ERAS program adherence-institutionalization, major morbidity and anastomotic leakage after elective colorectal surgery: the iCral2 multicenter prospective study

Background Enhanced recovery after surgery (ERAS) programs influence morbidity rates and length of stay after colorectal surgery (CRS), and may also impact major complications and anastomotic leakage rates. A prospective multicenter observational study to investigate the interactions between ERAS program adherence and early outcomes after elective CRS was carried out. Methods Prospective enrolment of patients submitted to elective CRS with anastomosis in 18 months. Adherence to 21 items of ERAS program was measured upon explicit criteria in every case. After univariate analysis, independent predictors of primary endpoints [major morbidity (MM) and anastomotic leakage (AL) rates] were identified through logistic regression analyses including all significant variables, presenting odds ratios (OR). Results Institutional ERAS protocol was declared by 27 out of 38 (71.0%) participating centers. Median overall adherence to ERAS program items was 71.4%. Among 3830 patients included in the study, MM and AL rates were 4.7% and 4.2%, respectively. MM rates were independently influenced by intra- and/or postoperative blood transfusions (OR 7.79, 95% CI 5.46-11.10; p < 0.0001) and standard anesthesia protocol (OR 0.68, 95% CI 0.48-0.96; p = 0.028). AL rates were independently influenced by male gender (OR 1.48, 95% CI 1.06-2.07; p = 0.021), intra- and/or postoperative blood transfusions (OR 4.29, 95% CI 2.93-6.50; p < 0.0001) and non-standard resections (OR 1.49, 95% CI 1.01-2.22; p = 0.049). Conclusions This study disclosed wide room for improvement in compliance to several ERAS program items. It failed to detect any significant association between institutionalization and/or adherence rates to ERAS program with primary endpoints. These outcomes were independently influenced by gender, intra- and postoperative blood transfusions, non-standard resections, and standard anesthesia protocol

Endoscopic ultrasound-guided drainage of a fungal liver abscess using a lumen-apposing metal stent: case report and literature review

Abstract Liver abscesses are rare entities for which percutaneous drainage is traditionally employed. The technique is simple, but associated with a significant rate of side effects and patient discomfort. We herein report a case of fungal left liver lobe abscess that was successfully treated by using EUS-guided drainage, with insertion of a large caliber lumen-apposing metal stent. The literature review we performed on the topic seems to favor, at least for abscess in the left and/or caudate liver lobes, EUS as compared to percutaneous drainage

Blood Transfusions and Adverse Events after Colorectal Surgery: A Propensity-Score-Matched Analysis of a Hen-Egg Issue

Blood transfusions are considered a risk factor for adverse outcomes after colorectal surgery. However, it is still unclear if they are the cause (the hen) or the consequence (the egg) of adverse events. A prospective database of 4529 colorectal resections gathered over a 12-month period in 76 Italian surgical units (the iCral3 study), reporting patient-, disease-, and procedure-related variables, together with 60-day adverse events, was retrospectively analyzed identifying a subgroup of 304 cases (6.7%) that received intra- and/or postoperative blood transfusions (IPBTs). The endpoints considered were overall and major morbidity (OM and MM, respectively), anastomotic leakage (AL), and mortality (M) rates. After the exclusion of 336 patients who underwent neo-adjuvant treatments, 4193 (92.6%) cases were analyzed through a 1:1 propensity score matching model including 22 covariates. Two well-balanced groups of 275 patients each were obtained: group A, presence of IPBT, and group B, absence of IPBT. Group A vs. group B showed a significantly higher risk of overall morbidity (154 (56%) vs. 84 (31%) events; OR 3.07; 95%CI 2.13-4.43; p = 0.001), major morbidity (59 (21%) vs. 13 (4.7%) events; OR 6.06; 95%CI 3.17-11.6; p = 0.001), and anastomotic leakage (31 (11.3%) vs. 8 (2.9%) events; OR 4.72; 95%CI 2.09-10.66; p = 0.0002). No significant difference was recorded between the two groups concerning the risk of mortality. The original subpopulation of 304 patients that received IPBT was further analyzed considering three variables: appropriateness of BT according to liberal transfusion thresholds, BT following any hemorrhagic and/or major adverse event, and major adverse event following BT without any previous hemorrhagic adverse event. Inappropriate BT was administered in more than a quarter of cases, without any significant influence on any endpoint. The majority of BT was administered after a hemorrhagic or a major adverse event, with significantly higher rates of MM and AL. Finally, a major adverse event followed BT in a minority (4.3%) of cases, with significantly higher MM, AL, and M rates. In conclusion, although the majority of IPBT was administered with the consequence of hemorrhage and/or major adverse events (the egg), after adjustment accounting for 22 covariates, IPBT still resulted in a definite source of a higher risk of major morbidity and anastomotic leakage rates after colorectal surgery (the hen), calling urgent attention to the implementation of patient blood management programs

Procalcitonin Reveals Early Dehiscence in Colorectal Surgery: The PREDICS Study

Objectives: We designed a multicentric, observational study to test if Procalcitonin (PCT) might be an early and reliable marker of anastomotic leak (AL) after colorectal surgery (ClinicalTrials.govIdentifier:NCT01817647). Background: Procalcitonin is a biomarker used to monitor bacterial infections and guide antibiotic therapy. Anastomotic leak after colorectal surgery is a severe complication associated with relevant short and long-term sequelae. Methods: Between January 2013 and September 2014, 504 patients underwent colorectal surgery, for malignant colorectal diseases, in elective setting. White blood count (WBC), C-reactive protein (CRP) and PCT levels were measured in 3rd and 5th postoperative day (POD). AL and all postoperative complications were recorded. Results: We registered 28 (5.6%) anastomotic leaks. Specificity and negative predictive value for AL with PCT less than 2.7 and 2.3 ng/mL were, respectively, 91.7% and 96.9% in 3rd POD and 93% and 98.3% in 5th POD. Receiver operating characteristic curve for biomarkers shows that in 3rd POD, PCTand CRP have similar area under the curve (AUC) (0.775 vs 0.772), both better than WBC (0.601); in 5th POD, PCT has a better AUC than CRP and WBC (0.862 vs 0.806 vs 0.611). Measuring together PCT and CRP significantly improves AL diagnosis in 5th POD (AUC: 0.901). Conclusions: PCTand CRP demonstrated to have a good negative predictive value for AL, both in 3rd and in 5th POD. Low levels of PCT, together with low CRP values, seem to be early and reliable markers of AL after colorectal surgery. These biomarkers might be safely added as additional criteria of discharge protocols after colorectal surgery

High adherence to enhanced recovery pathway independently reduces major morbidity and mortality rates after colorectal surgery: a reappraisal of the iCral2 and iCral3 multicenter prospective studies

Background: Enhanced recovery after surgery (ERAS) offers lower overall morbidity rates and shorter hospital stay after colorectal surgery (CRS); high adherence rates to ERAS may significantly reduce major morbidity (MM), anastomotic leakage (AL), and mortality (M) rates as well. Methods: Prospective enrollment of patients submitted to elective CRS with anastomosis in two separate 18- and 12-month periods among 78 surgical centers in Italy from 2019 to 2021. Adherence to ERAS pathway items was measured upon explicit criteria in every case. After univariate analysis, independent predictors of primary endpoints (MM, AL, and M rates) were identified through logistic regression analyses, presenting odds ratios (OR) and 95% confidence intervals. Results: An institutional ERAS status was declared by 48 out of 78 (61.5%) participating centers. The median overall adherence to ERAS was 75%. Among 8,359 patients included in both studies, MM, AL, and M rates were 6.3%, 4.4%, and 1.0%, respectively. Several patient-related and treatment-related variables showed independently higher rates for primary endpoints: male gender, American Society of Anesthesiologists class III, neoadjuvant treatment, perioperative steroids, intra- and/or postoperative blood transfusions, length of the operation >180’, surgery for malignancy. On the other hand, ERAS adherence >85% independently reduced MM (OR, 0.91) and M (OR, 0.25) rates, whereas no mechanical bowel preparation independently reduced AL (OR, 0.68) rates. Conclusions: Among other patient- or treatment-related variables, ERAS adherence >85% independently reduced MM and M rates, whereas no mechanical bowel preparation independently reduced AL rates after CRS

Is robotic right colectomy economically sustainable? A multicentre retrospective comparative study and cost analysis

Background Following the Food and Drug Administration approval, robot-assisted colorectal surgery has gained more acceptance among surgeons. One of the open issues about robotic surgery is the economic sustainability. The aim of our study is to evaluate the economic sustainability of robotic as compared to laparoscopic right colectomy for the Italian National Health System. Methods We performed a retrospective multicentre case-matched study including 94 patients for each group from four different Italian surgical departments. An economic evaluation gathered from a real-world data was performed to assess the sustainability of the robotic approach for right colectomy in the Italian National Health System. In particular, a differential cost analysis between the two procedures was performed. Results No statistical differences were found between the two groups for postoperative outcomes. After a careful review of the literature on the cost assessment for the operative room, medical devices and hospital stay according with our data, we estimated the followings: (a) the mean operative room cost for robotic group was 2179 ± 476 € vs. 1376 ± 322 € for laparoscopic group; (b) the mean hospital stay cost for robotic group was 3143 ± 1435 € vs. 3292 ± 1123 € for laparoscopic group; and (c) the mean cost for instruments was 6280 € for robotic group vs. 1504 € for laparoscopic group. The total mean cost of robotic right colectomy was 11,576 ± 1915 € vs. 6196 ± 1444 € for laparoscopic right colectomy. Conclusion In conclusion, to date, robotic right colectomy with intracorporeal anastomosis does not provide any significant clinical advantages, which may justify the additional costs, as compared to its laparoscopic counterpart. Further evolution of robotic technology and experience may lead to a reduction of costs, especially if the robotic platform is used in an appropriate healthcare setting

Colorectal surgery in Italy during the Covid19 outbreak: a survey from the iCral study group

Background The COVID19 pandemic had a deep impact on healthcare facilities in Italy, with profound reorganization of surgical activities. The Italian ColoRectal Anastomotic Leakage (iCral) study group collecting 43 Italian surgical centers experienced in colorectal surgery from multiple regions performed a quick survey to make a snapshot of the current situation. Methods A 25-items questionnaire was sent to the 43 principal investigators of the iCral study group, with questions regard- ing qualitative and quantitative aspects of the surgical activity before and after the COVID19 outbreak. Results Two-thirds of the centers were involved in the treatment of COVID19 cases. Intensive care units (ICU) beds were partially or totally reallocated for the treatment of COVID19 cases in 72% of the hospitals. Elective colorectal surgery for malignancy was stopped or delayed in nearly 30% of the centers, with less than 20% of them still scheduling elective colo- rectal resections for frail and comorbid patients needing postoperative ICU care. A significant reduction of the number of colorectal resections during the time span from January to March 2020 was recorded, with significant delay in treatment in more than 50% of the centers. Discussion Our survey confirms that COVID19 outbreak is severely affecting the activity of colorectal surgery centers partici- pating to iCral study group. This could impact the activity of surgical centers for many months after the end of the emergency

ICG fluorescence imaging in colorectal surgery: a snapshot from the ICRAL study group

Background: Fluorescence-guided visualization is a recently proposed technology in colorectal surgery. Possible uses include evaluating perfusion, navigating lymph nodes and searching for hepatic metastases and peritoneal spread. Despite the absence of high-level evidence, this technique has gained considerable popularity among colorectal surgeons due to its significant reliability, safety, ease of use and relatively low cost. However, the actual use of this technique in daily clinical practice has not been reported to date. Methods: This survey was conducted on April 2020 among 44 centers dealing with colorectal diseases and participating in the Italian ColoRectal Anastomotic Leakage (iCral) study group. Surgeons were approximately equally divided based on geographical criteria from multiple Italian regions, with a large proportion based in public (89.1%) and nonacademic (75.7%) centers. They were invited to answer an online survey to snapshot their current behaviors regarding the use of fluorescence-guided visualization in colorectal surgery. Questions regarding technological availability, indications and techniques, personal approaches and feelings were collected in a 23-item questionnaire. Results: Questionnaire replies were received from 37 institutions and partially answered by 8, as this latter group of centers do not implement fluorescence technology (21.6%). Out of the remaining 29 centers (78,4%), fluorescence is utilized in all laparoscopic colorectal resections by 72.4% of surgeons and only for selected cases by the remaining 27.6%, while 62.1% of respondents do not use fluorescence in open surgery (unless the perfusion is macroscopically uncertain with the naked eye, in which case 41.4% of them do). The survey also suggests that there is no agreement on dilution, dosing and timing, as many different practices are adopted based on personal judgment. Only approximately half of the surgeons reported a reduced leak rate with fluorescence perfusion assessment, but 65.5% of them strongly believe that this technique will become a minimum requirement for colorectal surgery in the future. Conclusion: The survey confirms that fluorescence is becoming a widely used technique in colorectal surgery. However, both the indications and methods still vary considerably; furthermore, the surgeons' perceptions of the results are insufficient to consider this technology essential. This survey emphasizes the need for further research to reach recommendations based on solid scientific evidence. Keywords: Colon cancer; Fluorescence guided surgery; ICG; Laparoscopy; Rectal cancer

Prescription appropriateness of anti-diabetes drugs in elderly patients hospitalized in a clinical setting: evidence from the REPOSI Register

Diabetes is an increasing global health burden with the highest prevalence (24.0%) observed in elderly people. Older diabetic adults have a greater risk of hospitalization and several geriatric syndromes than older nondiabetic adults. For these conditions, special care is required in prescribing therapies including anti- diabetes drugs. Aim of this study was to evaluate the appropriateness and the adherence to safety recommendations in the prescriptions of glucose-lowering drugs in hospitalized elderly patients with diabetes. Data for this cross-sectional study were obtained from the REgistro POliterapie-Società Italiana Medicina Interna (REPOSI) that collected clinical information on patients aged ≥ 65 years acutely admitted to Italian internal medicine and geriatric non-intensive care units (ICU) from 2010 up to 2019. Prescription appropriateness was assessed according to the 2019 AGS Beers Criteria and anti-diabetes drug data sheets.Among 5349 patients, 1624 (30.3%) had diagnosis of type 2 diabetes. At admission, 37.7% of diabetic patients received treatment with metformin, 37.3% insulin therapy, 16.4% sulfonylureas, and 11.4% glinides. Surprisingly, only 3.1% of diabetic patients were treated with new classes of anti- diabetes drugs. According to prescription criteria, at admission 15.4% of patients treated with metformin and 2.6% with sulfonylureas received inappropriately these treatments. At discharge, the inappropriateness of metformin therapy decreased (10.2%, P < 0.0001). According to Beers criteria, the inappropriate prescriptions of sulfonylureas raised to 29% both at admission and at discharge. This study shows a poor adherence to current guidelines on diabetes management in hospitalized elderly people with a high prevalence of inappropriate use of sulfonylureas according to the Beers criteria

Antidiabetic Drug Prescription Pattern in Hospitalized Older Patients with Diabetes

Objective: To describe the prescription pattern of antidiabetic and cardiovascular drugs in a cohort of hospitalized older patients with diabetes. Methods: Patients with diabetes aged 65 years or older hospitalized in internal medicine and/or geriatric wards throughout Italy and enrolled in the REPOSI (REgistro POliterapuie SIMI—Società Italiana di Medicina Interna) registry from 2010 to 2019 and discharged alive were included. Results: Among 1703 patients with diabetes, 1433 (84.2%) were on treatment with at least one antidiabetic drug at hospital admission, mainly prescribed as monotherapy with insulin (28.3%) or metformin (19.2%). The proportion of treated patients decreased at discharge (N = 1309, 76.9%), with a significant reduction over time. Among those prescribed, the proportion of those with insulin alone increased over time (p = 0.0066), while the proportion of those prescribed sulfonylureas decreased (p < 0.0001). Among patients receiving antidiabetic therapy at discharge, 1063 (81.2%) were also prescribed cardiovascular drugs, mainly with an antihypertensive drug alone or in combination (N = 777, 73.1%). Conclusion: The management of older patients with diabetes in a hospital setting is often sub-optimal, as shown by the increasing trend in insulin at discharge, even if an overall improvement has been highlighted by the prevalent decrease in sulfonylureas prescription