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The primary aim of this study was to develop and validate radiomics models, applied to ultrasound images, capable of differentiating from other cancers high-risk endometrial cancer, as defined jointly by the European Society for Medical Oncology, European Society of Gynaecological Oncology and European Society for RadiotherapyOncology (ESMO-ESGO-ESTRO) in 2016. The secondary aim was to develop and validate radiomics models for differentiating low-risk endometrial cancer from other endometrial cancers.This was a multicenter, retrospective, observational study. From two participating centers, we identified consecutive patients with histologically confirmed diagnosis of endometrial cancer who had undergone preoperative ultrasound examination by an experienced examiner between 2016 and 2019. Patients recruited in Center 1 (Rome) were included as the training set and patients enrolled in Center 2 (Milan) formed the external validation set. Radiomics analysis (extraction of a high number of quantitative features from medical images) was applied to the ultrasound images. Clinical (including preoperative biopsy), ultrasound and radiomics features that were statistically significantly different in the high-risk group vs the other groups and in the low-risk group vs the other groups on univariate analysis in the training set were considered for multivariate analysis and for developing ultrasound-based machine-learning risk-prediction models. For discriminating between the high-risk group and the other groups, a random forest model from the radiomics features (radiomics model), a binary logistic regression model from clinical and ultrasound features (clinical-ultrasound model) and another binary logistic regression model from clinical, ultrasound and previously selected radiomics features (mixed model) were created. Similar models were created for discriminating between the low-risk group and the other groups. The models developed in the training set were tested in the validation set. The performance of the models in discriminating between the high-risk group and the other groups, and between the low-risk group and the other risk groups for both validation and training sets was compared.The training set comprised 396 patients and the validation set 102 patients. In the validation set, for predicting high-risk endometrial cancer, the radiomics model had an area under the receiver-operating-characteristics curve (AUC) of 0.80, sensitivity of 58.7% and specificity of 85.7% (using the optimal risk cut-off of 0.41); the clinical-ultrasound model had an AUC of 0.90, sensitivity of 80.4% and specificity of 83.9% (using the optimal cut-off of 0.32); and the mixed model had an AUC of 0.88, sensitivity of 67.3% and specificity of 91.0% (using the optimal cut-off of 0.42). For the prediction of low-risk endometrial cancer, the radiomics model had an AUC of 0.71, sensitivity of 65.0% and specificity of 64.5% (using the optimal cut-off of 0.38); the clinical-ultrasound model had an AUC of 0.85, sensitivity of 70.0% and specificity of 80.6% (using the optimal cut-off of 0.46); and the mixed model had an AUC of 0.85, sensitivity of 87.5% and specificity of 72.5% (using the optimal cut-off of 0.36).Radiomics seems to have some ability to discriminate between low-risk endometrial cancer and other endometrial cancers and better ability to discriminate between high-risk endometrial cancer and other endometrial cancers. However, the addition of radiomics features to the clinical-ultrasound models did not result in any notable increase in performance. Other efficacy studies and further effectiveness studies are needed to validate the performance of the models. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

BACKGROUND Cytoreductive surgery (CRS) and hypertermic intraperitoneal chemotherapy (HIPEC) represent the most effective strategy to manage peritoneal metastases (PM). This systematic review and meta-analysis aimed to assess the impact of body composition on clinical outcomes in patients with PM. METHODS A systematic literature search was performed using Medline, Web of Science and EMBASE databases from inception to the 20st August 2020. Data were independently extracted by 3 authors. Newcastle-Ottawa Scale was used to assess quality and risk of bias of studies. Pooled analyses were performed using Mantel-Haenszel method to estimate overall effect size with mean differences or odd ratios (ORs) and 95% confidence interval (CI). The primary outcome was postoperative complication (POC) rate, while secondary outcomes were severe POC and postoperative mortality. RESULTS A total of 4 studies were included in the systematic review and meta-analysis, including 582 patients. A significant association between low skeletal muscle mass and POC was found (OR 1.45, 95% CI 1.04 to 2.03; p = 0.03), while no differences were found in terms operative time, estimated blood loss, length of hospital stay, and postoperative mortality (p > 0.05). CONCLUSIONS Low skeletal muscle mass at diagnosis is a valid prognostic factor for POC development in colorectal and PM patients undergoing CRS. Prospective and larger studies are needed to better investigate the role of CT scan derived body composition and to understand how to implement this tool in clinical practice.

Introduction The International Thymic Malignancy Interest Group (ITMIG) classifies thymoma recurrences on the basis of the topographic location, but its effectiveness in prognosis prediction has not been well investigated yet. Aims of this study are to analyze survival outcome of patients surgically treated for thymoma recurrence according to the ITMIG recurrence classification and to investigate possible alternatives. Methods From January 1, 1990, to January 7, 2017, data on 135 surgically treated patients for thymoma recurrence from three high-volume centers were collected and retrospectively analyzed. Patients were classified according to the ITMIG classification as local, regional, and distant. The ITMIG classification and alternative classifications were correlated to overall survival (OS). Results According to the ITMIG classification, recurrence was local in 17 (12.5%), regional in 97 (71.8%), and distant in 21 (15.7%) patients, with single localization in 38 (28.2%) and multiple localizations in 97 (71.8%). The 5- and 10-year OS were 79.9% and 49.7% in local, 68.3% and 52.6% in regional, and 66.3% and 35.4% in distant recurrences, respectively, but differences were not statistically significant (p = 0.625). A significant difference in survival was present considering single versus multiple localizations: 5- and 10-year OS of 86.2% and 81.2% versus 61.3% and 31.5% (p = 0.005, hazard ratio = 7.22, 95% confidence interval: 0.147–0.740), respectively. Combining the localization number with the recurrence site, ITMIG locoregional single recurrence had a statistically significant better survival compared with patients with ITMIG locoregional multiple recurrence or ITMIG distant recurrence (p = 0.028). Similarly, a significant difference was present considering intrathoracic single versus intrathoracic multiple versus distant recurrence (p = 0.024). Conclusions The ITMIG classification for thymoma recurrence did not have significant survival differences comparing local, regional, and distant recurrences. Integrating this classification with the number of the localizations may improve its effectiveness in prognosis prediction.

Introduction The standard treatment for epithelial early stage ovarian cancer (eEOC) includes laparotomic surgical staging, according to ESGO-ESMO guidelines. In the last decade, many investigators have assessed the safety and feasibility of minimally invasive surgery (MIS) staging in properly selected patients. However, survival data related to different surgical approaches (open versus MIS) are extremely limited. The aim of this study is to analyze the long-term oncological outcomes in eEOC patients treated with MIS. Materials and methods This is a multicenter observational retrospective study conducted in two tertiary oncological centers. We selected all consecutive women who underwent a laparoscopic or robotic staging for eEOC. Results From January 2008 to December 2016, 254 eEOC patients underwent a MIS staging (188 laparoscopic staging and 66 robotic staging). Overall, 18.1% of patients were upstaged due to pathological findings. A total of 203 (79.9%) patients received platinum-based adjuvant chemotherapy. After a median follow-up of 61 months (range 13–118), 39 (15.3%) patients experienced recurrence. The 5-years progression free survival (PFS) and overall survival rates were 84.0% and 93.8%, respectively. In the univariate analysis, favorable variables influencing PFS were young age (≤45 years), non-serous histotype, tumor grade 1-2, and FIGO stage IA/IB. In the multivariate analysis, only grade 3 was shown to keep its negative independent prognostic value (HR = 3.47; p = 0.004), whereas FIGO stage ≥ IC showed a trend toward significance (HR = 1.75; p = 0.099). Conclusion This retrospective study represents the longest follow-up of eEOC patients managed by MIS. The MIS is a valuable therapeutic option in appropriately selected patients, although a randomized controlled trial is needed.

Introduction: The SARS-CoV-2 pandemic has deeply revolutionized our lives and consequently the management of patients, specifically ones with severe asthma.Objective: A survey was conducted to evaluate the effects on adherence, exacerbations and quality of life in patients with severe asthma during the COVID-19 pandemic period.Methods: 100 severe asthma patients, who accepted to participate to the survey, were asked to respond to different questionnaires in order to assess asthma symptoms (Asthma Control Test - ACT, and Asthma Control Quality - ACQ) and rino-sinusal ones (Sino-nasal outcome test - SNOT-22).Results: 31 out of 100 patients reported worsening of respiratory symptoms requiring a step-up in therapy dosage or frequency during the observational period; however, exacerbation rate was very low. Only 17 (17%) of the 100 participants experienced a severe asthma exacerbation. Moreover, there was no confirmed diagnosis of COVID-19 in this population.Conclusion: Patients with severe asthma did not show higher rates of exacerbations during the pandemic outbreak as well as no increased risk of contracting COVID-19 infection or developing the disease. Self-administration of biological drugs could be useful to maintain high rates of adherence to therapy, and, at the same time, to decrease the risk of exacerbations or Intensive Care Unit (ICU) room access.

SUMMARY INTRODUCTION Surgical therapy for vulvar cancer involves wide defects that often require flap-based reconstruction. The goal of the reconstruction is fast wound healing with low donor site morbidity. MATERIALS AND METHODS This is a retrospective observational cohort study in which we reviewed all patients who underwent surgery for vulvar cancer followed by reconstruction using the Superficial Circumflex Iliac Artery Perforator (SCIP) flap between 2015 and 2020. The primary outcome measure of this investigation was the incidence of wound complications. Secondary outcomes were the surgical indications in terms of establishing the anatomical subunits involved in the resection that made us choose this flap for reconstruction. This study adheres to the STROBE guidelines. RESULTS Thirty-two patients were included; in two cases, the flap was performed bilaterally for a total of 34 SCIP flaps. The mean age of patients was 70.6±8.6years, and the mean BMI was 26.8±4.7. The SCIP flap was always feasible. The mean flap size was 128.8±74.3cm2. Three patients showed wound complication. In every patient, the defect involved the vulva, perineum and inguinal area; in 18 patients, the mons pubis was also involved. The mean follow-up was 30 months. During the follow-up, six patients died, and four showed local or nodal cancer relapse. CONCLUSION Our results suggest that the SCIP flap advantages for the reconstruction of vulvoperineal defects secondary to vulvar cancer surgery are low complication rate, minimal donor site morbidity, quick dissection, proximity of donor and recipient sites, possibility to harvest large skin islands of variable thickness and chimeric flaps.

Objective To characterize T lymphocyte infiltration and programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) expression in early-stage endometriosis-associated ovarian cancer (EAOC), ovarian endometriosis (OE), atypical endometriosis (AE), and deep endometriosis (DE). Design Case-control, retrospective study. Setting Research University Hospital. Patient(s) A total of 362 patients with a histologic diagnosis of EAOC, OE, AE, or DE were identified between 2000 and 2019 from Fondazione Policlinico Universitario Agostino Gemelli IRCCS and Gemelli Molise SpA tissue data banks. A 1:1 propensity score-matched method yielded matched pairs of 55 subjects with EAOC, 55 patients with OE, 12 patients with AE, and 42 patients with DE, resulting in no differences in family history of cancer, parity, and use of oral contraceptives. Intervention(s) Immunohistochemistry assays using the following primary antibodies: CD3+; CD4+; CD8+; PD-1; and PD-L1. Main Outcome Measure(s) To characterize T lymphocyte infiltration and PD-1/PD-L1 expression in 4 different endometriosis-related diseases. Result(s) Endometriosis-associated ovarian cancer cases displayed significantly higher levels of PD-1/PD-L1 expression compared with all other endometriosis-related diseases (vs. OE vs. AE vs. DE). Moreover, a significantly lower count of infiltrating T lymphocytes was observed in EAOC cases compared with OE ones. Finally, one-third of OE cases showed a cancer-like PD-1/PD-L1 expression profile. Conclusion(s) Endometriosis-associated ovarian cancer is characterized by higher levels of PD-1/PD-L1 expression compared with benign endometriosis-related diseases. This profile was found in one-third of clinically benign cases, suggesting that it develops early in the carcinogenesis process.

OBJECTIVES Fusion imaging is an emerging technique that combines real-time ultrasound examination with images acquired previously using other modalities, such as computed tomography (CT), magnetic resonance imaging and positron emission tomography. The primary aim of this study was to evaluate the feasibility of fusion imaging in patients with suspicion of ovarian or peritoneal cancer. Secondary aims were: to compare the agreement of findings on fusion imaging, CT alone and ultrasound imaging alone with laparoscopic findings, in the assessment of extent of intra-abdominal disease; and to evaluate the time required for the fusion imaging technique. METHODS Patients with clinical and/or radiographic suspicion of advanced ovarian or peritoneal cancer who were candidates for surgery were enrolled prospectively between December 2019 and September 2020. All patients underwent a CT scan and ultrasound and fusion imaging to evaluate the presence or absence of the following abdominal-cancer features according to the laparoscopy-based scoring model (predictive index value (PIV)): supracolic omental disease, visceral carcinomatosis on the liver, lesser omental carcinomatosis and/or visceral carcinomatosis on the lesser curvature of the stomach and/or spleen, involvement of the paracolic gutter(s) and/or anterior abdominal wall, involvement of the diaphragm and visceral carcinomatosis on the small and/or large bowel (regardless of rectosigmoid involvement). The feasibility of the fusion examination in these patients was evaluated. Agreement of each imaging method (ultrasound, CT and fusion imaging) with laparoscopy (considered as reference standard) was calculated using Cohen's kappa coefficient. RESULTS Fifty-two patients were enrolled into the study. Fusion imaging was feasible in 51 (98%) of these patients (in one patient, it was not possible for technical reasons). Two patients were excluded because laparoscopy was not performed, leaving 49 women in the final analysis. Kappa values for CT, ultrasound and fusion imaging, using laparoscopy as the reference standard, in assessing the PIV parameters were, respectively: 0.781, 0.845 and 0.896 for the great omentum; 0.329, 0.608 and 0.847 for the liver surface; 0.472, 0.549 and 0.756 for the lesser omentum and/or stomach and/or spleen; 0.385, 0.588 and 0.795 for the paracolic gutter(s) and/or anterior abdominal wall; 0.385, 0.497 and 0.657 for the diaphragm; and 0.336, 0.410 and 0.469 for the bowel. The median time needed to perform the fusion examination was 20 (range, 10-40) min. CONCLUSION Fusion of CT images and real-time ultrasound imaging is feasible in patients with suspicion of ovarian or peritoneal cancer and improves the agreement with surgical findings when compared with ultrasound or CT scan alone. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

PURPOSE To investigate the vascular remodeling of optical coherence tomography angiography in full-thickness macular hole surgery. METHODS This retrospective, observational case series included 33 eyes of 33 patients with a full-thickness macular hole who underwent epiretinal membrane removal. Data were collected on best-corrected visual acuity, structural B-scan optical coherence tomography, and optical coherence tomography angiography preoperatively and at 1, 3, and 6 months postoperatively. Optical coherence tomography angiography was used to assess the retinal vascular density (VD) of the superficial vascular plexus and deep vascular plexus (DVP). Vascular density was assessed using the Early Treatment Diabetic Retinopathy Study grid for the whole, inner, and outer grids. RESULTS A statistically significant correlation was found between the VD (whole, inner, and outer grids) of the superficial vascular plexus alone from baseline to 1-month postoperatively (P < 0.001). Similarly, VD was correlated from baseline to 1, 3, and 6 months postoperatively to the whole (P < 0.0005, F = 23.22), inner (P < 0.0005, F = 28.23), and outer Early Treatment Diabetic Retinopathy Study grids of DVP (P = 0.033, F = 3.49). The best-corrected visual acuity and VD were significantly correlated with the superficial vascular plexus and DVP at baseline and 6 months (P < 0.05, all correlations). The most significant correlation was observed at 6 months between best-corrected visual acuity and DVP in the whole, inner, and outer Early Treatment Diabetic Retinopathy Study grids (P < 0.001). CONCLUSION Superficial vascular plexus and DVP are affected by full-thickness macular holes, with the most significant effects being on the DVP. Full-thickness macular hole surgery leads to an improvement in the best-corrected visual acuity in many eyes and the restoration of the VD, especially of the DVP.

Introduction: The impact of school opening on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is still unknown. This study aims to provide preliminary information about the number of SARS-CoV-2 cases among students attending Italian schools.Methods: Data are extracted and analyzed from an open-access, online dataset that monitor, on a daily basis, media news about SARS-CoV-2 infections of students attending Italian schools.Results: As of October 5, 2020, a total of 1,350 cases of SARS-CoV-2 infections have been registered in the Italian territory schools (involving 1,059 students, 145 teachers, and 146 other school members), for a total of 1,212 out of 65,104 (1.8%) Italian schools involved. National schools reported only one case of SARS-CoV-2 infection in more than 90% of cases, and only in one high school a cluster of more than 10 cases has been described (P = 0.015). The detection of one or more SARS-CoV-2 infections led to the closure of 192 (15.8%) entire schools, more frequently nursery/kindergartens (P < 0.0005).Discussion: Our preliminary data support low transmission of SARS-CoV-2 within schools, at least among younger students. However, entire schools are frequently closed in the fear of larger outbreaks. Continuous monitoring of school settings, hopefully through daily updated open-access datasets, is needed to better understand the impact of schools on the pandemic and provide guidelines that better consider different risks within different age groups.

Background A correlation between unsuccessful noninvasive ventilation (NIV) and poor outcome has been suggested in de-novo Acute Respiratory Failure (ARF) patients. Consequently, it is of paramount importance to identify accurate predictors of NIV outcome. The aim of our preliminary study is to evaluate the Diaphragmatic Thickening Fraction (DTF) and the respiratory rate/DTF ratio as predictors of NIV outcome in de-novo ARF patients. Methods Over 36 months, we studied patients admitted to the emergency department with a diagnosis of de-novo ARF and requiring NIV treatment. DTF and respiratory rate/DTF ratio were measured by 2 trained operators at baseline, at 1, 4, 12, 24, 48, 72 and 96 h of NIV treatment and/or until NIV discontinuation or intubation. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the ability of DTF and respiratory rate/DTF ratio to distinguish between patients who were successfully weaned and those who failed. Results Eighteen patients were included. We found overall good repeatability of DTF assessment, with Intra-class Correlation Coefficient (ICC) of 0.82 (95% confidence interval 0.72–0.88). The cut-off values of DTF for prediction of NIV failure were p 0.6 for both operators (p Conclusion DTF and respiratory rate/DTF ratio may both represent valid, feasible and noninvasive tools to predict NIV outcome in patients with de-novo ARF. Trial registration ClinicalTrials.gov Identifier: NCT02976233, registered 26 November 2016.

Background: Surgical treatment of anal fistulas is still a challenge. The aims of this study were to evaluate the adoption and healing rates for the different surgical techniques used in Italy over the past 15 years. Methods: This was a multicenter retrospective observational study of patients affected by simple and complex anal fistulas of cryptoglandular origin who were surgically treated in the period 2003–2017. Surgical techniques were grouped as sphincter-cutting or sphincter-sparing and as technology-assisted or techno-free. All patients included in the study were followed for at least 12 months. Results: A total of 9,536 patients (5,520 simple; 4,016 complex fistulas) entered the study. For simple fistulas, fistulotomy was the most frequently used procedure, although its adoption significantly decreased over the years (P < .0005), with an increase in sphincter-sparing approaches; the overall healing rate in simple fistulas was 81.1%, with a significant difference between sphincter-cutting (91.9%) and sphincter-sparing (65.1%) techniques (P = .001). For complex fistulas, the adoption of sphincter-cutting approaches decreased, while sphincter-sparing techniques were mildly preferred (P < .0005). Moreover, there was a significant trend toward the use of technology-assisted procedures. The overall healing rate for complex fistulas was 69.0%, with a measurable difference between sphincter-cutting (81.1%) and sphincter-sparing (61.4%; P = .001) techniques and between techno-free and technology-assisted techniques (72.5% and 55.0%, respectively; P = .001). Conclusion: Surgical treatment of anal fistulas has changed, with a trend toward the use of sphincter-sparing techniques. The overall cure rate has remained stable, even if the most innovative procedures have achieved a lower success rate.

Background: The possible transmission of severe acute respiratory coronavirus 2 (SARS-CoV-2) by tears and conjunctiva is still debated. Methods: Main outcome was to investigate the agreement between nasopharyngeal swab (NPs) and conjunctival swabs (Cs) in patients with SARS-CoV-2 infection. We divided patients into four groups: (1) NPs and Cs both negative (C−NF−), (2) NPs positive and Cs negative (NFs+Cs−), (3) NPs negative and Cs positive (NFs−Cs+), and (4) NPs and Cs both positive (NFs−Cs+). The secondary outcomes were to correlate Cs results with systemic clinical parameters such as: oxygen saturation (SpO2), dyspnea degree (DP), radiologic pulmonary impairment based on chest radiography (XR) or computed tomography (CT), blood chemistry as D-Dimer (D-Dimer), fibrinogen, ferritin, lactate dehydrogenase (LDH), and C-reactive protein (C-RP). Results: A total of 100 conjunctival swabs in 50 patients with SARS-CoV-2 have been enrolled in this interventional clinical trials. Ocular signs (conjunctivitis) were present in five patients (10%). NPs and Cs highlighted a poor level of agreement (0.025; p = 0.404). Median SpO2 levels are the highest in the NF−C− group (98%) and the lowest (90%) in the group NF+C+ ( p = 0.001). Pulmonary impairment was statistically significantly different between NFs and Cs groups ( p = 0.019). Pulmonary impairment score increased from NFs−Cs− group (3.8 ± 3.9), to NFs+Cs+ group (6.7 ± 4.1). Intensive care unit patients showed higher COVID-19 Cs positivity in conjunctiva (12.5%) against hospitalized ones (5.8%). Conclusions: In patients hospitalized for SARS-CoV-2 the virus can be detected in conjunctival swab. Intensive care unit patients may reveal a higher COVID-19 presence in the conjunctiva. The most severe pulmonary impairment can be observed in NFs and Cs positivity. Trial registration: Clinicaltrials.gov registration. Ethical committee authorization: ID number: 0013008/20

Introduction The standard treatment for epithelial early stage ovarian cancer (eEOC) patients includes laparotomic surgical staging, according to FIGO classification. In the last decade, many investigators have assessed the safety, adequacy and feasibility of minimally invasive surgery (MIS) staging of eEOC in properly selected patients, but survival data related to different surgical approaches (open versus MIS) are extremely limited. The aim of this study is to analyze the long-term oncological outcomes in eEOC patients treated with MIS. Methods This is a multicenter observational retrospective study conducted in two tertiary oncological centers. We selected all consecutive women (N=254) who underwent a MIS staging for clinical eEOC from January 2008 until 31st December 2016, in order to have an adequate length of median follow-up. Results Most women had serous histotype (39.0%) and poorly differentiated tumors (53.0%). The rate of upstaged patients (final pathological FIGO stage >IIA) was 18.1%. The median duration of follow-up was 61 months (range:13–118). Eleven patients were lost to follow-up and excluded from survival analysis. Overall, 39 (16.0%) patients experienced recurrence. The 5-years disease-free survival and the 5-years overall survival rate was 84.0% and 92.5%, respectively. In the multivariate analysis the grading 1–2, FIGO stage IA-IB, and delayed surgical staging (vs. immediate staging) played a statistically significant favorable prognostic value. Conclusion This study represents the longest follow-up of eEOC patients managed by MIS. We confirmed that MIS will continue to be a valuable therapeutic option in appropriately selected patients.

IntroductionThe impact of school opening on the SARS-CoV-2 pandemic is still unknown. This study aims to provide preliminary information about the number of SARS-CoV-2 cases among students attending Italian schools.MethodsData are extracted and analysed from an open access, online dataset that monitor, on a daily basis, media news about SARS-CoV-2 infections of students attending Italian schoolsResultsAs of 5 October 2020, a total of 1350 cases of SARS-CoV-2 infections have been registered in the Italian territory schools (involving 1059 students, 145 teachers and 146 other school members), for a total of 1212 out of 65104 (1.8%) Italian schools involved. National schools reported only 1 case of SARS-CoV-2 infection in more than 90% of cases, and only in one high school a cluster of more than 10 cases have been described (P 0.015). The detection of one or more SARS-CoV-2 infections leaded to the closure of 192 (14.2%) entire schools, more frequently nursery/kindergartens (PDiscussionOur preliminary data support low transmission of SARS-CoV-2 within schools, at least among younger students. However, entire schools are frequently closed in the fear of larger outbreaks. Continuous monitoring of school settings, hopefully through daily updated open access datasets, are needed to better understand the impact of schools on the pandemic, and provide guidelines that better consider different risks within different age groups.

BackgroundA radical surgical approach represents the mainstay treatment for gynecological malignancy, and preoperative staging of ovarian cancer is crucial. Ultrasound evaluation is widely recognized as the gold standard technique for the characterization of ovarian masses due to a high sensitivity for malignancy. In addition, its accuracy in defining intra-abdominal ovarian cancer spread has been previously proposed.Primary objectiveTo analyze the agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intra-abdominal disease using six parameters as described by Fagotti’s score.Study hypothesisWhen performed by expert examiners, ultrasound can be an accurate technique to assess tumor spread in ovarian cancer and therefore to predict surgical resectability.Trial designThis is a single-center prospective observational study. Patients with clinical and/or radiological suspicion of advanced ovarian or peritoneal cancer will be assessed with preoperative ultrasound and assigned a score based on the six Fagotti’s laparoscopic score parameters. Each parameter will then be correlated with laparoscopic findings.Major inclusion/exclusion criteriaEligible patients include women 18–75 years of age with clinical and/or imaging suggestive of advanced ovarian or peritoneal cancer, and an ECOG performance status 0–3.Primary endpointsSensitivity and specificity of ultrasound in detecting carcinomatosis, using the parameters of Fagotti’s score as a reference standard. Agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intra-abdominal disease as described in Fagotti’s score.Sample size240 patients.Estimate dates for completing accrual and presenting resultsThe accrual started in January 2019. Enrollment should be completed approximately by October 2020 and the results will be analyzed by December 2020.Trial registrationThe study received the Ethical Committee approval on July 19 2018 (Protocol 28967/18 ID:2172).

ObjectiveTo describe the prevalence and characteristics of sleep-disordered breathing (SDB) in a large cohort of patients with genetically confirmed mitochondrial diseases.MethodsThis is a prospective observational study performed at the Neurophysiopatology Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS. All participants had a defined mitochondrial disease and were investigated by full-night polysomnography.ResultsOne hundred three consecutive patients were enrolled. SDB was demonstrated in 49 patients (47.6%). Regarding phenotypes, we found differences in distribution between the groups: patients affected by progressive external ophthalmoplegia with single or multiple mtDNA deletions frequently had obstructive apneas (50% and 43.8%) or REM-related hypoventilation when associated with m.3243A>G mutations (75%). Furthermore, a high percentage of participants with maternally inherited diabetes and deafness and myoclonic epilepsy with ragged-red fibers syndromes were characterized by obstructive sleep apnea and REM-related hypoventilation, respectively. In contrast to what has been described in previous studies, central sleep apnea was rarely reported in our cohort.ConclusionsSDB has a higher prevalence in mitochondrial diseases compared to general population–based data. Overall, these results suggest that patients characterized by a specific phenotype-genotype combination are most at risk of developing a specific subgroup of SDB. The early identification of this disorder is crucial in the management of these fragile patients.

The primary aim of this prospective study was to assess the efficacy of Sphinkeeper™ (SK) implantation in patients with faecal incontinence. Forty-two patients with faecal incontinence (14 with sphincter defects) underwent SK implantation and were followed up for a mean(s.d.) of 15·9(8·6) months. SK implantation was a safe and effective method that improved patients' quality of life. Implants and incontinence.

Objective In 5-30% of cases, endometrial cancer occurs in women age 45 or younger. A valid option for women desiring fertility is primary hormonal treatment, such as oral megestrol acetate (MA) alone or combined with hysteroscopic resection1, or levonorgestrel-releasing intrauterine system (LNG-IUS); however, 20-30% and 41% patients undergoing progestin-based treatments alone failed to achieve complete response (CR) and recur2. The current knowledge is drawn from observational cohort studies on small series of patients for which long follow-up is rare3. Moreover, the worldwide data on hysteroscopic treatment are still limited4. Here, we evaluated the prognostic outcome of a large, single-institution series of young women diagnosed with endometrial atypical hyperplasia (EAH)/endometrioid intraepithelial neoplasia (EIN) and early stage endometrial cancer (EEC) who were selected for fertility preservation and treated with oral MA combined with hysteroscopic resection in the subgroup of patients carrying a single lesion. Study Design Patients with EAH/EIN (n= 49) or well differentiated EEC (n= 36), FIGO stage IA (no myometrial invasion at MRI) were prospectively included from June 2007 to December 2019. The inclusion criteria for conservative treatment followed NCCN guidelines 20185. All patients received MA 160 mg daily for a minimum of 6 months and were evaluated by hysteroscopy-guided biopsy and ultrasounds every three months until achieving CR. Next, follow-up was performed every 3 months until pregnancy was obtained. Only suspected single lesion (cancerous polyp or neoformation) were hysteroscopically removed before progestin treatment with the NEMos (Neoplasia Endometrium Myometrium organized sections) technique1,6. Multifocal lesions were treated with MA alone. Results The median follow-up time was 36 months (range 6-150). A total of 82 patients (96.5%) achieved CR. The mean treatment duration for achieving CR was 4.51 months (range 3-18 months). Hysteroscopic removal of EAH/EIN or EEC prior to therapy was the only factor significantly associated with shorter treatment duration to achieve CR (p=0.001). Patients who underwent hysteroscopic resection plus MA (n=15) or MA therapy alone (n=67) achieved CR in 3.4 months (range 3-18) and 4.75 months (range 3-18), respectively. The cumulative relapse rate was 62% (51/82) and the median time to relapse was 21 months (28 months for EAH/EIN and 21 months for EEC). Patients with lesion removed by hysteroscopy plus MA relapsed later (average 38, median 33, range 6-150 months) compared to patients who were treated with MA alone (average 27, median 18, range 6-108 months) (p=0.043) (Fig. 1). Among the 82 patients who achieved CR, 52 patients planned for parenthood; and 26 patients (50%) achieved at least one pregnancy. Only 4 patients received in vitro fertilization. Spontaneous miscarriage rate was 17% (9 out of 52 cases) and live birth rate was 32.7% (17 out of 52 cases), respectively. Conclusion In this study, we report our institutional experience with a large series of EAH/EIN (n=49) and EEC (n=36) patients eligible for fertility-sparing treatment with MA alone or combined with NEMo’s hysteroscopic resection1,5. We found that hysteroscopic resection of EAH/EIN or EEC in combination with oral progestin therapy was significantly associated with shorter treatment duration to achieve CR and longer time to relapse, compared to patients treated with progestin therapy alone. This large, single-institution study provides convincing data on the efficacy of MA plus hysteroscopic resection in conservative treatment of both EAH/EIN and EC patients, which will have to be confirmed in a prospective multi-institutional trial.

Endometriosis is one of the most common medical conditions affecting the women. The study aimed to evaluate the safety and efficacy of robotic-assisted laparoscopic surgery (RAS) versus conventional laparoscopic surgery (LPS) in the treatment of endometriosis. PubMed, Embase, Cochrane and CINAHL databases were searched from January 1995 to March 2019. According to meta-analysis criteria, five comparative studies were selected. A total of 1527 patients were identified. In the meta-analysis, there were no significant differences in blood loss, complication, and hospital stay between RAS and LPS surgeries in the treatment of patients with endometriosis. However, RAS surgery required a higher weighted mean operating time than LPS surgery, 0.54 (95% confidence interval; 0.37 to 0.70; p

Purpose Chemoradiation (CT/RT) followed by radical surgery (RS) may play a role in locally advanced cervical cancer (LACC) patients with suboptimal response to CT/RT or in low-income countries with limited access to radiotherapy. Our aim is to evaluate oncological and surgical outcomes of minimally invasive radical surgery (MI-RS) compared with open radical surgery (O-RS). Patients and Methods Data for stage IB2–IVA cervical cancer patients managed by CT/RT and RS were retrospectively analyzed. Results Beginning with 686 patients, propensity score matching resulted in 462 cases (231 per group), balanced for FIGO stage, lymph node status, histotype, tumor grade, and clinical response to CT/RT. The 5-year disease-free survival (DFS) was 73.7% in the O-RS patients and 73.0% in the MI-RS patients (HR 1.034, 95% CI 0.708–1.512, p = 0.861). The 5-year locoregional recurrence rate was 12.5% (O-RS) versus 15.2% (MI-RS) (HR 1.174, 95% CI 0.656–2.104, p = 0.588). The 5-year disease-specific survival (DSS) was 80.4% in O-RS patients and 85.3% in the MI-RS group (HR 0.731, 95% CI 0.438–1.220, p = 0.228). Estimated blood loss was lower in the MI-RS group (p p p = 0.331). Fifty-six (24.2%) patients experienced late postoperative complications in the O-RS group, versus 61 patients (26.4%) in the MI-RS group (p = 0.668). Conclusion MI-RS and O-RS are associated with similar rates of recurrence and death in LACC patients managed by surgery after CT/RT. No difference in early or late complications was reported.

Background Physical and psychological factors, like wrong attitudes and behaviours, can negatively influence health outcomes of the patients receiving allogeneic hematopoietic stem cell transplantation (AHSCT). Educational interventions aiming to improve knowledge on side effects, risks, complications and preventive behaviour can reduce psychological distress, and improve quality of life (QoL). We aimed to compare a standard approach with therapeutic patient education (TPE) to analyse the impact on AHSCT patients’ QoL, psychological distress and knowledge of AHSCT side effects, risks complications and preventive behaviour. Material and methods A prospective interventional study was conducted analysing data of 36 patients who received one of two different educational approaches, which were a standard approach (not-exposed) or TPE (exposed). Results In the exposed group QoL improved 14 days after transplantation (42.2 vs 25.6; p

Hospital malnutrition is still underestimated among physicians, even in internal medicine settings. This is a cross-sectional study, aiming to estimate the risk, the prevalence and the impact of malnutrition in an Internal Medicine and Gastroenterology Department of a large Italian hospital (Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome). Patients were evaluated within 72 h from admission according to Nutritional Risk Screening-2002 (NRS-2002) and European Society for Clinical Nutrition and Metabolism (ESPEN) Criteria. Anthropometric, laboratory tests and Bioelectrical Impedance Analysis (BIA) derived phase angle were also performed. Length of hospital stay (LOS) and in-hospital mortality were collected. Univariate and multivariate analyses were conducted to correlate nutritional status with LOS and hospital mortality. In 10 months, 300 patients were enrolled: male patients were 172 (57.3%); mean age was 63.7 (± 17.6). At admission, 157 (52.3%) patients were at risk of malnutrition; 116 (38.7%) were malnourished. Malnourished patients had a mean LOS of 11.5 (± 8.0) days, not-malnourished 9.4 (± 6.2) days (p