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The incidence of T4b esophageal cancer with aortic invasion but without distant metastasis is estimated to be between 3.8% and 4.6% of all esophageal cancer cases. Development of an aortoesophageal fistula in such cases is a rare but not unlikely event, leading to catastrophic consequences. The aim of this systematic review is to evaluate the importance of aortic stenting (Thoracic Endovascular Aortic Repair-TEVAR) and its optimal timing in the management of locally advanced esophageal cancer. A systematic literature search of the MEDLINE, Scopus, and Google Scholar databases was undertaken to identify relevant studies published up to March 2024. An individual patient data analysis was performed by forming a patient cohort with elective and salvage TEVAR subgroups, depending on the timing of the stenting. The study pool consisted of 25 studies incorporating 101 cases of locally advanced esophageal cancer, with a median age of 64 years (range 45-87 years). Of them, 50 patients underwent elective TEVAR compared with 51 patients receiving TEVAR in an acute salvage setting. Elective or prophylactic TEVAR was found to significantly increase esophageal resection rates (65.6% vs. 16.7% in the salvage subgroup, P < 0.001), concurrently reducing complication rates (8.3% vs. 36.1%, P < 0.001). Overall survival was also prolonged in the elective subgroup (8.3 vs. 4 months, P = 0.001), with elective stenting being the only independent predictor of improved survival. In conclusion, management with aortic stenting in high-risk patients may reduce the catastrophic consequences of massive bleeding, minimize complications, and enhance survival rates.
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During first outburst of COVID-19, several strategies had been applied for surgical oncology patients to minimize COVID-19 transmission. COVID-19 infection seemed to compromise survival and major complication rates of surgical oncology patients. However, survival, tumor progression and recurrence rates of surgical oncology patients were associated to the consequences of COVID-19 pandemic on their management. In addition, the severity of COVID-19 infections has been downgraded. Therefore, management of surgical oncology patients should be reconsidered.
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COVID-19 , Neoplasias , Oncologia Cirúrgica , Humanos , COVID-19/epidemiologia , Pandemias , SARS-CoV-2 , Neoplasias/complicaçõesRESUMO
BACKGROUND: Paediatric Traumatic Brain Injury (TBI) has received less research attention compared to TBI in adults, despite its potential morbidity in all ages. Our aim was to determine whether neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR) and glucose levels at admission can reliably predict the need for imaging in children presenting with mild TBI. METHODS: We retrospectively reviewed the clinical records of paediatric patients who presented in the emergency department with mild TBI within a 5 year period and had undergone computed tomography (CT) scan of the head. RESULTS: Overall, 43 eligible patients were included in the study, with falls being the most commonly reported cause of injury. Twenty-three children had positive CT findings. Patients with abnormal CT findings were found to have higher NLR ratios compated with patients with normal CT, with the mean NLR on admission being 5.2 ± 3.8. Children with abnormal CT findings had lower PLR levels and higher glucose levels at presentation compared to children with normal CT, however the differences were not statistically significant. Using the receiver operating characteristic (ROC) curve, we found that a NLR cut off value of 6.1 yielded a sensitivity of 54.2% and a specificity of 89.5% for the prediction of abnormal CT findings. CONCLUSIONS: The findings of this study suggest that NLR may have a role in CT decision-making in the emergency department for mild TBI in paediatric patients.
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INTRODUCTION: Endoscopic procedures are expanding and have been evolving in recent years, increasing their volume along with the development of new devices. This is due to the low morbidity and complication rate, the reversibility of the procedures, and the positive impact on patients. Among the endoscopic procedures gaining interest is sleeve gastroplasty. It emerged as a feasible and safe alternative to traditional bariatric surgery. There are no guidelines available on the indications and use of endoscopic gastroplasty. The aim of this study is to present preliminary results of a case series of endoscopic gastric plication procedures performed for different options: as a primary endoscopic sleeve, as revision for sleeve gastrectomy, and as revision for gastric bypass. MATERIALS AND METHODS: A retrospective analysis was performed on a prospective database collecting data on all patients with obesity treated with endoscopic gastroplasty with the Overstitch™ (Apollo Endosurgery, Inc., Austin, Texas) device from 2022 to 2023 in the bariatric surgery unit. RESULTS: Twenty-three patients were treated from May 2022 to July 2023 with endoscopic gastric plication. Ten patients (43%) were submitted to primary endoscopic sleeve gastroplasty, three patients to revision of sleeve gastrectomy, one patient to revision of one anastomosis gastric bypass, and eight patients received a revision of Roux-en-Y gastric bypass. The body mass index (BMI) of patients submitted to primary ESG ranged from 33 to 42kg/m2, with a mean BMI of 37kg/m2. The age of the patients ranged from 22 to 70 years, with a mean age of 45. In one case, we registered a Clavien-Dindo 2 complication-an inflammatory perigastric reaction without a collection occurred 15 days after a primary ESG. CONCLUSION: Endoscopic gastric plication is emerging as a safe, mini-invasive, and effective procedure alternative to sleeve gastrectomy in patients with I or II class obesity or for those unfit for bariatric surgery. The endoscopic suturing device can be used both as a primary procedure or as a revisional option after failure of the primary surgery, thus proving to be a versatile option to provide to bariatric patients.
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We retrospectively reviewed the medical records of 109 patients who underwent curative laparoscopic or open resection for different types of gastrointestinal stromal tumors (GIST). Only primary GIST patients who did not receive preoperative chemotherapy or oral imatinib treatment were included in the analysis. We divided the patients into 2 groups according to the surgical approach:a laparoscopic group (LAP) and a laparotomic group (OPEN). Our aim was to confirm the feasibility and safety of laparoscopic surgery for GISTs that differed in size and location, and to assess its long-term oncologic outcome in terms of overall survival (OS) and disease-free survival (DFS). Furthermore, we performed a surgical short-term outcome analysis. The two groups did not differ with respect to age at operation, gender, BMI or comorbidities. Even the NIH and AFIP risk classifications were not significantly different between the two groups. Furthermore, in our analysis, there was no significant difference in mean tumor size or location between the two groups. Wedge resection was the most frequently performed procedure. The conversion rate was 7.8%. The operative time was 194.75 (60- 350) min for the open group and 181.70 (57-480) min for the laparoscopic group. Our data clearly indicated that the long-term oncologic outcome and DFS of laparoscopic resection were not inferior to those of traditional open operations and laparoscopic resection was still feasible in cases with large tumors: the median size of the tumor was 4.5 cm (3-25) and the tumor was larger than 4.5 cm in 47.7% of the cases in the LAP group. With regard to short-term outcomes, our study demonstrated that the LAP group had fewer complications, faster gastrointestinal recovery, reduced use of analgesic drugs and shorter postoperative hospital stay (each p<0.05). In conclusion, our experience confirms that GISTs are very uncommon cancers for which the prognosis is closely related to size, localization and class of risk. In light of our clinical data, laparoscopic resection for gastric and non-gastric GISTs is a safe, feasible and oncologically correct procedure. The most important advantage of this technique is that it ensures a better postoperative outcome compared with open surgery, without worsening the prognosis.
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Inflammatory bowel disease (IBD) consists of two disorders: Crohn's disease (CD) and ulcerative colitis (UC). Over the past few decades, a great body of knowledge has accumulated regarding the pathogenesis of IBD, and effective pharmaceutical agents, such as inhibitors of tumor necrosis factor (anti-TNF), have been introduced. Although these agents have dramatically improved the outcome of IBD, up to 70% of patients with CD and 10-30% of those with UC still undergo surgery within 10 years from diagnosis. Because of their young age and high recurrence rates, these patients are appropriate candidates for laparoscopic surgery as an alternative to laparotomy. Recently, considerable attention has been focused on perioperative outcomes of patients who are receiving anti-TNF agents and require surgery. The aim of this narrative review is to discuss the current evidence regarding the impact of perioperative anti-TNF treatment on post-operative complication rates with a special focus on laparoscopic surgery.
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Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Doenças Inflamatórias Intestinais/cirurgia , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Humanos , Laparoscopia , Período PerioperatórioRESUMO
PURPOSE: Lung cancer is among the leading causes of cancer-related cases and cancer-associated deaths. Tumor cells frequently acquire chemoresistance and, due to that, new therapies are always needed in the fight against cancer. Pharmaceutical plants continue to offer novel compounds as anticancer therapies. METHODS: We studied the action of N-p-coumaroyl-serotonin (CS), a natural compound from Centaurea seed and safflower on a lung adenocarcinoma cell line. Cytotoxic or antiproliferative effect was studied using the MTT assay. Cell cycle, caspase-8 activation, mitochondrial membrane potential (MMP) and expression of CD15/CD56/CD24/CD44/CD58/CD71 were studied by flow cytometry. RESULTS: CS exterted antiproliferative and cytotoxic activity, independent of mitochondrial membrane disruption. This compound caused S phase arrest and a decrease in the expression of CD24/CD44/CD58/CD71. CONCLUSION: This is the first report on the in vitro action of CS against lung cancer, necessitating further studies towards its use as a potential anticancer agent.
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Antineoplásicos Fitogênicos/farmacologia , Apoptose/efeitos dos fármacos , Proliferação de Células/efeitos dos fármacos , Neoplasias Pulmonares/patologia , Serotonina/farmacologia , Ciclo Celular/efeitos dos fármacos , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Potencial da Membrana Mitocondrial/efeitos dos fármacos , Espécies Reativas de Oxigênio/metabolismo , Células Tumorais CultivadasRESUMO
AIM: By identifying cancer driver genes involved in tumorigenesis, whole-exome sequencing (WES) analyses enable the development of robust biomarkers and novel therapeutic targets to reach precision oncology. PATIENTS & METHODS: WES analyses were performed in matched gastric cancer-normal gastric tissues from two patients. We compared genes highlighted with those of a database and recent WES/whole-genome sequencing studies. RESULTS: We identified 32 highlighted gastric cancer genes, two of these (DEFB118 and RNF43) may provide future potential clinical implications. CONCLUSION: Definitive evidence on extensive genetic heterogeneity suggests the need for large-scale next-generation sequencing studies to validate gastric cancer driver genes catalog. This list represents the foundation for developing genome-based biomarkers to guide precision gastric cancer treatment.
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Exoma , Estudos de Associação Genética , Sequenciamento de Nucleotídeos em Larga Escala , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/genética , Idoso , Idoso de 80 Anos ou mais , Biomarcadores , Biologia Computacional/métodos , Variações do Número de Cópias de DNA , Feminino , Humanos , Mutação INDEL , Masculino , Pessoa de Meia-Idade , Mutação , Gradação de Tumores , Estadiamento de Neoplasias , Polimorfismo de Nucleotídeo Único , Medicina de Precisão , PrognósticoRESUMO
Difluoromethylornithine (DFMO; eflornithine) is an irreversible suicide inhibitor of the enzyme ornithine decarboxylase which is involved in polyamine synthesis. Polyamines are important for cell survival, thus DFMO was studied as an anticancer agent and as a chemoprevention agent. DFMO exhibited mainly cytostatic activity and had single agent efficacy as well as activity in combination with other chemotherapeutic drugs for some cancers and leukemias. Herewith, we summarize the current knowledge of the anticancer and chemopreventive properties of DFMO and assess the status of clinical trials.
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Antineoplásicos/uso terapêutico , Eflornitina/uso terapêutico , Neoplasias/tratamento farmacológico , Inibidores da Ornitina Descarboxilase/uso terapêutico , Animais , Antineoplásicos/farmacologia , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Transformação Celular Neoplásica/efeitos dos fármacos , Transformação Celular Neoplásica/genética , Transformação Celular Neoplásica/metabolismo , Ensaios Clínicos como Assunto , Avaliação Pré-Clínica de Medicamentos , Eflornitina/farmacologia , Regulação Neoplásica da Expressão Gênica/efeitos dos fármacos , Humanos , Neoplasias/diagnóstico , Neoplasias/genética , Neoplasias/metabolismo , Inibidores da Ornitina Descarboxilase/farmacologia , Transdução de Sinais/efeitos dos fármacos , Resultado do TratamentoRESUMO
INTRODUCTION: The aim of this study is to compare short-term outcomes of right versus left colectomies performed as a form of cancer treatment. MATERIALS AND METHODS: This study includes 305 consecutive patients with adenocarcinoma treated by laparoscopic or open colectomy. Right colectomy has been compared with left colectomy. The study endpoints were the first flatus day, the first evacuation day, the first day of postoperative solid oral diet intake, and the postoperative hospital stay length. RESULTS: There were 140 (45.9%) right colectomies and 165 (54.1%) left colectomies performed. The cut-off values for the considered (median) endpoints were three, five, four, and eight days, respectively. The first day of postoperative solid oral diet intake and the length of postoperative hospital stay are significantly associated with the type of resection. CONCLUSIONS: The colon cancer patients treated by right-sided colectomy assumed a solid oral diet and presented a longer postoperative hospital stay compared with the patients treated by left-sided colectomy.
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Colectomia/métodos , Colectomia/estatística & dados numéricos , Neoplasias do Colo/epidemiologia , Neoplasias do Colo/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Neuroendocrine tumors (NETs) are rare and heterogeneous tumors and there is a paucity of randomized clinical trials evaluating the different therapeutic strategies. Over recent years, some important molecular aspects have been investigated and multiple targeted therapies are currently available. One of the most promising targets for the therapy of NETs are the mTOR and angiogenic growth factor receptors. The advent of the inhibitors of the mTOR pathway, tyrosine kinase inhibitors and of somatostatin analogs have shown their efficacy in randomized clinical trials in terms of implementing clinical hormone-induced syndromes and progression-free survival of advanced NETs. This article summarizes the standard therapies and new perspectives in NET's treatment, which remains still very heterogeneous and little known entity.
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Antineoplásicos/uso terapêutico , Terapia de Alvo Molecular , Tumores Neuroendócrinos/tratamento farmacológico , Antineoplásicos/farmacologia , Ensaios Clínicos como Assunto , Gerenciamento Clínico , Progressão da Doença , Humanos , Tumores Neuroendócrinos/genética , Tumores Neuroendócrinos/metabolismo , Tumores Neuroendócrinos/mortalidade , Síndrome , Resultado do TratamentoRESUMO
OBJECTIVE Congenital hydrocephalus (CH) is one of the most frequent CNS congenital malformations, representing an entity with serious pathological consequences. Although several studies have previously assessed child-related risk factors associated with CH development, there is a gap of knowledge on maternal environmental risk factors related to CH. The authors have systematically assessed extrinsic factors in the maternal environment that potentially confer an increased risk of CH development. METHODS The Cochrane Library, MEDLINE, and EMBASE were systematically searched for works published between 1966 and December 2015 to identify all relevant articles published in English. Only studies that investigated environmental risk factors concerning the mother-either during gestation or pregestationally-were included. RESULTS In total, 13 studies (5 cohorts, 3 case series, 3 case-control studies, 1 meta-analysis, and 1 case report) meeting the inclusion criteria were identified. Maternal medication or alcohol use during gestation; lifestyle modifiable maternal pathologies such as obesity, diabetes, or hypertension; lack of prenatal care; and a low socioeconomic status were identified as significant maternal environmental risk factors for CH development. Maternal infections and trauma to the mother during pregnancy have also been highlighted as potential mother-related risk factors for CH. CONCLUSIONS Congenital hydrocephalus is an important cause of serious infant health disability that can lead to health inequalities among adults. The present study identified several maternal environmental risk factors for CH, thus yielding important scientific information relevant to prevention of some CH cases. However, further research is warranted to confirm the impact of the identified factors and examine their underlying behavioral and/or biological basis, leading to the generation of suitable prevention strategies.
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Hidrocefalia/diagnóstico , Hidrocefalia/etiologia , Exposição Materna/efeitos adversos , Efeitos Tardios da Exposição Pré-Natal/diagnóstico , Efeitos Tardios da Exposição Pré-Natal/etiologia , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Humanos , Gravidez , Fatores de RiscoRESUMO
One of the most important trends in intraoperative neural monitoring (IONM) in thyroid surgery is currently the real-time monitoring of the vagus nerve (VN) in order to prevent recurrent laryngeal nerve (RLN) iatrogenic damages. Notably, continuous intraoperative neuromonitoring (C-IONM) seems to be superior to intermitted intraoperative neural monitoring (I-IONM) because it enhances standardization by permanent vagus nerve (VN) stimulation, and it provides entire and constant RLN function monitoring as the surgeon dissects and removes the thyroid gland. It also has to be highlighted that the surgical maneuvers for the automatic periodic stimulating (APS) placement must be accurate and standardized in order to avoid a potential iatrogenic morbidity on the VN function. We recommend the experienced surgeon be very careful in each step, with cautious dissection. With this review article we provide a comprehensive analyses of C-IONM technique with the APS accessory for conventional and endoscopic thyroid surgery.
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Endoscopia/instrumentação , Monitorização Neurofisiológica Intraoperatória/instrumentação , Monitorização Neurofisiológica Intraoperatória/métodos , Tireoidectomia/instrumentação , Tireoidectomia/métodos , Estimulação do Nervo Vago/instrumentação , Desenho de Equipamento , HumanosRESUMO
AIM: BMI and the lymph node (LN) ratio can affect short- and long-term outcomes of patients with gastric cancer. PATIENTS & METHODS: This study includes 104 consecutive patients with gastric adenocarcinoma who underwent curative gastrectomy divided in two groups: overweight group (group A) and normal weight group (group B). RESULTS: We found that 53.4% of our patients were overweight (group A). The overall rate of postoperative complications was 16.3%, while mortality was 1%. Statistical analyses revealed that postoperative morbidity was significantly higher in group A (p < 0.05). Long-term survival was significantly higher in group B. Cox regression showed a statistically significant correlation between higher BMI and poor long-term survival after curative gastrectomy. Multivariate analysis has identified age and the LN ratios as independent prognostic factors of survival. CONCLUSION: In this retrospective analysis, BMI and LN ratio were independently associated with survival in patients with gastric cancer. Further studies are needed to confirm our findings.
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Índice de Massa Corporal , Linfonodos/patologia , Neoplasias Gástricas/mortalidade , Neoplasias Gástricas/patologia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Complicações Pós-Operatórias , Prognóstico , Estudos Retrospectivos , Neoplasias Gástricas/cirurgiaRESUMO
INTRODUCTION: Coagulopathy after traumatic brain injury (TBI) is a frequent event and is associated with patients' prognosis. TBI is also associated with a stress response that includes hyperglycemia. This study investigated if coagulopathy occurrence is associated with admission blood glucose levels in patients with TBI. METHODS: This study retrospectively evaluated patients with TBI who were admitted to a neurosurgical department over a 4-year period. Coagulopathy was defined as an aPTT >40 seconds and/or INR >1.2 and/or a platelet count <120*10(9) per litre. RESULTS: One-hundred and forty-nine patients were included in the study. Thirty-four patients developed coagulopathy. Patients with coagulopathy had significantly lower haemoglobin levels, increased INR and increased aPTT. Patients with severe TBI had more frequent coagulopathy. Patients with severe TBI had significant higher serum glucose levels compared to patients with mild TBI. Using ROC curves it was found that a serum glucose of 151 mg dl(-1) was the threshold for the discrimination of patients that developed coagulopathy. Logistic regression analysis revealed that serum glucose greater than 151 mg dl(-1) and haemoglobin levels lower than 12.4 mg dL(-1) were significantly associated with coagulopathy occurrence. CONCLUSION: Coagulopathy frequently occur after TBI. Patients with lower GCS score and lower haemoglobin levels and increased blood glucose levels at admission are at greater risk.
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Transtornos da Coagulação Sanguínea/fisiopatologia , Glicemia/metabolismo , Lesões Encefálicas/complicações , Lesões Encefálicas/fisiopatologia , Hemoglobinas/metabolismo , Hiperglicemia/fisiopatologia , Adolescente , Adulto , Transtornos da Coagulação Sanguínea/diagnóstico , Transtornos da Coagulação Sanguínea/etiologia , Transtornos da Coagulação Sanguínea/metabolismo , Lesões Encefálicas/metabolismo , Criança , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Hiperglicemia/etiologia , Hiperglicemia/metabolismo , Incidência , Escala de Gravidade do Ferimento , Coeficiente Internacional Normatizado , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Tempo de Tromboplastina Parcial , Admissão do Paciente , Prognóstico , Curva ROC , Estudos Retrospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
The external branch of the superior laryngeal nerve (EBSLN) is surgically relevant since its close anatomical proximity to the superior thyroid vessels. There is heterogeneity in the EBSLN anatomy and EBSLN damage produces changes in voice that are very heterogenous and difficult to diagnose. The reported prevalence of EBSLN injury widely ranges. EBSLN iatrogenic injury is considered the most commonly underestimated complication in endocrine surgery because vocal assessment underestimates such event and laryngoscopic postsurgical evaluation does not show standardized findings. In order to decrease the risk for EBSLN injury, multiple surgical approaches have been described so far. IONM provides multiple advantages in the EBSLN surgical approach. In this review, we discuss the current state of the art of the monitored approach to the EBSLN. In particular, we summarize, providing our additional remarks, the most relevant aspects of the standardized technique brilliantly described by the INMSG (International Neuromonitoring Study Group). In conclusion, in our opinion, there is currently the need for more prospective randomized trials investigating the electrophysiological and pathological aspects of the EBSLN for a better understanding of the role of IONM in the EBSLN surgery.
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Medicina Baseada em Evidências , Monitorização Neurofisiológica Intraoperatória/métodos , Monitorização Neurofisiológica Intraoperatória/normas , Nervos Laríngeos/patologia , Assistência Perioperatória/normas , Tireoidectomia/normas , Humanos , Traumatismos do Nervo Laríngeo/diagnóstico , Traumatismos do Nervo Laríngeo/epidemiologia , Traumatismos do Nervo Laríngeo/terapia , Padrões de ReferênciaRESUMO
Laryngeal nerve injuries are one the most critical complications during thyroid and parathyroid surgery. Iatrogenic damages to the recurrent laryngeal nerve (RLN) are relevant in terms of clinical implications, economic costs, and for malpractice litigation. In order to minimize potential neural damages, a standardized surgical technique is mandatory. Intraoperatory neuromonitoring (IONM) of the RLN is an important adjunct to the traditional approach and is a reliable tool for neural mapping and in dissection and prognostication of postoperative neural function 4. Because of this, most of the iatrogenic damages are not related to direct transection, but they are visually undetectable. Notwithstanding the increasing use of IONM at this stage, there is still the need for prospective, randomized, well-powered, and well-designed trials in order to further validate (via evidence-based data) the role of IONM in thyroid surgery. The aim of this review is to provide a critical analysis of the scientific evidences on the clinical impact of IONM in thyroid surgery showing the unsolved problems and the future challenges.
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Despite numerous studies, gastric cancer (GC) still presents a high mortality rate in Eastern and Western countries, increasing attention for new therapeutic strategies [...].
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Background: Managing complex perianal fistulizing Crohn's disease (CD) remains challenging, despite current medical and surgical treatment approaches. Darvadstrocel, a therapy utilizing adipose-derived stem cells, shows promise in promoting tissue regeneration and healing, offering a novel and effective treatment for fistula management. Method: A systematic literature search was conducted on PubMed and Scopus to identify studies involving patients with complex perianal fistulizing CD treated with darvadstrocel. Results: In total, 2 randomized controlled trials (RCT), 5 observational studies with retrospective data collection and 2 observational studies with prospective design were included in the final review. Data from the European ADMIRE-CD RCT demonstrated that darvadstrocel is superior to placebo in terms of clinical and imaging improvement over both the short and long term. These findings align with the prospective studies analyzed in this systematic review. The rate of treatment-emergent adverse events in the ADMIRE-CD trial's RCTs was similar in both the darvadstrocel and control groups, with perianal abscess being the most common adverse event up to 52 weeks after drug administration. Retrospective studies indicated no side-effects beyond 52 weeks. Conclusions: Darvadstrocel appears to be a new, potentially effective and safe treatment option for the management of complex perianal fistulas. However, more randomized clinical trials are needed to evaluate the efficacy and safety profile of the drug.