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Background: In France, 62,000 hysterectomies are performed per year, 70% of which are benign. The choice of approach (laparotomy, laparoscopy or vaginal route) is particularly important in the case of large uterus (> 280g) which are associated with a higher risk of complications. The current data are not sufficient to favour one or other approach. A new medical device, the vNOTES (Natural Vaginal Orifice Transluminal Endoscopy System), offers the advantage of both laparoscopic and vaginal route for pelvic surgery. Objectives: To demonstrate the superiority in terms of intraoperative and postoperative complications of the use of a natural orifice transluminal endoscopic hysterectomy system (vNOTES) versus laparoscopic hysterectomy for benign pathologies on estimated large volume uteri (>280g). Materials and Methods: A randomised, double-blind, superiority trial will be performed at five hospital centres. Women with benign uterine pathology requiring hysterectomy and with a large uterus (> 280g) will be randomised to receive either laparoscopic or vNOTES hysterectomy. Main outcome measures: The primary outcome will be the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Secondary outcomes will be conversion during surgery, duration of surgery and hospitalisation, postoperative pain, postoperative complications, resumption of sexual life and satisfaction with the surgical team. Results: 248 women will be randomised. Conclusion: This trial will provide a better understanding of the approach to large uteri optimise the care of these thousands of women undergoing hysterectomy. What's new?: This trial will evaluate the vNotes for large uteri.
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We aimed to measure gastric antral cross-sectional area with ultrasound and estimate the gastric volume of 300 patients before unplanned surgery, fasted for at least six hours. Measurements were successfully recorded in 263 semi-recumbent patients. The median (IQR [range]) area was 333 (241-472 [28-1803]) mm2 and the mean (SD) estimated volume was 45.8 (34.0) ml. The area exceeded 410 mm2 in 92/263 (35%) measurements. Body mass index and morphine administration were associated with larger gastric areas on multivariable linear regression analysis, with beta coefficient (95%CI) 0.02 (0.01-0.04), p = 0.01, 0.23 (0.01-0.46), p = 0.04, respectively. Fasting time was not associated with gastric area and therefore could not substitute for ultrasound measurements in this cohort.
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Aspiração Respiratória de Conteúdos Gástricos/diagnóstico por imagem , Aspiração Respiratória de Conteúdos Gástricos/prevenção & controle , Estômago/diagnóstico por imagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anatomia Transversal , Índice de Massa Corporal , Estudos de Coortes , Estudos Transversais , Serviços Médicos de Emergência , Jejum , Feminino , Esvaziamento Gástrico , Humanos , Masculino , Pessoa de Meia-Idade , Morfina/farmacologia , Antro Pilórico/diagnóstico por imagem , Reprodutibilidade dos Testes , Ultrassonografia , Adulto JovemRESUMO
BACKGROUND AND AIMS: The usefulness of anti-glycan antibodies alone or combined with anti-Saccharomyces cerevisiae [ASCA] or perinuclear antineutrophil cytoplasmic [pANCA] antibodies for diagnosis of inflammatory bowel disease [IBD], differentiation between Crohn's disease [CD] and ulcerative colitis [UC], disease stratification including IBD phenotype, and also for determination of the course of the disease, remain unclear. METHODS: A large panel of serological anti-glycan carbohydrate antibodies, including anti-mannobioside IgG antibodies [AMCA], anti-chitobioside IgA [ACCA], anti-laminaribioside IgG antibodies [ALCA], anti-laminarin [anti-L] and anti-chitine [anti-C] were measured in the serum from a cohort of 195 patients with IBD] [107 CD and 88 UC]. The respective accuracy of isolated or combined markers for diagnosis, disease differentiation, stratification disease phenotype, and severity of the disease course, defined by a wide panel of criteria obtained from the past medical history, was assessed. RESULTS: The positivity of at least one anti-glycan antibody was detected in a significant higher proportion of CD and UC compared with healthy controls [p < 0.0001 and p < 0.0007, respectively]. Whereas ASCA and ANCA antibody status had the highest efficacy to be associated with CD in comparison with UC (area under receiver operating characteristic curve [AUROC] = 0.70 for each], the adjunction of anti-laminarin antibody substantially improved the differentiation between CD and UC [AUROC = 0.77]. Titres of ACCA [> 51U/ml] and anti-laminarin [> 31U/ml] were significantly linked with a higher association with steroid dependency (odds ratio [OR] =2.0 [1.0-4.0], p = 0.03 and OR = 2.4 [1.1-5.2], p = 0.02, respectively]. We further defined the respective performance of anti-glycan antibodies to discriminate between patients with severe or not severe CD and UC course and determined the associated optimal cut-off values: severe CD course was significantly more likely in case of AMCA > 77U/ml [OR = 4.3; p = 0.002], ASCA > 63U/ml [OR = 3.5; p < 0.009] and at a lesser degree ACCA > 50U/ml [OR = 2.8; p < 0.02] and severe UC course was significantly associated with AMCA > 52U/ml [OR = 3.4; p = 0.04] and ACCA > 25U/ml [OR = 3.0; p < 0.04]. CONCLUSIONS: Anti-glycan antibodies are valuable serological markers, especially AMCA antibodies that may help clinicians to promptly classify patients into high risk for severe disease.
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Anticorpos Anticitoplasma de Neutrófilos/sangue , Anticorpos Antifúngicos/sangue , Colite Ulcerativa/diagnóstico , Doença de Crohn/diagnóstico , Polissacarídeos/imunologia , Saccharomyces cerevisiae/imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Colite Ulcerativa/sangue , Doença de Crohn/sangue , Diagnóstico Diferencial , Feminino , Glucanos/imunologia , Humanos , Imunoglobulina A/sangue , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Curva ROC , Índice de Gravidade de Doença , Adulto JovemRESUMO
OBJECTIVE: To present results and to identify predictive factors of early outcome after fenestrated and/or branched endovascular repair (f/b-EVAR) for complex aortic aneurysms, abdominal (AAA) and thoracoabdominal (TAAA). BACKGROUND: Feasibility of f/b-EVAR for complex aneurysms is now established, but little is known about which patients will benefit from this technique. METHODS: Univariate and multivariate analysis of preoperative and intraoperative factors on postoperative mortality and complications was performed on 268 patients (group 1: juxta- and pararenal AAA; group 2: suprarenal and TAAA IV; group 3: TAAA I, II, III) enrolled in a prospective multicenter trial of f/b-EVAR. RESULTS: Thirty-day mortality, in-hospital mortality (IM), and combined mortality and severe complications (CMSC) rates were 6.7%, 10.1%, and 22.0%, respectively. Group belonging (2 or 3 vs 1) was the only preoperative predictive factor of CMSC [hazard ratio (HR) = 2.10; 95% confidence interval (CI): 1.26-3.48; P = 0.0043]. Occurrence of a technical complication and duration of intervention significantly influenced both IM (HR = 4.39; 95% CI: 2.05-9.38; P = 0.0001) and CMSC (HR = 3.07; 95% CI: 1.84-5.11; P < 0.0001). Postoperative events associated with increased IM were spinal cord ischemia (HR = 9.46; 95% CI: 3.98-22.47; P < 0.0001), hemodialysis (HR = 27.44; 95% CI: 12.63-59.61; P < 0.0001), and reintervention (HR = 4.45; 95% CI: 2.03-9.73; P = 0.0002). CONCLUSIONS: Although promising, f/b-EVAR still carries a significant rate of mortality and complications, mostly related to the complexity of the procedure. In these complex cases, new strategies should be investigated to improve outcomes.
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Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/métodos , Stents , Idoso , Implante de Prótese Vascular/efeitos adversos , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: Lymphedema treatment is based on Decongestive Lymphedema Therapy (DLT) with an intensive phase followed by a long-term maintenance phase. This study aimed to observe volume variation over the intensive phase and 6 months later. METHODS: Prospective multicentre observational study of patients with unilateral lymphedema. The primary objective was to assess lymphedema volume variation between baseline, the end of intensive phase and 6 months later. Secondary objectives were to assess the frequency of heaviness limiting limb function and treatments safety predictors for volume reduction. RESULTS: Three hundred and six patients (89.9% women; 59.9±14.3 years old) with upper/lower (n=184/122) limb lymphedema were included. At the end of the intensive phase, median excess lymphedema volume reduction was 31.0% (41.7-19.9) followed by a 16.5% (5.9-42.3) median increase over the 6-month maintenance period phase. Previous intensive treatment was the only significant predictor of this response. As compared to baseline, heaviness limiting limb use was much less frequently reported at the end of the reductive phase (75.5% versus 42.3% respectively), and was more frequent at the end of the maintenance phase (62.6%). The most frequent adverse events reported were skin redness and compression marks (18.4 and 15.7% of patients, respectively). Blisters requiring treatment stoppage were rare (1.4%). CONCLUSIONS: Intensive phase decreases lymphedema volume and heaviness limiting limb function. The benefit is partially abolished after the first 6 months of maintenance. There is a need to consider how to provide optimal patient care for the long-term control of lymphedema.
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Bandagens Compressivas , Terapia por Exercício , Linfedema/terapia , Massagem , Adulto , Idoso , Braço/patologia , Neoplasias da Mama/cirurgia , Bandagens Compressivas/efeitos adversos , Feminino , Seguimentos , Humanos , Perna (Membro)/patologia , Excisão de Linfonodo/efeitos adversos , Linfedema/etiologia , Linfedema/patologia , Linfedema/reabilitação , Pessoa de Meia-Idade , Tamanho do Órgão , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Several studies have examined inter-observer variability in measurements for standard EVAR, but little is known about measurements for complex aortic aneurysm. METHODS: Two independent observers reviewed all preoperative CT scans of 268 patients in a French trial of fenestrated and/or branched aortic stent-grafts (f/b-EVAR). Those data were compared with those obtained (1) by investigators (extent of aneurysm, target vessel stenosis, and aortic diameters), and (2) from manufacturers (proximal landing zone, device diameter, and target vessel position). We assessed the reproducibility using kappa statistics for qualitative data and both Bland-Altman plot and Passing-Bablok regression analysis for quantitative data. RESULTS: Reproducibility was moderate to almost perfect for all factors. However, a few critical discrepancies were found, such as target vessel clock position (≥45 minutes) and location (≥5 mm), level of proximal landing zone, and diameters of the endograft. CONCLUSIONS: This is the first large-scale analysis focused on inter-observer variability in sizing for f/b-EVAR. The measurement data showed good agreement, but there were some critical discrepancies between observers that may affect clinical results.
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Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aortografia/métodos , França , Humanos , Variações Dependentes do Observador , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Reprodutibilidade dos Testes , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: The management strategies for symptomatic isolated superficial vein thrombosis (SVT) (without concomitant deep vein thrombosis [DVT] or pulmonary embolism [PE]) have yet to achieve widespread consensus. Concerns have been raised regarding the usefulness of prescribing anticoagulant treatments to all patients with isolated SVT. Determining the isolated SVT subgroups who have the highest risks of venous thromboembolism (VTE) recurrence (composite of DVT, PE, and new SVT) may facilitate the identification of patients who are likely to benefit from anticoagulant treatment. DESIGN AND METHODS: We performed a pooled analysis on individual data from two observational, multicenter, prospective studies, to determine predictors for VTE recurrence and their impact in an unselected population of symptomatic isolated SVT patients. RESULTS: One thousand and seventy-four cases of symptomatic isolated SVT were followed up at 3 months. VTE recurrence was observed in 3.9% of the patients; 16.2% of the patients did not receive anticoagulants, and 0.6% experienced a VTE recurrence. Cancer, personal history of VTE and saphenofemoral/popliteal involvement significantly increased the risk of subsequent VTE or DVT/PE in univariate analyses. Only male sex significantly increased the risk of VTE or DVT/PE recurrence in multivariate analyses. Twelve percent of the patients had cancer or saphenofemoral junction involvement, and were at higher risk of DVT/PE recurrence than patients without those characteristics (4.7% vs. 1.9%, P= 0.06). CONCLUSIONS: In patients with symptomatic SVT, only male sex significantly and independently increased the risk of VTE recurrence. Cancer or saphenofemoral junction involvement defined a population at high risk for deep VTE recurrence. Some SVTs might be safely managed without anticoagulants.
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Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/tratamento farmacológico , Idoso , Anticoagulantes/efeitos adversos , Feminino , França , Hemorragia/induzido quimicamente , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Análise Multivariada , Neoplasias/epidemiologia , Modelos de Riscos Proporcionais , Recidiva , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/sangue , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/mortalidade , Trombose Venosa/sangue , Trombose Venosa/diagnóstico , Trombose Venosa/mortalidadeRESUMO
OBJECTIVE: Hip pathology of hip requiring a surgical assumption of responsibility (coxarthrose invalidating, hip fracture) is increasing, and after the year 2025, the number of interventions will double. In parallel, the number of elderly people (older than 75 years) with malnutrition associated with cognitive impairment and reduced autonomy is on the increase. So the concept of frail elderly identified by specific criteria allows for better defining the health needs of heterogeneous elderly people. The objective of this study was to determine the influence of frailty factors on autonomy and clinical outcome after intervention for prosthesis of the hip. METHODOLOGY: This prospective work, completed over 8 months, included 55 patients with total or intermediate prostheses of hip, whatever the cause, recruited from rehabilitation wards. Results from a pre-established questionnaire defined the personal status and social framework of these patients. A medical examination evaluated cognitive function Mini Mental State (MMS), nutritional state (IMC) and the level of autonomy immediately after surgery (the first 2 weeks) by the measurement of functional independence (MIF). The second MIF was carried out by the same operator at the end of the assumption of responsibility by the institution. RESULTS: Three factors of frailty influenced progress at the time of reacquisition of autonomy: cognitive impairment (P < 0001; 1 patient out of 2 [50%] had an MMS score < 22); reduced nutrition? (P < 0.0026; [29% had a BMI score < 20 or a perimeter of the calf < 30 cm]; and accommodations before the intervention (P < 0.028; [15% lived in an institution]). CONCLUSION: Nutritional state, cognitive level and social activity must be evaluated regularly in elderly subjects with hip prosthesis to evaluate optimal load and adaptation.