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BACKGROUND: Differential diagnosis between benign uterine smooth muscle tumors and malignant counterpart is challenging. OBJECTIVE: To evaluate the accuracy of a clinical and ultrasound based algorithm in predicting mesenchymal uterine malignancies, including smooth muscle tumors of uncertain malignant potential. STUDY DESIGN: We report the 12-month follow-up of an observational, prospective, single-center study that included women with at least 1 myometrial lesion ≥3 cm on ultrasound examination. These patients were classified according to a 3-class diagnostic algorithm, using symptoms and ultrasound features. "White" patients underwent annual telephone follow-up for 2 years, "Green" patients underwent a clinical and ultrasound follow-up at 6, 12, and 24 months and "Orange" patients underwent surgery. We further developed a risk class system to stratify the malignancy risk. RESULTS: Two thousand two hundred sixty-eight women were included and target lesion was classified as benign in 2158 (95.1%), as other malignancies in 58 (2.6%) an as mesenchymal uterine malignancies in 52 (2.3%) patients. At multivariable analysis, age (odds ratio 1.05 [95% confidence interval 1.03-1.07]), tumor diameter >8 cm (odds ratio 5.92 [95% confidence interval 2.87-12.24]), irregular margins (odds ratio 2.34 [95% confidence interval 1.09-4.98]), color score=4 (odds ratio 2.73 [95% confidence interval 1.28-5.82]), were identified as independent risk factors for malignancies, whereas acoustic shadow resulted in an independent protective factor (odds ratio 0.39 [95% confidence interval 0.19-0.82[). The model, which included age as a continuous variable and lesion diameter as a dichotomized variable (cut-off 81 mm), provided the best area under the curve (0.87 [95% confidence interval 0.82-0.91]). A risk class system was developed, and patients were classified as low-risk (predictive model value <0.39%: 0/606 malignancies, risk 0%), intermediate risk (predictive model value 0.40%-2.2%: 9/1093 malignancies, risk 0.8%), high risk (predictive model value ≥2.3%: 43/566 malignancies, risk 7.6%). CONCLUSION: The preoperative 3-class diagnostic algorithm and risk class system can stratify women according to risk of malignancy. Our findings, if confirmed in a multicenter study, will permit differentiation between benign and mesenchymal uterine malignancies allowing a personalized clinical approach.
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The primary aim of the present study was to investigate the prognostic impact (defined as disease-free-DFS and overall survival-OS) of the ultrasound scan tumor parameters, patients' anthropometric parameters, and their combination in early-stage cervical cancer. The secondary aim was to assess the relation between ultrasound characteristics and pathological parametrial infiltration. This is a retrospective, single-center, observational cohort study. Consecutive patients with clinical FIGO 2018 stage IA1-IB2 and IIA1 cervical cancer who underwent preoperative ultrasound examination and radical surgery between 02/2012 and 06/2019 were included. Patients who underwent neo-adjuvant treatment, fertility sparing surgery, and pre-operative conization were excluded. Data from 164 patients were analyzed. Body mass index (BMI) ≤20 Kg/m2 (p < 0.001) and ultrasound tumor volume (p = 0.038) were related to a higher risk of recurrence. The ratios between ultrasound tumor volume and BMI, ultrasound tumor volume and height, and ultrasound largest tumor diameter and BMI were significantly related to a higher risk of recurrence (p = 0.011, p = 0.031, and p = 0.017, respectively). The only anthropometric characteristic related to a higher risk of death was BMI ≤20 Kg/m2 (p = 0.021). In the multivariate analysis, the ratio between ultrasound-measured largest tumor diameter and cervix-fundus uterine diameter (with 37 as the cut-off) was significantly associated with pathological microscopic parametrial infiltration (p = 0.018). In conclusion, a low BMI was the most significant anthropometric biomarker impairing DFS and OS in patients with apparent early-stage cervical cancer. The ratios between ultrasound tumor volume and BMI, ultrasound tumor volume and height, and ultrasound largest tumor diameter and BMI significantly affected DFS but not OS. The ratio between ultrasound-measured largest tumor diameter and cervix-fundus uterine diameter was related to parametrial infiltration. These novel prognostic parameters may be useful in pre-operative workup for a patient-tailored treatment in early-stage cervical cancer.
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OBJECTIVE: The purpose of this study was to assess the rate and type of infections in gynecological cancer patients. We also performed an economic analysis to provide an overview of costs related to healthcare associated infections. METHODS: We retrospectively collected data from culture samples at the site of infection from patients undergoing surgery or chemotherapy, admitted to the Gynecologic Oncology Unit, Fondazione Policlinico Agostino Gemelli IRCCS, from January 2017 to December 2018. We performed univariate and multivariate analyses to calculate potential risk factors for prolonged length of hospitalization. The average cost per patient was calculated, including the cost of hospital stay, operating room, medications, and diagnostic and invasive procedures. RESULTS: Among 5682 patients, 322 (5.6%) gynecological cancer patients with healthcare associated infections were identified. A total of 249 patients (77.3%) had undergone surgery in the previous 30 days and 73 (22.7%) patients were receiving chemotherapy. In the whole population, the most common healthcare associated infections were urinary infections (58%) and surgical wound infections (42.1%). In addition, 14.5% of patients had central venous catheter infections and 21.7% had blood stream infections. Median length of stay was 20 days (range 1-100). Among surgical patients, advanced age (odds ratio (OR) 1.233, 95% confidence interval (CI) 1.001 to 1.519, p=0.049), bowel resection (OR 2.659, 95% CI 1.493 to 4.735, p=0.001), surgical site infection (OR 10.447, 95% CI 1.143 to 95.5, p=0.038), and central venous catheter infection (OR 9.856, 95% CI 1.139 to 85.319, p=0.038) were independently associated with an increased risk of prolonged hospital stay (>20 days). The overall direct cost of healthcare associated infections was $6 273 852 per year. CONCLUSIONS: The infection rate in our population was 5.6%. The most common healthcare associated infections were urinary and surgical wound infections. Among surgical patients, advanced age, bowel resection, surgical site, and central venous catheter infection were associated with an increased length of hospitalization. Healthcare associated infections cause an increase in the length of stay after surgery and hospital costs.
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Infección Hospitalaria , Neoplasias de los Genitales Femeninos , Humanos , Femenino , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/etiología , Neoplasias de los Genitales Femeninos/epidemiología , Neoplasias de los Genitales Femeninos/cirugía , Estudios Retrospectivos , Infección Hospitalaria/epidemiología , Infección Hospitalaria/etiología , Hospitalización , Tiempo de InternaciónRESUMEN
OBJECTIVE: Infections are a threat to frail patients as they have a higher risk of developing serious complications from bloodstream pathogens. The aim of this study was to determine which factors can predict or diagnose bloodstream infections in patients with an underlying gynecologic malignancy. MATERIALS AND METHODS: Between July 2016 and December 2017, 68 patients visiting the emergency room with an underlying gynecologic malignancy were evaluated. Variables concerning underlying disease, invasive procedures, and laboratory and clinical parameters were analyzed. Patients were divided into three groups based on their blood and urine specimens (positive blood specimens, positive urine specimens, and no positive specimens; patients who had both positive blood and urine specimens were included in the group of positive blood specimens). Risk factors for surgical site infections, recent (<30 days) surgery, and chemotherapy were studied separately. RESULTS: 68 patients were included in the analysis. Mean age was 55.6 years (standard deviation 14.1). 44% of patients had ovarian cancer, 35% cervical cancer, 12% endometrial cancer, and 9% had other cancer types. In total, 96% of all patients had undergone surgery. Patients who had been treated with chemotherapy were at a higher risk of developing bloodstream infection (P=0.04; odds ratio (OR)=7.9). C reactive protein, bilirubin, and oxygen saturation (SO2) were significantly different between patients with an underlying infection and those who had none. Only C reactive protein maintained its significance in a linear model, with a cut-off of 180 mg/L (linear regression, P=0.03; OR=4). CONCLUSIONS: Chemotherapy is a risk factor for the development of bloodstream infections in patients with an underlying gynecologic malignancy; C reactive protein could be a useful tool in making this diagnosis.
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Bacteriemia/etiología , Neoplasias de los Genitales Femeninos/microbiología , Bacteriemia/sangre , Bacteriemia/microbiología , Bacteriemia/patología , Proteína C-Reactiva/metabolismo , Femenino , Neoplasias de los Genitales Femeninos/sangre , Neoplasias de los Genitales Femeninos/patología , Neoplasias de los Genitales Femeninos/terapia , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Factores de RiesgoRESUMEN
To evaluate quality of life and sexual function of childbearing-age women, affected by uterine fibromatosis undergoing medical treatment with ulipristal acetate. The data obtained by filling the questionnaires European Quality of Life Five-Dimension Scale and modified Female Sexual Function Index, were analyzed to assess UPA usefulness in improving QoL and sexual activity. A total of 139 patients affected by uterine fibromatosis undergoing conservative ulipristal acetate treatment were enrolled in this prospective observational cohort study. Seventy-one women (average age 46.5 years) answered the questionnaires: QoL and sexuality were evaluated before and after ulipristal acetate treatment. 59 patients (83.1%) had an improvement of QoL and general health state, with a reduction of VAS score after ulipristal acetate treatment. EQ-5D-5L showed a statistically significant improvement of usual act impairment, mobility, discomfort, anxiety/depression (p < .0005). There was no difference in personal care management after therapy. Modified FSFI showed a statistically significant improvement (p < .0001) of sexual satisfaction and sexual life. A not statistically significant improvement in dyspareunia was also highlighted. This study provides a clear picture about QoL impact on women and confirms the effectiveness of the ulipristal acetate in improving different aspects of daily and sexual life of patients undergoing medical treatment.
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Agentes Anticonceptivos Hormonales/uso terapéutico , Leiomioma/tratamiento farmacológico , Neoplasias Primarias Múltiples/tratamiento farmacológico , Norpregnadienos/uso terapéutico , Calidad de Vida , Salud Sexual , Neoplasias Uterinas/tratamiento farmacológico , Actividades Cotidianas , Adulto , Ansiedad/psicología , Depresión/psicología , Dismenorrea/fisiopatología , Dispareunia/fisiopatología , Dispareunia/psicología , Femenino , Humanos , Leiomioma/fisiopatología , Leiomioma/psicología , Libido , Menorragia/fisiopatología , Metrorragia/fisiopatología , Persona de Mediana Edad , Neoplasias Primarias Múltiples/fisiopatología , Neoplasias Primarias Múltiples/psicología , Dolor Pélvico/fisiopatología , Estudios Prospectivos , Disfunciones Sexuales Fisiológicas/fisiopatología , Resultado del Tratamiento , Neoplasias Uterinas/fisiopatología , Neoplasias Uterinas/psicologíaRESUMEN
STUDY OBJECTIVE: To investigate the feasibility, safety, and short-term outcomes of robotic surgery (RS) for gynecologic oncologic indications (cervical, endometrial, and ovarian cancer) in elderly patients, especially women age 65 to 74 years (elderly group [EG]) compared with women age ≥75 years (very elderly group [VEG]). DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Catholic University of the Sacred Heart, Rome, Italy. PATIENTS: Between May 2013 and April 2017, 204 elderly and very elderly patients underwent RS procedures for gynecologic malignancies. RESULTS: The median age was 71 years (range, 65-74 years) in the EG and 77 years (range, 75-87 years) in the VEG. The incidence of cardiovascular disease was higher in the VEG (p = .038). The EG and VEG were comparable in terms of operative time, blood loss, and need for blood transfusion. Almost all (98.5%) of the patients underwent total/radical hysterectomy, 109 patients (55.6% of the EG vs 48.3% of the VEG) underwent pelvic lymphadenectomy, and 19 patients (10.5% of the EG vs 6.7% of the VEG) underwent aortic lymphadenectomy. A total of 7 (3.4%) conversions to open surgery were registered. Only 3 patients required postoperative intensive care unit admission. The median length of hospital stay was 2 days in each group. A total of 11 patients (5.6%) had early postoperative complications. Four patients (2.8%) in the EG and 2 patients (3.3%) in the VEG experienced grade ≥2 complications. At the time of analysis, median follow-up was 18 months (range, 6-55 months). Eleven patients (5.6%) experienced disease relapse, 2 (1%) died of disease, and 3 (1.5%) died of cardiovascular disease. CONCLUSIONS: This study demonstrates the feasibility, safety, and good short-term outcomes of RS in elderly and very elderly gynecologic cancer patients. No patient can be considered too old for a minimally invasive robotic approach, but a multidisciplinary approach is the best management pathway; efforts to reduce associated morbidity are essential.
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Neoplasias de los Genitales Femeninos/cirugía , Histerectomía/métodos , Laparoscopía/métodos , Escisión del Ganglio Linfático/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Anciano , Anciano de 80 o más Años , Pérdida de Sangre Quirúrgica/estadística & datos numéricos , Estudios de Casos y Controles , Conversión a Cirugía Abierta/estadística & datos numéricos , Estudios de Factibilidad , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Tempo Operativo , Complicaciones Posoperatorias/etiología , Estudios RetrospectivosRESUMEN
Endometriotic lesions are associated with hormonal imbalance, including increased estrogen synthesis, metabolism and progesterone resistance. These hormonal changes cause increased proliferation, inflammation, pain and infertility. Hormonal imbalances are targets for treatment. Therapeutic strategies and innovations of hormonal drugs for endometriosis are increasing. Acting on estrogen receptors are hormonal drugs decreasing systemic and local estrogen synthesis (GnRH analogs, GnRH antagonists, Aromatase inhibitors) or estrogen activity (selective estrogen receptor modulators). The progesterone resistance is counteracted by progestins (Medroxyprogesterone acetate, Dienogest, Danazol, Levonorgestrel) or by Selective progesterone receptor modulators, a class of drugs under development. The future trend will be to define new drugs to use for prolonged period of time and with poor side effects considering endometriosis a chronic disease.
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Inhibidores de la Aromatasa/uso terapéutico , Endometriosis/tratamiento farmacológico , Antagonistas de Hormonas/uso terapéutico , Levonorgestrel/uso terapéutico , Acetato de Medroxiprogesterona/uso terapéutico , Moduladores Selectivos de los Receptores de Estrógeno/uso terapéutico , Femenino , Humanos , Resultado del TratamientoRESUMEN
Endometriosis is defined as the presence of endometrial glands and stroma outside the uterine cavity. Endometriosis affects 7-10% of women of reproductive age, 60% of women with pelvic pain, and up to 50% of women with infertility. Etiology and pathogenesis of the disease are still unclear, with the theory of retrograde menstruation, and possibly associated cofactors, as the most important. The definitive method to diagnose endometriosis is visualization at surgery, preferably at laparoscopy, with histology confirmation of disease. The revised classification of the American Society for Reproductive Medicine is used to stage the disease and determine the patient's prognosis. The treatment of the disease depends on the patient's age, associated symptoms, and disease stage. Medical or surgical therapy may be used in case of pain associated with endometriosis, whereas surgery is the mainstay of treatment in case of endometriosis-associated infertility.