A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial).

BACKGROUND: Although complete mesocolic excision (CME) is supposed to be associated with a higher lymph node (LN) yield, decreased local recurrence, and survival improvement, its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials. METHOD: This is a multicenter, randomized, superiority trial (NCT04871399). The 3-year disease-free survival (DFS) was the primary end point of the study. The secondary end points were safety (duration of operation, perioperative complications, hospital length of stay), oncologic outcomes (number of LNs retrieved, 3- and 5-year overall survival, 5-year DFS), and surgery quality (specimen length, area and integrity rate of mesentery, length of ileocolic and middle-colic vessels). The trial design required the LN yield to be higher in the CME group at interim analysis. RESULTS: Interim data analysis is presented in this report. The study enrolled 258 patients in nine referral centers. The number of LNs retrieved was significantly higher after CME (25 vs. 20; p = 0.012). No differences were observed with respect to intra- or post-operative complications, postoperative mortality, or duration of surgery. The hospital stay was even shorter after CME (p = 0.039). Quality of surgery indicators were higher in the CME arm of the study. Survival data still were not available. CONCLUSIONS: Interim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications. The study documented with evidence that quality of surgery and LN yield are higher after CME, and this is essential for continuation of patient recruitment and implementation of an optimal comparison. Trial registration The trial was registered at ClinicalTrials.gov with the code NCT04871399 and with the acronym CoME-In trial.

Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

PURPOSE: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. MATERIALS AND METHODS: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. RESULTS: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. CONCLUSION: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. CLINICAL IMPACT: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

Collagen-Based Vascular Closure Device Multicenter Italian Experience in Endovascular Aortic Aneurysm Repair Compared With Suture-Mediated Closure Vascular Device.

PURPOSE: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device. MATERIALS AND METHODS: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies. RESULTS: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide. CONCLUSION: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide. CLINICAL IMPACT: Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group.

An international Delphi consensus for surgical quality assessment of lymphadenectomy and anastomosis in minimally invasive total gastrectomy for gastric cancer.

BACKGROUND: Minimally invasive total gastrectomy (MITG) is a mainstay for curative treatment of patients with gastric cancer. To define and standardize optimal surgical techniques and further improve clinical outcomes through the enhanced MITG surgical quality, there must be consensus on the key technical steps of lymphadenectomy and anastomosis creation, which is currently lacking. This study aimed to determine an expert consensus from an international panel regarding the technical aspects of the performance of MITG for oncological indications using the Delphi method. METHODS: A 100-point scoping survey was created based on the deconstruction of MITG into its key technical steps through local and international expert opinion and literature evidence. An international expert panel comprising upper gastrointestinal and general surgeons participated in multiple rounds of a Delphi consensus. The panelists voted on the issues concerning importance, difficulty, or agreement using an online questionnaire. A priori consensus standard was set at > 80% for agreement to a statement. Internal consistency and reliability were evaluated using Cronbach's α. RESULTS: Thirty expert upper gastrointestinal and general surgeons participated in three online Delphi rounds, generating a final consensus of 41 statements regarding MITG for gastric cancer. The consensus was gained from 22, 12, and 7 questions from Delphi rounds 1, 2, and 3, which were rephrased into the 41 statetments respectively. For lymphadenectomy and aspects of anastomosis creation, Cronbach's α for round 1 was 0.896 and 0.886, and for round 2 was 0.848 and 0.779, regarding difficulty or importance. CONCLUSIONS: The Delphi consensus defined 41 steps as crucial for performing a high-quality MITG for oncological indications based on the standards of an international panel. The results of this consensus provide a platform for creating and validating surgical quality assessment tools designed to improve clinical outcomes and standardize surgical quality in MITG.

Work and the Veins. A Retrospective Analysis of Work Activities in Patients with Chronic Venous Disease.

BACKGROUND: This study aimed to investigate the relationship between work activities and chronic venous disease of the lower limbs. METHODS: Patients referred to our clinical units of Interuniversity Center of Phlebolymphology for chronic venous disease (CVD) assessment between January 2019 and December 2023 were retrospectively enrolled in the study. Inclusion criteria were (a) CVD status confirmed by office visit and Duplex ultrasound, (b) not having any other vascular disease of the lower limbs (such as arterial or lymphatic problems), (c) work activities of at least 1-year duration, in the medical records. RESULTS: A total of 948 patients (642 females and 306 males) were retrospectively enrolled. Of these, 613 patients (431 females and 182 males) were affected by CVD and 335 patients (211 females and 124 males) were not affected by CVD and served as controls. Sedentary jobs and jobs where the ambient work temperature ambient is hot have been associated with CVD. Other types of work with no sedentary activities or with a cool ambient work temperature were not associated with CVD. CONCLUSIONS: Work activity and the occupational environment may be tightly related to the onset and progression of CVD. Forced postures, excessive standing or sitting, and high ambient temperatures can reduce lower limb venous function at work and cause CVD.

The role of inflammation biomarkers in carotid artery stenosis procedures.

BACKGROUND: Carotid revascularization procedures, such as carotid endarterectomy (CEA) and carotid artery stenting (CAS), can lead to restenosis. Monitoring restenosis onset through biomarkers is crucial in clinical practice. This study aimed to evaluate inflammation biomarkers in CEA and CAS to determine their predictive value for restenosis risk postprocedure. METHODS: A retrospective analysis was conducted on the clinical records of patients with carotid stenosis who underwent CEA or CAS over 1 year at the vascular surgery departments of an interuniversity center. Eligible asymptomatic patients with carotid stenosis (70%-99%) underwent revascularization. Differences between preprocedural and early postprocedural inflammation indices were assessed, and restenosis risk was evaluated using receiver operating curve analysis and logistic regression. RESULTS: The cohort comprised 100 patients, 68 undergoing CEA and 32 undergoing CAS. Significant values were observed for inflammation ratios post-CEA: neutrophils to lymphocytes ratio (NLR) (P = 0.036), platelets to lymphocytes ratio (PLR) (P = 0.009), monocytes to lymphocytes ratio (MLR) (P < 0.001), systemic inflammation index (SII) (P = 0.024), systemic immune response index (SIRI) (P = 0.003), and aggregate inflammation response index (AISI) (P < 0.001). At 12-month follow-up, 12% of patients experienced restenosis; 50% were men and 50% women. Women showed a higher restenosis rate (26.1% vs 7.8%). Preintervention NLR (odds ratio {OR} [95% confidence interval {CI}] = 13.38 [1.88 to 95.44], P = 0.010) and SIRI (OR [95% CI] = 10.22 [2.65 to 39.43], P = 0.001) remained significantly associated with restenosis after adjusting for sex and smoking. CONCLUSIONS: The study provided a predictive model for restenosis, identifying preintervention NLR and SIRI as independent predictors of restenosis at 12-month follow-up.

Robotic versus laparoscopic transabdominal preperitoneal (TAPP) approaches to bilateral hernia repair: a multicenter retrospective study using propensity score matching analysis.

BACKGROUND: Since the introduction of minimally invasive surgery, new techniques like transabdominal preperitoneal (TAPP) repair have progressively gained acceptance for the treatment of groin hernia. Laparoscopic TAPP (LTAPP) is recommended for bilateral repairs. Likewise, the introduction of robotic platforms has promised additional surgical benefits for robotic TAPP (RTAPP), which are yet to be confirmed. This study compared multicenter data obtained from patients undergoing bilateral inguinal hernia repair with RTAPP, performed during the preliminary learning curve period, versus conventional LTAPP. MATERIALS AND METHODS: All consecutive bilateral inguinal hernia patients from four Italian centers between June 2015 and July 2020 were selected. A propensity score model was used to compare patients treated with LTAPP versus RTAPP, considering sex, age, body mass index, current smoking status, overall comorbidity, hernia classification (primary or recurrent), and associated procedures as covariates. After matching, intraoperative details and postoperative outcomes were evaluated. RESULTS: In total, 275 LTAPP and 40 RTAPP were performed. After matching, 80 and 40 patients were allocated to the LTAPP and RTAPP cohorts, respectively. No intraoperative complications or conversion to open surgery occurred. However, a longer operative time was recorded in the RTAPP group (79 ± 21 versus 98 ± 29 min; p < 0.001). Postoperative visual analog scale (VAS) pain scores (p = 0.13) did not differ and complication rates were similar. There were no clinical recurrences in either group, with mean follow-up periods of 52 ± 14 (LTAPP) and 35 ± 8 (RTAPP) months. A statistical difference in length of hospital stay was found between the groups (1.05 ± 0.22 vs 1.50 ± 0.74 days; p < 0.001). CONCLUSION: In this patient population, outcomes for bilateral inguinal hernia repair appear comparable for RTAPP and LTAPP, except for a shorter recovery after laparoscopic surgery. A longer operative time for robotic surgery could be attributable to the learning curve period of each center.

High-energy devices in different surgical settings: lessons learnt from a full health technology assessment report developed by SICE (Società Italiana di Chirurgia Endoscopica).

BACKGROUND: The present paper aims at evaluating the potential benefits of high-energy devices (HEDs) in the Italian surgical practice, defining the comparative efficacy and safety profiles, as well as the potential economic and organizational advantages for hospitals and patients, with respect to standard monopolar or bipolar devices. METHODS: A Health Technology Assessment was conducted in 2021 assuming the hospital perspective, comparing HEDs and standard monopolar/bipolar devices, within eleven surgical settings: appendectomy, hepatic resections, colorectal resections, cholecystectomy, splenectomy, hemorrhoidectomy, thyroidectomy, esophago-gastrectomy, breast surgery, adrenalectomy, and pancreatectomy. The nine EUnetHTA Core Model dimensions were deployed considering a multi-methods approach. Both qualitative and quantitative methods were used: (1) a systematic literature review for the definition of the comparative efficacy and safety data; (2) administration of qualitative questionnaires, completed by 23 healthcare professionals (according to 7-item Likert scale, ranging from - 3 to + 3); and (3) health-economics tools, useful for the economic evaluation of the clinical pathway and budget impact analysis, and for the definition of the organizational and accessibility advantages, in terms of time or procedures' savings. RESULTS: The literature declared a decrease in operating time and length of stay in using HEDs in most surgical settings. While HEDs would lead to a marginal investment for the conduction of 178,619 surgeries on annual basis, their routinely implementation would generate significant organizational savings. A decrease equal to - 5.25/-9.02% of operating room time and to - 5.03/-30.73% of length of stay emerged. An advantage in accessibility to surgery could be hypothesized in a 9% of increase, due to the gaining in operatory slots. Professionals' perceptions crystallized and confirmed literature evidence, declaring a better safety and effectiveness profile. An improvement in both patients and caregivers' quality-of-life emerged. CONCLUSIONS: The results have demonstrated the strategic relevance related to HEDs introduction, their economic sustainability, and feasibility, as well as the potentialities in process improvement.

Vascular Biology of Arterial Aneurysms.

BACKGROUND: This review aims to analyze biomolecular and cellular events responsible for arterial aneurysm formation with particular attention to vascular remodeling that determines the initiation and the progression of arterial aneurysm, till rupture. METHODS: This review was conducted searching libraries such as Web of Science, Scopus, ScienceDirect, and MEDLINE. Used keywords with various combinations were "arterial aneurysms," "biology," "genetics," "proteomics," "molecular," "pathophysiology," and extracellular matrix". RESULTS: There are several genetic alterations responsible of syndromic and nonsyndromic disease that predispose to aneurysm formation. Extracellular matrix imbalance, mainly due to the alteration of vascular smooth muscle cells homeostasis, overexpression of metalloproteinases, and cytokines activation, determines weakness of the arterial wall that dilates thus causing aneurysmal disease. Altered mechanotransduction in the extracellular matrix may also trigger and sustain anomalous cellular and biochemical signaling. Different cell population such as vascular smooth muscle cells, macrophages, perivascular adipose tissue cells, and vascular wall resident stem cells are all involved at different levels. CONCLUSIONS: Improving knowledge in vascular biology may help researchers and physicians in better targeting aneurysmal disease to better prevent and better treat such important disease.

Results of New Dual-Drug Coated Balloon Angioplasty versus POBA for Femoropopliteal Lesions.

BACKGROUND: The study aimed to assess the 24-month safety and effectiveness of a new generation drug-coated balloon (DCB) (Elutax; AR Baltic Medical, Vilnius Lithuania-also marketed as Emperor in some European countries; Aachen Resonance, Germany, and AB Medica, Italy) for the treatment of patients with femoropopliteal lesions. METHODS: From January 2019 to January 2020, DCB angioplasties using Elutax were performed on 53 consecutive patients (53 limbs) with femoropopliteal lesions (group A) and compared with a noncontemporary control group (group B) consisting of 71 patients (71 limbs) treated with plain old balloon angioplasty (POBA) between January 2017 and January 2018. Before performing the angioplasty, both groups underwent clinical examination, ultrasound evaluation, and computed tomography angiography to delineate subject clinical and baseline lesion characteristics. Primary end point was primary patency rate at 24 months. Secondary end points included clinically driven target lesion revascularization (CD-TLR), overall survival and limb salvage rates. RESULTS: In both groups technical success rate was 100% with bailout stenting performed in 16.9% (9/53) of lesions in group A, while stenting was necessary in 22.5% of lesions (16/71) in group B. Patients treated with Elutax exhibited lower 24-month restenosis/reocclusion rate and improved primary patency compared to those treated with POBA (restenosis/reocclusion rate: 9.4% vs. 25.3%, CI 95% 0.01-0.30, P = 0.034; primary patency: 88.2% vs. 71.5%, log rank P = 0.03). Twenty-four-month CD-TLR rate was 7.5% for DCB versus 18.3% for POBA. No device or procedure-related deaths occurred, and no 30-day mortality was observed in either group. During the follow-up period, the limb salvage rate was 94.9% for A group and 92.1% for B group. All minor amputations occurred in limbs presented with chronic limb threatening ischemia (CLTI). Overall survival was 91.7% for group A and 89.4% for group B. CONCLUSIONS: Paclitaxel + Dextran DCB angioplasty proved safe and effective in managing chronic lesions of femoropopliteal arteries. Our experience has shown superior primary patency rate for Elutax when compared to POBA.

A Multicenter Experience of Three Different "Iliac Branched" Stent Grafts for the Treatment of Aorto-Iliac And/Or Iliac Aneurysms.

BACKGROUND: The aim of study was to assess the safety and effectiveness of 3 different commercial iliac branch devices (IBDs): the Zenith Branch Iliac Endovascular Graft; the Gore Excluder Iliac Branch System and the E-liac Stent Graft System for the treatment of aorto-iliac or iliac aneurysms. METHODS: From January 2017 to February 2020, a retrospective reviewed was conducted on a total of 96 patients. Primary endpoint was IBD instability rate at 24 months. Secondary endpoints included onset of any endoleaks, buttock claudication, IBD-related reintervention and all-death rates, postoperative acute kidney, and changes in maximum diameter from baseline of the aortic aneurysmal sac. RESULTS: At 24 months, the branch instability rate was similar among the 3 IBDs employed [Jotec 1/24 (4.1%), Gore 1/12 (8.3%), Cook 6/47 (12.7%), P-value = 0.502]. As well, no statistical difference in terms of branch occlusion and branch-related endoleaks was observed. The Jotec group showed a significant decrease in maximum diameter from the baseline of the aortic aneurysmal sac when compared to the Gore group alone. No other differences were found relevant to the onset of any endoleaks, reinterventions, and all-death rates. At 24 months, the Kaplan-Meier estimate of survival freedom from any branch instability was 95.8%, 91.6%, and 86.8% for Jotec, Gore and Cook groups, respectively. CONCLUSIONS: The use of IBDs represents a safe method for preserving patency of the IIA during treatment of aorto-iliac or iliac aneurysms providing a low rate of IBD instability.

Short- and long-term outcomes in ypT2 rectal cancer patients after neoadjuvant therapy and local excision: a multicentre observational study.

BACKGROUND: Although local excision (LE) after neoadjuvant treatment (NT) has achieved encouraging oncological outcomes in selected patients, radical surgery still remains the rule when unfavorable pathology occurs. However, there is a risk of undertreating patients not eligible for radical surgery. The aim of this study was to evaluate the outcomes of patients with pathological incomplete response (ypT2) in a multicentre cohort of patients undergoing LE after NT and to compare them with ypT0-is-1 rectal cancers. METHODS: From 2010 to 2019, all patients who underwent LE after NT for rectal cancer were identified from five institutional retrospective databases. After excluding 12 patients with ypT3 tumors, patients with ypT2 tumors were compared to patients with ypT0-is-1 tumors). The endpoints of the study were early postoperative and long-term oncological outcomes. RESULTS: A total of 177 patients (132 males, 45 females, median age 70 [IQR 16] years) underwent LE following NT. There were 46 ypT2 patients (39 males, 7 females, median age 72 [IQR 18.25] years) and 119 ypT0-is-1 patients (83 males, 36 females, median age 69 [IQR 15] years). Patients with pathological incomplete response (ypT2) were frailer than the ypT0-is-1 patients (mean Charlson Comorbidity Index 6.15 ± 2.43 vs. 5.29 ± 1.99; p = 0.02) and there was a significant difference in the type of NT used for the two groups (long- course radiotherapy: 100 (84%) vs. 23 (63%), p = 0.006; short-course radiotherapy: 19 (16%) vs. 17 (37%), p = 0.006). The postoperative rectal bleeding rate (13% vs. 1.7%; p = 0.008), readmission rate (10.9% vs. 0.8%; p = 0.008) and R1 resection rate (8.7% vs. 0; p = 0.008) was significantly higher in the ypT2 group. Recurrence rates were comparable between groups (5% vs. 13%; p = 0.15). Five-year overall survival was 91.3% and 94.9% in the ypT2 and ypT0-is-1 groups, respectively (p = 0.39), while 5-year cancer specific survival was 93.4% in the ypT2 group and 94.9% in the ypT0-is-1 group (p = 0.70). No difference was found in terms of 5-year local recurrence free-survival (p = 0.18) and 5-year distant recurrence free-survival (p = 0.37). CONCLUSIONS: Patients with ypT2 tumors after NT and LE have a higher risk of late-onset rectal bleeding and positive resection margins than patients with complete or near complete response. However, long-term recurrence rates and survival seem comparable.

Molecular Determinants of Chronic Venous Disease: A Comprehensive Review.

Chronic Venous Disease (CVD) refers to several pathological and hemodynamic alterations of the veins of lower limbs causing a wide range of symptoms and signs with a high prevalence in the general population and with disabling consequences in the most severe forms. The etiology and pathophysiology of CVD is complex and multifactorial, involving genetic, proteomic, and cellular mechanisms that result in changes to the venous structure and functions. Expressions of several genes associated with angiogenesis, vascular development, and the regulation of veins are responsible for the susceptibility to CVD. Current evidence shows that several extracellular matrix alterations (ECM) could be identified and in some cases pharmacologically targeted. This review shows the most up to date information on molecular determinants of CVD in order to provide a complete overview of the current knowledge on this topic. In particular, the article explores the genetic influence, the hormonal influence, ECM imbalance, and histopathology of CVD and the role of endothelial dysfunction in CVD.

Risk Factors for Bleeding Varicose Veins in Patients with Chronic Venous Disease.

Background and Objectives: Chronic venous disease (CVD) is a widespread clinical condition that is very common in western countries in the adult general population with a wide range of clinical manifestations, such as varicose veins (VVs) that in certain circumstances may complicate with rupture and subsequent bleeding that may even be fatal. The aim of this study is to evaluate risk factors for bleeding VVs. Materials and Methods: This is a retrospective study conducted in patients with CVD complicating with bleeding of VVs over a 4-year period (2019-2022). A random sample, for the same 4-year period and with a 3:1 ratio, was selected from other CVD patients without VVs bleeding that served as the control group. Results: From a global population of 1048 patients with CVD over a 4-year period, a total of 33 patients (3.15%) with VVs bleeding were selected. A group of 99 patients without VVs bleeding were randomly selected from the total population of 1048 patients with CVD. Findings of this study showed that advanced clinical stage of CVD (i.e., C4b stage), advanced age, living alone, suffering from cardiovascular co-morbidity (i.e., hypertension and CHF), assuming certain drugs that act on blood coagulation (i.e., aspirin, anticoagulants), assuming psychotropic medication, having particular venous reflux patterns (i.e., below-knee GSV reflux, non-saphenous veins reflux, Cockett's perforators reflux), and not having been assessed and treated previously for CVD (i.e., with VADs, CT, or surgery) may predispose a high risk for bleeding VVs. Conclusions: Bleeding VVs may be a life-threatening complications of CVD patients, and monitoring risk factors found in this study and others that, hopefully, may be discovered in the future through further focused research will help to reduce the impact of this problem in this patient population.

Open veress assisted technique for laparoscopic entry.

Background: The creation of the pneumoperitoneum is the first step for any minimally invasive surgical procedure. Although rare, iatrogenic vascular or visceral injuries are reported and they are mainly related to the insertion of the first trocar. The Open Veress Assisted (OVA) technique allows a safe maneuver of the first trocar in order to minimize the risk of intraoperative complications during positioning of the first trocar. The purpose of this study was to describe the OVA technique and discuss the use in our current surgical practice. Patients and Methods: Each step of OVA technique is described in the text. A retrospective review of prospectively maintained institutional databases was performed to report clinical outcomes related to OVA technique use. Results: Between December 2018 and July 2021 OVA technique was used in a total of 324 laparoscopic procedures categorized in 259 colorectal resection and 24 subtotal or total gastrectomies. No intraoperative and postoperative complications related to creation of the peritoneum occurred. Conclusion: OVA technique can be considered a safe alternative procedure for laparoscopic entry. By avoiding potentially dangerous insertion-related forces, this technique can be used even in previously operated patients, when the first trocar needs to be positioned away from the umbilicus or abdominal scar.

Benchmarks in colorectal surgery: multinational study to define quality thresholds in high and low anterior resection.

BACKGROUND: Benchmark comparisons in surgery allow identification of gaps in the quality of care provided. The aim of this study was to determine quality thresholds for high (HAR) and low (LAR) anterior resections in colorectal cancer surgery by applying the concept of benchmarking. METHODS: This 5-year multinational retrospective study included patients who underwent anterior resection for cancer in 19 high-volume centres on five continents. Benchmarks were defined for 11 relevant postoperative variables at discharge, 3 months, and 6 months (for LAR). Benchmarks were calculated for two separate cohorts: patients without (ideal) and those with (non-ideal) outcome-relevant co-morbidities. Benchmark cut-offs were defined as the 75th percentile of each centre's median value. RESULTS: A total of 3903 patients who underwent HAR and 3726 who had LAR for cancer were analysed. After 3 months' follow-up, the mortality benchmark in HAR for ideal and non-ideal patients was 0.0 versus 3.0 per cent, and in LAR it was 0.0 versus 2.2 per cent. Benchmark results for anastomotic leakage were 5.0 versus 6.9 per cent for HAR, and 13.6 versus 11.8 per cent for LAR. The overall morbidity benchmark in HAR was a Comprehensive Complication Index (CCI®) score of 8.6 versus 14.7, and that for LAR was CCI® score 11.9 versus 18.3. CONCLUSION: Regular comparison of individual-surgeon or -unit outcome data against benchmark thresholds may identify gaps in care quality that can improve patient outcome.

Early versus delayed defunctioning ileostomy closure after low anterior resection for rectal cancer: a meta-analysis and trial sequential analysis of safety and functional outcomes.

PURPOSE: We performed a systematic review and meta-analysis with trial sequential analysis (TSA) to answer whether early closure of defunctioning ileostomy may be suitable after low anterior resection. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched, up to October 2021, for RCTs comparing early closure (EC ≤ 30 days) and delayed closure (DC ≥ 60 days) of defunctioning ileostomy. The risk ratio (RR) with 95% CI was calculated for dichotomous variables and the mean difference (MD) with 95% CI for continuous variables. The GRADE methodology was implemented for assessing Quality of Evidence (QoE). TSA was implemented to address the risk of random error associated with sparse data and/or multiple testing. RESULTS: Seven RCTs were included for quantitative synthesis. 599 patients were allocated to either EC (n = 306) or DC (n = 293). EC was associated with a higher rate of wound complications compared to DC (RR 2.56; 95% CI 1.33 to 4.93; P = 0.005; I2 = 0%, QoE High), a lower incidence of postoperative small bowel obstruction (RR 0.46; 95% CI 0.24 to 0.89; P = 0.02; I2 = 0%, QoE moderate), and a lower rate of stoma-related complications (RR 0.26; 95% CI 0.16 to 0.42; P < 0.00001; I2 = 0%, QoE moderate). The rate of minor low anterior resection syndrome (LARS) (RR 1.13; 95% CI 0.55 to 2.33; P = 0.74; I2 = 0%, QoE low) and major LARS (RR 0.80; 95% CI 0.59 to 1.09; P = 0.16; I2 = 0%, QoE low) did not differ between the two groups. TSA demonstrated inconclusive evidence with insufficient sample sizes to detect the observed effects. CONCLUSION: EC may confer some advantages compared with a DC. However, TSA advocated a cautious interpretation of the results. PROSPERO REGISTER ID: CRD42021276557.

Laparoscopic gastrectomy for stage II and III advanced gastric cancer: long­term follow­up data from a Western multicenter retrospective study.

INTRODUCTION: There has been an increasing interest for the laparoscopic treatment of early gastric cancer, especially among Eastern surgeons. However, the oncological effectiveness of Laparoscopic Gastrectomy (LG) for Advanced Gastric Cancer (AGC) remains a subject of debate, especially in Western countries where limited reports have been published. The aim of this paper is to retrospectively analyze short- and long-term results of LG for AGC in a real-life Western practice. MATERIALS AND METHODS: All consecutive cases of LG with D2 lymphadenectomy for AGC performed from January 2005 to December 2019 at seven different surgical departments were analyzed retrospectively. The primary outcome was diseases-free survival (DFS). Secondary outcomes were overall survival (OS), number of retrieved lymph nodes, postoperative morbidity and conversion rate. RESULTS: A total of 366 patients with stage II and III AGC underwent either total or subtotal LG. The mean number of harvested lymph nodes was 25 ± 14. The mean hospital stay was 13 ± 10 days and overall postoperative morbidity rate 27.32%, with severe complications (grade ≥ III) accounting for 9.29%. The median follow-up was 36 ± 16 months during which 90 deaths occurred, all due to disease progression. The DFS and OS probability was equal to 0.85 (95% CI 0.81-0.89) and 0.94 (95% CI 0.92-0.97) at 1 year, 0.62 (95% CI 0.55-0.69) and 0.63 (95% CI 0.56-0.71) at 5 years, respectively. CONCLUSION: Our study has led us to conclude that LG for AGC is feasible and safe in the general practice of Western institutions when performed by trained surgeons.

Sequential Minimally Invasive Treatment of Concomitant Abdominal Aortic Aneurysm and Colorectal Cancer: A Single-Center Experience.

BACKGROUND: The surgical management of concomitant occurrence of abdominal aortic aneurysm (AAA) and colorectal cancer (CRC) is still controversial. Conversely, benefits from a minimally invasive approach are well known concerning the treatment of both AAA and CRC. The aim of this study is to assess safety and feasibility of a sequential 2-staged minimally invasive during the same recovery by endovascular aneurysm repair (EVAR) technique and laparoscopic colorectal resection. METHODS: From January 2008 to December 2020, all patients with concomitant AAA and CRC were consecutively treated by EVAR and laparoscopic colorectal resection. Perioperative data were retrospectively collected in order to evaluate short- and long-term outcomes following the sequential 2-staged procedures. RESULTS: A total of 24 patients were included. The localization of the aneurysm was infrarenal abdominal aortic in 23 cases and in one case of common iliac artery. EVAR procedure has always been performed first. In 18 patients, a percutaneous access has been used while in 6 patients a surgical access has been adopted. Twelve patients had cancer in the left colon, 9 in the right colon, and 3 patients had rectal cancer. No conversions or intraoperative complications had occurred during laparoscopic surgery. The major complications rate after EVAR and CRC surgery was 8.3% and 12.5%, respectively. The mean interval between EVAR and CRC treatment was 7.8 ± 1 and the mean length of stay was 15.4 ± 3.6. No deaths occurred during hospitalization and between the procedures. Overall mortality was 20.8% with a mean follow-up of 39.41 ± 19.2 months. CONCLUSION: Elective sequential 2-staged minimally invasive treatment is a safe and feasible approach with acceptable morbidity and mortality rates and it should be adopted in current clinical practice to manage concomitant AAA and CRC.

Carotid Endarterectomy versus Carotid Artery Stenting With Double-Layer Micromesh Carotid Stent: Contemporary Results of a Single-Center Retrospective Study.

BACKGROUND: Severe carotid stenosis (CS) is a major risk factor for stroke. Carotid Endarterectomy (CEA) is the gold standard revascularization technique of CS while carotid artery stenting (CAS) is considered an alternative treatment option, especially in high-risk patients or those with relative contraindications to CEA. The aim of this study was to evaluate the results of CEA and CAS with Roadsaver® stent device. METHODS: We made a retrospective analysis of 119 patients undergoing treatment of CS. All CS were evaluated with imaging exams. The patients were divided into CEA group and CAS group. As primary endpoints of the study overall and cardiovascular cause - related mortality, freedom from stroke, and restenosis were considered. All patients were followed up and revaluated with duplex scan over a minimum of 6 months and a maximum of 36 months (follow-up mean time 22.3 ± 3.4 months). RESULTS: In the whole cohort 86 of 119 patients underwent CEA and 33 of 119 CAS. Risk factors were superposable in both groups. During follow-up, we observed 4 deaths, 2 cardiovascular events and 12 restenosis. CEA was associated with lower death probability than CAS (P = 0.036). Probability of Restenosis and cardiovascular events did not vary between CAS and CEA groups. CONCLUSIONS: Albeit CEA remains the gold standard for the treatment of severe CS, CAS with new double layer micromesh stent can be considered a useful and safe alternative in some clinical conditions.