Showing papers in "Reviews on Recent Clinical Trials in 2021"

Anatomy, Physiology and Pathophysiology of Haemorrhoids.

Abstract: Background: Haemorrhoidal disease (HD) is a frequent anal disorder and one of the most common findings identified at colorectal clinic. This article aims to provide an overview of the anatomy, physiology and pathophysiology of haemorrhoids and haemorrhoidal disease. Introduction: Internal haemorrhoids are vascular cushions located in the anal canal, above the dentate line and covered by columnar epithelium. They contribute to the faecal continence and to the sensitivity of the anal canal. The enlargement and/or sliding of haemorrhoidal tissue produce symptoms and complications, the so-called haemorrhoidal disease. Method: A systematic research was realized, looking at the best evidence in literature , searching PubMed, Embase, Cochrane library and most renowned text of colorectal surgery from January 1980 to January 2020. Result: Aetiology and pathophysiology of HD are still controversial, but multifactorial. Disruption of stromal scaffolding, enlargement of vascular component, elevated anal pressure and rectal redundancy represent key events in the development and complications of the disease. Local inflammation may play also a role. Goligher's classification remains the most widely used. A careful patient history and examination are paramount to diagnose HD, excluding other anal or colonic pathologies. Conclusion: Several aspects of etiopathogenesis and pathophysiology remain controversial. Further studies are needed to obtain a better understanding of the disease.

Tocilizumab in Sars-cov-2 Patients with the Syndrome of Cytokine Storm; a Narrative review.

Abstract: INTRODUCTION: Coronavirus is a group of viruses which causes diseases in mammals and birds. In humans, these family of viruses can cause the respiratory infections from mild form to fatal forms. It is preferably called as coronavirus. Formally it known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or 2019 novel coronavirus (2019- nCoV) and this disease is called as coronavirus disease 2019 (COVID-19). SARS-CoV-2 is infectious in humans and world health organization has announced that Covid-19 as a pandemic disease. Tocilizumab is a biological agent which inhibits the cytokine, interleukin 6 (IL-6 inhibitor). As SARS-CoV-2 infection leads to the development of cytokine storm syndrome, the drug tocilizumab seems to have positive effect in patients with covid-19. PURPOSE OF THE STUDY: To analyze and review the possible effects and efficacy of the tocilizumab (monoclonal antibody against IL-6 receptors) in SARS-CoV-2 patients. MATERIALS AND METHODS: The search strategy on recent research and review articles is used for the SARS-CoV-2 disease and their characteristics. Furthermore we have analyzed most recent research article on monoclonal antibody against IL-6 receptors (tocilizumab) and their possible clinical effects in Covid-19 and their clinical trials on Covid-19 patients. RESULTS AND CONCLUSION: Covid-19 is a disease caused by SARS-CoV-2 infection. It is a life threatening condition which can give rise to fatal outcomes if left untreated. However there are no approved treatment for covid-19 globally. Furthermore we can conclude that SARS-CoV-2 is associated with worsening of lung conditions characterized by interstitial pneumonia with acute respiratory distress syndrome as a result of cytokine storm syndrome. According to available research data tocilizumab, a recombinant humanized anti-human monoclonal antibody of IgG1τ (gamma 1, kappa) can improve patient's condition from cytokine storm syndrome by inhibiting the IL-6 (Interleukin 6) receptors. The rational use of the tocilizumab in severe and critically ill covid-19 patients can prevent the development of irreversible lung injury and death of the patient. Three retrospective studies of Xiaoling Xu et al., Pan luo et al. and Paola Tonaiti et al. has shown the efficacy of tocilizumab in severe and critically ill covid-19 patients. However we need more randomized research studies with significant number of patients which can confirm the promising results on tocilizumab treatment in covid-19 patients and even ongoing clinical trails such as TOSCA, COVACTA results has not been published yet which are expected to give better and more significant results on tocilizumab's effectiveness and safety.

Impact of Covid-19 on Mental Health: An Overview.

Abstract: BACKGROUND: The COVID-19 (2019-nCoV) pandemic is a major threat to public health affecting the world; it has been identified as originating in Wuhan, Hubei province, China. It is spreading widely and rapidly spread across the globe, causing an outbreak of acute infectious pneumonia. Such global outburst is associated with adverse effects on mental health. Fear, stress, anxiety seem more definitely an outcome of mass quarantine. METHODS: Keeping this pandemic situation in mind, existing literature on the COVID-19 crisis relevant to mental health was redeemed via a literature search from PubMed database. Collected published articles were classified according to their overall themes and summarized. RESULTS: Preliminary evidence suggests that symptoms of self-reported stress, anxiety and depression are common psychological impact to the pandemic, and may be associated with disrupted sleep. Regional, state, National-international borders have almost been shut down, economies crashed, and billions of people quarantined or isolated at their own homes and quarantine centers. In this situational frame of covid-19, patients, front-line healthcare professionals, geriatric population with existing psychiatric conditions may be encountering further suffering. CONCLUSION: COVID-19 will continue to affect mental health and wellbeing intensely; also, mental health serves an important role in battling the epidemic. With the scare of COVID-19 pandemic on the rise, it is time that as psychiatrists should try to integrate the health-care services keeping mental health at prime.

Classifications and Clinical Assessment of Haemorrhoids: The Proctologist's Corner.

Abstract: Background Haemorrhoidal disease (HD) is a benign condition affecting a considerable part of adult population. HD can be considered a social and economic burden with high impact on patients' lifestyle. Several new techniques and devices have been proposed for HD treatment; however, preoperative assessment is essential and the use of classification system is recommended. Methods In the last two decades many studies described the preoperative assessment and several attempts of classification for HD. This review focuses on the most relevant studies found in literature where classification systems and clinical evaluation with differential diagnosis have been evaluated. Results The knowledge of classification systems and differential diagnosis for HD has been shown to play a central role in the clinical assessment and the best treatment choice. Although there are new challenging techniques and devices for HD treatment, a preoperative assessment is always mandatory. Conclusion Preoperative clinical evaluation is essential for HD patient treatment and outcome. Classification systems are useful for the therapeutic choice and researches on new medical or surgical treatments. In fact, the international guidelines advise several therapeutic options depending on the severity of the HD.

Post-Hemorrhoidectomy Pain Management: The Latest News

Abstract: Anal post-operative pain is one of the principal issues of surgical treatment of hemorrhoids and remains a distressing problem, for patients and physicians. Recent studies have concluded that appropriate postoperative pain management leads to higher patient satisfaction, earlier mobilization, fewer drug complications, eliminated adverse events, faster recovery, and decreased health care cost. However, despite advances in pain medicine, postoperative pain control remains problematic and remains an important unresolved issue that causes expense and patient dissatisfaction. Therefore, this situation calls for multi-modal pain management, choosing medication, dosing regimens and route of administration in an individualized way to optimize efficacy and minimize adverse effects. Multiple approaches, including pharmacological and surgical interventions, have been used to manage pain after hemorrhoidal surgery. Our aim was to check the latest instruments and strategies available in literature designed to find practical solutions to this challenging problem.

Stapled Surgery for Hemorrhoidal Prolapse: From the Beginning to Modern Times.

Abstract: Introduction Hemorrhoidal disease is the most common proctologic condition in adults. Among the different surgical procedures, one of the greatest innovations is represented by the stapled hemorrhoidopexy. The history of this technique started with a single stapler use passing thorough a double stapler technique to resect the adequate amount of prolapse, finally arriving to the use of high volume devices. Methods Nevertheless each device has its own specific feature, the stapler is basically made up with one or more circular lines of titanium staples whose height may be variable. The procedure is based on different steps: Introduction of the CAD, evaluation of the prolapse, fashioning purse string or parachute suture, introduction of the stapler head beyond the suture, pull the wires through the window, close the stapler and keep pulled the wires of the suture held together with a forcep, fire using two hands, open the stapler and remove it and check the staple line and then check the specimen. One of the latest innovations in stapled surgery the Tissue Selective Therapy. It is a minimally invasive procedure in which there is a partial circular stapled hemorrhoidopexy focused on the prolapsing piles with bridges of normal mucosa left. Results Several studies have reported that SH is a safe and effective procedure to treat the hemorrhoidal prolapse. It is a quicker procedure with a shorter hospital stay and earlier return to work if compared with the conventional treatment. This is due to a less postoperative pain, postoperative bleeding, wound complications and constipation. Furthermore, the first generation devices had worse outcomes if compared with those of the new generation stapler that showed lower postoperative complication rate with better anatomical and symptomatic results. Conclusions Stapled procedure for the treatment of symptomatic hemorrhoidal prolapse represents one of the most important innovations in proctology of the last century bringing with it the new revolutionary concept of the rectal intussusception as a determining factor involved in the natural history of the disease. Stapled hemorrhoidopexy marked an era in which the surgeon may to offer to the patients a safe, effective treatment with less pain and fast recovery.

Do We Have Another Option to Treat Bleeding Hemorrhoids? The Emborrhoid Technique: Experience in 16 Patients.

Abstract: Background Hemorrhoidal disease is very common in western countries and rectal bleeding is the main symptom complained by patients. Nowadays the ultimate goal of treatment is to block the bleeding with minimally-invasive techniques to minimize post-procedural pain. Objective The aim of this study is to assess the preliminary results of the emborrhoid technique (embolization of the superior rectal arteries branches) as a new tool for the proctologist to treat severe bleeding hemorrhoids causing anemia. Many categories of patients might benefit from this treatment, such as patients not eligible for conventional surgery, patients not responding to conventional treatment and fit patients with severe bleeding who refused endorectal surgical therapy. Methods From May 2017 to November 2018 a total of 16 patients with chronic rectal bleeding due to hemorrhoids underwent super-selective embolization of the superior rectal arteries at the department of General Surgery in La Spezia, S. Andrea Hospital, Italy. Median age was 59 years. 14 patients were males (87.5%). Results No post-procedural and short-term complications were observed at maximum follow up (12 months). The reduction of rectal bleeding with improvement of the quality of life was obtained in 14 patients (87.5%). Conclusion Our study, although small in number, demonstrates that embolization of superior rectal arteries with coils to treat severe bleeding due to hemorrhoids is safe and effective and does not lead to immediate complications.

COVID-19 and Pneumolysis Simulating Extreme High-altitude Exposure with Altered Oxygen Transport Physiology; Multiple Diseases, and Scarce Need of Ventilators: Andean Condor's-eye-view.

Abstract: BACKGROUND Critical hypoxia in this COVID-19 pandemic results in high mortality and economic loss worldwide. Initially, this disease' pathophysiology was poorly understood and interpreted as a SARS (Severe Acute Respiratory Syndrome) pneumonia. The severe atypical lung CAT scan images alerted all countries, including the poorest, to purchase lacking sophisticated ventilators. However, up to 88% of the patients on ventilators lost their lives. It was suggested that COVID-19 could be similar to a High-Altitude Pulmonary Edema (HAPE). New observations and pathological findings are gradually clarifying the disease. METHODS As high-altitude medicine and hypoxia physiology specialists working and living in the highlands for over 50 years, we perform a perspective analysis of hypoxic diseases treated at high altitudes and compare them to Covid-19. Oxygen transport physiology, SARS-Cov-2 characteristics, and its transmission, lung imaging in COVID-19, and HAPE, as well as the causes of clinical signs and symptoms, are discussed. RESULTS High-altitude oxygen transport physiology has been systematically ignored. COVID-19 signs and symptoms indicate a progressive and irreversible failure in the oxygen transport system, secondary to pneumolysis produced by SARS-Cov-2's alveolar-capillary membrane "attack". HAPE's pulmonary compromise is treatable and reversible. COVID-19 is associated with several diseases, with different individual outcomes, in different countries, and at different altitudes. CONCLUSIONS The pathophysiology of High-altitude illnesses can help explain COVID-19 pathophysiology, severity, and management. Early diagnosis and use of EPO, acetylsalicylic-acid, and other anti-inflammatories, oxygen therapy, antitussives, antibiotics, and the use of Earth open-circuit- astronaut-resembling suits to return to daily activities, should all be considered. Ventilator use can be counterproductive. Immunity development is the only feasible long-term survival tool.

Neutrophil-to-lymphocyte Ratio and Platelet-to-lymphocyte Ratio as Biomarkers for Cardiovascular Surgery Procedures: A Literature Review.

Abstract: BACKGROUND Neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) have been studied so far as prognostic factors of cardiovascular diseases. Their role interplayed with endothelial inflammation has emerged as optimal predictors for major cardiovascular disease events and prognostic factors for post-procedural outcomes. METHODS A review of the current literature was undertaken to investigate the relationship between NLR and PLR with percutaneous, cardiac surgery, and vascular surgery procedures. RESULTS Our findings show that perioperative NLR and PLR levels are significantly correlated with patient morbidity and mortality rates. CONCLUSION These biomarkers have several attractive characteristics, as they are inexpensive and quickly available, and they can contribute to the early identification of patients at high risk for periprocedural adverse events.

Metabolic Benefits of Probiotic Combination with Absorbent Smectite in type 2 Diabetes Patients a Randomised Controlled Trial.

Abstract: BACKGROUND Numerous non-drug therapies have emerged in recent years for the prevention and improvement of type 2 diabetes (T2D). However, therapies based on dietary modification and/or microbiota may replace a large part of drug therapies in the coming years. AIM The aim of the current study was to conduct placebo-controlled randomize clinical trial for the efficiency of a combination of multiprobiotics with smectite absorbent gel (Symbiter-Forte formulation) as an adjunction to the standard anti-diabetic therapy. METHODS A total of 55 patients met the criteria and were included in double-blind single center RCT, to receive "Symbiter-Smectite" or placebo for 8-weeks administered as a sachet formulation. The primary outcome was the change in HOMA2-IR and insulin sensitivity (% S). Secondary outcomes were glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response. RESULTS Combined use of the probiotic mixture with smectite leads to a significant reduction in HOMA2-IR (3.14±0.97 vs 2.79±0.85; р=0.009) and improvement in % S (34.65±9.92 vs 39.42±12.78; p=0.011) after 8 weeks of the treatment period. Simultaneously, in the secondary outcome analysis lowering of HbA1c, waist circumference but not BMI and pro-inflammatory cytokines IL-1β (p=0.004), TNF-α (p=0.008), IL-6 (p=0.005) and IL-8 (p=0.042) were detected. In placebo group, changes were insignificant. CONCLUSION Probiotic with smectite due to its absorbent activity and stabilization mucus layer properties can impact the synergistic enhancement of a single effect, which manifested with a significant reduction in IR, waist circumference, markers of chronic systemic inflammation and improvement of glycemic profile as compared to placebo.

Gut Alterations in Septic Patients: A Biochemical Literature Review

Abstract: Background Sepsis is a life-threatening organ dysfunction with high mortality and morbidity rate and with the disease progression many alterations are observed in different organs. The gastrointestinal tract is often damaged during sepsis and septic shock and main symptoms are related to increased permeability, bacterial translocation and malabsorption. These intestinal alterations can be both cause and effect of sepsis. Objective The aim of this review is to analyze different pathways that lead to intestinal alteration in sepsis and to explore the most common methods for intestinal permeability measurement and, at the same time to evaluate if their use permit to identify patients at high risk of sepsis and eventually to estimate the prognosis. Material and methods The peer-reviewed articles analyzed were selected from PubMed databases using the keywords "sepsis" "gut alteration", "bowel permeability", "gut alteration", "bacterial translocation", "gut permeability tests", "gut inflammation". Among the 321 papers identified, 190 articles were selected, after title - abstract examination and removing the duplicates and studies on pediatric population,only 105 articles relating to sepsis and gut alterations were analyzed. Results Integrity of the intestinal barrier plays a key role in the preventing of bacterial translocation and gut alteration related to sepsis. It is obvious that this dysfunction of the small intestine can have serious consequences and the early identification of patients at risk - to develop malabsorption or already malnourished - is very recommended to increase the survivor rate. Until now, in critical patients, the dosage of citrullinemia is easily applied test in clinical setting, in fact, it is relatively easy to administer and allows to accurately assess the functionality of enterocytes. Conclusion The sepsis can have an important impact on the gastrointestinal function. In addition, the alteration of the permeability can become a source of systemic infection. At the moment, biological damage markers are not specific, but the dosage of LPS, citrulline, lactulose/mannitol test, FABP and fecal calprotectin are becoming an excellent alternative with high specificity and sensitivity.

Erythema Pernio-like in four Adolescents in the era of the Coronavirus-2 Infection.

Abstract: Background Although epidemic, novel coronavirus (SARS-CoV-2) infection rarely affects the pediatric population. However, in the last months, an increasing number of Italian pediatricians have reported the occurrence of erythema pernio-like in children following a flu-like syndrome, after the outbreak of SARS-CoV-2 infection. Objective The study aims to report cutaneous manifestation of SARS-CoV-2 infection in 4 adolescents. Methods Observational study reporting 4 adolescents with skin lesions, 2 weeks after the occurrence of a flu-like syndrome. Results Fourteen days after a flu-like syndrome, adolescents exhibited skin lesions to toes and feet. These lesions were rounded, with blurred limits, with a 5-15 mm diameter, red-violaceous- bluish colored, sometimes resulting in bullous lesions in correspondence of the central or apical portion, which tended to be covered with blackish crusts after evolution. Lesions were also accompanied by pain of variable intensity and evolved within two or three weeks to self-resolution without particular sequelae. In two patients, pharyngeal and nasal swabs were negative for SARSCoV- 2 infection, at the presentation of skin lesions. After 2 months from clinical manifestations, patients were tested positive for SARS-CoV-2 antibodies. Conclusions In the pediatric and adolescent population, the occurrence of an erythema pernio-like after a flu-like syndrome could be associated with SARS-CoV-2 infection.

A Critical Overview of Systematic Reviews of Chemotherapy for Advanced and Locally Advanced Pancreatic Cancer using both AMSTAR2 and ROBIS as Quality Assessment Tools.

Abstract: BACKGROUND We performed a critical overview of published systematic reviews (SRs) of chemotherapy for advanced and locally advanced pancreatic cancer, and evaluated their quality using AMSTAR2 and ROBIS tools. MATERIALS AND METHODS PubMed and Cochrane Central Library were searched for SRs on 13th June 2020. SRs with meta-analysis which included only randomized controlled trials and that had assessed chemotherapy as one of the treatment arms were included. The outcome measures, which were looked into, were progression-free survival (PFS), overall survival (OS), and adverse events (AEs) of grade 3 or above. Two reviewers independently assessed all the SRs with both ROBIS and AMSTAR2. RESULTS Out of the 1,879 identified records, 26 SRs were included for the overview. Most SRs had concluded that gemcitabine-based combination regimes, prolonged OS and PFS, but increased the incidence of grade 3-4 toxicities when compared to gemcitabine monotherapy, but survival benefits were not consistent when gemcitabine was combined with molecular targeted agents. As per ROBIS, 24/26 SRs had 'high' risk of bias, with only 1/26 SR having 'low' risk of bias. As per AMSTAR2, 25/26 SRs had 'critically low', and 1/26 SR had 'low' confidence in the results. The study which scored 'low risk of bias' in ROBIS scored 'low confidence in results' in AMSTAR2. The inter- rater reliability for scoring the overall confidence in the SRs with AMSTAR2 and the overall domain in ROBIS was substantial; ROBIS: kappa=0.785, SEM=0.207, p<0.001; AMSTAR2: kappa= 0.649, SEM=0.323, p<0.001. CONCLUSION Gemcitabine-based combination regimens can prolong OS and PFS but also worsen AEs when compared to gemcitabine monotherapy. The included SRs have an overall low methodological quality and high risk of bias as per AMSTAR2 and ROBIS respectively.

Clinical Management of Infectious Diarrhea.

Abstract: Background Infectious diarrhea is the most common cause of diarrhea worldwide and is responsible for more deaths than other gastrointestinal tract diseases such as gastrointestinal cancers, peptic ulcer disease or inflammatory bowel disease. Diarrheal disease still represents the 8th leading cause of death worldwide, with more than 1,6 million attributed fatalities in 2016 alone. The majority of cases can be divided into three principal clinical presentations: acute watery diarrhea lasting 5-10 days and normally self-limiting, bloody diarrhea (dysentery), and persistent diarrhea with or without intestinal malabsorption. Methods We performed an electronic search on PUBMED of the scientific literature concerning infectious diarrhea and its clinical management. Aim In this review article, we analyze the most important causes of infectious diarrhea and their constellation of signs and symptoms, providing an update on the diagnostic tools available in today's practice and on the different treatment options. Conclusion Even though the majority of intestinal infections are self-limiting in immunocompetent individuals, specific diagnosis and identification of the causative agent remain crucial from public health and epidemiological perspectives. Specific diagnostic investigation can be reserved for patients with severe dehydration, more severe illness, persistent fever, bloody stools, immunosuppression, and for cases of suspected nosocomial infection or outbreak and it includes complete blood count, creatinine and electrolytes evaluation, determination of leukocytes and lactoferrin presence in the stools, stool culture, together with C. difficile testing, PCR, ova and parasites' search, endoscopy and abdominal imaging. Since acute diarrhea is most often self-limited and caused by viruses, routine antibiotic use is not recommended for most adults with mild, watery diarrhea. However, when used appropriately, antibiotics are effective against shigellosis, campylobacteriosis, C. difficile colitis, traveler's diarrhea, and protozoal infections. Furthermore, antibiotics use should be considered in patients who are older than 65 years, immunocompromised, severely ill, or septic.

Scoring System for Haemorrhoidal Disease.

Abstract: Hemorrhoidal Disease (HD) is widely diffused throughout the general population. The system of classification currently used to categorize this pathology is that of Goligher (1975). Several attempts in literature have been made to refine this classification, but as of yet, no single system has been universally accepted. Some studies, however, have succeeded in identifying specific characteristics, besides morphology, that would be able to aptly define HD. An analysis of the literature, with careful consideration of the scores that have previously been proposed, was performed, with the aim of deepening and stimulating discussion about a possible new definition of HD.

Bedside Cardiac Pocus in Emergency Setting: A Practice Review.

Abstract: Background In the last years, ultrasound technology has entered clinical practice as a tank and today, it has also allowed no-cardiologists to extend their medical examination without needing to call the consultant and having a good profile of diagnostic accuracy. The ultrasound bedside does not replace the consultant, but it allows not to perform inappropriate consultations with more savings for hospitals. Objective The aim was to review the recently published literature to inform the clinician about the most up to date management of use bedside echography in the emergency setting. In this short review, we focused on two types of syndromes, no traumatic- hypotension and dyspnea, common to the three holistic disciplines of medicine, showing the main and basic questions and answers that ultrasound can give us for rapid identification of the problems. Methods We conducted a systematic review using Pubmed/Medline, Ovid/Willey and Cochrane Library, combining key terms such as "cardiac ultrasound, "cardiac diseases", "emergency medicine", "pocus", "dyspnea", " hypotension". We selected the most relevant clinical trials and review articles (excluding case reports) published in the last 19 years and in our opinion, 59 publications appeared to be the best choice according to the PRISMA statement. In additional papers identified from individual article reference lists were also included. Conclusion Recent studies have shown a promise in establishing best practices for evaluation of heart, lung abdomen and deep vessels At the moment, bedside US is widely used in an integrated ultrasound vision just like the holistic view have internal medicine, intensive care and emergency medicine and many medical schools in Europe and the USA are inserting ultrasonography into the core curriculum, but we still have to find a standard method for the training program for minimum competence acquisition.

Outpatient Treatment of Hemorrhoidal Disease: The Alternative Way to Treat Hemorrhoidal Disease in a Simple, Safe and Effective Manner.

Abstract: Background Hemorrhoidal disease is a widespread problem in healthy working patients. The traditional surgical approaches cause a loss of several working days related to the post-operative course that is often painful. To avoid these problems while offering a symptoms resolution in patients with low degrees hemorrhoids, the non-surgical treatments are nowadays largely proposed in proctological clinics. Methods We resume the recent literature on the issue to offer a practical and easy to use guide for clinicians. Results Rubber band ligation, injection sclerotherapy and infrared coagulation are cost effective, safe and effective treatments for patients with II- and III-degree hemorrhoids. Relapses are commons even if the procedures can be repeated until symptoms resolution. IV-degree hemorrhoids are not suitable of these treatments. Conclusion The proctological clinics must evaluate the quality of life offered to patients and discuss with them the appropriate treatment in order to select the most appropriate one for symptoms resolution and disease cure. Less is not always the best but can be an alternative to be offered.

SARS-CoV-2 Spread Dynamics in Italy: The Calabria Experience.

Abstract: Introduction The first case of infection by SARS-CoV-2 (i.e., COVID-19) has been officially recorded by the Italian National Health Service on February 21st, 2020. Lombardy was the first Italian region to be affected by the pandemic. Subsequently, the entire Northern part of Italy recorded a high number of cases, while the South was hit following the migratory waves. On March 8th, the Italian Government has issued a decree that imposed a total lockdown defined as a state of isolation and restricted access in Lombardy and in the other 14 provinces of Northern Italy. Methods We analyzed the virus trend in the period between February 24th and September 8th, 2020, focusing on Calabria, with regards to the following items: new positives, change of total positives and total cases. Furthermore, we included other information, such as the incubation period, symptom resolution period, quarantine period. Results On March 27th, the epidemic curve spiked with 101 new positive cases validating the hypothesis that this abnormal event was related to the displacement of non-residents people, living in the Northern part of Italy, to the home regions in the South. The epidemic curve showed a decreasing trend in the period after lockdown proving the effectiveness of this measure. From the end of the lockdown (May 04th) to September 8th, the registered trend was -94.51%. A negative growth rate indicates that the number of new positive cases is lower than the number of healed patients. Conclusion This study describes the effectiveness of the Italian Government policy, particularly the role of lockdown, for the containment of SARS-CoV-2 contagion in Calabria, a region with a low SARS-CoV-2 infection rate within the registered period.

Excisional Haemorrhoidectomy: Where Are We?

Abstract: Haemorrhoidal disease (HD) is defined as the symptomatic enlargement and/or distal displacement of anal cushions and is one of the most frequent and ancient anorectal conditions. Bleeding, during or after defecation, is the most common symptom. The color of the blood is typically bright red covering the outer surface of the stools. The severity of HD is based on the degree of the prolapse. There are several excisional surgery treatments. In this review, we describe the most common techniques such as Milligan and Morgan, Parks, Ferguson and Whitehead technique. Despite significant improvements in conservative treatments, excisional haemorrhoidectomy techniques are the most effective treatment for III- and IV degree.

Prevalence and Related Factors of Sarcopenia in Community-dwelling Elderly with Long-term Care Insurance.

Abstract: BACKGROUND AND OBJECTIVE The purpose of this investigation was to examine the prevalence, related factors, and cut-off value of body mass index for sarcopenia in community-dwelling elderly covered by long-term care insurance. METHODS Design was a cross-sectional study, in which113 consecutive community-dwelling elderly with long-term care insurance who underwent rehabilitation at a daycare center in Japan from January 2016 to January 2018, those who were aged ≥65 years old and could walk were included. Those in whom skeletal muscle mass index could not be measured were excluded. The determination of sarcopenia was made according to the criteria of the Asian Working Group for Sarcopenia. We analyzed the data with the unpaired t-test, χ2 test, logistic regression analysis, and receiver operating characteristic curves. RESULTS The 99 elderly meeting the criteria were included and divided into the sarcopenia group (n=36) and no sarcopenia group (n=63). The prevalence was 36.4%. The sarcopenia group was significantly older and had lower body mass index, skeletal muscle mass index, and grip strength than the group without sarcopenia (p <0.05). Age and body mass index were extracted as significant sarcopenia- related factors (p <0.05). The cut-off value of body mass index for sarcopenia was 22.6 kg/m2. CONCLUSION The prevalence of sarcopenia in the elderly in the long-term care insurance region was 36.4%, and age and body mass index were extracted as sarcopenia-related factors. The cut-off value of body mass index for sarcopenia was 22.6 kg/m2.

Liver Cirrhosis Complications Management At The Emergency Department

Abstract: Background and aims liver cirrhosis (LC) of any origin has always been a source of several emergencies for physicians working at the Emergency Department (ER). LC patients can present with several complications that are sometimes difficult to recognize and treat. Thus, we reviewed the literature evidences for the diagnosis and management of several LC related emergencies. Methods We conducted a search on the main medical databases for papers, reviews, metanalyses, case series, and RCTs using the following keywords and their associations: liver cirrhosis, variceal hemorrhage, ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepato-renal syndrome, emergency. Results Main LC emergencies are upper gastrointestinal hemorrhage, decompensated ascites and spontaneous bacterial peritonitis, hepatic encephalopathy, hepato-renal syndrome. Their management is partly medical and interventional. Very often, the final cure of some complications, such as hepato-renal syndrome, is represented by liver transplantation. Conclusions Although LC prevalence is going to fall in the following years, due to HBV and HCV optimized treatments, its complications represent a significant admission percentage at the ER and challenge for physicians' skills.

Conservative Treatment of Hemorrhoidal Disease.

Abstract: Background Hemorrhoids are vascular cushions underlying the distal rectal mucosa and contributing to approximately 15-20% of the resting anal pressure with a complete closure of the anal canal. They can become pathological (hemorrhoidal disease, HD) being the most common cause of painless rectal bleeding during defecation with or without prolapsing anal tissue. The treatment of HD must be tailored to both the severity of disease and patient's expectation. Methods A narrative review of all the most relevant papers present on the three major databases (PUBMED, EMBASE and WEB OF SCIENCE) regarding conservative treatment was conducted. Results Conservative treatment is effective in managing the majority of patients complaining of early stages of the disease. Dietary and lifestyle modifications are the first therapeutic step necessary to achieve a regular defecation with soft stool whereas oral phlebotonic drugs can help to control symptoms. The use of topical medications, particularly during the acute phase or in the post-operative period can also be beneficial for all patients complaining of HD. Conclusion Despite a large number of available products in the market and the high incidence of HD, very few randomized controlled trials have been carried out and most of the studies are uncontrolled case series. Larger and better designed studies are necessary to establish the real benefit of all types of drugs for the treatment of early stages of HD.

Management of Idiopathic Intracranial Hypertension During the COVID-19 Pandemic.

Abstract: BACKGROUND: In the current coronavirus disease 2019 (COVID-19) pandemic, health systems are struggling to prioritize care for affected patients, however, physicians globally are also attempting to maintain care for other lessthreatening medical conditions that may lead to permanent disabilities if untreated. Idiopathic intracranial hypertension (IIH) is a relatively common condition affecting young females that could lead to permanent blindness if not properly treated. In this article, we provide some insight and recommendations regarding the management of IIH during the pandemic. METHODS: The diagnosis, follow-up, and treatment methods of IIH during the COVID-19 pandemic period are reviewed. COVID-19 as a mimic of IIH is also discussed. RESULTS: Diagnosis and follow-up of papilledema due to IIH during the COVID-19 pandemic can be facilitated by nonmydriatic fundus photography and optical coherence tomography. COVID-19 may mimic IIH by presenting as cerebral venous sinus thrombosis, papillophlebitis, or meningoencephalitis, so a high index of suspicious is required in these cases. When surgical treatment is indicated, optic nerve sheath fenestration may be the primary procedure of choice during the pandemic period. CONCLUSION: IIH is a serious vision threatening condition that could lead to permanent blindness and disability at a relatively young age if left untreated. It could be the first presentation of a COVID-19 infection. Certain precautions during the diagnosis and management of this condition could be taken that may allow appropriate care to be delivered to these patients while minimizing the risk of coronavirus infection.

Postoperative Complications in Hemorrhoidal Disease and Special Conditions.

Abstract: Background Hemorrhoidal disease is still one of the most prevalent proctological diseases. Pain is the most common complication after surgery but bleeding, urinary retention and perianal infection are also frequent. There is also an important group of patients, such as those with inflammatory bowel disease, pregnancy or immunosuppression, who can present an increased rate or more severe complications. Objective To describe the complications following different surgical and instrumental techniques for hemorrhoids in a literature review. Special situations were reviewed to determine how they affect the management of the disease. Methods During August 2019, a narrative review of hemorrhoid surgery complications and special situations was performed using the Pubmed MESH DATABASE. Conclusion Pain, urinary retention and bleeding remain the most frequent complications after surgery for hemorrhoids; however, special situations must be taken into account in order to choose the best technique to prevent more severe complications.

Management of Immunotherapy Adverse Events in Oncological Patients: Anti-CTLA-4, Anti-PD-1/PD-L1.

Abstract: Background The widespread use of immunotherapy drugs in the oncological field has led to the spread of new toxicities compared to the more common chemotherapy treatments This is because immunotherapy with anti-CTLA-4 (Cytotoxic T Lymphocytes-Associated Antigen 4), anti- PD-1 and anti-PD-L1 monoclonal antibodies has become the standard-of-care in a growing number of indications Any organ or tissue can be involved, but more commonly, side effects are reported regarding skin, colon, endocrine glands, liver, lung and kidney Other less frequent, but more serious, adverse events are neurological and myocarditis Methods We performed an electronic search on PUBMED of the literature concerning immunotherapy- related toxicities and their management in oncological patients from 2007 to 2020, with particular attention to the most recent publications Aim To summarize the different types of immunotherapy-related toxicities, together with their incidence and diagnosis, and to simplify their management, especially in the emergency setting Conclusion Usually, for grade I toxicities, it is not recommended to stop immunotherapy; for most of grade II toxicities, immunotherapy should be postponed to when toxicity will have regressed to grade I, considering the possibility of corticosteroid treatment for most toxicities The majority of grade III and IV require administration of high-dose corticosteroid intravenous therapy and suspension of immunotherapy Mortality related to immune checkpoint inhibitors' toxicity, occurring at a rate of 03-13%, is well below fatality rates due to other oncologic interventions and should not discourage the promising results so far reached by immunotherapy

Ligasure Hemorrhoidectomy: Updates on Complications after an 18-Year Experience

Abstract: Background Hemorrhoidal disease represents one of the most common anorectal disorders in the general population. Energy devices, such as LigaSureTM scalpel, have reshaped the concept of hemorrhoid surgery and in turn, have improved patient outcomes and simplified the work of surgeon. Objective The study aims to evaluate the outcomes of LigaSureTM hemorrhoidectomy (LH) analyzing main post-operative complications rate, length of stay, operating time and time to return to work. Methods In this monocentric descriptive study, from June 2001 to February 2019, 1454 consecutive patients, treated with LH for grade III and IV haemorrhoids, were analyzed. Complications were classified in early, late and long-term if they occurred within 1 month, between 1 and 2 months or after 2 months, respectively. Results (90.2%) of patients were treated in day surgery regimen and mean operating time was 14.3 minutes. The post-operative pain decreased from 3.7 mean VAS on the 1st post-operative day to 0.1 mean VAS on 30th post-operative day. Early complications rate was 2.1%: urinary retention accounted for 1.8% of patients. 0.3% of patients experienced post-operative bleeding and only one required reoperation. Late complications rate was 5.8%: anal stenosis, incomplete healing and anal fissure were detected in 3.6%, 1.2% and 1% of patients, respectively. The Long term complications rate was 5.3 % : anal fistula, soiling, perianal abscess and recurrence were identified in 0.2%, 0.1%, 0.3% and 4.8% of patients, respectively. Conclusion LH is a safe and fast procedure with a proven minimal complications rate.

Management of Hemorrhoidal Disease in Special Conditions: A Word of Caution

Abstract: Background Hemorrhoids are a common disease that is often considered an easy problem to solve. Unfortunately, some particular clinical conditions, including Inflammatory Bowel Diseases (IBD), pregnancy, immunosuppression, coagulopathy, cirrhosis with portal hypertension, and proctitis after radiotherapy, challenge hemorrhoids management and the outcomes. Methods Research and online contents related to hemorrhoids' treatment in special conditions are reviewed in order to help colorectal surgeons in daily practice. Results There are very limited data about the outcomes of hemorrhoids treatment in these subgroups of patients. Patients in pregnancy can be effectively treated with medical therapy, reserving surgical intervention in highly selected and urgent cases. In case of thrombosed haemorrhoids, the excision allows a fast symptoms' resolution, with a low incidence of recurrence and a long remission interval. In case of immunosuppressed patients, there is no consensus for the best treatment, even in most HIV positive patients, a surgical procedure can be safely proposed when indicated. There is no sufficient data in the literature related to transplanted patients. The surgical treatment of hemorrhoids in patients with IBD, especially Crohn's Disease, can be unsafe, although there is a paucity of literature on this topic. In case of previous pelvic radiotherapy, it must always be considered that severe complications, like abscesses and fistulas with subsequent pelvic and retroperitoneal sepsis, can occur after surgical treatment of hemorrhoids, so a conservative treatment is advocated. Moreover, caution is recommended in treating patients with coagulopathy, considering possible complications (mostly bleeding) also after outpatient treatments. In case of portal hypertension and cirrhosis, a 'conservative treatment' is recommended. Bleeding hemorrhoids can be treated with hemorrhoidectomy when they do not respond to other treatments. Conclusion International literature is very scant about the treatment of patients affected by hemorrhoids in particular situations. A word of caution and concern even about the indication for minor outpatient procedures must be expressed in these patients, in order to avoid possible life-threatening complications. The first-line treatment is the conservative medical approach associated with the treatment of the primary disease.

Physical and Mental Functions of Cardiovascular Diseased Patients Decrease During the State of Emergency Initiated by the COVID-19 Pandemic in Japan.

Abstract: BACKGROUND AND OBJECTIVE: We aimed to examine the differences in life-space mobility and quality of life (QoL) of patients with cardiovascular disease (CVD) between the pre- and post-nationwide state of emergency initiated by the Coronavirus disease 2019 (COVID-19) pandemic in Japan and to show the factors associated with the decrease in life-space mobility and QoL in these patients. METHODS: We undertook a longitudinal study of 20 of 51 consecutive CVD patients with coronary artery disease (CAD) who met the study criteria. We used the Life-Space Assessment (LSA) tool to evaluate Life-space mobility and assessed QoL with the five-level EuroQoL five-dimensional questionnaire (EQ-5D-5L) in Japanese. RESULTS: The LSA scores and EQ-5D-5L QoL score decreased significantly from the pre- to post-nationwide state of emergency in Japan (p < 0.01). ΔLSA was significantly positively associated with body mass index and significantly negatively associated with knee extensor muscle strength and pre-LSA score (p < 0.05). There were no significant relationships between ΔLSA and ΔEQ-5D-5L QoL scores and between ΔEQ-5D-5L QoL scores and patient characteristics. CONCLUSION: The policies promoted to address the state of emergency in Japan might affect life-space mobility and QoL of CAD patients. Moreover, CAD patients in Japan who were not obese and maintained their physical function and activity tended to refrain from activity during the period between the pre- and post-nationwide state of emergency. Clarification of the effects of the COVID-19 pandemic on the relationship between living space motility and QoL in CAD patients will require further study.

The Clinical Difference between Gabapentin and Pregabalin: Data from a Pilot Comparative Trial.

Abstract: Background Similar anticonvulsants, such as gabapentin and pregabalin are recommended in neuropathic pain management, however little is known about their clinical differences in cases of low back pain. This paper aims to highlight some of the possible clinical differences between gabapentin and pregabalin in low back pain. Methods Patients with moderate to severe low back pain were recruited. Eligible patients were randomised to receive either pregabalin (300 mg/day)or gabapentin (800 mg/day) for six weeks. The primary outcome measure was pain intensity according to the Visual Analogue Score (VAS) at baseline and at six weeks. The secondary outcome measures were: anxiety, insomnia, fatigue and the self-rated (GCI), measured at baseline, second, fourth, and the sixth week. Results A total of 64 patients, pregabalin group (n=28), gabapentin group (n=36) completed the study. While pregabalin group showed a significantly lower pain score (p=0.039). The gabapentin group showed significant improvement in anxiety (p=0.001), insomnia (p=0.001), general fatigue (p=0.009), physical fatigue (p=0.001), reduce activity (p=0.001), and mental fatigue (p=0.014) higher than that of pregabalin. No difference in (GCI) was seen at six weeks. Conclusion This is the first trial aimed at comparing gabapentin with pregabalin in NLBP. Although the results are preliminary, in our pilot study pregabalin was found to be superior in pain reduction, gabapentin demonstrated better effect on anxiety, insomnia and fatigue symptoms. The results are preliminary and studies with a larger sample size are still required.

Review and Analysis of Massively Registered Clinical Trials of COVID-19 using the Text Mining Approach.

Abstract: Objective Immediately after the outbreak of nCoV, many clinical trials are registered for COVID-19. The numbers of registrations are now raising inordinately. It is challenging to understand which research areas are explored in this massive pool of clinical studies. If such information can be compiled, then it is easy to explore new research studies for possible contributions in COVID-19 research. Methods In the present work, a text-mining technique of artificial intelligence is utilized to map the research domains explored through the clinical trials of COVID-19. With the help of the open-- source and graphical user interface-based tool, 3007 clinical trials are analyzed here. The dataset is acquired from the international clinical trial registry platform of WHO. With the help of hierarchical cluster analysis, the clinical trials were grouped according to their common research studies. These clusters are analyzed manually using their word clouds for understanding the scientific area of a particular cluster. The scientific fields of clinical studies are comprehensively reviewed and discussed based on this analysis. Results More than three-thousand clinical trials are grouped in 212 clusters by hierarchical cluster analysis. Manual intervention of these clusters using their individual word-cloud helped to identify various scientific areas which are explored in COVID19 related clinical studies. Conclusion The text-mining is an easy and fastest way to explore many registered clinical trials. In our study, thirteen major clusters or research areas were identified in which the majority of clinical trials were registered. Many other uncategorized clinical studies were also identified as "miscellaneous studies". The clinical trials within the individual cluster were studied, and their research purposes are compiled comprehensively in the present work.