Colorectal cancer with synchronous unresectable liver metastases: resecting the primary tumor improves survival.

PURPOSE: The optimal treatment strategy of patients affected by colorectal cancer (CRC) with synchronous unresectable liver metastases (SULM) is at present undefined. It is not known if a palliative primary tumor resection followed by chemotherapy could have a survival benefit compared to upfront chemotherapy (CT). The aim of the study is to analyze the safety and effectiveness of both therapeutic strategies in a group of patients treated at one institution. METHODS: A prospectively collected database was queried for patients affected by colorectal cancer with synchronous unresectable liver metastases between January 2004 and December 2018, defining and comparing 2 groups: patients treated by chemotherapy alone (group 1) vs patients who underwent primary tumor resection with or without a first line chemotherapy (group 2). The primary end point was Overall Survival (OS), estimated by the Kaplan-Meier method. RESULTS: One hundred sixty-seven patients were included: 52 in group 1 and 115 in group 2, median follow-up 48 months (range 25-126). A difference of 14 months in overall survival was observed between group 2 compared to group 1 (28 vs 14 months respectively; p < 0.001). Furthermore, overall survival increased in patients who underwent liver metastases resection (p < 0.001) or percutaneous radiofrequency ablation after surgery (p < 0.001). CONCLUSION: With the limits of a retrospective analysis, the study shows that surgical resection of the primary tumor has a significant impact on survival compared to chemotherapy alone. Randomized controlled trials are needed to confirm these data.

Intracorporeal or extracorporeal ileocolic anastomosis after laparoscopic right colectomy: cost analysis of the Torino trial.

BACKGROUND: Intracorporeal (IIA) and extracorporeal anastomosis (EIA) are two well-established techniques for restoration of bowel continuity after laparoscopic right colectomy (LRC). Since no economic analysis comparing the two different anastomotic techniques has been performed yet, it is still unclear if IIA can reduce perioperative costs. The aim of the study was to compare costs of LRC with IIA or EIA for right-sided colon neoplasm. METHODS: This is a cost analysis of a single-institution double-blinded randomized controlled trial comparing the outcomes of LRC with IIA and LRC with EIA in patients with a right-sided colon neoplasm. All direct in-hospital costs related to patient's admission were recorded (intraoperative costs: operative room, surgical tools, blood units-postoperative costs: hospital stay, laboratory and microbiology analyses, diagnostic services, analgesic drugs and antibiotic therapy, blood units, reoperation-outpatient costs: post-discharge wound medications). This trial was registered with ClinicalTrials.gov, Number NCT03045107. RESULTS: A total of 140 patients were randomized and analyzed. Mean overall costs in the IIA group exceeded 349 € the mean overall costs of the EIA group (7926.87 ± 4617.23 € vs. 7577.45 ± 6131.17 €; P = 0.704). A mean extra charge of 608 € regarding total intraoperative costs was recorded in the IIA group (3058.84 ± 897.42 € vs. 2450.15 ± 558.90 €; P < 0.001). The cost of surgical instruments resulted in 542 € additional charge per patient in the IIA group compared to EIA group (1782.74 ± 541.26 € vs. 1240.55 ± 384.09 €; P < 0.001). The mean cost of operative room occupancy was comparable in IIA and EIA group: 1276.09 ± 514.94 € vs. 1209.60 ± 422.80 € (P = 0.405). No significant differences were observed in postoperative costs and in outpatient costs. CONCLUSION: This economic analysis showed that IIA and EIA after LRC had similar overall costs, even though there were intraoperative extra costs of IIA.

Risk factors for Low Anterior Resection Syndrome (LARS) in patients undergoing laparoscopic surgery for rectal cancer.

BACKGROUND: Total mesorectal excision (TME) represents the "gold standard" of rectal cancer surgery. In locally advanced lesions neoadjuvant treatments (e.g. radiotherapy-nRT, radio chemotherapy-cnRT) have been shown to improve TME oncological results, reducing local recurrences rate. Nevertheless, these treatments have significant functional consequences impacting patients' quality of life (QoL). The resulting syndrome is known as Low Anterior Resection Syndrome (LARS). The purpose of this work was to evaluate the association between risk factors and the development of LARS in a prospective series of laparoscopic sphincter-saving TME. METHODS: The study was conducted as a retrospective observational epidemiological study of a prospective database, including all patients undergoing laparoscopic anterior resection surgery for rectal cancer at our Unit from 1st January 2013 to 31st May 2018. The diagnosis of LARS was performed using the LARS Score. We classified risk factors in patient-related, pre-, intra- and post-operative factors. RESULTS: The sample included 153 consecutive patients. Forty-one were affected by "low" rectal cancer, 74 by "middle" rectal cancer, 38 by "high" rectal cancer. The prevalence of overall LARS (major LARS + minor LARS) in our series was 35.9% (55/153 cases). Association between nRT and overall/major LARS was significant (respectively p = 0.03 and 0.02). Distal localization of tumor was also significantly associated with LARS [overall LARS (p = 0.03), major LARS (p = 0.014)]. CONCLUSIONS: In our study, neoadjuvant radiotherapy and tumor localization resulted independent risk factors for LARS after laparoscopic sphincter-saving TME. Tumor localization in the "middle" and "high" rectum resulted a protective factor compared to the localization in "low" rectum.

Should be a locally advanced colon cancer still considered a contraindication to laparoscopic resection?

BACKGROUND: The role of elective laparoscopic resection (LR) for the treatment of locally advanced colon cancer (LACC) is unclear. Most studies have retrospectively investigated the outcomes of LR for pT4 cancers, while clinical T4 (cT4) cancers are excluded in the large randomized controlled trials comparing LR and open resection (OR). The aim of this study was to investigate the outcomes in patients undergoing elective LR for LACC. METHODS: A prospective single-institution database including consecutive patients undergoing elective LR for clinical LACC (high-risk T3 or T4 N0-2) between March 1996 and March 2017 was retrospectively reviewed. A multivariate analysis was performed to identify predictors of conversion to OR and risk factors for adverse oncologic outcomes. RESULTS: A total of 300 patients undergoing LR for LACC were included. A multi-visceral resection was needed in 17 (5.7%) patients. A total of 63 (21%) LRs were converted to OR, mainly due to suspected adjacent organ invasion (82.5%) or obesity (9.5%). Overall postoperative Clavien-Dindo 3-4 complication rate was 4.7%, with no significant differences between completed and converted LRs. Final pathology showed 18 (6%) pT2, 215 (71.7%) pT3, 54 (18%) pT4a, and 13 (4.3%) pT4b cancers. A R0 resection was achieved in 98.3% of patients. On multivariate analysis, tumor size ≥ 7 cm and tumor site (splenic flexure) were the independent risk factors for conversion to OR. A pT4 colon cancer and LNR of 0.25 or greater, but not conversion to OR, were independently associated with both poorer OS and DFS. CONCLUSION(S): Clinical LACC should not be considered a contraindication to LR itself. Bulky tumors ≥ 7 cm and splenic flexure cancers are at higher risk of conversion to OR; however, there is no increased postoperative morbidity or adverse oncologic outcomes in converted patients.

Minimally invasive adrenalectomy for large pheochromocytoma: not recommendable yet? Results from a single institution case series.

BACKGROUND: Minimally invasive adrenalectomy represents the treatment of choice of pheochromocytoma (PCC). For large or invasive PCCs, an open approach is currently recommended, in order to ensure complete tumor resection, prevent tumor rupture, avoid local recurrence, and limit perioperative hemodynamic instability. The aim of this study is to analyze perioperative outcomes of laparoscopic adrenalectomies (LAs) for large adrenal PCCs. METHODS: All consecutive LAs for PCC performed at a single institution between 1998 and 2020 were included. Two groups were defined: lesions larger (group 1) and smaller (group 2) than 5 cm. Short-term outcomes were compared in order to find any significant difference between the two groups. OUTCOMES: One hundred fourteen patients underwent LA during the study period: 46 for lesions larger and 68 for lesions smaller than 5 cm. No significant differences were found in patients' characteristics, median operative time, conversion rate, intraoperative hemodynamic and metabolic parameters, postoperative intensive care unit (ICU) admission rate, complications rate, and length of hospital stay. Long-term oncologic outcomes were similar, with a recurrence rate of 5.1% in group 1 vs 3.6% in group 2 (p = 1). CONCLUSION: Minimally invasive adrenalectomy seems to be safe and effective even in large PCC. The recommendation to prefer an open approach for large PCCs should probably be reconsidered.

Multicenter retrospective cohort Italian study on elective laparoscopic cholecystectomy performed by the surgical residents.

PURPOSE: This retrospective multicenter cohort study aimed to evaluate the clinical outcomes (mortality rate, operative time, complications) of elective laparoscopic cholecystectomy (LC) when performed by a surgical resident in comparison to experienced consultant in the backdrop of Italian academic centers. METHODS: Retrospective review of all patients undergoing elective LC between January 2016 and January 2022 at six teaching hospitals across Italy was performed. Cases were identified using the Current Procedural Terminology (CPT) code 5123 (LC without cholangiogram). All cases of emergency surgery, ASA score > 3, or when cholecystectomy was performed with another surgical procedure, were excluded. All suitable cases were divided into 2 groups based on primary surgeon: consultant or senior resident. Main outcome was complication rates (intraoperative and peri/postoperative); secondary outcomes included operative time, the length of stay, and the rate of conversion to open. RESULTS: A total of 2331 cases (1425 females) were included, of which, consultants performed 1683 LCs (72%), while the residents performed 648 (28%) surgeries. The groups were statistically comparable regarding demographics, history of previous abdominal surgery, operative time, or intraoperative complications. The rate of conversion to open cholecystectomy was 1.42% for consultant and none for resident (p = 0.02). A statistically significant difference was observed between groups regarding the average length of stay (2.2 ± 3 vs 1.6 ± 1.3 days p = 0.03). Similarly, postoperative complications (1.7% vs 0.5%) resulted in statistically significant (p = 0.02) favoring resident group. CONCLUSIONS: Our study demonstrates that in selected patients, senior residents can safely perform LC when supervised by senior staff surgeons.

Robotic endoscopic submucosal dissection and full-thickness excision for laterally spreading tumors of the rectum.

Endoscopic submucosal dissection (ESD) is technically demanding and time-consuming. Moreover, it bears a high risk of adverse events compared to other endoscopic methods, due to the lack of tissue manipulation. Robotic technology can significantly reduce the time of the procedure and increase the rate of complete resection for ESD. In the case of an unclear deep margin it allows to proceed to the full-thickness excision of the bowel wall. While the gain over transanal endoscopic microsurgery (TEM) is limited today, the longer systems currently under development will allow these complex procedures to be performed at least in the left side of the colon. The Supplementary video shows the application of the Flex Robotic System to perform an ESD and a full-thickness excision.

Transanal Local Excision or Endoscopic Dissection for Benign and Large Lesions of the Rectum.

Since the introduction of transanal endoscopic microsurgery, local excision of "early" rectal lesions has offered the possibility to reduce the invasiveness of treatment for the limited disease. Flexible endoscopy techniques allow today different alternatives consisting of endoscopic mucosal resection or endoscopic submucosal dissection. The first is a straightforward and relatively easy technique, but it prevents a correct pathological staging of the lesion due to fragmentation and the verification of disease-free margins. The second relies on operators' audacity depending on their increasing experience due to the limited progress in technology. What is the preferable technique today is questionable. All the methods have pros and cons. The future certainly will see the use of ideal systems, allowing the possibility of precision surgery for partial- or full-thickness excision, depending on intraoperative findings, and the extension above the rectosigmoid junction. Miniaturized flexible robotic devices may represent the solution for both issues.

Robotic "Double Loop" Roux-en-Y gastric bypass reduces the risk of postoperative internal hernias: a prospective observational study.

BACKGROUND: Internal herniation (IH) is a potentially serious complication after laparoscopic Roux-en-Y gastric bypass (RYGB). The aim of the study is to evaluate the incidence of IH after robot-assisted RYGB (RA-RYGB) performed with the "Double Loop" technique at our Institution. METHODS: Prospective cohort study of patients submitted to RA-RYGB with the "Double Loop" technique, with a minimum follow-up of 2 years. Patients with complaints of abdominal pain at clinical visits or entering the emergency department were evaluated. Primary outcome was the incidence of IH, defined as the presence of herniated bowel through a mesenteric defect, diagnosed at imaging or at surgical exploration. RESULTS: A total of 129 patients were included: 65 (50.4%) were primary procedures, while 64 (49.6%) were revisional operations after primary restrictive bariatric surgery. Mean age was 47.9 ± 10.2 years, mean weight, and body mass index were, respectively, 105.3 ± 22.6 kg and 39.7 ± 9.6 kg/m2. Postoperative morbidity rate was 7.0%. Mean follow-up was 53.2 ± 22.6 (range 24-94) months. During the follow-up period, a total of 14 (10.8%) patients entered the emergency department: 1 patient had melena, 4 renal colic, 1 acute cholecystitis, 2 gynecologic pathologies, 2 anastomotic ulcers, 1 perforated gastric ulcer, 1 diverticulitis and 2 gastroenteritis. There were no diagnoses of IH. During the follow-up period, no patient experienced recurrence of symptoms. CONCLUSIONS: In the present study, the robotic approach confirms the low complication rate and absence of IH after "Double Loop" RA-RYGB in a large case-series at a medium-term follow-up.

Impact of COVID-19 outbreak on esophageal cancer surgery in Northern Italy: lessons learned from a multicentric snapshot.

Coronavirus Disease-19 (COVID-19) outbreak has significantly burdened healthcare systems worldwide, leading to reorganization of healthcare services and reallocation of resources. The Italian Society for Study of Esophageal Diseases (SISME) conducted a national survey to evaluate changes in esophageal cancer management in a region severely struck by COVID-19 pandemic. A web-based questionnaire (26 items) was sent to 12 SISME units. Short-term outcomes of esophageal resections performed during the lockdown were compared with those achieved in the same period of 2019. Six (50%) centers had significant restrictions in their activity. However, overall number of resections did not decrease compared to 2019, while a higher rate of open esophageal resections was observed (40 vs. 21.7%; P = 0.034). Surgery was delayed in 24 (36.9%) patients in 6 (50%) centers, mostly due to shortage of anesthesiologists, and occupation of intensive care unit beds from intubated COVID-19 patients. Indications for neoadjuvant chemo (radio) therapy were extended in 14% of patients. Separate COVID-19 hospital pathways were active in 11 (91.7%) units. COVID-19 screening protocols included nasopharyngeal swab in 91.7%, chest computed tomography scan in 8.3% and selective use of lung ultrasound in 75% of units. Postoperative interstitial pneumonia occurred in 1 (1.5%) patient. Recovery from COVID-19 pandemic was characterized by screening of patients in all units, and follow-up outpatient visits in only 33% of units. This survey shows that clinical strategies differed considerably among the 12 SISME centers. Evidence-based guidelines are needed to support the surgical esophageal community and to standardize clinical practice in case of further pandemics.

Colonic Stenting in the Emergency Setting.

Nowadays, colorectal cancer (CRC) is the third most frequent cancer, and about a third of patients with CRC presents themselves with symptoms of large bowel obstruction. Historically, surgical resection was the treatment of choice for colonic obstruction, but this kind of approach is burdened by a high risk of postoperative morbidity and mortality. In recent times, the use of a colonic stent has been proposed to overcome the obstruction and transform an emergency surgical case into an elective one to avoid emergency surgery complications. Endoscopic stenting is the first-line treatment option in the palliative management of colonic obstruction, and there is sufficient scientific evidence to support this approach. However, endoscopic stent used as a bridge to surgery is not yet widely adopted because the concern was raised about the long-term survival and cancer safety of this approach. The recent scientific evidence has shown that this approach improves the short-term outcomes, such as postoperative complications and the stoma rate, without differences in long-term outcomes compared to emergency surgery. Therefore, the European Society for Gastrointestinal Endoscopy in 2020 has reconsidered stenting as a bridge to surgery as a valid alternative to emergency surgery.

Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction: A Multicenter Randomized Controlled Trial (ESCO Trial).

OBJECTIVE: To assess overall (OS), time to progression (TTP), and disease-free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial. BACKGROUND: While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival. METHODS: Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1-62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49-1.76), P = 0.822), TTP (HR 0.81 (95% CI 0.42-1.54), P = 0.512), and DFS (HR 1.01 (95% CI 0.56-1.81), P = 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals. CONCLUSIONS: This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months.

Surgically induced weight loss effects on sexual quality of life of obese men: a prospective evaluation.

BACKGROUND: Sexual difficulties are common among obese patients, but only a few research studies have examined the relationship between obesity and sexual quality of life (QoL). The aim of this study is to investigate the efficacy of bariatric surgery to improve sexual function and related quality of life in obese men. METHODS: Prospective study including consecutive male patients undergoing bariatric surgery procedures, both sleeve gastrectomy and Roux en Y gastric bypass, between 2013 and 2017. Anthropometric parameters, biochemical and hormonal assessment and QoL questionnaires [International Index of Erectile Function (IIEF), Sexual Desire Inventory (SDI), Short Form-36 (SF-36) health survey questionnaire] were collected before and 12 months after surgery. RESULTS: 44 male patients were recruited in the study. 40/44 (90.91%) underwent a SG and 4/44 a RYGB (9.09%). Median age was 43.45 years. Waist Circumference, Hip Circumference, body weight and body mass index significantly decreased 12 months after surgery, with a median weight loss of 49 kg and a median BMI difference of 14.28 kg/m2 12 months after surgery. Basal glycaemia, HbA1c, basal insulin, triglycerides, HDL cholesterol and CRP levels significantly decreased, while FSH, total testosterone and SHBG levels significantly increased. IEEF total score was significantly higher 12 months after surgery. Univariate analysis identified SHBG, estradiol and inhibin B levels, IIEF erectile function, IIEF intercourse satisfaction, IIEF total and SF-36 physical functioning scores as significant negative predictive factors of sexual improvement. None of them reached the statistical significance in the multivariate analysis. CONCLUSIONS: Sexual impairment in morbidly obese men represents an underestimated problem, with a high prevalence in the IIEF domains in our series. Bariatric surgery represents the most effective therapy of morbid obesity, having a tremendous impact on metabolic profile, sexual function and self-perceived QoL.

Long-term oncologic outcomes following anastomotic leak after anterior resection for rectal cancer: does the leak severity matter?

BACKGROUND: The evidence regarding the impact of anastomotic leak (AL) after anterior resection (AR) for rectal cancer on oncologic outcomes is controversial, and there are no data about the prognostic relevance of the International Study Group of Rectal Cancer (ISREC) AL classification. The aim was to evaluate the oncologic outcomes in patients with AL after AR for rectal cancer. The prognostic value of the ISREC AL grading system was also investigated. METHODS: It is a retrospective analysis of a prospectively collected database including all patients undergoing curative elective AR for rectal cancer (April 1998-September 2013). AL severity was defined according to the ISREC criteria. A multivariable analysis was performed to identify predictors of poor survival. RESULTS: A total of 532 patients underwent curative AR (69% laparoscopic) for rectal cancer. The overall AL rate was 7.9%: 15 grade B and 27 grade C ALs. With a median follow-up of 80 (range 12-266) months, 5-year overall survival (OS) was 67.2% in patients with AL and 86.5% in those without AL (P = 0.001). Five-year disease-free survival (DFS) was 50.5% and 80.3%, respectively (P < 0.001). Local recurrence and distant metastases developed more frequently in AL patients (P < 0.05). Grade B AL and no administration or delay of adjuvant chemotherapy were independent predictors for poorer OS and DFS. Grade B AL independently affected also the administration of adjuvant chemotherapy. Circulating C-reactive protein levels at 2 weeks after AL treatment were higher in grade B than grade C patients (P = 0.006) and in patients with tumor relapse (P = 0.011). CONCLUSION: AL after curative AR for rectal cancer and impaired use of adjuvant chemotherapy are associated with poor survival. Postoperative systemic inflammation seems to be more sustained in grade B than that in grade C AL patients, with possible adverse impact on long-term survival.

Intraoperative use of fluorescence with indocyanine green reduces anastomotic leak rates in rectal cancer surgery: an individual participant data analysis.

BACKGROUND: Fluorescence imaging by means of Indocyanine green (ICG) has been applied to intraoperatively determine the perfusion of the anastomosis. The purpose of this Individual Participant Database meta-analysis was to assess the effectiveness in decreasing the incidence of anastomotic leak (AL) after rectal cancer surgery. METHODS: We searched PubMed, Embase, Cochrane Library and ClinicalTrial.gov, EU Clinical Trials and ISRCTN registries on September 1st, 2019. We considered eligible those studies comparing the assessment of anastomotic perfusion during rectal cancer surgery by intraoperative use of ICG fluorescence compared with standard practice. We defined as primary outcome the incidence of AL at 30 days after surgery. The studies were assessed for quality by means of the ROBINS-I and the Cochrane risk tools. We calculated odds ratios (ORs) using the Individual patient data analysis, restricted to rectal lesions, according to original treatment allocation. RESULTS: The review of the literature and international registries produced 15 published studies and 5 ongoing trials, for 9 of which the authors accepted to share individual participant data. 314 patients from two randomized trials, 452 from three prospective series and 564 from 4 non-randomized studies were included. Fluorescence imaging significantly reduced the incidence of AL (OR 0.341; 95% CI 0.220-0.530; p < 0.001), independent of age, gender, BMI, tumour and anastomotic distance from the anal verge and neoadjuvant therapy. Also, overall morbidity and reintervention rate were positively influenced by the use of ICG. CONCLUSIONS: The incidence of AL may be reduced when ICG fluorescence imaging is used to assess the perfusion of a colorectal anastomosis. Limitations relate to the consistent number of non-randomized studies included and their heterogeneity in defining and assessing AL. Ongoing large randomized studies will help to determine the exact role of routine ICG fluorescence imaging may decrease the incidence of AL in surgery for rectal cancer.

Metastatic colorectal cancer prior to expanded RAS assessment: evidence from long-term outcome analysis of a real-life cohort within a dedicated colorectal cancer unit.

BACKGROUND: Molecular assessment and treatment of metastatic colorectal cancer (mCRC) quickly evolved during the last decades, hampering longitudinal evaluation of prognostic markers. The aim of this study was to evaluate prognostic predictors of long-term survival in a retrospective series of mCRC, treated prior to the expanded RAS assessment era. METHODS: mCRC cases treated at the Città della Salute e della Scienza University Hospital (Turin, Italy) between January 2004 and December 2012 were evaluated, including cases with ≥ 5-year follow-up only. Long-term survival was defined as an overall survival (OS) ≥ 4 years based on the observed OS interquartile range values. Univariate/multivariate Cox proportional hazards regression models were performed to assess the prognostic significance of the clinical/biological features, while binary logistic regression models were used to verify their associations with long-term survival. RESULTS: Two hundred and forty-eight mCRC cases were included and analyzed. Sixty out of two hundred and forty-eight (24%) patients were long-term survivors. Univariate binary logistic regression analysis demonstrated a significant association between long-term survival and age at diagnosis < 65 (OR = 2.28, p = 0.007), single metastatic site (OR = 1.89, p = 0.039), surgical resection of metastases (OR = 5.30, p < 0.001), local non-surgical treatment of metastases (OR = 4.74, p < 0.001), and a bevacizumab-including first-line treatment schedule (OR = 2.19, p = 0.024). Multivariate binary logistic regression analysis confirmed the prognostic significance of surgical resection of metastases (OR = 3.96, p < 0.001), local non-surgical treatment of metastases (OR = 3.32, p = 0.001), and of bevacizumab-including first-line treatment schedule (OR = 2.49, p = 0.024). CONCLUSION: Long-term survival could be achieved in a significant rate of patients with mCRC even in an era of limited molecular characterization. Local treatment of metastases proved to be a significant predictor of long-term survival.

Vedolizumab for treatment of chronic refractory pouchitis: a systematic review with pool analysis.

BACKGROUND AND OBJECTIVES: about 1%-2% of patients with chronic refractory pouchitis, in the context of ulcerative colitis, end up with a permanent ileostomy. The aim of this systematic review was to collect all published studies involving patients treated with vedolizumab for chronic refractory or antibiotic-dependent pouchitis and then pool the data regarding the effectiveness of this therapeutic strategy. METHODS: a MEDLINE and Web of Science search of all studies published in English until March 17, 2019 was conducted using the terms "vedolizumab and pouchitis". RESULTS: seven studies with a total of 44 patients with chronic pouchitis were included. Twenty-three out of 44 patients (52.3%) had undergone previous treatment with anti-tumor necrosis factor (TNF) drugs. At week 12, 33 out of 44 patients (75%) reported clinical improvement. Endoscopic improvement, evaluated within 6 months of the start of vedolizumab therapy, was obtained in 28 out of the 38 patients in whom such data were available (73.7%). CONCLUSIONS: this first systematic review published in the literature on this issue suggests that vedolizumab has significant efficacy in chronic refractory or antibiotic-dependent pouchitis, also in patients who failed to respond to other treatments including those with anti-TNF agents.

Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn's disease: an observational study.

BACKGROUND AND OBJECTIVE: there are no studies in the literature about the effectiveness of adalimumab biosimilar ABP 501 in Crohn's disease. The aim of this study was to evaluate its effectiveness and safety. METHODS: an observational study was performed in Crohn's disease patients treated with ABP 501, with the classic induction and maintenance regimen and in Crohn's disease patients who were switched from the adalimumab originator to ABP 501. RESULTS: eighty-seven patients were included in the study, of which 25 were naïve to the adalimumab originator and 62 were switched to ABP 501. In adalimumab-naïve patients, clinical response at three months was 60% (15/25) and clinical remission at three months was 56% (14/25). At six months, 95.2% (59/62) of the patients switched to ABP 501 were still in therapy, without a significant increase of clinical activity (Harvey-Bradshaw index from 3.4, 95% CI = 2.4-4.4, to 3.8, 95% CI = 2.7-4.9, p = 0.23) and inflammatory biomarkers (C-reactive protein from 4.2 mg/l, 95% CI = 2.5-5.9 mg/l, to 3.6 mg/l, 95% CI = 2.2-5 mg/l, p = 0.32). There were no unexpected adverse events during the study period. CONCLUSIONS: our results support ABP 501 as an effective and well-tolerated drug, with a good interchangeability with its originator for the treatment of Crohn's disease.

Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy: A Double-blinded Randomized Controlled Trial.

OBJECTIVES: The aim of the study was to determine whether there are clinically relevant differences in outcomes between laparoscopic right colectomy (LRC) with intracorporeal ileocolic anastomosis (IIA) and LRC with extracorporeal IA (EIA). BACKGROUND: IIA and EIA are 2 well-established techniques for restoration of bowel continuity after LRC. There are no high-quality studies demonstrating the superiority of one anastomotic technique over the other. METHODS: This is a double-blinded randomized controlled trial comparing the outcomes of LRC with IIA and LRC with EIA in patients with a benign or malignant right-sided colon neoplasm. Primary endpoint was length of hospital stay (LOS). This trial was registered with ClinicalTrials.gov, number NCT03045107. RESULTS: A total of 140 patients were randomized and analyzed. Median operative time was comparable in IIA versus EIA group {130 [interquartile range (IQR) 105-195] vs 130 (IQR 110-180) min; P = 0.770} and no intraoperative complications occurred. The quicker recovery of bowel function after IIA than EIA [gas: 2 (IQR 2-3) vs 3 (IQR 2-3) days, P = 0.003; stool: 4 (IQR 3-5) vs 4.5 (IQR 3-5) days, P = 0.032] was not reflected in any advantage in the primary endpoint: median LOS was similar in the 2 groups [6 (IQR 5-7) vs 6 (IQR 5-8) days; P = 0.839]. No significant differences were observed in the number of lymph nodes harvested, length of skin incision, 30-day morbidity (17.1% vs 15.7%, P = 0.823), reoperation rate, and readmission rate between the 2 groups. CONCLUSIONS: LRC with IIA is associated with earlier recovery of postoperative bowel function than LRC with EIA; however, it does not reflect into a shorter LOS.

Procedural Surgical RCTs in Daily Practice: Do Surgeons Adopt Or Is It Just a Waste of Time?

OBJECTIVE: To assess the adoption of recommendation from randomized clinical trials (RCTs) and investigate factors favoring or preventing adoption. BACKGROUND: RCT are considered to be the cornerstone of evidence-based medicine by representing the highest level of evidence. As such, we expect RCT's recommendations to be followed rigorously in daily surgical practice. METHODS: We performed a structured search for RCTs published in the medical and surgical literature from 2009 to 2013, allowing a minimum of 5-year follow-up to convincingly test implementation. We focused on comparative technical or procedural RCTs trials addressing the domains of general, colorectal, hepatobiliary, upper gastrointestinal and vascular surgery. In a second step we composed a survey of 29 questions among ESA members as well as collaborators from their institutions to investigate the adoption of surgical RCTs recommendation. RESULTS: The survey based on 36 RCTs (median 5-yr citation index 85 (24-474), from 21 different countries, published in 15 high-ranked journals with a median impact factor of 3.3 (1.23-7.9) at the time of publication. Overall, less than half of the respondents (47%) appeared to adhere to the recommendations of a specific RCT within their field of expertise, even when included in formal guidelines. Adoption of a new surgical practice was favored by watching videos (46%) as well as assisting live operations (18%), while skepticism regarding the methodology of a surgical RCT (40%) appears to be the major reason to resist adoption. CONCLUSION: In conclusion, surgical RCTs appear to have moderate impact on daily surgical practice. While RCTs are still accepted to provide the highest level of evidence, alternative methods of evaluating surgical innovations should also be explored.