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INTRODUCTION: Parastomal hernias are a challenging complication of digestive ostomies. Ileal-conduit parastomal hernias after cystectomy have specific aspects. The aim of this study was to describe the incidence and natural history of ileal-conduit parastomal hernias in order to guide their management, as well as to identify risk factors to prevent them. PATIENTS AND METHODS: All consecutive patients undergoing cystectomy with a Bricker's ileal conduit in 3 academic centers were retrospectively identified. Data were collected regarding their medical history prior to cystectomy, the operation, the postoperative period, imaging results within 5 years of follow-up, and the onset and timing of clinically or radiologically diagnosed ICPH. RESULTS: Among 577 patients included in the study, 115 (20.6%) developed an ICPH during the study period. Most patients did not present any symptom and the diagnosis was made at imaging in 74.8% of them. Most hernias were detected between 1 and 2 years after the cystectomy, with a mean time to diagnosis of 12.4 months. At multivariate analysis, overweight and obesity were independent risk factors for developing an ICPH (adjusted hazard ratio [aHR] 1.96; p = 0.046), while a trans-rectus position of the ostomy was a significant protective factor (aHR 0.45; p = 0.011). CONCLUSIONS: A PH develops in almost 20% of patients after ileal conduit urinary diversion, with a mean time of onset of 12.4 months. It is often a subclinical condition detected at medical imaging. Obesity increases the risk, while passing the ileal-conduit through the rectus muscle can help to prevent it.
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Cistectomia , Hérnia Incisional , Derivação Urinária , Humanos , Masculino , Feminino , Derivação Urinária/efeitos adversos , Fatores de Risco , Estudos Retrospectivos , Incidência , Idoso , Cistectomia/efeitos adversos , Pessoa de Meia-Idade , Hérnia Incisional/etiologia , Hérnia Incisional/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Hérnia Ventral/etiologia , Hérnia Ventral/epidemiologiaRESUMO
In metastatic breast cancer (MBC), blood is a source of circulating tumor cells (CTCs). CTCs may serve as a ''real-time liquid biopsy" as they represent metastatic tumor genetics better than primary tumor. PIK3CA is one of the most important oncogenes in treatment-unresponsive breast cancers. The aim of this study was to detect PIK3CA mutations and hereditary cancer variants in CTCs from MBC patients. Forty-seven blood samples were obtained from 20 MBC patients from at least 1/3 consecutive time points. CTCs were quantified using the CellSearch system and isolated from 11/20 patients with ≥5/7.5 ml CTCs (14/47 blood samples) using the DEPArray system. DNA was extracted and amplified to perform Sanger sequencing on PIK3CA gene. Sequencing revealed a pathogenic PIK3CA mutation in 2/11 (18 %) cases. Subsequently, we evaluated a 26-target hereditary gene panel by Next Generation Sequencing and identified a concomitant pathogenic mutation in the TP53 gene in a patient with a PIK3CA mutation. No pathogenic germline variants were found. Our data support the conclusion that CTCs analysis may be used to identify mutations in patients to identify those more likely to metastasize.
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Background: Diastasis recti (DR) is a common condition, especially in women after pregnancy, often associated with concomitant hernia defects and defined as a rupture of the midline and a separation of the rectus muscle more than 2 cm. Symptoms related to this are low back pain, urinary incontinence and pelvic prolapse, as well as abdominal bulging and core instability. We analyzed clinical and functional outcomes after treatment of DR alone or associated with midline hernias in 219 patients who underwent a midline reconstruction using miSAR® technique (minimally invasive stapled abdominal wall reconstruction). Methods: Between April 2019 and April 2022, 219 patients were treated with miSAR®. All patients were requested to quantify preoperative and postoperative functional symptoms (urinary incontinence, low back pain, abdominal swelling, and respiratory distress). Results: Twenty-seven men and 192 women underwent the miSAR® technique. The mean body mass index was 23.9 kg/m2. We performed the miSAR® technique in patients affected by incisional midline hernia and umbilical hernia alone or associated with DR. Composite mesh was used in 91.8% of cases. The average operating time was 90 minutes. Seven percent of the patients had postoperative complications, including two retromuscular hematomas, two retromuscular seromas, and one postoperative bleeding event. Two patients were readmitted for bowel obstruction. After surgery, there was symptomatic improvement in urinary incontinence, low back pain, respiratory symptoms, and abdominal swelling; this improvement was confirmed at 6 months and at 1- and 2-year follow-up. At the 1-year follow-up, the overall recurrence rate was 2.83%. Conclusion: miSAR® is a feasible and effective technique and shows promising results in the treatment of DR and ventral hernia. Possible enhancements include use of preoperative Botox to treat defects larger than 6 cm. Multicentric analysis is needed to validate the technique, and longer follow-up is required to assess the recurrence rate.
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Herniorrafia , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Idoso , Herniorrafia/métodos , Grampeamento Cirúrgico/métodos , Parede Abdominal/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Estudos Retrospectivos , Complicações Pós-Operatórias , Diástase Muscular/cirurgia , Telas Cirúrgicas , Hérnia Umbilical/cirurgia , Hérnia Ventral/cirurgiaAssuntos
Doenças do Íleo , Obstrução Intestinal , Doenças do Colo Sigmoide , Humanos , Doenças do Íleo/cirurgia , Doenças do Íleo/etiologia , Obstrução Intestinal/etiologia , Obstrução Intestinal/cirurgia , Obstrução Intestinal/diagnóstico por imagem , Doenças do Colo Sigmoide/cirurgia , Doenças do Colo Sigmoide/etiologia , Doenças do Colo Sigmoide/complicaçõesRESUMO
BACKGROUND: Small non-coding (snc)RNAs, including microRNAs and P-element induced wimpy testis (PIWI)-interacting-RNAs (piRNAs), crucially regulate gene expression in both physiological and pathological conditions. In particular, some muscle-specific microRNAs (myomiRs) have been involved in the pathogenesis of cancer-induced muscle wasting. The aims of the present study were (i) to profile sncRNAs in both skeletal muscle and plasma of gastrointestinal cancer patients and (ii) to investigate the association among differentially expressed sncRNAs and the level of muscularity at body composition analysis. METHODS: Surgical patients with gastrointestinal cancer or benign disease were recruited. Blood samples and muscle biopsies (rectus abdominis) were collected during surgery. Low muscularity patients were those at the lowest tertile of skeletal muscle index (SMI; CT-scan), whereas moderate/high muscularity patients were in the middle and highest SMI tertiles. SncRNAs in the muscle were assessed by RNAseq, circulating microRNAs were evaluated by qPCR. RESULTS: Cancer patients (n = 25; 13 females, 52%) showed a mean age of 71.6 ± 11.2 years, a median body weight loss of 4.2% and a mean BMI of 27.0 ± 3.2 kg/m2 . Control group (n = 15; 9 females, 60%) showed a mean age 58.1 ± 13.9 years and a mean BMI of 28.0 ± 4.3 kg/m2 . In cancer patients, the median L3-SMI (cm2 /m2 ) was 42.52 (34.42; 49.07). Males showed a median L3-SMI of 46.08 (41.17-51.79) and females a median L3-SMI of 40.77 (33.73-42.87). Moderate-high and low muscularity groups included 17 and 8 patients, respectively. As for circulating microRNAs, miR-21-5p and miR-133a-3p were up-regulated in patients compared with controls, whereas miR-15b-5p resulted down-regulated in the same comparison (about 30% of control values). Sample clustering by muscularity and sex revealed increased miR-133a-3p and miR-206 only in moderate-high muscularity males. SncRNA profiling in the muscle identified 373 microRNAs and 190 piRNAs (72.5% and 18.7% of raw reads, respectively). As for microRNAs, 10 were up-regulated, and 56 were down-regulated in cancer patients versus controls. Among the 24 dysregulated piRNAs, the majority were down-regulated, including the top two most expressed piRNAs in the muscle (piR-12790 and piR-2106). Network analysis on validated mRNA targets of down-regulated microRNAs revealed miR-15b-5p, miR-106a-5p and miR-106b-5p as main interactors of genes related to ubiquitin ligase/transferase activities. CONCLUSIONS: These results show dysregulation of both muscle microRNAs and piRNAs in cancer patients compared with controls, the former following a sex-specific pattern. Changes in circulating microRNAs are associated with the degree of muscularity rather than body weight loss.
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MicroRNA Circulante , Neoplasias Gastrointestinais , MicroRNAs , Pequeno RNA não Traduzido , Masculino , Feminino , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Adulto , Pequeno RNA não Traduzido/genética , RNA de Interação com Piwi , Perfilação da Expressão Gênica , MicroRNAs/metabolismo , Redução de PesoRESUMO
Intraoperative neuromonitoring (IONM) in thyroid surgery offers a valid aid to the operator in identifying the recurrent laryngeal nerve and preserving its function. Recently, IONM has also been used in other surgeries, such as spinal accessory nerve dissection, during lymphectomy of the II, III, IV, and V laterocervical lymph nodes. The goal is the preservation of the spinal accessory nerve, whose macroscopic integrity does not always indicate its functionality. A further difficulty is the anatomical variability of its course at the cervical level. The aim of our study is to assess whether the use of the IONM helps to reduce the incidence of transient and permanent paralysis of the spinal accessory nerve, compared to "de visu" identification by the surgeon alone. In our case series, the use of the IONM reduced the incidence of transient paralysis, and no permanent paralysis was recorded. In addition, if the IONM registers a reduction in nerve potential, compared to the baseline value during surgery, it could indicate the need for early rehabilitation treatment, increasing the patients' chances of regaining function and reducing the costs of prolonged physiotherapy treatment.
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Traumatismos do Nervo Laríngeo Recorrente , Paralisia das Pregas Vocais , Humanos , Tireoidectomia/efeitos adversos , Monitorização Intraoperatória , Esvaziamento Cervical/efeitos adversos , Nervo Acessório , Paralisia das Pregas Vocais/etiologia , Traumatismos do Nervo Laríngeo Recorrente/etiologiaRESUMO
Locally advanced non-small cell lung cancer (NSCLC) is frequent at diagnosis and requires multimodal treatment approaches. Neoadjuvant chemotherapy (NACT) followed by surgery is the treatment of choice for operable locally advanced NSCLC (Stage IIIA). However, the majority of patients are NACT-resistant and show persistent lymph nodal metastases (LNmets) and an adverse outcome. Therefore, the identification of mechanisms and biomarkers of NACT resistance is paramount for ameliorating the prognosis of patients with Stage IIIA NSCLC. Here, we investigated the miRNome and transcriptome of chemo-naïve LNmets collected from patients with Stage IIIA NSCLC (N = 64). We found that a microRNA signature accurately predicts NACT response. Mechanistically, we discovered a miR-455-5p/PD-L1 regulatory axis which drives chemotherapy resistance, hallmarks metastases with active IFN-γ response pathway (an inducer of PD-L1 expression), and impacts T cells viability and relative abundances in tumor microenvironment (TME). Our data provide new biomarkers to predict NACT response and add molecular insights relevant for improving the management of patients with locally advanced NSCLC.
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , MicroRNAs , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/metabolismo , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/metabolismo , MicroRNAs/genética , MicroRNAs/uso terapêutico , Antígeno B7-H1/genética , Antígeno B7-H1/metabolismo , Biomarcadores , Microambiente TumoralRESUMO
BACKGROUND: In rectal cancer surgery, anastomotic leakage (AL) remains the most feared complication, with a frequency of up to 30% in non-high-volume centers. The preservation of proper vascularization is a key factor for successful anastomosis. The use of fluorescence with indocyanine green (ICG) as an intraoperative method to verify optimal perfusion is becoming an interesting tool in rectal surgery. Today, robotic surgery, together with the use of the intraoperative evaluation of the perfusion with ICG, could be a real strategy to deal with AL, allowing for a more delicate and less traumatic surgical technique. This strategy may allow for an extremely accurate surgery, and for optimal control of the proper vascularization of the rectum. METHODS: The purpose of this descriptive review is to analyze the impact of fluorescence and robotic surgery on short-term surgical outcomes for rectal cancer. RESULTS: We performed a systematic literature search using the PubMed, Embase and Cochrane library databases. The primary endpoints were to evaluate the application of ICG fluorescence in robotic rectal surgery and the rate of anastomotic leakage when using these technological implementations. The secondary endpoints were to evaluate the dosage of ICG and the timing of application by different surgeons. CONCLUSIONS: ICG fluorescence is an inexpensive and quick method to assess bowel perfusion, providing immediate feedback to the surgeon, even if its role has not been proven. A quantitative system must be systematically introduced to minimize the subjectiveness of the visualized image.
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We assessed the molecular phenotype of the browning of white adipose tissue in newly diagnosed cancer patients and controls undergoing surgery for gastrointestinal tumors and for non-malignant diseases, respectively. We collected subcutaneous adipose tissue (SAT) samples and using RT-PCR, we analyzed the expression of markers of browning and using Western blot the protein levels of UCP1 and PGC1α. The Ucp1 mRNA levels were lower in cancer patients vs. controls (p = 0.01), whereas Cidea and Tmem26 mRNA levels were higher in cancer patients. We found higher PGC1α protein levels in patients vs. controls, while no differences were seen for UCP1. The Ucp1 expression was lower in cachectic and non-cachectic patients vs. controls, whereas Cidea expression was higher in cachectic and non-cachectic patients vs. controls. Pgc1α mRNA levels were higher in cachectic vs. non-cachectic patients (p = 0.03) vs. controls (p = 0.016). According to type of tumors, we did not observe differences in Cidea expression, whereas Pgc1α was higher in pancreatic cancer vs. colorectal and vs. controls. We observed the lower expression of Ucp1 in pancreatic and colorectal cancer vs. controls. We documented higher UCP1 protein levels in pancreatic cancer patients vs. colorectal (p = 0.002) and vs. controls (p = 0.031). PGC1α protein levels were higher in pancreatic cancer patients vs. controls. Different markers of the browning of SAT are modulated, and pancreatic cancer showed changes in UCP1 and PGC1α; PGC1α was highly expressed in cachectic patients, with clinical implications that should be further clarified.
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BACKGROUND: During cancer cachexia, several alterations occur in peripheral tissues, and the adipose tissue may be involved during the catabolic state. We aimed at investigating histological rearrangement and infiltration of inflammatory cells in subcutaneous adipose tissue (SAT) of patients with cancer undergoing surgery, according to the presence/absence of cachexia. METHODS: We considered gastrointestinal cancer patients and controls with non-malignant diseases undergoing surgery. We collected SAT samples and performed histomorphological analyses [cross-sectional area (CSA) and per cent of fibrosis] and immunohistochemistry to characterize the inflammatory cells. By computed tomography (CT) scan, we calculated SAT and visceral adipose tissue (VAT). RESULTS: We enrolled 51 participants (31 gastrointestinal cancer patients and 20 controls). In cancer patients, cachexia was present in 13/31 (42%). The CSA (µm2 ) of the adipocytes from SAT was reduced in cancer patients vs. controls (3148, inter-quartile range 2574-3755 vs. 4474, inter-quartile range 3654-5183) (P < 0.001), in particular in cachectic patients vs. non-cachectic (median 2518 vs. median 3470) (P = 0.03) and in cachectic vs. controls (P < 0.001), as well as in non-cachectic vs. controls (P = 0.04). The median per cent of fibrosis was higher in cancer patients vs. controls (9 vs. 3) (P = 0.0001), in particular in cachectic vs. non-cachectic (13.35 vs. 7.13) (P = 0.03). We observed a higher number of macrophages (CD68) (P = 0.0001) and T lymphocytes (CD3) (P = 0.002) in SAT of cancer patients vs. controls, and the number of T lymphocytes was higher in cachectic vs. non-cachectic patients (P = 0.025). Anorexic cancer patients showed in SAT a higher number of macrophages and T lymphocytes with respect to controls (P < 0.0001), whereas no difference was present between anorexic and non-anorexic patients. At CT scan, cachectic patients showed lower VAT and SAT vs. non-cachectic (VAT: 97.64 ± 40.79 vs. 212.53 ± 79.24, P = 0.0002; SAT: 126.27 ± 87.92 vs. 206.27 ± 61.93, P = 0.01, respectively). Cancer patients with low CSA, high degree of fibrosis, and high number of T lymphocytes presented with lower body mass index and lower SAT and VAT at CT scan (P ≤ 0.01). CONCLUSIONS: We found histological alterations of SAT among gastrointestinal cancer patients and in particular significant changes in CSA, fibrosis, and inflammation when cachexia was present; the changes in histomorphological parameters of the adipocytes reflected alterations in adiposity at body composition analysis.
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Caquexia , Neoplasias Gastrointestinais , Tecido Adiposo/patologia , Caquexia/patologia , Neoplasias Gastrointestinais/complicações , Neoplasias Gastrointestinais/patologia , Humanos , Gordura Intra-Abdominal/metabolismo , Gordura SubcutâneaRESUMO
Background: A bilateral diaphragmatic rupture is a rare event that occurs in cases of blunt thoracic-abdominal trauma. Case Presentation: We report the case of a 56-year-old female patient with pelvic fracture and second-stage bilateral rupture of the diaphragm due to a car accident. After a chest and abdominal contrast-enhanced computed tomography (CT) scan, the patient underwent emergency suturing of the left hemidiaphragm. On postoperative day (POD) 4, a CT scan performed due to the sudden onset of dyspnea revealed rupture of the right hemidiaphragm, which was not detected on the preoperative CT scan. On POD 9, the right hemidiaphragm was repaired with mesh during a right thoracotomy. The patient recovered 14 days after surgery. However, the postoperative course was complicated by an asymptomatic COVID-19 infection that significantly delayed her discharge from the hospital. Conclusions: Difficulties in preoperative diagnosis and treatment, together with the lack of data in the literature, make this type of trauma a challenge for all acute care and general surgeons.
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BACKGROUND: Major vascular invasion represents one of the most frequent reasons to consider pancreatic adenocarcinomas unresectable, although in the last decades, demolitive surgeries such as distal pancreatectomy with celiac axis resection (DP-CAR) have become a therapeutical option. METHODS: A meta-analysis of studies comparing DP-CAR and standard DP in patients with pancreatic adenocarcinoma was conducted. Moreover, a systematic review of studies analyzing oncological, postoperative and survival outcomes of DP-CAR was conducted. RESULTS: Twenty-four articles were selected for the systematic review, whereas eleven were selected for the meta-analysis, for a total of 1077 patients. Survival outcomes between the two groups were similar in terms of 1 year overall survival (OS) (odds ratio (OR) 0.67, 95% confidence interval (CI) 0.34 to 1.31, p = 0.24). Patients who received DP-CAR were more likely to have T4 tumors (OR 28.45, 95% CI 10.46 to 77.37, p < 0.00001) and positive margins (R+) (OR 2.28, 95% CI 1.24 to 4.17, p = 0.008). Overall complications (OR, 1.72, 95% CI, 1.15 to 2.58, p = 0.008) were more frequent in the DP-CAR group, whereas rates of pancreatic fistula (OR 1.16, 95% CI 0.81 to 1.65, p = 0.41) were similar. CONCLUSIONS: DP-CAR was not associated with higher mortality compared to standard DP; however, overall morbidity was higher. Celiac axis involvement should no longer be considered a strict contraindication to surgery in patients with locally advanced pancreatic adenocarcinoma. Considering the different baseline tumor characteristics, DP-CAR may need to be compared with palliative therapies instead of standard DP.
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BACKGROUND: Diastasis recti is an abdominal wall defect that occurs frequently in women during pregnancy. Patients with diastasis can experience lower back pain, uro-gynecological symptoms, and discomfort at the level of the defect. Diastasis recti is diagnosed when the inter-rectus distance is > 2 cm. Several techniques, including both minimally invasive and open access surgical treatment, are available. Abdominoplasty with plication of the anterior rectus sheath is the most commonly used, with the major limitation of requiring a wide skin incision. The new technique we propose is a modification of Costa's technique that combines Rives-Stoppa principles and minimally invasive access using a surgical stapler to plicate the posterior sheaths of the recti abdominis. METHODS: It is a fully laparoscopic technique. The pneumoperitoneum is induced from a sovrapubic trocar, placed using an open access technique. The posterior rectus sheath is dissected from the rectus muscle using a blunt dissector to create a virtual cavity. The posterior sheets of the recti muscles are plicated using an endo-stapler. A mesh is then placed in the retromuscular space on top of the posterior sheet without any fixation. Using a clinical questionnaire, we analyzed the outcomes in 74 patients who underwent minimally invasive repair for diastasis of the rectus abdominis sheath. RESULTS: Seventy-four patients (9 men and 65 women) were treated using this technique. Follow-up was started two months after surgery. All procedures were conducted successfully. There were no major complications or readmissions. No postoperative infections were reported. There were two recurrences after six months. There was a significant reduction in symptoms. CONCLUSIONS: This new method is feasible and has achieved promising results, even though a longer follow-up is needed to objectively assess this technique.
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Parede Abdominal , Abdominoplastia , Diástase Muscular , Parede Abdominal/cirurgia , Feminino , Humanos , Masculino , Projetos Piloto , Reto do Abdome/cirurgiaRESUMO
OBJECTIVE: The aim of the study was to retrospectively evaluate the prevalence of reported and unreported potentially important incidental findings (PIFs) in consecutive nonenhanced abdominal CTs performed specifically for renal colic in the urgent setting. METHODS: One radiologist, blinded to the finalized report, retrospectively re-evaluated nonenhanced abdominal CTs performed from January to December 2017 on adult patients from the emergency department with the specific request of urgent evaluation for renal colic, searching for PIFs. RESULTS: The CTs of 312 patients were included in the study. Thirty-eight findings were reported in 38 different CTs, whereas the re-evaluation added 47 unreported findings in 47 different CTs, adding to total of 85 findings (27%). The difference in the proportion of reported and unreported PIFs between the original report and re-evaluation was significant (p < 0.001). No significant difference was found between the age of patients with and without reported findings. The proportion of potentially important findings did not vary significantly among the 3 shifts in the original report and in re-evaluation. The most frequent findings, both reported and unreported, were pleural effusion, lymphadenopathies, and liver nodules. CONCLUSIONS: Potentially important additional findings are frequently present in urgent nonenhanced abdominal CTs performed for renal colic, and many are not described in the finalized reports. Radiologists should take care not to underreport PIFs even in the urgent setting because of the possible consequences on the patient's health and in order to avoid legal issues, while at the same time satisfying the need for timely and efficient reporting.
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Achados Incidentais , Nefrolitíase , Cólica Renal/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Cólica Renal/epidemiologia , Estudos RetrospectivosRESUMO
Primary bone lymphoma is a rare entity and it usually occurs in long bones. Primary mandibular involvement is very rare, and it usually shows unspecific features, mimicking odontogenic inflammatory lesions. We present the unusual case of a diffuse large B-cell lymphoma (DLBCL) of the right mandibular body in a 91-year-old woman, who presented with acute pain in the mandibular region initially suspicious for odontogenic abscess. No significant findings were seen on orthopantomography (OPG) and her almost complete edentulism made the diagnosis of abscess unlikely. Computed tomography and magnetic resonance images showed an expansive mass around the right mandibular body with erosion of cortical bone and involving the right mandibular canal and nerve. Final diagnosis of DLBCL was pathologically proven. The presence of odontogenic-like pain in nearly complete edentulism should be suspicious for malignancy, and it needs further diagnostic workup despite the absence of signs on OPG.
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INTRODUCTION: A Coriolus versicolor-based vaginal gel is available for treating women with cervical uterine high-risk human papillomavirus (HPV) infection through re-epithelizing and re-balancing microbiota actions. METHODS: A longitudinal retrospective observational study was performed to evaluate efficacy and safety of the gel. Women treated with Coriolus versicolor-based vaginal gel were compared with women not treated with the gel. Both groups were monitored for HPV infection by an HPV DNA test, Pap smear (cytology) and colposcopy at baseline and after 6 months. RESULTS: Overall, 183 high-risk HPV positive women were enrolled (97 treated and 86 controls). After 6 months, the HPV DNA test became negative in 67.0% versus 37.2% of treated and controls, respectively (p < 0.0001). Furthermore, 76.1% versus 40.8% registered a colposcopy improvement (p = 0.0005) and 60.4% versus 40.8% showed a remission (p = 0.05), for treated versus controls, respectively. Regarding to cytology, 78.5% of treated versus 37.7% of controls registered an improvement, while 70.8% of treated versus 34.8% of controls had a remission (p < 0.0001 for both variables). At multivariate analyses adjusted for age, smoking habit, and use of estroprogestinic pill, compared to controls, women treated with the gel showed a significantly higher likelihood to experience the clearence of HPV DNA (OR 4.81; 95% 2.43-9.53), and remission at colposcopy (OR 2.30; 95% 1.00-5.31), and cytology (OR 5.13; 95% 2.40-10.96) at 6 months. No adverse event was reported during the follow-up. CONCLUSIONS: The use of a Coriolus versicolor-based vaginal gel in high-risk HPV patients is safe and effective based on all examined tests.