Three-Dimensional vs Two-Dimensional Minimally Invasive Surgery. A comparison of the visual work load and surgical outcomes

BACKGROUND Three-dimensional (3D) imaging, a recent technical innovation in laparoscopic surgery, has been introduced to enhance depth perception and facilitate operations. The clear benefit of the 3D laparoscopy has never been tested. Some concerns emerged regarding the possible negative effects over the visual system in those surgeons who performed 3D surgery every day. 3D laparoscopy has been validated both in “in-vitro” and “in-vivo” (clinical) settings. All survey done in laparoscopic simulator comparing surgical exercise (suturing, peg transfer, cutting) performed with 2D or 3D system reported better results in the second group, regardless the surgeon experience. Less data is disposable in the clinical setting, but with same conclusions. The use of 3D technology needs passive or active polarized glasses. Optometric tests, objective exams (RMN or EEG) and subjective questionnaires have been widely used to evaluate the alterations in the visual system utilizing the 3D technology. Each test concluded that 3D technology causes alteration in the EEG waves, but how long these alterations last is still unknown. AIM The aim of this study was to evaluate the possible benefit of using the 3D technology in terms of surgical outcomes (study 1) and to evaluate the alterations over the visual system operating in 3D laparoscopy (study 2). MATERIALS AND METHODS The study was a single-center prospective observational clinical trial, divided in two sub-study with a single patients-population. Participants included patients aged 18 years old and above, eligible for colorectal resections for neoplastic or inflammatory diseases. Four experienced surgeons in colorectal and laparoscopic surgery participated in the study. Each surgeon followed the standard laparoscopic surgical rules performing the different type of colorectal resection, regardless the study subgroup. Data were collected at the pre-operative clinic, during surgery, during the hospitalizations and at the short term follow-up (30th days). For each study, there was a primary endpoint: 1. Primary endpoint for Study 1: incidence of Clavien grade 3, 4 and 5 postsurgical complications in patients undergone 3D colorectal resection; 2. Primary endpoint for Study 2: to grade the visual work load of surgeons operating with 3D screens and glasses. At the end of each procedure (2D or 3D) the first surgeon had to fill in two different subjective questionnaire (the NASA task load index questionnaire and the Simulator Sickness questionnaire) to grade the visual sickness felt during the operation. RESULTS From January 2015 to September 2017, 313 patients were enrolled in the study: 82 in the 2D group, 231 in the 3D group. STUDY 1: Colorectal cancer was the main indication for surgery (n 235, 75.1%), followed by colonic diverticulosis, benign polyposis and inflammatory bowel diseases (IBD), respectively 43 (13.8 %), 25 (7.9 %) and 10 (3.2 %). Age, sex, ASA score were comparable between the two groups. The median operative time showed no statistically significant difference between the 3D and 2D groups (p 0.611). Less drains were positioned at the end of the 3D operations comparing with 2D procedures (p 0.013). The stapled anastomosis was the most frequent performed over other techniques. The other intra-operative findings showed no significant difference between the two study groups. The median hospitalization and the reoperation rate showed no difference between the two groups. STUDY 2: The statistical analysis done over all 313 cases divided in 2D and 3D did not reveled significant difference of the visual work scored by the NASA TLX. Data emerging from the SSQ questionnaire reveled no case of moderate or severe symptoms in both groups. CONCLUSIONS 3D laparoscopic surgery had the same postoperative results of the 2D standard laparoscopy. The more frequent intra-abdominal anastomosis in the 3D group might suggest a more safeness felt by the surgeon using the new technology. The NASA TLX and the SSQ questionnaire did not reveled significant difference of the visual work between 2D and 3D vision

Laparoscopic treatment of ventral hernias: the Italian national guidelines

Primary and incisional ventral hernias are significant public health issues for their prevalence, variability of professional practices, and high costs associated with the treatment In 2019, the Board of Directors of the Italian Society for Endoscopic Surgery (SICE) promoted the development of new guidelines on the laparoscopic treatment of ventral hernias, according to the new national regulation. In 2022, the guideline was accepted by the government agency, and it was published, in Italian, on the SNLG website. Here, we report the adopted methodology and the guideline's recommendations, as established in its diffusion policy. This guideline is produced according to the methodology indicated by the SNGL and applying the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) methodology. Fifteen recommendations were produced as a result of 4 PICO questions. The level of recommendation was conditional for 12 of them and conditional to moderate for one. This guideline's strengths include relying on an extensive systematic review of the literature and applying a rigorous GRADE method. It also has several limitations. The literature on the topic is continuously and rapidly evolving; our results are based on findings that need constant re-appraisal. It is focused only on minimally invasive techniques and cannot consider broader issues (e.g., diagnostics, indication for surgery, pre-habilitation)

Hybrid Approach to Atrial Fibrillation Ablation

Sequential surgical thoracoscopic and electrophysiological (EP) ablation is gaining popularity as a novel approach for the treatment of patients with stand-alone, persistent and long standing persistent atrial fibrillation (AF)

New-generation atrial antitachycardia pacing (Reactive ATP) is associated with reduced risk of persistent or permanent atrial fibrillation in patients with bradycardia: Results from the MINERVA randomized multicenter international trial

Background Atrial fibrillation (AF) is a frequent comorbidity in patients with pacemaker and is a recognized cause of mortality, morbidity, and quality-of-life impairment. The international MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial established that atrial preventive pacing and atrial antitachycardia pacing (DDDRP) in combination with managed ventricular pacing (MVP) reduce permanent AF occurrence in comparison with standard dual-chamber pacing (DDDR). Objective We aimed to determine the role of new-generation atrial antitachycardia pacing (Reactive ATP) in preventing AF disease progression. Methods Patients with dual-chamber pacemaker and with previous atrial tachyarrhythmias were randomly assigned to DDDR (n = 385 (33%)), MVP (n = 398 (34%)), or DDDRP+MVP (n = 383 (33%)) group. The incidence of permanent AF, as defined by the study investigator, or persistent AF, defined as ≥7 consecutive days with AF, was estimated using the Kaplan-Meier method, while its association with patients' characteristics was evaluated via multivariable Cox regression. Results At 2 years, the incidence of permanent or persistent AF was 26% (95% confidence interval [CI] 22%-31%) in the DDDR group, 25% (95% CI 21%-30%) in the MVP group, and 15% (95% CI 12%-20%) in the DDDRP+MVP group (P 44.4%) as a significant predictor of reduced permanent or persistent AF risk (hazard ratio 0.32; 95% CI 0.13-0.781; P =.012) and episodes' characteristics, such as long atrial arrhythmia cycle length, regularity, and the number of rhythm transitions, as predictors of high ATP efficacy. Conclusion In patients with bradycardia, DDDRP+MVP delays AF disease progression, with Reactive ATP efficacy being an independent predictor of permanent or persistent AF reduction

Appendectomy during the COVID-19 pandemic in Italy: a multicenter ambispective cohort study by the Italian Society of Endoscopic Surgery and new technologies (the CRAC study)

Major surgical societies advised using non-operative management of appendicitis and suggested against laparoscopy during the COVID-19 pandemic. The hypothesis is that a significant reduction in the number of emergent appendectomies was observed during the pandemic, restricted to complex cases. The study aimed to analyse emergent surgical appendectomies during pandemic on a national basis and compare it to the same period of the previous year. This is a multicentre, retrospective, observational study investigating the outcomes of patients undergoing emergent appendectomy in March-April 2019 vs March-April 2020. The primary outcome was the number of appendectomies performed, classified according to the American Association for the Surgery of Trauma (AAST) score. Secondary outcomes were the type of surgical technique employed (laparoscopic vs open) and the complication rates. One thousand five hundred forty one patients with acute appendicitis underwent surgery during the two study periods. 1337 (86.8%) patients met the inclusion criteria: 546 (40.8%) patients underwent surgery for acute appendicitis in 2020 and 791 (59.2%) in 2019. According to AAST, patients with complicated appendicitis operated in 2019 were 30.3% vs 39.9% in 2020 (p = 0.001). We observed an increase in the number of post-operative complications in 2020 (15.9%) compared to 2019 (9.6%) (p < 0.001). The following determinants increased the likelihood of complication occurrence: undergoing surgery during 2020 (+ 67%), the increase of a unit in the AAST score (+ 26%), surgery performed > 24 h after admission (+ 58%), open surgery (+ 112%) and conversion to open surgery (+ 166%). In Italian hospitals, in March and April 2020, the number of appendectomies has drastically dropped. During the first pandemic wave, patients undergoing surgery were more frequently affected by more severe appendicitis than the previous year's timeframe and experienced a higher number of complications. Trial registration number and date: Research Registry ID 5789, May 7th, 202

Infected pancreatic necrosis: outcomes and clinical predictors of mortality. A post hoc analysis of the MANCTRA-1 international study

: The identification of high-risk patients in the early stages of infected pancreatic necrosis (IPN) is critical, because it could help the clinicians to adopt more effective management strategies. We conducted a post hoc analysis of the MANCTRA-1 international study to assess the association between clinical risk factors and mortality among adult patients with IPN. Univariable and multivariable logistic regression models were used to identify prognostic factors of mortality. We identified 247 consecutive patients with IPN hospitalised between January 2019 and December 2020. History of uncontrolled arterial hypertension (p = 0.032; 95% CI 1.135-15.882; aOR 4.245), qSOFA (p = 0.005; 95% CI 1.359-5.879; aOR 2.828), renal failure (p = 0.022; 95% CI 1.138-5.442; aOR 2.489), and haemodynamic failure (p = 0.018; 95% CI 1.184-5.978; aOR 2.661), were identified as independent predictors of mortality in IPN patients. Cholangitis (p = 0.003; 95% CI 1.598-9.930; aOR 3.983), abdominal compartment syndrome (p = 0.032; 95% CI 1.090-6.967; aOR 2.735), and gastrointestinal/intra-abdominal bleeding (p = 0.009; 95% CI 1.286-5.712; aOR 2.710) were independently associated with the risk of mortality. Upfront open surgical necrosectomy was strongly associated with the risk of mortality (p < 0.001; 95% CI 1.912-7.442; aOR 3.772), whereas endoscopic drainage of pancreatic necrosis (p = 0.018; 95% CI 0.138-0.834; aOR 0.339) and enteral nutrition (p = 0.003; 95% CI 0.143-0.716; aOR 0.320) were found as protective factors. Organ failure, acute cholangitis, and upfront open surgical necrosectomy were the most significant predictors of mortality. Our study confirmed that, even in a subgroup of particularly ill patients such as those with IPN, upfront open surgery should be avoided as much as possible. Study protocol registered in ClinicalTrials.Gov (I.D. Number NCT04747990)

Burnout among surgeons before and during the SARS-CoV-2 pandemic: an international survey

Background: SARS-CoV-2 pandemic has had many significant impacts within the surgical realm, and surgeons have been obligated to reconsider almost every aspect of daily clinical practice. Methods: This is a cross-sectional study reported in compliance with the CHERRIES guidelines and conducted through an online platform from June 14th to July 15th, 2020. The primary outcome was the burden of burnout during the pandemic indicated by the validated Shirom-Melamed Burnout Measure. Results: Nine hundred fifty-four surgeons completed the survey. The median length of practice was 10 years; 78.2% included were male with a median age of 37 years old, 39.5% were consultants, 68.9% were general surgeons, and 55.7% were affiliated with an academic institution. Overall, there was a significant increase in the mean burnout score during the pandemic; longer years of practice and older age were significantly associated with less burnout. There were significant reductions in the median number of outpatient visits, operated cases, on-call hours, emergency visits, and research work, so, 48.2% of respondents felt that the training resources were insufficient. The majority (81.3%) of respondents reported that their hospitals were included in the management of COVID-19, 66.5% felt their roles had been minimized; 41% were asked to assist in non-surgical medical practices, and 37.6% of respondents were included in COVID-19 management. Conclusions: There was a significant burnout among trainees. Almost all aspects of clinical and research activities were affected with a significant reduction in the volume of research, outpatient clinic visits, surgical procedures, on-call hours, and emergency cases hindering the training. Trial registration: The study was registered on clicaltrials.gov "NCT04433286" on 16/06/2020

The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study

AIM: The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery. METHODS: This was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January-April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin. RESULTS: Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P < 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90-1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69-1.27, P = 0.672). Longer delays were not associated with poorer outcomes. CONCLUSION: One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease

Effects of hospital facilities on patient outcomes after cancer surgery: an international, prospective, observational study

Background Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide.Methods A multimethods analysis was performed as part of the GlobalSurg 3 study-a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital.Findings Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3.85 [95% CI 2.58-5.75]; p&lt;0.0001), with excess mortality predominantly explained by a limited capacity to rescue following the development of major complications (63.0% vs 82.7%; OR 0.35 [0.23-0.53]; p&lt;0.0001). Across LMICs, improvements in hospital facilities would prevent one to three deaths for every 100 patients undergoing surgery for cancer.Interpretation Hospitals with higher levels of infrastructure and resources have better outcomes after cancer surgery, independent of country income. Without urgent strengthening of hospital infrastructure and resources, the reductions in cancer-associated mortality associated with improved access will not be realised

Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort