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BackgroundIntraoperative ureteral injury, a serious complication of abdominopelvic surgeries, can be avoided through ureter visualization. Near-infrared fluorescence imaging offers real-time anatomical visualization of ureters during surgery. Pudexacianinium (ASP5354) chloride is an indocyanine green derivative under investigation for intraoperative ureter visualization during colorectal or gynecologic surgery in adult and pediatric patients.MethodsIn this phase 2 study (NCT04238481), adults undergoing laparoscopic colorectal surgery were randomized to receive one intravenous dose of pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg. The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30 min after pudexacianinium administration and at end of surgery. Safety and pharmacokinetics were also assessed.ResultsParticipants received pudexacianinium 0.3 mg (n = 3), 1.0 mg (n = 6), or 3.0 mg (n = 3). Most participants were female (n = 10; 83.3%); median age was 54 years (range 24–69) and median BMI was 29.3 kg/m2 (range 18.7–38.1). Successful intraoperative ureter visualization occurred in 2/3, 5/6, and 3/3 participants who received pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg, respectively. Median intensity values per surgeon assessment were 1 (mild) with the 0.3-mg dose, 2 (moderate) with the 1.0-mg dose, and 3 (strong) with the 3.0-mg dose. A correlation was observed between qualitative (surgeon’s recognition/identification of the ureter during surgery) and quantitative (video recordings of the surgeries after study completion) assessment of fluorescence intensity. Two participants experienced serious adverse events, none of which were drug-related toxicities. One adverse event (grade 1 proteinuria) was related to pudexacianinium. Plasma pudexacianinium concentrations were dose-dependent and the mean (± SD) percent excreted into urine during surgery was 22.3% ± 8.0% (0.3-mg dose), 15.6% ± 10.0% (1.0-mg dose), and 39.5% ± 12.4% (3.0-mg dose).ConclusionsIn this study, 1.0 and 3.0 mg pudexacianinium provided ureteral visualization for the duration of minimally invasive, laparoscopic colorectal procedures and was safe and well tolerated.

The impact and efficacy of the World Health Organization Surgery Safety Checklist (SSC) is uncertain. We sought to determine if the SSC decreases complications and examined the attitudes of the surgical team members following implementation of the SSC. A 28-question survey was developed to assess perspectives of surgical team members at the University of Vermont Medical Center (UVMC). The University Health System Consortium database was examined to compare the rates of nine complications before and after SSC implementation using Chi square analysis and Fisher's exact test. There was no significant decrease in any of the nine complications 2 years after SSC implementation. There was overall agreement that the SSC improved communication, safety, and prevented errors in the operating room. However, there was disagreement between nursing and surgeons over whether all three parts of the SSC were always completed. Implementation of the SSC did not result in a significant decrease in perioperative morbidity or mortality. However, it did improve the perception of safety culture by operating room staff.

Background There is substantial variation in the surgical complexity of hepatectomy. Currently, the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) risk adjusts for hospital quality comparisons using only the primary procedure code. Our objectives were to (1) assess the association between secondary procedures and complications; (2) assess model performance with inclusion of surgical complexity adjustment; and (3) examine whether secondary procedures affect hospital quality rankings. Methods Using ACS NSQIP (2007–2012), patients undergoing hepatectomy were identified. Secondary procedure codes and total work relative value units (RVUs) were used to approximate procedural complexity. The effect of procedural complexity variables on outcomes and hospital quality rankings were examined using hierarchical models. Results Among 11,826 patients who underwent hepatectomy at 261 hospitals, 32.8 % underwent at least one secondary procedure. Serious morbidity occurred in 18.0 % of patients. Seven of nine secondary procedures were significantly associated with death or serious morbidity on multivariable analysis. Model performance improved when secondary procedure categories were included, and secondary procedure categories outperformed total RVUs. The C-statistic for death or serious morbidity was 0.689 in the standard NSQIP model, 0.703 when total RVU was included, and 0.718 when secondary procedure categories were included. Of the 26 hospitals that were poor performers for death or serious morbidity using the standard ACS NSQIP model, three became average performers when secondary procedure categories were included in the model. Conclusions Secondary procedures are associated with an increased risk of postoperative complications. Inclusion of secondary procedure code categories in research and risk prediction models should be considered for hepatectomy.

Background: Interest in comparing hospital surgical quality continues to increase, particularly with respect to examining certain hospital designations such as National Cancer Institute-designated Cancer Centers (NCI-CC). Our objectives were to compare patients, surgical complexity, and risk-adjusted 30-day outcomes following major cancer surgery at NCI-CC versus non-NCI centers. Methods: From the American College of Surgeons National Surgical Quality Improvement Program, patients were identified who underwent colorectal, pancreatic, or esophagogastric resection for cancer (2007—2011). Regression methods were used to evaluate characteristics associated with undergoing treatment at NCI-CCs and surgical-complexity—adjusted 30-day morbidity, mortality, and prolonged length-of-stay at NCI-CC versus non-NCI centers. Results: NCI-CCs performed 20.2% of colorectal (10,555/52,265), 53.5% of pancreatic (6335/11,838), and 49.8% of esophagogastric (1596/3208) operations for cancer. NCI-CCs were more likely to treat patients who were younger, white, and with fewer comorbidities, but were more likely to perform more complex procedures including synchronous liver resection (eg, colorectal), adjacent organ resections (rectal cancer), and vascular reconstructions (eg, pancreas) (all P<0.05). NCI-CCs had a lower mortality rate for colorectal surgery only (1.2% vs. 1.9%) and increased rates of superficial surgical site infection (SSI) for colorectal (9.8% vs. 7.1%) and pancreatic (10.7% vs. 8.8%) surgery. No differences existed for the remaining complications by NCI-CC designation status. NCI-CCs were distributed throughout hospital quality rankings for all procedures and complications assessed. Conclusions: NCI-CCs treated younger, healthier patients, but performed more complex procedures. Patients treated at NCI-CCs had a lower risk of mortality for colorectal resection, but morbidity was similar to non-NCI centers. Comparison of cancer surgery hospital quality is feasible and should adjust for differences in patient demographics, comorbidities, and surgical complexity.

The tumor suppressor protein p53 remains in a wild type but inactive form in ~50% of all human cancers. Thus, activating it becomes an attractive approach for targeted cancer therapies. In this regard, our lab has previously discovered a small molecule, Inauhzin (INZ), as a potent p53 activator with no genotoxicity. To improve its efficacy and bioavailability, here we employed nanoparticle encapsulation, making INZ-C, an analog of INZ, to nanoparticle-encapsulated INZ-C (n-INZ-C). This approach significantly improved p53 activation and inhibition of lung and colorectal cancer cell growth by n-INZ-C and while it displayed a minimal effect on normal human Wi38 and mouse MEF cells. The improved activity was further corroborated with the enhanced cellular uptake observed in cancer cells and minimal cellular uptake observed in normal cells. pharmacokinetic evaluation of these nanoparticles showed that the nanoparticle encapsulation prolongates the half-life of INZ-C from 2.5 h to 5 h in mice. These results demonstrate that we have established a nanoparticle system that could enhance the bioavailability and efficacy of INZ-C as a potential anti-cancer therapeutic.

Background No real-time postoperative risk stratification model exists to predict complications following surgery. The aim of this work is to understand if we can successfully risk stratify patients across three distinct surgeries using group-based trajectory modeling (GBTM) with only a single variable, temperature. Methods We performed a retrospective study of adults undergoing elective total knee arthroplasty (TKA), total hip arthroplasty (THA), colectomy, and pancreatectomy at an academic medical center from October 2014 to February 2018. Clinical data were abstracted using definitions from the National Surgical Quality Improvement Program (NSQIP) and temperature data were extracted from the Database Warehouse. GBTM was used to identify distinct clusters of patients with similar temperature trajectories. We calculated rates of complications and combined all NSQIP infectious and inflammatory complications into a single metric hence forth labeled inflammatory complications. Chi-square test was used to compare categorical variables. Results We identified 815 independent surgical patients: 307 TKA/THA, 195 pancreatectomy, and 313 colectomy patients. Rates of all NSQIP complications were 1.6% for TKA/THA, 35.4% for pancreatectomy and 10.2% for colectomy at 30 days after surgery. Pancreatectomy patients clustered into two temperature trajectories and both TKA/THA and colectomy patients (Figure 1) clustered into three groups. Inflammatory complication frequencies were significantly different in colectomy and trended toward significance for TKA/THA and pancreatectomy (Table 1). Table 1: Rates of Inflammatory Complications by Temperature Trajectory Low risk (n) Medium Risk (n) High Risk (n) P-value Colectomy 9.3% (150) 7.1% (140) 26.1% (23) 0.02 Pancreatectomy 27.1% (118) 41.6% (77) 0.05 TKA/THA 0.52% (194) 2.0% (99) 7.1% (14) 0.08 Conclusion Temperature trajectory modeling may help identify postoperative patients at higher risk for surgical complication after surgery. While risk stratification seems to work better in high complication surgeries or models with more patients, the promise of this modeling technique relies on the ability to identify high-risk patients with a single variable. Disclosures All authors: No reported disclosures.

Background Changes in vital signs are frequently the first sign to point to pathology in the postoperative setting. There is no prediction model that exists that evaluates risk of postoperative complication in real-time. We are interested in understanding if we are able to risk stratify patients after surgery using novel predictors, trajectories of the various vital signs and evaluating their ability to risk stratify patients. Methods We reviewed patients who underwent pancreatectomy at an academic health system from January 2015 to February 2018. Postoperative complications were abstracted using definitions set by the National Surgical Quality Improvement Program (NSQIP) and vital signs, including pain score, were extracted from the Data Warehouse. Group-based trajectory modeling, a technique used to identify distinct clusters of patients with similar trajectories, was used to group patients with similar temperature, heart rate, blood pressure and pain scores. Postoperative complications were tabulated for each risk group and chi-square test was used to compare categorical variables. Results A total of 195 patients with pancreatectomy were evaluated and the rate of NSQIP complications was 35.4%. Pancreatectomy patients clustered into two distinct clusters for temperature, heart rate, systolic blood pressure and pain score. All four of these vital signs were able to stratify infectious and inflammatory complications between low- and high-risk groups but only systolic blood pressure was significant in stratifying readmission risk and heart rate and pain score for stratifying sepsis risk (Table 1). Conclusion Trends of vital signs may be important predictors of complications. Some vital signs may be better at predicting distinct complications. More work is required to understand if different covariates within trajectory analysis can be combined to further enhance risk stratification for any and specific postoperative complications. Table 1: Rates of Complications by Trajectory Analysis Sepsis % Any Complication % Readmission % Temperature high 6.1 27.0* 14.8 Temperature low 6.8 41.9* 16.2 HR high 2.8* 25.7* 13.8 HR low 11.3* 42.5* 17.5 SBP high 6.9 23.0* 9.2* SBP low 5.9 41.2* 20.6* Pain score high 3.5* 27.0* 15.7 Pain score low 10.8* 41.2* 14.9 * Significant at P < 0.05. Disclosures All authors: No reported disclosures.

Background Medical students are taught that wind, water and wound complications occur at specific post-operative times. This may influence the timing of work-up for specific complications. The goal of this study was to investigate the relationship between post-operative temperature curve and time to diagnosis of inflammatory complications. Methods We reviewed patients who underwent pancreatectomy at an academic health system from January 2015–February 2018. Clinical data including complications were extracted using definitions set by the National Surgical Quality Improvement Program and temperature was extracted from the Data Warehouse. Time of diagnosis, as determined by labs, microbiologic cultures, radiology and procedures, was extracted for each complication. Group-based trajectory modeling, a technique used to identify distinct clusters of temperature trajectories of patients in the postoperative setting was used to group patients into low- and high-temperature trajectories. Results Among 195 patients who underwent pancreatectomy, 35.5% (69/195) experienced at least one complication within 30 days of surgery. Of the patients who developed complications, 49% (n = 34) and 51% (n = 35) were classified into the low and high temperature trajectory groups based on their temperature trajectory. For most individual inflammatory complications, time to diagnosis was later in the low rather than high temperature groups (Figure 1) and this was significant when averaging all inflammatory complications (12.7d low and 8.6d high; P = 0.002). Time to diagnosis tended to be later in the high rather than low temperature trajectory but this was not statistically significant when averaging all non-inflammatory complications (11.7d low and 11.9d high; P = 0.95). Conclusion We identified earlier diagnosis of inflammatory complications in patients with elevated temperature trajectories. There was no difference in timing of diagnosis for non-inflammatory complications. Temperature trajectory modeling may allow for earlier diagnosis of patients at high risk for inflammatory complications. Disclosures All authors: No reported disclosures.