Trends and outcome of neoadjuvant treatment for rectal cancer: A retrospective analysis and critical assessment of a 10-year prospective national registry on behalf of the Spanish Rectal Cancer Project

Introduction: Preoperative treatment and adequate surgery increase local control in rectal cancer. However, modalities and indications for neoadjuvant treatment may be controversial. Aim of this study was to assess the trends of preoperative treatment and outcomes in patients with rectal cancer included in the Rectal Cancer Registry of the Spanish Associations of Surgeons. Method: This is a STROBE-compliant retrospective analysis of a prospective database. All patients operated on with curative intention included in the Rectal Cancer Registry were included. Analyses were performed to compare the use of neoadjuvant/adjuvant treatment in three timeframes: I)2006–2009; II)2010–2013; III)2014–2017. Survival analyses were run for 3-year survival in timeframes I-II. Results: Out of 14, 391 patients, 8871 (61.6%) received neoadjuvant treatment. Long-course chemo/radiotherapy was the most used approach (79.9%), followed by short-course radiotherapy ± chemotherapy (7.6%). The use of neoadjuvant treatment for cancer of the upper third (15-11 cm) increased over time (31.5%vs 34.5%vs 38.6%, p = 0.0018). The complete regression rate slightly increased over time (15.6% vs 16% vs 18.5%; p = 0.0093); the proportion of patients with involved circumferential resection margins (CRM) went down from 8.2% to 7.3%and 5.5% (p = 0.0004). Neoadjuvant treatment significantly decreased positive CRM in lower third tumors (OR 0.71, 0.59–0.87, Cochrane-Mantel-Haenszel P = 0.0008). Most ypN0 patients also received adjuvant therapy. In MR-defined stage III patients, preoperative treatment was associated with significantly longer local-recurrence-free survival (p < 0.0001), and cancer-specific survival (p < 0.0001). The survival benefit was smaller in upper third cancers. Conclusion: There was an increasing trend and a potential overuse of neoadjuvant treatment in cancer of the upper rectum. Most ypN0 patients received postoperative treatment. Involvement of CRM in lower third tumors was reduced after neoadjuvant treatment. Stage III and MRcN + benefited the most

The Cholecystectomy As A Day Case (CAAD) score: a validated score of preoperative predictors of successful day-case cholecystectomy using the CholeS data set

Background: Day-case surgery is associated with significant patient and cost benefits. However, only 43% of cholecystectomy patients are discharged home the same day. One hypothesis is day-case cholecystectomy rates, defined as patients discharged the same day as their operation, may be improved by better assessment of patients using standard preoperative variables. Methods: Data were extracted from a prospectively collected data set of cholecystectomy patients from 166 UK and Irish hospitals (CholeS). Cholecystectomies performed as elective procedures were divided into main (75%) and validation (25%) data sets. Preoperative predictors were identified, and a risk score of failed day case was devised using multivariate logistic regression. Receiver operating curve analysis was used to validate the score in the validation data set. Results: Of the 7426 elective cholecystectomies performed, 49% of these were discharged home the same day. Same-day discharge following cholecystectomy was less likely with older patients (OR 0.18, 95% CI 0.15–0.23), higher ASA scores (OR 0.19, 95% CI 0.15–0.23), complicated cholelithiasis (OR 0.38, 95% CI 0.31 to 0.48), male gender (OR 0.66, 95% CI 0.58–0.74), previous acute gallstone-related admissions (OR 0.54, 95% CI 0.48–0.60) and preoperative endoscopic intervention (OR 0.40, 95% CI 0.34–0.47). The CAAD score was developed using these variables. When applied to the validation subgroup, a CAAD score of ≤5 was associated with 80.8% successful day-case cholecystectomy compared with 19.2% associated with a CAAD score &gt;5 (p &lt; 0.001). Conclusions: The CAAD score which utilises data readily available from clinic letters and electronic sources can predict same-day discharges following cholecystectomy

Long term outcome of acute pancreatitis in Italy: Results of a multicentre study

Background: In Italy, no long-term studies regarding the natural history of acute pancreatitis have been carried out. Aim: To report the results of a follow-up on a large series of patients hospitalised for pancreatitis. Methods: Data of 631 patients admitted to 35 Italian hospitals were retrospectively evaluated 51.7 ± 8.4 months after discharge. Results: The average recovery time after mild or severe pancreatitis was 28.2 and 53.4 days respectively. Fourteen sequelae were not resolved and 9 cases required late surgical intervention. Eighty patients (12.7%) had a second hospital admission. Of the patients with mild biliary pancreatitis, 67.9% underwent a cholecystectomy. The overall incidence of relapse was 12.7%. Mortality was 9.8% and no death was related to pancreatitis. Three patients died from carcinoma of the pancreas. Conclusion: Reported recovery time after an attack of pancreatitis was longer than expected in the mild forms. The treatment of sequelae was delayed beyond one year after discharge. The incidence of relapse of biliary pancreatitis in patients not undergoing a cholecystectomy was low, due to endoscopic treatment. Mortality from pancreatic-related causes is low, but there is an association with malignant pancreatic or ampullary tumours not diagnosed during the acute phase of the illness

Long term outcome of acute pancreatitis in Italy: Results of a multicentre study

Background: In Italy, no long-term studies regarding the natural history of acute pancreatitis have been carried out. Aim: To report the results of a follow-up on a large series of patients hospitalised for pancreatitis. Methods: Data of 631 patients admitted to 35 Italian hospitals were retrospectively evaluated 51.7 \ub1 8.4 months after discharge. Results: The average recovery time after mild or severe pancreatitis was 28.2 and 53.4 days respectively. Fourteen sequelae were not resolved and 9 cases required late surgical intervention. Eighty patients (12.7%) had a second hospital admission. Of the patients with mild biliary pancreatitis, 67.9% underwent a cholecystectomy. The overall incidence of relapse was 12.7%. Mortality was 9.8% and no death was related to pancreatitis. Three patients died from carcinoma of the pancreas. Conclusion: Reported recovery time after an attack of pancreatitis was longer than expected in the mild forms. The treatment of sequelae was delayed beyond one year after discharge. The incidence of relapse of biliary pancreatitis in patients not undergoing a cholecystectomy was low, due to endoscopic treatment. Mortality from pancreatic-related causes is low, but there is an association with malignant pancreatic or ampullary tumours not diagnosed during the acute phase of the illness. \ua9 2013 Editrice Gastroenterologica Italiana S.r.l

A prospective multicentre survey on the treatment of acute pancreatitis in Italy

Background: The Italian Association for the Study of the Pancreas released a diagnostic and therapeutic algorithm for acute pancreatitis in 1999. Aim: This study focused on the analysis of the therapeutic approach for the treatment of acute pancreatitis in Italy. Patients: One thousand, one hundred and seventy-three patients were recruited: 1006 patients (85.8%) had mild acute pancreatitis (MAP) and 167 (14.2%) had the severe acute pancreatitis (SAP); 161 patients showed pancreatic necrosis at computed tomography; 121 patients (10.3%) had sequelae and 36 (3.1%) died. Results: Non-steroidal anti-inflammatory drugs and tramadol were used more frequently in patients with the MAP whereas opioids and the association schedules were used more frequently in patients with the SAP (P < 0.001). Gabexate mesilate was utilised in 831 out of 1173 patients (70.8%); in particular, gabexate mesilate was used in 70.6% patients with MAP and in 73.1% of those with SAP (P = 0.521). The duration of the drug administration was significantly shorter in those having MAP than in those having the SAP (P < 0.001). The antibiotics most frequently used for the prophylaxis against infection from pancreatic necrosis (43.1%) were carbapenems. Only a small number of patients received enteral nutrition (4.7%). Endoscopic retrograde cholangiopancreatography was carried out in 344 of the 1173 patients (29.3%). Surgery was performed in 48 with SAP (19 had elective biliary surgery and 29 had pancreatic surgery). Conclusions: The results of this survey indicate a lack of compliance with the guidelines which regard the indications mainly for interventional endoscopy and surgery. \ua9 2007 Editrice Gastroenterologica Italiana S.r.l

Diagnostic assessment and outcome of acute pancreatitis in Italy: Results of a prospective multicentre study. ProInf-AISP: Progetto informatizzato pancreatite acuta, Associazione Italiana Studio Pancreas, phase II

Background and aim: Up till now, only one study providing practically complete information on acute pancreatitis in Italy has been published. The aim of this prospective study was to evaluate the clinical characteristics, in terms of diagnostic assessment and outcome, of a large series of patients affected by acute pancreatitis in Italy. Materials and methods: The study involved 56 Italian centres, homogeneously distributed throughout the entire national territory. Each participating centre was furnished with an ad hoc software including 530 items along with subsequent collection, tabulation and quality control of the data. Results: One thousand five hundred and forty case report forms of patients affected by acute pancreatitis were collected but 367 of them (24%) were subsequently eliminated from the final analysis. Therefore, 1173 patients (581 females and 592 males) were recruited. Mean age of patients was 62.0 \ub1 18.2 years (95% confidence interval, 60.9-63.0). On the basis of Atlanta classification, 1006 patients (85.8%) were defined as mild and 167 (14.2%) as severe pancreatitis. Biliary forms represented the most frequent aetiological category (813 cases, 69.3%) while alcoholic forms only 6.6% (77 cases); the remaining aetiologies accounted for 7.1% (83 cases) while 200 cases (17.1%) remained without a definite aetiological factor. Complete recovery was achieved in 1016 patients (86.6%) whereas morphological sequelae were found in 121 patients (10.3%) and mortality in 36 patients (3.1%; 0.4% in mild and 19.2% in severe acute pancreatitis). Ultrasonography was largely utilised as a first line diagnostic tool in all patients, with valuable visualisation of the pancreas in 85% of patients. Computer tomography scan was also widely used, with 66.7% of exams in mild and 33.3% in severe pancreatitis. Patients affected by biliary pancreatitis presented more severe (p = 0.004) and necrotizing forms (p = 0.021). Mortality was significantly related (p < 0.001) with the extension of pancreatic necrosis and with an age of over 70 years. Body mass index presented significantly greater values in severe than in mild forms (p < 0.001). Conclusions: Association of creatinine serum level over 2 mg/dl with an abnormal chest X-ray showed a high significant correlation with a more severe outcome in terms of morphological sequalae and mortality (p = 0.0001). Acute pancreatitis in Italy more commonly presents biliary aetiology and favourable outcome with low rate of complications and mortality. From a cost-effectiveness standpoint, diagnostic approach to this disease needs to be better standardised. \ua9 2007

Predicting the difficult laparoscopic cholecystectomy: development and validation of a pre-operative risk score using an objective operative difficulty grading system

Background: The prediction of a difficult cholecystectomy has traditionally been based on certain pre-operative clinical and imaging factors. Most of the previous literature reported small patient cohorts and have not used an objective measure of operative difficulty. The aim of this study was to develop a pre-operative score to predict difficult cholecystectomy, as defined by a validated intra-operative difficulty grading scale. Method: Two cohorts from prospectively maintained databases of patients who underwent laparoscopic cholecystectomy were analysed: the CholeS Study (8755 patients) and a single surgeon series (4089 patients). Factors potentially predictive of difficulty were correlated to the Nassar intra-operative difficulty scale. A multivariable binary logistic regression analysis was then used to identify factors that were independently associated with difficult laparoscopic cholecystectomy, defined as operative difficulty grades 3 to 5. The resulting model was then converted to a risk score, and validated on both internal and external datasets. Result: Increasing age and ASA classification, male gender, diagnosis of CBD stone or cholecystitis, thick-walled gallbladders, CBD dilation, use of pre-operative ERCP and non-elective operations were found to be significant independent predictors of difficult cases. A risk score based on these factors returned an area under the ROC curve of 0.789 (95% CI 0.773–0.806, p &lt; 0.001) on external validation, with 11.0% versus 80.0% of patients classified as low versus high risk having difficult surgeries. Conclusion: We have developed and validated a pre-operative scoring system that uses easily available pre-operative variables to predict difficult laparoscopic cholecystectomies. This scoring system should assist in patient selection for day case surgery, optimising pre-operative surgical planning (e.g. allocation of the procedure to a suitably trained surgeon) and counselling patients during the consent process. The score could also be used to risk adjust outcomes in future research

The development and validation of a scoring tool to predict the operative duration of elective laparoscopic cholecystectomy

Background: The ability to accurately predict operative duration has the potential to optimise theatre efficiency and utilisation, thus reducing costs and increasing staff and patient satisfaction. With laparoscopic cholecystectomy being one of the most commonly performed procedures worldwide, a tool to predict operative duration could be extremely beneficial to healthcare organisations. Methods: Data collected from the CholeS study on patients undergoing cholecystectomy in UK and Irish hospitals between 04/2014 and 05/2014 were used to study operative duration. A multivariable binary logistic regression model was produced in order to identify significant independent predictors of long (&gt; 90 min) operations. The resulting model was converted to a risk score, which was subsequently validated on second cohort of patients using ROC curves. Results: After exclusions, data were available for 7227 patients in the derivation (CholeS) cohort. The median operative duration was 60 min (interquartile range 45–85), with 17.7% of operations lasting longer than 90 min. Ten factors were found to be significant independent predictors of operative durations &gt; 90 min, including ASA, age, previous surgical admissions, BMI, gallbladder wall thickness and CBD diameter. A risk score was then produced from these factors, and applied to a cohort of 2405 patients from a tertiary centre for external validation. This returned an area under the ROC curve of 0.708 (SE = 0.013, p &lt; 0.001), with the proportions of operations lasting &gt; 90 min increasing more than eightfold from 5.1 to 41.8% in the extremes of the score. Conclusion: The scoring tool produced in this study was found to be significantly predictive of long operative durations on validation in an external cohort. As such, the tool may have the potential to enable organisations to better organise theatre lists and deliver greater efficiencies in care