Biomedical engineering and ethics: reflections on medical devices and PPE during the first wave of COVID-19.

In March 2019, the World Health Organization (WHO) declared that humanity was entering a global pandemic phase. This unforeseen situation caught everyone unprepared and had a major impact on several professional categories that found themselves facing important ethical dilemmas. The article revolves around the category of biomedical and clinical engineers, which were among those most involved in dealing with and finding solutions to the pandemic. In hindsight, the major issues brought to the attention of biomedical engineers have raised important ethical implications, such as the allocation of resources, the responsibilities of science and the inadequacy and non-universality of the norms and regulations on biomedical devices and personal protective equipment. These issues, analyzed one year after the first wave of the pandemic, come together in the appeal for responsibility for thought, action and, sometimes, even silence. This highlights the importance of interdisciplinarity and the definitive collapse of the Cartesian fragmentation of knowledge, calling for the creation of more fora, where this kind of discussions can be promoted.

Outcomes of Renal Stone Surgery Performed Either as Predonation or Ex Vivo Bench Procedure in Renal Grafts from Living Donors: A Systematic Review.

AIMS: We aimed to summarize available evidence about intraoperative and postoperative donors' and recipients' outcomes following stone surgery in renal grafts from living donors performed either before donation or as ex vivo bench surgery at the time of living-donor nephrectomy. METHODS: A systematic review of PubMed, ISI Web of Knowledge, and Scopus databases was performed in September 2020. We included full papers that met the following criteria: original research, English language, human studies, and describing the results of stone surgery in renal grafts from living donors performed either before transplantation or as ex vivo bench surgery. RESULTS: We identified 11 studies involving 106 patients aged between 22 and 72 years. Predonation and bench stone surgery was performed in 9 (8.5%) and 96 (90.6%) patients, respectively. Predonation stone surgery involved extracorporeal shock wave lithotripsy, retrograde intrarenal surgery, and percutaneous nephrolithotomy in 8, 1, and 1 patient, respectively. The overall success rate of predonation stone surgery was 78%, and the complication rate was 0%. Bench stone surgery involved ureteroscopy, pyelolithotomy, or a combination of both in 79 (82.3%), 10 (10.4%), and 7 (7.3%) cases, respectively, with an overall success rate of 95.8% and an overall complication rate of 9.37%. CONCLUSIONS: Predonation and bench stone surgery in grafts from living donors represents efficacious and safe procedures. Further studies on wider series with a longer follow-up are required.

Gastroenterological complications in kidney transplant patients.

Kidney transplantation is the surgical operation by which one of the two original kidneys is replaced with another healthy one donated by a compatible individual. In most cases, donors are recently deceased. There is the possibility of withdrawing a kidney from a consenting living subject. Usually, living donors are direct family members, but they could be volunteers completely unrelated to the recipient. A much-feared complication in case of kidney transplantation is the appearance of infections. These tend to arise due to immune-suppressor drugs administered as anti-rejection therapy. In this review, we describe the gastrointestinal complications that can occur in subjects undergoing renal transplantation associated with secondary pathogenic microorganisms or due to mechanical injury during surgery or to metabolic or organic toxicity correlated to anti-rejection therapy. Some of these complications may compromise the quality of life or pose a significant risk of mortality; fortunately, many of them can be prevented and treated without the stopping the immunosuppression, thus avoiding the patient being exposed to the risk of rejection episodes.

Combined Timed Surgery and Conservative Management of Primary Necrotizing Fasciitis of the Breast: A Case Report.

BACKGROUND Necrotizing fasciitis is a life-threatening infection that involves the deep fascia and the surrounding tissue, but rarely involves the female breast. The most common treatment for necrotizing fasciitis of the breast is total mastectomy. However, the use of negative pressure wound therapy (NPWT), after surgical debridement, is reported to promote the more rapid development of granulation tissue, before reconstructive surgery. This report presents the case of a 53-year-old woman with necrotizing fasciitis of the breast who underwent combined timed surgery and conservative management. CASE REPORT A 53-year-old woman presented with necrotizing fasciitis of the right breast, involving the right lateral chest wall and flank. She was referred to the Intensive Care Unit (ICU) of the hospital with septic shock. After hemodynamic stabilization was achieved, she underwent surgical debridement. Excised breast tissues were sent for histology, and intraoperative swabs were collected and sent for microbiological examination. Intravenous antibiotic therapy and hyperbaric oxygen therapy commenced. The patient was managed with NPWT dressings, followed by reconstructive breast surgery. The right chest and flank completely healed. CONCLUSIONS This case has shown that early diagnosis and management of necrotizing fasciitis of the breast can be life-saving and may allow for breast conservation. Early aggressive debridement combined with NPWT dressings and reconstructive breast surgery resulted in successful wound healing and preservation of the breast with a satisfactory cosmetic outcome.

Use of Rituximab in NHL Malt Type Pregnant in I° Trimester for Two Times.

Administration of rituximab, one of the basic drugs for the therapy of B-cell lymphoproliferative diseases, during pregnancy has been suspected to cause developmental fetal events, particularly if given during the first trimester of pregnancy. Therefore, use in pregnancy is not permitted. Howe ver, several cases of pregnant women being treated with rituximab are reported herein; an exception is often made in cases with grave illness. We describe an exceptional case of a woman with non-Hodgkin lymphoma of the mucosa-associated lymphoid tissue type where rituximab was given as a single agent without interruption during two consecutive pregnancies. This case can certainly supply important indications on the safety of rituximab.

Cancer- and Non-cancer Related Chronic Pain: From the Physiopathological Basics to Management.

The prevalence of chronic pain is between 33% to 64% and is due to cancer pain, but it has also been observed in non-cancer patients. Chronic pain is associated with lower quality of life and higher psychological distress and depressive/anxiety disorders in patients without a history of disorder. In this study we evaluated in clinical practice the effectiveness of the intrathecal pump in 140 patients who underwent pain therapy at our Center. These patients were consecutively enrolled from January 2010 to July 2018. Follow-up was carried out over these eight years regarding the infusion modalities. Pain relief was obtained in 71 (50,7%) patients out of the 140 that experienced satisfactory pain control globally. Intrathecal therapy is one of the best options for chronic severe refractory pain. The greatest advantage of this therapy is due to the possibility of treating the pain with minimal dosages of the drug, avoiding the appearance of troublesome side effects.

Familial Polyposis Coli: The Management of Desmoid Tumor Bleeding.

Background: There is currently no standard treatment for desmoid tumors (DTs) associated with familial polyposis coli (FAP). Familial adenomatous polyposis in DT patients is sometimes a life-threatening condition. Methods: We enrolled all consecutive patients with FAP treated at Unit of General Surgery and Transplant, University of Naples Federico II and evaluated the incidence of DTs on FAP between 1996 and 2016. Results: We observed 45 consecutive patients with FAP; of these 5 were DT-FAP-associated. All 5 cases with FAP were young women, age 25 to 65 years, previously treated by colectomy. Of these, 4 patients presented a parietal localization and had been treated with a wide surgical exeresis; one patient had an intra-abdominal, mesenteric tumor that was unresectable at laparotomy. We performed CT-guided drainage, ureteral stenting, medical therapy (sulindac+tamoxifene), and chemotherapy (dacarba-zine+doxorubicine).All patients were alive and underwent follow-ups for 5 years post-surgery; only 1 patient with parietal localization showed a local relapse after 2 years. Conclusions: We propose a modulated approach to the single patient with FAP, with surgery as treatment of choice for parietal localization disease and integrating different kinds of therapies (surgery alone or associated with RT, CT) for the intra-abdominal tumor.

Colorectal Cancer in the Elderly Patient: The Role of Neo-adjuvant Therapy.

BACKGROUND: Neoadjuvant chemoradiotherapy has a significant role in downstaging cancer. It improves the local control of the disease and can make conservative resection of rectal cancer possible. METHODS: We enrolled 114 patients with subperitoneal rectal cancer who underwent neoadjuvant chemoradio-therapy and radical excision with total mesorectal excision (TME). The primary endpoint was oncological outcomes and the secondary endpoint was surgical outcomes.We evaluate the experience of a multidisciplinary team and the role of neoadjuvant chemoradiotherapy in integrated treatment of cancer of the subperitoneal rectum. RESULTS: Surgical procedures performed were abdominal perineal resection in 4 cases (3.5%), anterior resection in 89 cases (78%), Hartmann's procedure in 5 cases (4.4%), and ultralow resection with coloanal anastomosis and diverting stoma in 16 patients (14%).Local recurrence occurred in 6 patients (5.2%), the overall survival was 71.9% at 5 years and disease-free survival was about 60%. CONCLUSIONS: The effect of pathological downstaging amounted to 58.8%, including cPR. The pathologic complete remission occurred in 8.8% of cases.The outcomes of neoadjuvant therapy can be achieved when this treatment is associated with correct surgical technique with TME and the prognosis is defined by an anatomopathological examination performed according to Quirke's protocol.

Erratum to "Eradication of HCV Infection with the Direct-Acting Antiviral Therapy in Renal Allograft Recipients".

[This corrects the article DOI: 10.1155/2019/4674560.].

Eradication of HCV Infection with the Direct-Acting Antiviral Therapy in Renal Allograft Recipients.

Hepatitis C virus (HCV) infection unfavorably affects the survival of both renal patients undergoing hemodialysis and renal transplant recipients. In this subset of patients, the effectiveness and safety of different combinations of interferon-free direct-acting antiviral agents (DAAs) have been analyzed in several small studies. Despite fragmentary, the available data demonstrate that DAA treatment is safe and effective in eradicating HCV infection, with a sustained virologic response (SVR) rates nearly 95% and without an increased risk of allograft rejection. This review article analyzes the results of most published studies on this topic to favor more in-depth knowledge of the readers on the subject. We suggest, however, perseverating in this update as the optimal DAA regimen may not be proposed yet, because of the expected arrival of newer DAAs and of the lack of data from large multicenter randomized controlled trials.

Donor and Recipient Outcomes following Robotic-Assisted Laparoscopic Living Donor Nephrectomy: A Systematic Review.

AIMS: We aimed to summarize available lines of evidence about intraoperative and postoperative donor outcomes following robotic-assisted laparoscopic donor nephrectomy (RALDN) as well as outcomes of graft and recipients. METHODS: A systematic review of PubMed/Medline, ISI Web of Knowledge, and Scopus databases was performed in May 2018. The following search terms were combined: nephrectomy, robotic, and living donor. We included full papers that met the following criteria: original research; English language; human studies; enrolling patients undergoing RALDN. RESULTS: Eighteen studies involving 910 patients were included in the final analysis. Mean overall operative and warm ischemia times ranged from 139 to 306 minutes and from 1.5 to 5.8 minutes, respectively. Mean estimated blood loss varied from 30 to 146 mL and the incidence of intraoperative complications ranged from 0% to 6.7%. Conversion rate varied from 0% to 5%. The mean hospital length of stay varied from 1 to 5.8 days and incidence of early postoperative complications varied from 0% to 15.7%. No donor mortality was observed. The incidence of delayed graft function was reported in 7 cases. The one- and 10-year graft loss rates were 1% and 22%, respectively. CONCLUSIONS: Based on preliminary data, RALDN appears as a safe and effective procedure.

Does virtual reality reduce pain in pediatric patients? A systematic review.

Virtual Reality (VR) as a tool for pain reduction is the research topic of several clinical trial for Randomized Controlled Trials despite its wide use in the daily clinical practice for non- pharmacological reduction of pain in some countries. At present, there are no published reviews of VR-efficacy of pain reduction in pediatric patients. That is why we made a systematic review of the efficacy of VR as a tool for pain reduction in children and adolescents. Electronic databases and gray literature published between 2014 and 2019 were analyzed. A total of 9 studies were eligible according to the established inclusion criteria. Results show that virtual reality is a valid tool for non-pharmacological pain reduction and that this approach is to be preferred to the standard reduction techniques currently in use. However, more studies using standardized experimental methodologies are needed to provide more systematic comparison and quantitative synthesis.

Characterisation of mesenchymal colon tumour-derived cells in tumourspheres as a model for colorectal cancer progression.

Cellular plasticity, the ability of cells to switch from an epitheial phenotype to a mesenchymal one and vice versa, plays a crucial role in tumour progression and metastases development. In 20-25% of patients with colon cancer and in 18% of patients with rectal cancer, metastases are present at the time of the first diagnosis. They are the first cause of colorectal cancer (CRC)-related mortality, defining stage IV CRC, which is characterized by a relatively short overall survival. We previously isolated two primary colon adenocarcinoma cell cultures that had undergone epithelial-mesenchymal transition (EMT), one with a high microsatellite instability phenotype (T88) and one with a chromosomal instability phenotype (T93). The aim of this study was to establish a model with which to study EMT, stemness features and cell plasticity in cancer progression and to examine the effects of incubation with lithium chloride (LiCl), a specific glycogen synthase kinase 3 ß (GSK-3ß) inhibitor, on these cellular processes. Indeed, GSK3ß is an important regulator of cell survival, which promotes tumourigenesis in colon cells by facilitating the crosstalk between colorectal cancer pathways. Thus, we further characterized our system of adherent primary mesenchymal colon cancer cells and their paired tumourspheres by examining the expression and localisation of a panel of markers, including E- and N­cadherin, CD133, CD44v6, aldehyde dehydrogenase 1 (ALDH1) and leucine-rich repeat­containing G-protein coupled receptor 5 (LGR5). We also characterised the molecular features of these tumourspheres and examined their response to LiCl. Furthermore, we explored the effects of LiCl on cell motility and plasticity. We demonstrated that LiCl reduced cell migration, stemness features and cell plasticity. We also observed the atypical nuclear localisation of membrane proteins, including N­cadherin, CD133 and CD44v6 in mesenchymal tumour cells. Of note, CD133 and CD44v6 appeared to localise at the plasma membrane in cells with a more epithelial phenotype, suggesting that the cytoplasmic/nuclear localisation of these proteins could favour and characterize cell plasticity in colorectal cancer progression.

Current Tissue Molecular Markers in Colorectal Cancer: A Literature Review.

BACKGROUND: Colorectal cancer (CRC) is one of the most spread neoplasia types all around the world, especially in western areas. It evolves from precancerous lesions and adenomatous polyps, through successive genetic and epigenetic mutations. Numerous risk factors intervene in its development and they are either environmental or genetic. AIM OF THE REVIEW: Alongside common screening techniques, such as fecal screening tests, endoscopic evaluation, and CT-colonography, we have identified the most important and useful biomarkers and we have analyzed their role in the diagnosis, prevention, and prognosis of CRC. CONCLUSION: Biomarkers can become an important tool in the diagnostic and therapeutic process for CRC. But further studies are needed to identify a noninvasive, cost-effective, and highly sensible and specific screening test for their detection and to standardize their use in clinical practice.

Diagnostic, Predictive, Prognostic, and Therapeutic Molecular Biomarkers in Third Millennium: A Breakthrough in Gastric Cancer.

INTRODUCTION: Gastric cancer is the fifth most common cancer and the third cause of cancer death. The clinical outcomes of the patients are still not encouraging with a low rate of 5 years' survival. Often the disease is diagnosed at advanced stages and this obviously negatively affects patients outcomes. A deep understanding of molecular basis of gastric cancer can lead to the identification of diagnostic, predictive, prognostic, and therapeutic biomarkers. MAIN BODY: This paper aims to give a global view on the molecular classification and mechanisms involved in the development of the tumour and on the biomarkers for gastric cancer. We discuss the role of E-cadherin, HER2, fibroblast growth factor receptor (FGFR), MET, human epidermal growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR), mammalian target of rapamycin (mTOR), microsatellite instability (MSI), PD-L1, and TP53. We have also considered in this manuscript new emerging biomarkers as matrix metalloproteases (MMPs), microRNAs, and long noncoding RNAs (lncRNAs). CONCLUSIONS: Identifying and validating diagnostic, prognostic, predictive, and therapeutic biomarkers will have a huge impact on patients outcomes as they will allow early detection of tumours and also guide the choice of a targeted therapy based on specific molecular features of the cancer.

Changes in the MicroRNA Profile Observed in the Subcutaneous Adipose Tissue of Obese Patients after Laparoscopic Adjustable Gastric Banding.

Background. Laparoscopic adjustable gastric banding (LAGB) results in significant lasting weight loss and improved metabolism in obese patients. To evaluate whether epigenetic factors could concur to these benefits, we investigated the subcutaneous adipose tissue (SAT) microRNA (miRNA) profile before (T0) and three years (T1) after LAGB in three morbidly obese women. Case Reports. SAT miRNA profiling, evaluated by TaqMan Array, showed four downexpressed (miR-519d, miR-299-5p, miR-212, and miR-671-3p) and two upexpressed (miR-370 and miR-487a) miRNAs at T1 versus T0. Bioinformatics predicted that these miRNAs regulate genes belonging to pathways associated with the cytoskeleton, inflammation, and metabolism. Western blot analysis showed that PPAR-alpha, which is the target gene of miR-519d, increased after LAGB, thereby suggesting an improvement in SAT lipid metabolism. Accordingly, the number and diameter of adipocytes were significantly higher and lower, respectively, at T1 versus T0. Bioinformatics predicted that the decreased levels of miR-212, miR-299-5p, and miR-671-3p at T1 concur in reducing SAT inflammation. Conclusion. We show that the miRNA profile changes after LAGB. This finding, although obtained in only three cases, suggests that this epigenetic mechanism, by regulating the expression of genes involved in inflammation and lipid metabolism, could concur to improve SAT functionality in postoperative obese patients.

Advantages and disadvantages of day surgery in a department of general surgery.

INTRODUCTION: We make our study of day surgery to awaken health worker that is possible to reduce the mean hospitalization time for each type of procedure: it needs improvement in communication, organizational and medical skills with a specific training both for medical and nursing staff. MATERIAL OF STUDY: A retrospective study on all patients who underwent day surgery procedures from 1st January 2008 to 31st December 2011. Out of 486 hospitalizations for programmed surgery, 177 (36.41%) were made in Day Surgery (DS) for a total of 450 operations. Of those patients, 105 (59.3%) stayed Overnight. RESULTS: Re-conversion rate of day surgery hospitalization reached 1% and referred to haemorrhagy post-hemorroidectomy. DISCUSSION: Nowadays in Italy many surgical procedures that could be performed in day surgery, are made in routine hospitalization with an higher cost for NHS. In our department DS is made for small surgery but even other procedures (hernioplasty, hemorroidectomy, stripping of vein safena, etc.). Our day surgery activity has had some negative aspects both for the availability of operating rooms and for the possibility of improvement of specific skills in our health staff. CONCLUSIONS: Day surgery permits a better use of resources and also a cut of costs. The dates of our series demonstrate the necessity of improving DS, considering trends of the most part of European Countries. The Authors highlight the importance of creating specific Units for Day-Surgery activity to permit a training for all health staff.