectrum of short- and long-term mortality risk, either under medical or surgical management. This innovative prognostic indicator may provide a specific framework for future clinical trials aiming to compare new technologies for DMR treatment in homogeneous risk categories of patients.

The role of neoadjuvant radiotherapy for locally-advanced rectal cancer with resectable synchronous metastasis.

BACKGROUND: Although neoadjuvant radiotherapy is typically administered for locally-advanced rectal cancer to reduce local recurrence (LR), its role for patients who present with synchronous resectable liver and/or lung metastasis is not well defined. The aim of this study was to evaluate the role of neoadjuvant radiotherapy for patients with stage IV rectal cancer undergoing curative-intent surgery. METHODS: This study is a retrospective review of a prospectively maintained surgical registry of all consecutive adult patients who underwent curative-intent resection at Mayo Clinic in Rochester, MN, from January 1990 until December 2014 with a median follow-up time of 43 (IQR 16-67) months. Eligible patients had locally-advanced rectal cancer (T3, T4 and/or nodal involvement) with synchronous resectable liver and/or lung metastasis. Exclusion criteria were as follows: patients with primary tumor stage of T1N0 or T2N0, patients with metastasis to organs other than the liver or lung, patients who had palliative resection, patients who had non-surgical treatment of synchronous metastasis (e.g., radiofrequency ablation), patients who received postoperative radiotherapy, or absence of research authorization. Ninety three patients were included of which 47 received neoadjuvant radiotherapy and 46 did not. All patients received neoadjuvant chemotherapy +/- radiotherapy followed by curative-intent surgery with metastasectomy performed either simultaneously with resection of the primary tumor or as a planned staged resection. The primary outcomes of this study are LR, distant metastasis, overall and disease-specific survival (DSS). RESULTS: LR was observed in 12 patients (26%) who did not receive radiotherapy, while no LR developed in those who received neoadjuvant radiotherapy, P<0.001. Univariate analysis showed that neither age, sex, ASA class, BMI, tumor location, procedure performed, or neoadjuvant chemotherapy were associated with subsequent LR. The 5-year overall survival (OS) rates were: 43.3% (95% CI: 30.1, 62.3) for no radiotherapy vs. 58.3% (95% CI: 43.4, 78.2) with radiotherapy. CONCLUSIONS: Neoadjuvant radiotherapy should be considered in patients with locally-advanced stage IV rectal cancer. These data add to the evidence supporting neoadjuvant radiotherapy in the setting of resectable metastatic disease.