Reviews on Recent Clinical Trials - Volume 17, Issue 2, 2022

Introduction: Women undergoing mastectomy choose to pursue breast reconstruction (BR) in order to reduce their body image distress.Adjuvant chest wall irradiation is associated with a negative cosmetic outcome. The aim of our review was to identify the optimal timing of BR relating to radiotherapy delivery. Materials and Methods: Using Cochrane Library, Embase, PubMed, Springer, Wanfang and CNKI, we performed a non-systematic review of articles published up to August 2021. Results: There is no hard evidence in favor of immediate, delayed or 2-stage BR when post-mastectomy radiation is indicated. Immediate and 2-stage BR seem to be valid alternatives to delayed BR. Conclusions: Further research is essential in order to assess clinician and patient reported aesthetic outcomes and determine the optimal timing of BR in view of post-mastectomy radiotherapy, in breast cancer survivors.

Background: The COVID-19 pandemic has encouraged doctors to look for novel ways of treating patients with respiratory failure due to the limited availability of ventilators and highflow nasal cannula. The study aims to assess the efficacy of using the Bains circuit as an alternative to HFNC and NIV as life-saving tools in patients with respiratory failure during the second wave of the COVID-19 pandemic in India. Methods: This is a prospective interventional study carried out in the intensive care unit of Shri B.M Patil Medical College Hospital and Research Centre, Vijayapur, India, from May 2021 to June 2021. All patients (n=90) with respiratory failure not responding to therapy with an oxygen mask were included. Patients were placed on Bain circuits, one end connected to a non-invasive ventilation mask fitted to the face of the patients, and the other end connected to a central oxygen port. Patients’ vital parameters were assessed on an hourly basis. The blood gas analyses were done before and after using Bains. Results: The study showed diabetes (33.4%), hypertension (22.2%), and diabetes with hypertension (11.1%) as comorbid factors among the ICU admitted patients. The results from the arterial blood gas analyses showed a statistically significant increase in Sp02 (%) and a decrease in respiratory rate (cycles/min) in the patients after being kept on Bains (p<0.05). Further, it showed that 72% of ICU patients with 70-79% Sp02 had a recovery by using Bains. The overall outcome of ICU admitted COVID-19 patients on Bains showed that 38.9% of patients improved and were shifted to 02/NRBM masks. Conclusion: The study highlights a novel concept of using the Bains circuit as an effective alternative to HFNC and NIV for oxygenation in critically ill COVID-19 patients during scarcity of NIV and HFNC at the peak of the pandemic.

Background: In the era of novel agents, many multiple myeloma patients can achieve a complete remission, but most of them relapse, and minimal residual disease detection can play a crucial role. Next-generation flow (NGF) can detect monoclonal plasma cells with a sensitivity of 10^-6. Little is known about long-term remission patients (> 2 years) and in particular, if more sensitive techniques such as NGF can still detect minimal disease in those patients. Objective: Aim of the study was to analyze patients with MM in response to NGF at > 2 years of sustained remission after several treatments. Methods: MRD was studied by NGF in bone marrow aspirates according to Euroflow Consortium indications. Results: 62 patients with sustained CR at >2 years were studied, MRD+ status was detected at a threshold cut-off of 10^-6 in 32/62 (52%); 4/15 (27%) patients were MRD positive at >5 years of remission and they displayed a prevalence of normal vs abnormal monoclonal plasma cell immune-phenotype (MGUS-like). Conclusion: NGF is a powerful technique to detect MRD. Myeloma patients in prolonged sustained complete remission can show in high percentage an MRD negative status or MGUS like.

Background: Ulcerative colitis may impair anorectal function, causing disabling symptoms such as incontinence and/or increase in the stool frequency, urgency and tenesmus. Data on anorectal function in these patients evaluated by conventional anorectal manometry are conflicting. Objectives: The aim of this prospective study was to assess by means of high resolution anorectal manometry the anorectal function in patients with mild-to-moderate ulcerative colitis at presentation and after remission. Anorectal function of ulcerative colitis patients was compared to that observed in healthy volunteers. Methods: 20 patients with mild to moderate left-sided ulcerative colitis or proctitis and 20 healthy volunteers were prospectively enrolled. All ulcerative colitis patients underwent high resolution anorectal manometry before treatment and after clinical remission. Results: Ulcerative colitis patients showed similar values for anal sphincter function as healthy volunteers, whereas rectal threshold volume for the first sensation, desire to defecate, urgency to defecate and maximum discomfort were significantly lower than in healthy volunteers (p<0.05). Rectal compliance was significantly lower in ulcerative colitis than in healthy volunteers (p<0.05). After remission, rectal threshold volumes, as well as rectal compliance, significantly increased. An inverse linear correlation was found between regression of urgency and stool frequency and rectal compliance (r=0.811; p<0.05). Conclusion: Ulcerative colitis patients show altered rectal function, with increased rectal sensitivity and lower compliance, compared to controls. This altered function is restored after successful treatment of the underlying inflammatory process. Finally high resolution anorectal manometry provides useful information on anorectal functionality and, in our opinion, should be preferred over conventional manometry.

Aims: To explore the long-term survival in lung cancer patients with persistent mediastinal lymph nodal disease after neoadjuvant followed by surgical resection and to analyse prognostic factors in this specific subset of patients. Background: Surgery in non-small-cell lung cancer (NSCLC) patients with N2-disease after neoadjuvant therapy (NAD) has been debated and has been even more questioned with the advent of immunotherapy. Objective: Describe long-term results of a multimodal approach in locally-advanced NSCLC patients with persistence of N2-disease and identify prognostic factors to target the strategy of care. Methods: We retrospectively reviewed data of 121 consecutive Stage IIIA-N2 NSCLC patients who underwent NAD (chemoradiotherapy or chemotherapy) from 01/00 to 12/19, focusing our analysis on 37 patients with persistent N2s status after surgery. Kaplan-Meier and Cox regression analysis explored the associations between mortality and potential risk factors. Results: The 5-year survival was 29.8%. Cox regression analysis suggested that young age (HR=0.98, C.I.95%: 0.97- 1.00; p=0.062), male sex (HR=3.8,C.I.95%:1.06-13.73;p=0.04), and adjuvant therapy (HR=6.81,C.I.95%:0.96-53.94;p=0.06) influenced long-term outcomes in these patients. Conclusion: We herein observed suboptimal long-term results in this NSCLC patient subset, and, considering emerging results adopting immunotherapy following chemoradiotherapy, surgery should be carefully considered in very selected cases (young and clinically fit patients) and combined with adjuvant therapy after surgery.

Background: During the COVID-19 pandemic in Italy, decisions were taken to adopt restrictive legislative measures, such as the first half of the 2020 lockdown. In those months, patients with inflammatory bowel disease experienced social isolation and reduced access to health care. Objective: We aimed to evaluate, in this condition, the presence of remission subgroups that were most impacted by the lockdown. Methods: During the first Italian lockdown, we recruited patients with remission of inflammatory bowel disease by administering an online questionnaire including patient demographics, the Beck Anxiety Questionnaire Inventory, the Beck Depression Inventory questionnaire, and the Pittsburg Sleep Quality Index, all validated standardized questionnaires for anxiety symptom levels, depression, and sleep quality. Results: Our results showed how female patients (p<0.0001) with Crohn’s disease (p<0.001) experienced worse levels of anxiety symptoms. Female patients (p<0.0001) between 50 and 60 years of age (p=0.013) with Crohn’s disease (p=0.047) experienced worse levels of depressive symptoms. Females also experienced significantly worse sleep levels (p<0.001). We found a correlation between the number of sleeping hours (p<0.001) and the time taken to fall asleep (p<0.001) and the Beck Anxiety Questionnaire Inventory,which showed a linear worsening of the number of minutes it took to fall asleep, and the Beck Depression Inventory questionnaire. Conclusion: Among patients with remission of inflammatory bowel disease, female patients, patients with Crohn’s disease, and people aged between 50 and 70 years should be considered for screening for anxiety and depression disorders and an assessment of sleep quality.

Background: Recently, the number of Japanese people living in Asia has increased. A previous study suggested that obesity and overweight are growing health problems both in Malaysia and worldwide that result from lifestyle changes such as a decrease in physical activity, an increase in sedentary behaviour, and poor eating habits. Objective: The purpose of the present study was to investigate the effects of differences in social demographic factors and domain-specific sedentary behaviour and health-related quality of life by age in Japanese living overseas. Methods: We surveyed 109 participants by self-entry questionnaire for social demographic factors and domain-specific sedentary behaviour by life scenario and by Short Form-36 (SF-36) for healthrelated quality of life. The subjects were divided into the ≥65 years group and <65 years group. Results: Significant differences were noted in age, employment, alcohol intake, and marital status between the groups, whereas none were noted for transportation, driving, television viewing, and smartphone/personal computer use. Work time and total sitting time of sedentary behaviour were higher, and leisure-time activity and SF-36 Mental Component Score for health-related quality of life were lower in the <65 years group. Conclusion: By assessing differences in social demographic factors and discouraging sedentary behaviour, sitting time in overseas-dwelling Japanese residents may be reduced, and effective strategies to improve health-related quality of life can be developed to combat such behaviour.

Background: The international health emergency caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which, at the end of 2019, hit the world, forced the governments of all countries to adopt stringent restrictive measures to contain the spread of the virus. Several studies have revealed worsening levels of anxiety, depression and perceived stress related to these restrictions and the resulting lifestyle changes. Some studies have also confirmed the presence of a relationship between SARS-CoV-2-related emotional distress and drinking behavior. Indeed, is a wellknown fact that alcohol consumption is one of the behavioral strategies used to reduce negative emotional states. However, it was documented that young people developed different responses to alcohol use during the pandemic than adults. Objective: The aim of this work was to investigate the consumption habits of young Italians and how the consumption and purchase of alcoholic beverages have changed following the pandemic. New ways of drinking alcohol were also interesting to observe, such as online. Methods: Young people between 18 and 35 years old were subjected to an anonymous questionnaire of 22 questions on the adoption of forms of behavior at risk through alcohol consumption, the quantity and occasions of preferential consumption, and on the methods and quantities of alcoholic beverage purchase, before and during the SARS-CoV-2 pandemic. The subjects who declared themselves "non-drinkers" were not included in the statistical survey. Results: About 33% of the enrolled "drinkers" (268/823), adopted risky forms of alcoholic behavior. Males reported a higher average habit of drinking wine or alcohol (M = 1.9953 ± 1.39743, F = 1.7373 ± 1.36688, p <0.005); an increased frequency of drinking (M = 2.3025 ± 0.80610 F = 2.0494 ± 0.75043 p <0.001); a higher average number of drinks consumed (M = 1.5182 ± 0.85646, F = 1.2618 ± 0.53292, p <0.001) and binge drinking to the greatest extent (M = 1.1933 ± 0.96522 F = 0.8176 ± 0.85446 p <0.001). Education and employment were significantly correlated with the frequency of alcohol consumption (r = 0.107 p <0.005 and r = 0.120 p = 0.001 respectively). Subjects reported buying alcoholic beverages during the pandemic with a frequency of "less than once a month" (N = 291, 35.36%) and mainly in shops (N = 556, 67.56%), while before the pandemic they mainly bought alcohol once a week (N = 431, 52.37%) and predominantly in bars / clubs (N = 619, 75.21%). New ways of drinking alcohol such as online drinking, have not been significantly identified. Conclusion: A change in alcohol consumed and alcohol purchased before and during the SARSCoV- 2 pandemic was revealed.

Background: Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by progressive destruction of the intrahepatic bile ducts, followed by fibrous substitution of the ducts and potential evolution in cirrhosis. The geographical disparity in the prevalence of PBC suggests a possible role of environmental factors in developing the disease. We analyzed two groups of patients with different geographical prevalence. Methods: This study concerned the analysis of 14 Caucasian patients in two groups: ten patients enrolled in the Digestive Diseases Unit, University of Catanzaro (Italy), and four patients enrolled in the Department of Hepatology, University Hospital Kràlovskè Vinohrady of Prague (Czech Republic). The statistical analysis was performed using the software IBM SPSS (v. 20, Windows). Results: The Italian group showed a statistically significant difference in the total bilirubin values at diagnosis and during the last control (0.74±0.267 vs. 0.56±0.246; p-value: 0.013). Moreover, the comparison between the two groups showed a statistically significant difference in the serum albumin values at the time of the last control (4.6±0.231 vs. 4.15±0.532; p-value: 0.048). Conclusion: Our data indicate an effective difference in the onset and clinical presentation between our two groups. More epidemiologic, prospective, and multicenter research projects are warranted to advance PBC knowledge in Europe.