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Objectives: To describe the epidemiology of complex colon surgical procedures (COLO), stratified by present at time of surgery (PATOS) surgical-site infections (SSIs) and non-PATOS SSIs and their impact on the epidemiology of colon-surgery SSIs. Design: Retrospective cohort study. Methods: SSI data were prospectively collected from patients undergoing colon surgical procedures (COLOs) as defined by the National Healthcare Safety Network (NHSN) at 34 community hospitals in the southeastern United States from January 2015 to June 2019. Logistic regression models identified specific characteristics of complex COLO SSIs, complex non-PATOS COLO SSIs, and complex PATOS COLO SSIs. Results: Over the 4.5-year study period, we identified 720 complex COLO SSIs following 28,188 COLO surgeries (prevalence rate, 2.55 per 100 procedures). Overall, 544 complex COLO SSIs (76%) were complex non-PATOS COLO SSIs (prevalence rate [PR], 1.93 per 100 procedures) and 176 (24%) complex PATOS COLO SSIs (PR, 0.62 per 100 procedures). Age >75 years and operation duration in the >75th percentile were independently associated with non-PATOS SSIs but not PATOS SSIs. Conversely, emergency surgery and hospital volume for COLO procedures were independently associated with PATOS SSIs but not non-PATOS SSIs. The proportion of polymicrobial SSIs was significantly higher for non-PATOS SSIs compared with PATOS SSIs. Conclusions: Complex PATOS COLO SSIs have distinct features from complex non-PATOS COLO SSIs. Removal of PATOS COLO SSIs from public reporting allows more accurate comparisons among hospitals that perform different case mixes of colon surgeries.

Background Despite a burgeoning literature during the last two decades regarding perioperative risk management of anal fistula, little is known about its risk factors that influence postoperative recurrence. We performed a meta-analysis to summarize and assess the credibility of evidence of potential risk factors for anal fistula recurrence (AFR) after surgery. Methods Pubmed and EMBASE without language restriction were searched from inception to April 2018 that reported risk factors which predisposed recurrence after anal fistula surgery. We excluded studies that involved patients with anal fistula associated with Crohn's disease. MOOSE guidelines were followed when this meta-analysis was performed. We used random-effects models to pool relative risks (RRs) with 95% confidence intervals (CIs). Evidence from observational studies was graded into high-quality (Class I), moderate-quality (Class II/III) and low-quality (Class IV) based on Egger's P value, total sample size and between-study heterogeneity. Results Of 3514 citations screened, 20 unique observational studies comprising 6168 patients were involved in data synthesis. High-quality evidence showed that AFR was associated with high transsphincteric fistula (RR, 4.77; 95% CI, 3.83 to 5.95), internal opening unidentified (RR, 8.54; 95% CI, 5.29 to 13.80), and horseshoe extensions (RR, 1.92; 95% CI, 1.43 to 2.59). Moderate-quality evidence suggested an association with prior anal surgery (RR, 1.52; 95% CI, 1.04 to 2.23), seton placement surgery (RR, 2.97; 95% CI, 1.10 to 8.06), and multiple fistula tract (RR, 4.77; 95% CI, 1.46 to 15.51). High-quality evidence demonstrated no significant association with gender or smoking; moderate-quality evidence also suggested no association with age, tertiary referral, alcohol use, diabetes mellitus, obesity, preoperative seton drainage, high internal opening, postoperative drainage, mucosal advancement flap surgery, supralevator extensions, location or type of anal fistula. Conclusion Several patient, surgery and fistula-related factors are significantly associated with postoperative AFR. These findings strengthen clinical awareness of early warning to identify patients with high-risk disease recurrence for AFR.

Introduction A high prevalence of cryptoglandular and Crohn’s perianal fistulas has been reported worldwide, and several surgical options are available for the management of anal fistula, with varying clinical efficacy. However, currently, the available evidence for the effectiveness of these surgical approaches are lacking and of concern in terms of the credibility and strength. The purpose of this study is to evaluate the credibility of the published systematic reviews and meta-analyses that assess the efficacy and safety of the surgical options for cryptoglandular and Crohn’s perianal fistulas through an umbrella review. Methods and analysis A systematic search in PubMed, Embase and Cochrane library will be performed from inception to December 2020 without any language restriction. We will include systematic reviews and meta-analyses that investigate the efficacy and safety of surgical approaches in the management of cryptoglandular and Crohn’s perianal fistulas. Two reviewers will independently screen search results through reading the titles or abstracts. Relevant information will be extracted from each eligible systematic review or meta-analysis. Based on random effects model summary estimates along with their p values, 95% prediction intervals, between-study heterogeneity, small-study effects and excess significance, we will classify the evidence from convincing (class I) to weak (class IV). Findings will be summarized using quantitative synthesis combined with a narrative approach. Cryptoglandular and Crohn’s perianal fistulas will be summarized separately. Two authors will independently perform the literature search, data extraction, and quality assessment of each included systematic review and meta-analysis. Any unresolved conflicts or doubts will be resolved by discussion or by consulting a senior author. The risk of bias of the systematic reviews will be assessed using a 16-item Assessment of Multiple Systematic Reviews 2 (AMSTAR2) checklist. The strength of evidence for the included systematic reviews will be classified as "high", "moderate", "low", or "critically low" quality. Ethics and dissemination Ethics approval is not required as we will collect data from the published systematic reviews and meta-analyses without using individual patient data. The results of this umbrella review will be published in a peer-reviewed journal and will be presented at an anorectal disease conference. PROSPERO registration number CRD42020200754.

IntroductionPostoperative recurrence and related complications are common and related to poor outcomes in patients with anal fistula (AF). Due to being associated with short-term and long-term cure rates, perioperative complications have received widespread attention following AF surgery. This study aims to identify a set of predictive factors to develop risk prediction models for recurrence and related complications following AF surgery. We plan to develop and validate risk prediction models, using information collected through a WeChat patient-reported questionnaire system combined with clinical, laboratory and imaging findings from the perioperative period until 3–6 months following AF surgery.Methods and analysisThis is a prospective hospital-based cohort study using a linked database of collected health data as well as the follow-up outcomes for all adult patients who suffered from AF at a tertiary referral hospital in Shanghai, China. We will perform logistic regression models to predict anal fistula recurrence (AFR) as well as related complications (eg, wound haemorrhage, faecal impaction, urinary retention, delayed wound healing and unplanned hospitalisation) during and after AF surgery, and machine learning approaches will also be applied to develop risk prediction models. This prospective study aims to develop the first risk prediction models for AFR and related complications using multidimensional variables. These tools can be used to warn, motivate and empower patients to avoid some modifiable risk factors to prevent postoperative complications early. This study will also provide alternative tools for the early screening of high-risk patients with AFR and related complications, helping surgeons better understand the aetiology and outcomes of AF in an earlier stage.Ethics and disseminationThe study was approved by the Institutional Review Board of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (approval number: 2019-699-54-01). The results of this study will be submitted to international scientific peer-reviewed journals or conferences in surgery, anorectal surgery or anorectal diseases.Trial registration numberChiCTR1900025069; Pre-results.

Background Despite the emerging knowledge about postoperative anal fistula recurrence (AFR) and the increasing number of clinical studies, there is no better understanding or consensus regarding the risk factors for AFR. The aim of this study was to generate international consensus guidance statements focusing on AFR. Methods A two-round modified Delphi process was conducted among international surgical specialists via an online survey delivered by email with a secure link created with Google Forms. Surgeons were asked to use a 9-point Likert scale to rate the importance of patient-, fistula-, and surgery-related statements developed based on our previous systematic review. Consensus was reached when at least 70% of panel members rated a statement as being of critical importance (ratings of 7–9). Results Of a total of 60 experts invited, 38 experts representing 13 countries from four continents agreed to participate in the first round of the Delphi process and 31 in the second round. In total, consensus was reached on 14 statements on the risk factors for AFR in three domains: patient-related risk factors included comorbid colitis, inflammatory bowel disease and use of immunosuppressants; fistula-related factors included transsphincteric fistula, number of fistula, horseshoe extension, undetected internal opening, location of anal fistula, recurrent fistula, suprasphincteric fistula, and height of the internal opening; and surgery-related factors included type of surgery, previous fistula surgery and surgeon. Conclusion This Delphi study provides an evidence-based profile of risk factors for AFR in the patient-, surgery- and fistula-related domains from a global perspective. Clinically, these indicators can be incorporated to develop risk calculation tools for the early detection of AFR in high-risk patients, allowing early prevention and intervention.

Background Colon surgeries are commonly performed, and surgical site infections (SSIs) following these procedures are routinely reported to the National Healthcare Safety Network (NHSN). However, the impact of infections present at the time of surgery (PATOS) and emergent surgeries on the epidemiology of colon surgery SSIs has not been well described. Methods We retrospectively analyzed prospectively collected data on complex (i.e., deep incisional or organ space) SSIs following colon surgery performed at 34 community hospitals in the southeastern United States from January 2015 to June 2019. We excluded SSIs categorized as PATOS. We then stratified colon surgery SSI rates according to age, sex, body mass index (BMI), operation duration, diabetes diagnosis, American Society of Anesthesiologists (ASA) physical status, wound class, emergent procedure, endoscopic procedure, and hospital colon surgery volume. Finally, we explored effect measure modification of emergent surgery and open surgery on hospital volume using log-binomial modeling and tests of homogeneity. Results A total of 722 complex SSIs occurred following 28,642 colon surgeries (prevalence rate [PR], 2.52 per 100 procedures). After PATOS SSIs were excluded, 545 complex SSIs remained (PR 1.90 per 100 procedures). Risk factor analysis revealed that age < 75 years and operation time > 75th percentile (188 minutes) during the 5-year study period) significantly increased risk of SSI (Table 1). The most common pathogens that caused SSIs in this study cohort were Escherichia coli, Enterococcus, and Klebsiella. (Table 2) 105 (19%) SSIs were culture-negative and 378 (69%) of the SSIs were polymicrobial. We defined hospital volume as high (>500 procedures in the 5-year period) based on the median hospital volume in the dataset. No significant effect measure modification occurred between hospital volume and either laparoscopic surgery or emergent surgery (Table 3). Table 1: Characteristics of patients who underwent colon surgery from January 2015 to June 2018 in 34 community hospitals. Table 2: Count and frequency of pathogens that caused complex surgical site infections after colon surgery Table 3: Colon surgery complex surgical site infection rates, stratified by emergent, elective, open, and laparoscopic procedures and hospital colon surgery volume Conclusion In our cohort, we found that one-fourth of colon surgery SSIs were categorized as PATOS, which are no longer publicly reported to the Centers for Medicare & Medicaid Services. While most SSI literature describes higher volume hospitals having lower SSI rates, high colon surgery volume was associated with increased SSI rates in our community hospital cohort. Disclosures All Authors: No reported disclosures

Supplemental material, OPP880604 Supplemetal Material for A simple method to identify undiagnosed drug-induced liver injury (DILI) and its application in oncology pharmacy practice by Haini Wen, Maojun Ge, Di Yao and Li Liu in Journal of Oncology Pharmacy Practice