ObjectiveTo determine the best second-step approach for discriminating benign from malignant adnexal masses classified as inconclusive by International Ovarian Tumour Analysis Simple Rules (IOTA-SR). MethodsSingle-center prospective study comprising a consecutive series of patients diagnosed as having an adnexal mass classified as inconclusive according to IOTA-SR. All women underwent Risk of Ovarian Malignancy Algorithm (ROMA) analysis, MRI interpreted by a radiologist, and ultrasound examination by a gynecological sonologist. Cases were clinically managed according to the result of the ultrasound expert examination by either serial follow-up for at least 1 year or surgery. Reference standard was histology (patient was submitted to surgery if any of the tests was suspicious) or follow-up (masses with no signs of malignancy after 12 months were considered benign). Diagnostic performance of all three approaches was calculated and compared. Direct cost analysis of the test used was also performed. ResultsEighty-two adnexal masses in 80 women (median age 47.6 years, range 16 to 73 years) were included. Seventeen patients (17 masses) were managed expectantly (none had diagnosis of ovarian cancer after at least 12 months of follow-up) and 63 patients (65 masses) underwent surgery and tumor removal (40 benign and 25 malignant tumors). Sensitivity and specificity for ultrasound, MRI, and ROMA were 96% and 93%, 100% and 81%, and 24% and 93%, respectively. The specificity of ultrasound was better than that for MRI (p=0.021), and the sensitivity of ultrasound was better than that for ROMA (p<0.001), sensitivity was better for MRI than for ROMA (p<0.001) and the specificity of ROMA was better than that for MRI (p<0.001). Ultrasound evaluation was the most effective and least costly method as compared with MRI and ROMA. ConclusionIn this study, ultrasound examination was the best second-step approach in inconclusive adnexal masses as determined by IOTA-SR, but the findings require confirmation in multicenter prospective trials.

Background: The principal objective of this study was to correlate biophysical properties of vaginal discharge present in the cervical mucus with the timing of the fertile window. In particular, we produce measures of the viscoelasticity of the cervical secretion using two methods. The first uses only the elasticity extracted from the Creighton Model Fertility Care System (CrMs) scale, calculated P-6 ovulation estimated day (OED) with respect to the peak day of the CrMs. The second uses a numerical method that takes into account the changes in viscoelasticity, but without reference to the peak day calculated using the CrMs model. Using both methods, twelve records were obtained from a single female subject. Methods: The methodology used to evaluate the viscoelasticity factor was by measuring the approximate length in centimeters (cm) of the vaginal discharge of cervical discharge. For this, the scale of the stretching graph established by observing the stretching of CrMS was used, taking into account the previous 6 days at peak day P-6. The first method, which we termed CFW (Clinical Fertile Window), uses a measure based on the approximate length (cm) of the maximal stretchiness of the vaginal discharge. The second method we termed SFW (Software-CrMS/strectching) (Software-based Fertile Window). Results: The fertile window was detected correctly in 100% of the cases using either method, and a correlation value of 0.71 was observed between the two methods. Conclusions: We conclude that the assessment of viscoelasticity using SFW algorithm allowed in this pilot study to detect the fertile window and to describe the evolution pattern of cervical discharge throughout the fertile window. Our study provides support for the use of computational methods in detecting the fertile window, taking only into account the time evolution of the cervical discharge throughout the menstrual cycle.

Objective Defining the normal range for the anterior/posterior myometrial wall thickness ratio in a cohort of women without adenomyosis or any other uterine wall anomaly on ultrasound examination. Methods Anterior and posterior miometrial wall thickness was measured in 555 women (mean age 34.6 years old, range: 20-50 years) without any ultrasound findings of adenomiosis or other uterine pathology. Measurements were performed in the longitudinal plane of a stored 3D volume. Two observers made all measurements. The myometrial wall thickness ratio was estimated and distribution by centiles obtained. Correlation of myometrial thickness ratio with patient's age and parity was also estimated, using the Pearson's correlation coefficient. Intra- and inter-observer reproducibility were estimated using the intra-class correlation coefficient (ICC). Results The mean ratio of the myometrial walls thickness (understood as anterior thickness/posterior thickness ratio) was 0.99 (95% CI: 0.96-1.01). The distribution of the ratio by centiles were as follows: 5%: 0.64, 10%: 0.70, 25%: 0.82, 50%: 0.96, 75%: 1.12, 90%: 1.30 and 95%: 1.45). The myometrial wall thickness ratio was not related to patient's age (Pearson's coefficient: 0.039, p = 0.371), neither to patient's parity (Pearson's coefficient: 0.004, p = 0.923). The ICC was 0.94 and 0.88 for observers 1 and 2, respectively. Inter-observer reproducibility was high (ICC: 0.83). Conclusions Myometrial thickness ratio in women with normal uterus at ultrasound examination is about 1. However, centile distribution shows that values as low as 0.64 or as high as 1.45 could be considered as normal.

Objective To investigate the association between personal history, anthropometric features and lifestyle characteristics and endometrial malignancy in women with abnormal vaginal bleeding. Methods Prospective observational cohort assessed by descriptive and multivariable logistic regression analyses. Three features-age, body mass index (BMI; calculated as weight in kilograms divided by the square of height in meters), and nulliparity-were defined a priori for baseline risk assessment of endometrial malignancy. The following variables were tested for added value: intrauterine contraceptive device, bleeding pattern, age at menopause, coexisting diabetes/hypertension, physical exercise, fat distribution, bra size, waist circumference, smoking/drinking habits, family history, use of hormonal/anticoagulant therapy, and sonographic endometrial thickness. We calculated adjusted odds ratio, optimism-corrected area under the receiver operating characteristic curve (AUC), R-2, and Akaike's information criterion. Results Of 2417 women, 155 (6%) had endometrial malignancy or endometrial intraepithelial neoplasia. In women with endometrial cancer median age was 67 years (interquartile range [IQR] 56-75 years), median parity was 2 (IQR 0-10), and median BMI was 28 (IQR 25-32). Age, BMI, and parity produced an AUC of 0.82. Other variables marginally affected the AUC, adding endometrial thickness substantially increased the AUC in postmenopausal women. Conclusion Age, parity, and BMI help in the assessment of endometrial cancer risk in women with abnormal uterine bleeding. Other patient information adds little, whereas sonographic endometrial thickness substantially improves assessment.

Objective To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009). Methods A multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width <= 0.2 standard deviations of the logit odds of the estimated propensity score. Results We obtained a weighted cohort of 374 patients (187 patients with prior conization and 187 non-conization patients). We found a 65% reduction in the risk of relapse for patients who had cervical conization prior to radical hysterectomy (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.16 to 0.75, p=0.007) and a 75% reduction in the risk of death for the same sample (HR 0.25, 95% CI 0.07 to 0.90, p=0.033). In addition, patients who underwent minimally invasive surgery without prior conization had a 5.63 times higher chance of relapse compared with those who had an open approach and previous conization (HR 5.63, 95% CI 1.64 to 19.3, p=0.006). Patients who underwent minimally invasive surgery with prior conization and those who underwent open surgery without prior conization showed no differences in relapse rates compared with those who underwent open surgery with prior cone biopsy (reference) (HR 1.94, 95% CI 0.49 to 7.76, p=0.349 and HR 2.94, 95% CI 0.80 to 10.86, p=0.106 respectively). Conclusions In this retrospective study, patients undergoing cervical conization before radical hysterectomy had a significantly lower risk of relapse and death.

Objective Based on the SUCCOR study database, our primary objective was to identify the independent clinical pathological variables associated with the risk of relapse in patients with stage IB1 cervical cancer who underwent a radical hysterectomy. Our secondary goal was to design and validate a risk predictive index (RPI) for classifying patients depending on the risk of recurrence. Methods Overall, 1116 women were included from January 2013 to December 2014. We randomly divided our sample into two cohorts: discovery and validation cohorts. The test group was used to identify the independent variables associated with relapse, and with these variables, we designed our RPI. The index was applied to calculate a relapse risk score for each participant in the validation group. Results A previous cone biopsy was the most significant independent variable that lowered the rate of relapse (odds ratio [OR] 0.31, 95% confidence interval [CI] 0.17-0.60). Additionally, patients with a tumor diameter >2 cm on preoperative imaging assessment (OR 2.15, 95% CI 1.33-3.5) and operated by the minimally invasive approach (OR 1.61, 95% CI 1.00-2.57) were more likely to have a recurrence. Based on these findings, patients in the validation cohort were classified according to the RPI of low, medium, or high risk of relapse, with rates of 3.4%, 9.8%, and 21.3% observed in each group, respectively. With a median follow-up of 58 months, the 5-year disease-free survival rates were 97.2% for the low-risk group, 88.0% for the medium-risk group, and 80.5% for the high-risk group (p < 0.001). Conclusion Previous conization to radical hysterectomy was the most powerful protective variable of relapse. Our risk predictor index was validated to identify patients at risk of recurrence.

Objective To analyze the reproducibility of ultrasonographic (US) findings of rectosigmoid endometriosis among examiners with different level of expertise using stored three-dimensional (3D) volumes of the posterior compartment of the pelvis as a part of SANABA (Sardinia-Navarra-Barcelona) collaborative study. Materials and methods Six examiners in 3 academic Department of Obstetrics and Gynecology, with different levels of experience and blinded to each other, evaluated 60 stored 3D volumes from the posterior compartment of the pelvis and looked for the presence or absence of features of rectosigmoid endometriotic lesions defined as an irregular hypoechoic nodule with or without hypoechoic foci at the level of the muscularis propria of the anterior wall rectum sigma. Multiplanar view and virtual navigation were used. All examiners had to assess the 3D volume of posterior compartment of the pelvis and classify it as present or absent disease. To analyze intra-observer and the inter-observer agreements, each examiner performed the assessment twice with a 2-week interval between the first and second assessments. Reproducibility was assessed by calculating the weighted Kappa index. Results Intra-observer reproducibility was moderate to very good for all observers (Kappa index ranging from 0.49 to 0.96) associated with a good diagnostic accuracy of each reader. Inter-observer reproducibility was fair to very good (Kappa index range: 0.21-0.87). Conclusions The typical US sign of rectosigmoid endometriosis is reasonably recognizable to observers with different level of expertise when assessed in stored 3D volumes.

Objectives: The aim of this study was to develop a model that can discriminate between different etiologies of abnormal uterine bleeding. Design: The International Endometrial Tumor Analysis 1 study is a multicenter observational diagnostic study in 18 bleeding clinics in 9 countries. Consecutive women with abnormal vaginal bleeding presenting for ultrasound examination (n = 2,417) were recruited. The histology was obtained from endometrial sampling, D&C, hysteroscopic resection, hysterectomy, or ultrasound follow-up for >1 year. Methods: A model was developed using multinomial regression based on age, body mass index, and ultrasound predictors to distinguish between: (1) endometrial atrophy, (2) endometrial polyp or intracavitary myoma, (3) endometrial malignancy or atypical hyperplasia, (4) proliferative/secretory changes, endometritis, or hyperplasia without atypia and validated using leave-center-out cross-validation and bootstrapping. The main outcomes are the model's ability to discriminate between the four outcomes and the calibration of risk estimates. Results: The median age in 2,417 women was 50 (interquartile range 43-57). 414 (17%) women had endometrial atrophy; 996 (41%) had a polyp or myoma; 155 (6%) had an endometrial malignancy or atypical hyperplasia; and 852 (35%) had proliferative/secretory changes, endometritis, or hyperplasia without atypia. The model distinguished well between malignant and benign histology (c-statistic 0.88 95% CI: 0.85-0.91) and between all benign histologies. The probabilities for each of the four outcomes were over- or underestimated depending on the centers. Limitations: Not all patients had a diagnosis based on histology. The model over- or underestimated the risk for certain outcomes in some centers, indicating local recalibration is advisable. Conclusions: The proposed model reliably distinguishes between four histological outcomes. This is the first model to discriminate between several outcomes and is the only model applicable when menopausal status is uncertain. The model could be useful for patient management and counseling, and aid in the interpretation of ultrasound findings. Future research is needed to externally validate and locally recalibrate the model.

Objective To compare the diagnostic accuracy of transvaginal ultrasound (TVS) and magnetic resonance imaging (MRI) for assessing myometrial infiltration (MI) in patients with low grade endometrioid endometrial cancer. Methods Observational prospective study performed at a single tertiary care center from 2016 to 2020, comprising 156 consecutive patients diagnosed by endometrial sampling as having an endometrioid grade 1/grade 2 endometrial cancer. TVS and MRI were performed prior to surgical staging for assessing MI, which was estimated using subjective examiner's impression and Karlsson's method for both TVS and MRI. During surgery, intraoperative assessment of MI was also performed. Definitive pathological study considered as reference standard. Diagnostic accuracy for ultrasound, MRI, and intraoperative biopsy was estimated and compared. Results Sensitivity and specificity of TVS for detecting deep MI were 75 and 73.5% for subjective impression and 65 and 70% for Karlsson method, respectively (P = .54). Sensitivity and specificity of MRI for detecting deep MI were 80 and 87% for subjective impression and 70 and 71.3% for Karlsson method. MRI subjective impression showed a significant better specificity than MRI Karlsson method (P = .03). MRI showed better specificity than TVS when subjective impression was considered (P <.05), but not for Karlsson method. Sensitivity and specificity of intraoperative were 75 and 97%, respectively. Intraoperative biopsy showed better specificity than ultrasound and MRI either using examiner's impression or Karlsson method (P <.05). Conclusions MRI revealed a significant higher specificity than TVS when assessing deep myometrial infiltration. However, the intraoperative biopsy offers a significant better diagnostic accuracy than preoperative imaging techniques.

Objectives To evaluate the performance of a two-step strategy compared with the International Ovarian Tumor Analysis (IOTA) - Assessment of Different NEoplasias in the adneXa (ADNEX) model for preoperative classification of adnexal masses. Methods An ambispective diagnostic accuracy study based on ultrasound data collected at one university hospital between 2012 and 2018. Two ultrasonographers classified the adnexal masses using IOTA Simple Rules (first step). Not classifiable masses were evaluated using the IOTA ADNEX model (second step). Also, all masses were classified using the IOTA ADNEX model. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-), and receiver operating characteristic (ROC) curve were estimated. A P value of <.05 was used to determine statistical significance. Results The study included 548 patients and 606 masses. Patients' median age was 41 years with an interquartile range between 32 and 51 years. In the first step, 89 (14%) masses were not classifiable. In the second step, 55 (61.8%) masses were classified as malignant. Furthermore, for the totality of 606 masses, the IOTA ADNEX model estimated the probability that 126 (20.8%) masses were malignant. The two-step strategy had a sensitivity, specificity, PPV, NPV, LR+, LR-, and ROC curve of 86.8%, 91.01%, 51.9%, 98.4%, 9.7, 0.1, and 0.889, respectively; compared to IOTA ADNEX model that had values of 91.8%, 87.16%, 44.4%, 99%, 7.1, 0.09, and 0.895, respectively. Conclusion The two-step strategy shows a similar diagnostic performance when compared to the IOTA ADNEX model. The IOTA ADNEX model involves only one step and can be more practical, and thus would be recommended to use.

The aim of the study was to evaluate the usefulness of 4D Power Doppler tissue evaluation to discriminate between normal ovaries and ovarian cancer tumors. This was a prospective observational study. Twenty-three cases of surgically confirmed ovarian High Grade Serous Carcinoma (HGSC) were analyzed. The control group consisted of 23 healthy patients, each matching their study-group counterpart age wise (+/- 3 years) and according to their menopausal status. Transvaginal Doppler 4D ultrasound scans were done on every patient and analyzed with 3D/4D software. Two 4D indices-volumetric Systolic/Diastolic Index (vS/D) and volumetric Pulsatility Index (vPI)-were calculated. To keep results standardized and due to technical limitations, virtual 1cc spherical tissue samples taken from the part with highest vascularization as detected by bi-directional Power Doppler were analyzed for both groups of ovaries. Values of volumetric S/D indices and volumetric PI indices were statistically lower in ovarian malignant tumors compared to normal ovaries: 1.096 vs. 1.794 and 0.092 vs. 0.558, respectively (p < 0.001). The 4D bi-directional Power Doppler vascular indices were statistically different between malignant tumors and normal ovaries. These findings could support the rationale for future studies for assessing this technology to discriminate between malignant and benign tumors.

Objectives: The aim of this study was to compare the accuracy of seven classical Machine Learning (ML) models trained with ultrasound (US) soft markers to raise suspicion of endometriotic bowel involvement. Materials and Methods: Input data to the models was retrieved from a database of a previously published study on bowel endometriosis performed on 333 patients. The following models have been tested: k-nearest neighbors algorithm (k-NN), Naive Bayes, Neural Networks (NNET-neuralnet), Support Vector Machine (SVM), Decision Tree, Random Forest, and Logistic Regression. The data driven strategy has been to split randomly the complete dataset in two different datasets. The training dataset and the test dataset with a 67 % and 33 % of the original cases respectively. All models were trained on the training dataset and the predictions have been evaluated using the test dataset. The best model was chosen based on the accuracy demonstrated on the test dataset. The information used in all the models were: age; presence of US signs of uterine adenomyosis; presence of an endometrioma; adhesions of the ovary to the uterus; presence of "kissing ovaries"; absence of sliding sign. All models have been trained using CARET package in R with ten repeated 10-fold cross-validation. Accuracy, Sensitivity, Specificity, positive (PPV) and negative (NPV) predictive value were calculated using a 50 % threshold. Presence of intestinal involvement was defined in all cases in the test dataset with an estimated probability greater than 0.5. Results: In our previous study from where the inputs were retrieved, 106 women had a final expert US diagnosis of rectosigmoid endometriosis. In term of diagnostic accuracy the best model was the Neural Net (Accuracy, 0.73; sensitivity, 0.72; specificity 0.73; PPV 0.52; and NPV 0.86) but without significant difference with the others. Conclusions: The accuracy of ultrasound soft markers in raising suspicion of rectosigmoid endometriosis using Artificial Intelligence (AI) models showed similar results to the logistic model. (C) 2021 Elsevier B.V. All rights reserved.

Objective Currently, there are up to three different classifications for diagnosing septate uterus. The interobserver agreement among them has been poorly assessed. Objective To assess the interobserver agreement of nonexpert sonographers for classifying septate uterus using the European Society of Human Reproduction and Embryology/European Society for Gynaecological Endoscopy (ESHRE/ESGE), American Society for Reproductive Medicine (ASRM), and Congenital Uterine Malformations by Experts (CUME) classifications. Methods A total of 50 three-dimensional (3D) volumes of a nonconsecutive series of women with suspected uterine malformation were used. Two nonexpert examiners evaluated a single 3D volume of the uterus of each woman, blinded to each other. The following measurements were performed: indentation depth, indentation angle, uterine fundal wall thickness, external fundal indentation, and indentation-to-wall-thickness (I:WT) ratio. Each observer had to assign a diagnosis in each case, according to the three classification systems (ESHRE/ESGE, ASRM, and CUME). The interobserver agreement regarding the ESHRE/ESGE, ASRM, and CUME classifications was assessed using the Cohen weighted kappa index (k). Agreement regarding the three classifications (ASRM versus ESHRE/ESGE, ASRM versus CUME, ESHRE/ESGE versus CUME) was also assessed. Results The interobserver agreement between the 2 nonexpert examiners was good for the ESHRE/ESGE (k = 0.74; 95% confidence interval [CI]: 0.55-0.92) and very good for the ASRM and CUME classification systems (k = 0.95; 95%CI: 0.86-1.00; and k = 0.91; 95%CI: 0.79-1.00, respectively). Agreement between the ESHRE/ESGE and ASRM classifications was moderate for both examiners. Agreement between the ESHRE/ESGE and CUME classifications was moderate for examiner 1 and good for examiner 2. Agreement between the ASRM and CUME classifications was good for both examiners. Conclusion The three classifications have good (ESHRE/ESGE) or very good (ASRM and CUME) interobserver agreement. Agreement between the ASRM and CUME classifications was higher than that for the ESHRE/ESGE and ASRM and ESHRE/ESGE and CUME classifications.

Objetivo: valoración de la señal Doppler ovárica como predictor de la respuesta ovárica en el tratamiento de la fecundación in vitro. Material y métodos: cohorte prospectiva (n = 62) de pacientes estériles sometidas a tratamiento de estimulación ovárica para la técnica de fecundación in vitro (FIV), medición de técnicas ecográficas no vasculares, de la señal Doppler de vasos ováricos y su análisis estadístico. Resultados: el recuento folicular (RFA) es el predictor más precoz de la respuesta ovárica y del número de ovocitos recuperados, así como el IP promedio de las arterias intraováricas estromales (IP-IOE) siendo significativo el día del control de la supresión hipofisaria. El volumen ovárico (VOM), el IP promedio de las arterias útero-ováricas (IP-UO) y el mapa color (SCOM) se relacionan tardíamente con el número de folículos presentes en el día de la administración de hCG.y que pueden ser considerados marcadores tardíos en un ciclo de FIV. Conclusión: hay parámetros en la ecografía Doppler transvaginal del ovario que son útiles predictores de la respuesta ovárica a la estimulación en el ciclo de fecundación in vitro.

Objective: To determine the feasibility,tolerability, and safety of the ultrasound assessment of tubal patency using foam as contrast. Methods: This was a prospective multicenter study of 915 infertile nulliparous women scheduled for sonohysterosalpingography with foam instillation (HYFOSY) for tubal patency testing as a part of the fertility workup. Clinical and sonographic data were recorded into a web-shared database. Tubal patency, cervical catheterization, pain during the procedure and post-procedural complications were collected. Patients reported discomfort or pain experienced during the procedure with a visual analogue scale (VAS) score. Results: Nine hundred fifteen women were included in the ¿nal analysis. Median age was 34 (range, 21-45) years and median body mass index was 23 (range, 16-41) kg/m2. Of 839 women, only 8(0.95 %) cases were abandoned due to impossibility of introducing the intracervical catheter. Most of the cervical os were easily cannulated with either paediatric nasogastric probes or special catheter for intrauterine insemination / sonohysterosalpingography 688/914(75.3 %). With a median instillation of 4 mL (range 1-16) of foam, both tubes were identified in 649/875 (70.9 %) patients, while unilateral patency was observed in 190/875 (20.8 %). Only 36/875 (3.9 %) of the women had bilateral tubal obstruction. The median VAS score for perception of pain during HyFoSy examination was 2 (range 0-10), and only 17 (1.9 %) of women reported severe pain (VAS ¿ 7). Pain was unrelated to tubal patency or tubal blockage. Unexpectedly, difficult cervical catheterizations that needed tenaculum, were more likely associated with mild pain during procedure [nasogastric probe group 176/289 (70.9 %) vs. insemination catheter group 166/399 (41.6 %) vs. tenaculum group 190/218(87.2 %) p < 0.001]. Finally, among 915 patients, we only noticed 3 (0.32 %) complications of the technique: two vasovagal episodes and a mild urinary infection. Conclusion: HYFOSY is a feasible, well-tolerated and safe technique for the evaluation of tubal patency in infertile women.

Background Pelvic recurrences from previously irradiated gynecological cancer lack solid evidence for recommendation on salvage. Methods A total of 58 patients were included in this clinical analysis. Salvage surgery was performed for locoregional relapse within previously irradiated pelvic area after initial surgery and adjuvant radiotherapy or radical external beam radiotherapy. The primary tumor diagnosis included cervical cancer (n = 47, 81%), uterine cancer (n = 4, 7%), and other types (n = 7, 12%). Thirty-three patients received adjuvant IOERT (1984-2000) at a median dose of 15 Gy (range 10-20 Gy) and 25 patients received adjuvant PHDRB (2001-2016) at a median dose of 32 Gy (range 24-40 Gy) in 6, 8, or 10 b.i.d. fractions. Results The median follow-up was 5.6 years (range 0.5-14.2 years). Twenty-nine (50.0%) patients had positive surgical margins. Grade >= 3 toxic events were recorded in 34 (58.6%) patients. The local control rate at 2 years was 51% and remained stable up to 14 years. Disease-free survival rates at 2, 5, and 10 years were 17.2, 15.5, and 15.5%, respectively. Overall survival rates at 2, 5, and 10 years were 58.1, 17.8, and 17.8%, respectively. Conclusions IOERT and PHDRB account for an effective salvage in oligorecurrent gynecological tumors. Patients with previous pelvic radiation suitable for salvage surgery and at risk of inadequate margins could benefit from adjuvant reirradiation in form of IOERT or PHDRB. However, the rate of severe grade >= 3 toxicity associated with the entire treatment program is relevant and needs to be closely counterbalanced against the expected therapeutic gain.

Background. To investigate the value of a single determination of hyperglycosylated hCG (hCG-H) for predicting the clinical outcome of patients with threatened abortion in the first trimester of pregnancy. Methods. Prospective study performed on 86 consecutively selected women with a diagnosis of threatened abortion and viable intrauterine pregnancy in the first trimester of pregnancy, conducted in two tertiary care hospitals. All patients underwent a single blood sample to determine hCG-H and total hCG serum levels and a transvaginal ultrasound 12-24 hours after diagnosis. Patients were monitored to determine whether the outcome was a miscarriage before the 20th week of pregnancy. Results. Forty-three women (50%) had a miscarriage during the follow-up. We observed a very high correlation between hCG-H and total hCG (r = 0.91, p < 0.001). Median hCG-H and total hCG from pregnancies with normal outcome was significantly higher than those ending in abortion. hCG-H and total hCG were very similar predictors of pregnancy outcomes (AUC: 0.90 and 0.89, respectively). The ratio hCG-H / total hCG was a poor predictor (AUC: 0.64). Conclusion. A single hCG-H assay is helpful for predicting pregnancy outcomes in women with first trimester threatened abortion and viable or potentially viable pregnancy at the time of presentation. However, hCG-H is not a better predictor than total hCG.

Introduction Comprehensive updated information on cervical cancer surgical treatment in Europe is scarce. Objective To evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database. Methods The SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified. Results The mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m(2) (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) <2 cm was observed in 667 (57.7%) patients. The most frequent histology type was squamous carcinoma (794 (68.7%) patients), and positive lymph nodes were found in 143 (12.4%) patients. A total of 633 (54.8%) patients were operated by open abdominal surgery. Intra-operative complications occurred in 108 (9.3%) patients, and post-operative complications during the first month occurred in 249 (21.5%) patients, with bladder dysfunction as the most frequent event (119 (10.3%) patients). Clavien-Dindo grade III or higher complication occurred in 56 (4.8%) patients. A total of 510 (44.1%) patients received adjuvant therapy. After a median follow-up of 58 months (range 0-84), the 5-year disease-free survival was 88.3%, and the overall survival was 94.9%. In our population, 10 of the 11 surgical-related quality indicators currently recommended by ESGO were fully fulfilled 5 years before its implementation. Conclusions In this European cohort, the rate of adjuvant therapy after radical hysterectomy is higher than for most similar patients reported in the literature. The majority of centers were already following the European recommendations even 5 years prior to the ESGO quality indicator implementations.

Objective: To describe the ultrasound features of different endometrial and other intracavitary pathologies inpre- and postmenopausal women presenting with abnormal uterine bleeding, using the International Endometrial Tumor Analysis (IETA) terminology. Methods: This was a prospective observational multicenter study of consecutive women presenting with abnormal uterine bleeding. Unenhanced sonography with color Doppler and fluid-instillation sonography were performed. Endometrial sampling was performed according to each center's local protocol. The histological endpoints were cancer, atypical endometrial hyperplasia/endometrioid intraepithelial neoplasia (EIN), endometrial atrophy, proliferative or secretory endometrium, endometrial hyperplasia without atypia, endometrial polyp, intracavitary leiomyoma and other. For fluid-instillation sonography, the histological endpoints were endometrial polyp, intracavitary leiomyoma and cancer. For each histological endpoint, we report typical ultrasound features using the IETA terminology. Results: The database consisted of 2856 consecutive women presenting with abnormal uterine bleeding. Unenhanced sonography with color Doppler was performed in all cases and fluid-instillation sonography in 1857. In 2216 women, endometrial histology was available, and these comprised the study population. Median age was 49 years (range, 19-92 years), median parity was 2 (range, 0-10) and median body mass index was 24.9 kg/m(2) (range, 16.0-72.1 kg/m(2) ). Of the study population, 843 (38.0%) women were postmenopausal. Endometrial polyps were diagnosed in 751 (33.9%) women, intracavitary leiomyomas in 223 (10.1%) and endometrial cancer in 137 (6.2%). None (0% (95% CI, 0.0-5.5%)) of the 66 women with endometrial thickness < 3 mm had endometrial cancer or atypical hyperplasia/EIN. Endometrial cancer or atypical hyperplasia/EIN was found in three of 283 (1.1% (95% CI, 0.4-3.1%)) endometria with a three-layer pattern, in three of 459 (0.7% (95% CI, 0.2-1.9%)) endometria with a linear endometrial midline and in five of 337 (1.5% (95% CI, 0.6-3.4%)) cases with a single vessel without branching on unenhanced ultrasound. Conclusions: The typical ultrasound features of endometrial cancer, polyps, hyperplasia and atrophy and intracavitary leiomyomas, are described using the IETA terminology. The detection of some easy-to-assess IETA features (i.e. endometrial thickness < 3 mm, three-layer pattern, linear midline and single vessel without branching) makes endometrial cancer unlikely.

Introduction: We aimed to analyze the outcome in a series of women with primary advanced ovarian cancer in an Intermediate Volume Hospital where new surgical and chemotherapy treatments were implemented over a period of 14 years. Material and Methods: One hundred and twenty-seven women with stage IIIB-IV disease underwent primary (76.4%) or interval debulking surgery (23.6%). Fifty-seven were operated on from 2000 to 2005 (Group 1) and 70 from 2006 to 2014 (Group 2). Results: No gross residual disease was achieved in 51.5% and 43.3% of women who underwent primary and interval surgery, respectively. For no gross and < 1cm residual disease, median overall and progression-free survival were 94.7 vs. 60.6 months (p = 0.001) and 25.3 vs. 20.0 months, respectively (p = 0.02). The rate of no gross residual (36.8 to 60.0%) and 5-yr median overall survival (56.3 to 73.7 months) increased between 2000-2005 (Group 1) and from 2006 to 2014 (Group 2). On multivariate analysis, interval surgery, multiple peritoneal implants and residual disease were predictive of overall and progression-free survival. Conclusions: Survival after primary and interval debulking surgery progressively correlates with decrease in residual disease. Increasing rates of successful primary surgery are possible through standardization and adoption of best practices without increasing morbidity.

Objectives: To identify uterine measurements that are reliable and accurate to distinguish between T-shaped and normal/arcuate uterus, and define T-shaped uterus, using Congenital Uterine Malformation by Experts (CUME) methodology, which uses as reference standard the decision made most often by several independent experts. Methods: This was a prospectively planned multirater reliability/agreement and diagnostic accuracy study, performed between November 2017 and December 2018, using a sample of 100 three-dimensional (3D) datasets of different uteri with lateral uterine cavity indentations, acquired from consecutive women between 2014 and 2016. Fifteen representative experts (five clinicians, five surgeons and five sonologists), blinded to each others' opinions, examined anonymized images of the coronal plane of each uterus and provided their independent opinion as to whether it was T-shaped or normal/arcuate; this formed the basis of the CUME reference standard, with the decision made most often (i.e. that chosen by eight or more of the 15 experts) for each uterus being considered the correct diagnosis for that uterus. Two other experienced observers, also blinded to the opinions of the other experts, then performed independently 15 sonographic measurements, using the original 3D datasets of each uterus. Agreement between the diagnoses made by the 15 experts was assessed using kappa and percent agreement. The interobserver reliability of measurements was assessed using the concordance correlation coefficient (CCC). The diagnostic test accuracy was assessed using the area under the receiver-operating-characteristics curve (AUC) and the best cut-off value was assessed by calculating Youden's index, according to the CUME reference standard. Sensitivity, specificity, negative and positive likelihood ratios (LR- and LR+) and post-test probability were calculated. Results: According to the CUME reference standard, there were 20 T-shaped and 80 normal/arcuate uteri. Individual experts recognized between 5 and 35 (median, 19) T-shaped uteri on subjective judgment. The agreement among experts was 82% (kappa = 0.43). Three of the 15 sonographic measurements were identified as having good diagnostic test accuracy, according to the CUME reference standard: lateral indentation angle (AUC = 0.95), lateral internal indentation depth (AUC = 0.92) and T-angle (AUC = 0.87). Of these, T-angle had the best interobserver reproducibility (CCC = 0.87 vs 0.82 vs 0.62 for T-angle vs lateral indentation depth vs lateral indentation angle). The best cut-off values for these measurements were: lateral indentation angle ¿ 130° (sensitivity, 80%; specificity, 96%; LR+, 21.3; LR-, 0.21), lateral indentation depth ¿ 7 mm (sensitivity, 95%; specificity, 77.5%; LR+, 4.2; LR-, 0.06) and T-angle ¿ 40° (sensitivity, 80%; specificity, 87.5%; LR+, 6.4; LR-, 0.23). Most of the experts diagnosed the uterus as being T-shaped in 0% (0/56) of cases when none of these three criteria was met, in 10% (2/20) of cases when only one criterion was met, in 50% (5/10) of cases when two of the three criteria were met, and in 93% (13/14) of cases when all three criteria were met. Conclusions: The diagnosis of T-shaped uterus is not easy; the agreement among experts was only moderate and the judgement of individual experts was commonly insufficient for accurate diagnosis. The three sonographic measurements with cut-offs that we identified (lateral internal indentation depth ¿ 7 mm, lateral indentation angle ¿ 130° and T-angle ¿ 40°) had good diagnostic test accuracy and fair-to-moderate reliability and, when applied in combination, they provided high post-test probability for T-shaped uterus. In the absence of other anomalies, we suggest considering a uterus to be normal when none or only one criterion is met, borderline when two criteria are met, and T-shaped when all three criteria are met. These three CUME criteria for defining T-shaped uterus may aid in determination of its prevalence, clinical implications and best management and in the assessment of post-surgical morphologic outcome. The CUME definition of T-shaped uterus may help in the development of interventional randomized controlled trials and observational studies and in the diagnosis of uterine morphology in everyday practice, and could be adopted by guidelines on uterine anomalies to enrich their classification systems.

Objective: "En-bloc" resection of pelvic tumor in ovarian cancer (OC) is still controversial. The aim was to analyze results in an OC series from a single center, all of whom underwent "en-bloc" resection as part of cytoreductive surgery. Material and Methods: Clinical and surgical records from sixty patients with ovarian carcinoma who underwent "en-bloc" resection surgery were retrospectively analyzed. Results: Patients' mean age was 56 years; 36 patients had primary disease and 24 had recurrent disease. Carcinomatosis was present in 46.7% of patients. Primary surgery was performed in 49 and interval debulking surgery in eleven. Complete cytoreduction was achieved in 55.0% and optimal in 38.3% of patients. Carcinomatosis significantly decreased the probability of complete cytoreduction [odds ratio (OR): 0.22; p=0.021]. Mesorectal infiltration occurred in 83% of patients. Risk of death was non-significantly higher (hazard ratio: 1.9) in women with mesorectal infiltration. Median overall survival was longer for patients without infiltration (46.1 vs 79.1 months; p=0.15). Eighty-five percent suffered from mild to moderate complications and colorectal anastomosis (CRA) leak occurred in two patients (3.6%) with CRA below 6 cm. Diaphragm resection had >5 times the risk for major complications (OR: 5.35; p=0.014). There was no three month mortality. Conclusion: When contiguous gross extension of disease to pelvic peritoneum and sigmoid colon is found, in patients with advanced OC, microscopic involvement of the mesorectum and intestinal wall is present in most cases making "en-bloc" resection necessary if complete cytoreduction is to be achieved. The associated morbidity is acceptable.

Objective: To describe the clinical and sonographic characteristics of extragastrointestinal stromal tumors (eGISTs). Methods: This was a retrospective multicenter study. The data of patients with a histological diagnosis of eGIST who had undergone preoperative ultrasound examination were retrieved from the databases of nine large European gynecologic oncology centers. One investigator from each center reviewed stored images and ultrasound reports, and described the lesions using the terminology of the International Ovarian Tumor Analysis and Morphological Uterus Sonographic Assessment groups, following a predefined ultrasound evaluation form. Clinical, surgical and pathological information was also recorded. Results: Thirty-five women with an eGIST were identified; in 17 cases, the findings were incidental, and 18 cases were symptomatic. Median age was 57 years (range, 21-85 years). Tumor marker CA 125 was available in 23 (65.7%) patients, with a median level of 23 U/mL (range, 7-403 U/mL). The vast majority of eGISTs were intraperitoneal lesions (n = 32 (91.4%)); the remaining lesions were retroperitoneal (n = 2 (5.7%)) or preperitoneal (n = 1 (2.9%)). The most common site of the tumor was the abdomen (n = 23 (65.7%)), and less frequently the pelvis (n = 12 (34.3%)). eGISTs were typically large (median largest diameter, 79 mm) solid (n = 31 (88.6%)) tumors, and were less frequently multilocular-solid tumors (n = 4 (11.4%)). The echogenicity of solid tumors was uniform in 8/31 (25.8%) cases, which were all hypoechogenic. Twenty-three solid eGISTs were non-uniform, either with mixed echogenicity (9/23 (39.1%)) or with cystic areas (14/23 (60.9%)). The tumor shape was mainly lobular (n = 19 (54.3%)) or irregular (n = 10 (28.6%)). Tumors were typically richly vascularized (color score of 3 or 4, n = 31 (88.6%)) with no shadowing (n = 31 (88.6%)). Based on pattern recognition, eGISTs were usually correctly classified as a malignant lesion in the ultrasound reports (n = 32 (91.4%)), and the specific diagnosis of eGIST was the most frequent differential diagnosis (n = 16 (45.7%)), followed by primary ovarian cancer (n = 5 (14.3%)), lymphoma (n = 2 (5.7%)) and pedunculated uterine fibroid (n = 2 (5.7%)). Conclusions: On ultrasound, eGISTs were usually solid, non-uniform pelvic or abdominal lobular tumors of mixed echogenicity, with or without cystic areas, with rich vascularization and no shadowing. The presence of a tumor with these features, without connection to the bowel wall, and not originating from the uterus or adnexa, is highly suspicious for eGIST.

Background Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study was to evaluate disease-free survival in patients with stage IB1 (FIGO 2009) cervical cancer undergoing open vs minimally invasive radical hysterectomy. As a secondary objective, we aimed to investigate the association between protective surgical maneuvers and the risk of relapse. Methods We obtained data from 1272 patients that underwent a radical hysterectomy by open or minimally invasive surgery for stage IB1 cervical cancer (FIGO 2009) from January 2013 to December 2014. After applying all the inclusion-exclusion criteria, we used an inverse probability weighting to construct a weighted cohort of 693 patients to compare outcomes (minimally invasive surgery vs open). The first endpoint compared disease-free survival at 4.5 years in both groups. Secondary endpoints compared overall survival among groups and the impact of the use of a uterine manipulator and protective closure of the colpotomy over the tumor in the minimally invasive surgery group. Results Mean age was 48.3 years (range; 23-83) while the mean BMI was 25.7 kg/m(2)(range; 15-49). The risk of recurrence for patients who underwent minimally invasive surgery was twice as high as that in the open surgery group (HR, 2.07; 95% CI, 1.35 to 3.15; P=0.001). Similarly, the risk of death was 2.42-times higher than in the open surgery group (HR, 2.45; 95% CI, 1.30 to 4.60, P=0.005). Patients that underwent minimally invasive surgery using a uterine manipulator had a 2.76-times higher hazard of relapse (HR, 2.76; 95% CI, 1.75 to 4.33; P<0.001) and those without the use of a uterine manipulator had similar disease-free-survival to the open surgery group (HR, 1.58; 95% CI, 0.79 to 3.15; P=0.20). Moreover, patients that underwent minimally invasive surgery with protective vaginal closure had similar rates of relapse to those who underwent open surgery (HR, 0.63; 95% CI, 0.15 to 2.59; P<0.52). Conclusions Minimally invasive surgery in cervical cancer increased the risk of relapse and death compared with open surgery. In this study, avoiding the uterine manipulator and using maneuvers to avoid tumor spread at the time of colpotomy in minimally invasive surgery was associated with similar outcomes to open surgery. Further prospective studies are warranted.

Objective: Analyze the effect on survival of secondary cytoreduction surgery (SCS) in treatment of first recurrence platinum-sensitive epithelial ovarian cancer (REOC). Methods: Retrospective analysis of patients with first REOC who had platinum time-free interval (TFIp) > 6 months and were treated either with SCS followed by chemotherapy or chemotherapy only (CT). Clinical data such as patient's performance status and number of sites with metastases were specifically assessed. The primary endpoint was overall survival (OS). Results: Seventy-one patients were treated either by SCS (n = 37) or CT (n = 34). Complete resection after SCS was achieved in 89% of patients. After a median follow-up of 51.2 months, median OS, and progression-free survival (PFS) were 68.2 and 21.6 months, respectively, for the whole series of the SCS patients had better survival and disease progression survival than the CT only patients (HR: 0.33, 95% CI: 0.17-0.6; p= 0.001) and (HR: 0.28, 95% CI: 0.15-0.5; p= 0.001), respectively. TFIp < 12 months and multiple metastases were most important prognostic factors for risk of death (HR: 7.7 and 6.2, respectively) and recurrence (HR: 5.8 and 3.8, respectively). Probability to undergo successful SCS is related to oligometastatic disease and no residual disease after first surgery (OR: 30.0 and 5.9, respectively). Conclusions: In women with REOC oligometastatic disease and no residual disease at first surgery are associated with successful SCS. In these patients oligometastatic disease and long platinum TFI are associated with improved probability of survival.

Objectives: The aim of this study was to evaluate the use of ultrasound (US) soft markers as a first-line imaging tool to raise suspicion of rectosigmoid (RS) involvement in women suspected of having deep endometriosis. Methods: We included in this prospective observational study all patients with clinical suspicion of deep endometriosis who underwent diagnostic transvaginal US evaluation at our unit from January 2016 to February 2017. Several US soft markers were evaluated for prediction of RS involvement (presence of US signs of uterine adenomyosis, presence of an endometrioma, adhesion of the ovary to the uterus (reduced ovarian mobility), presence of 'kissing ovaries' (KO) and absence of the 'sliding sign'), using as the gold standard expert US examination for the presence of RS endometriosis. Results: Included were 333 patients with clinical suspicion of deep endometriosis. Of these, 106 had an US diagnosis of RS endometriosis by an expert. The only significant variables found in the prediction model were absence of the sliding sign (odds ratio (OR), 13.95; 95% CI, 7.7-25.3), presence of KO (OR, 22.5; 95% CI, 4.1-124.0) and the interaction between these two variables (OR, 0.03; 95% CI, 0.004-0.28). Regarding their interaction, RS endometriosis was present when KO was absent and the sliding sign was present in 10% (19/190) of cases, when both KO and the sliding sign were present in 71.4% (5/7) of cases, when both KO and the sliding sign were absent in 60.8% (76/125) of cases and when KO was present and the sliding sign was absent in 54.5% (6/11) of cases. Thus, when the sliding sign was absent and/or KO was present, transvaginal US showed a specificity of 75% (95% CI, 69-80%) and a sensitivity of 82% (95% CI, 73-88%). Conclusions: US findings of absence of the sliding sign and/or presence of KO in patients with clinical suspicion of endometriosis should raise suspicion of RS involvement and indicate referral for expert US examination, with a low rate of false-negative diagnosis.

Objective: To develop a preoperative risk model, using endometrial biopsy results and clinical and ultrasound variables, to predict the individual risk of lymph-node metastases in women with endometrial cancer. Methods: A mixed-effects logistic regression model for prediction of lymph-node metastases was developed in 1501 prospectively included women with endometrial cancer undergoing transvaginal ultrasound examination before surgery, from 16 European centers. Missing data, including missing lymph-node status, were imputed. Discrimination, calibration and clinical utility of the model were evaluated using leave-center-out cross validation. The predictive performance of the model was compared with that of risk classification from endometrial biopsy alone (high-risk defined as endometrioid cancer Grade 3/non-endometrioid cancer) or combined endometrial biopsy and ultrasound (high-risk defined as endometrioid cancer Grade 3/non-endometrioid cancer/deep myometrial invasion/cervical stromal invasion/extrauterine spread). Results: Lymphadenectomy was performed in 691 women, of whom 127 had lymph-node metastases. The model for prediction of lymph-node metastases included the predictors age, duration of abnormal bleeding, endometrial biopsy result, tumor extension and tumor size according to ultrasound and undefined tumor with an unmeasurable endometrium. The model's area under the curve was 0.73 (95% CI, 0.68-0.78), the calibration slope was 1.06 (95% CI, 0.79-1.34) and the calibration intercept was 0.06 (95% CI, -0.15 to 0.27). Using a risk threshold for lymph-node metastases of 5% compared with 20%, the model had, respectively, a sensitivity of 98% vs 48% and specificity of 11% vs 80%. The model had higher sensitivity and specificity than did classification as high-risk, according to endometrial biopsy alone (50% vs 35% and 80% vs 77%, respectively) or combined endometrial biopsy and ultrasound (80% vs 75% and 53% vs 52%, respectively). The model's clinical utility was higher than that of endometrial biopsy alone or combined endometrial biopsy and ultrasound at any given risk threshold. Conclusions: Based on endometrial biopsy results and clinical and ultrasound characteristics, the individual risk of lymph-node metastases in women with endometrial cancer can be estimated reliably before surgery. The model is superior to risk classification by endometrial biopsy alone or in combination with ultrasound.

OBJECTIVE To evaluate the performance of diagnostic prediction models for ovarian malignancy in all patients with an ovarian mass managed surgically or conservatively. DESIGN Multicentre cohort study. SETTING 36 oncology referral centres (tertiary centres with a specific gynaecological oncology unit) or other types of centre. PARTICIPANTS Consecutive adult patients presenting with an adnexal mass between January 2012 and March 2015 and managed by surgery or follow-up. MAIN OUTCOME MEASURES Overall and centre specific discrimination, calibration, and clinical utility of six prediction models for ovarian malignancy (risk of malignancy index (RMI), logistic regression model 2 (LR2), simple rules, simple rules risk model (SRRisk), assessment of different neoplasias in the adnexa (ADNEX) with or without CA125). ADNEX allows the risk of malignancy to be subdivided into risks of a borderline, stage I primary, stage II-IV primary, or secondary metastatic malignancy. The outcome was based on histology if patients underwent surgery, or on results of clinical and ultrasound follow-up at 12 (+/- 2) months. Multiple imputation was used when outcome based on follow-up was uncertain. RESULTS The primary analysis included 17 centres that met strict quality criteria for surgical and follow-up data (5717 of all 8519 patients). 812 patients (14%) had a mass that was already in follow-up at study recruitment, therefore 4905 patients were included in the statistical analysis. The outcome was benign in 3441 (70%) patients and malignant in 978 (20%). Uncertain outcomes (486, 10%) were most often explained by limited follow-up information. The overall area under the receiver operating characteristic curve was highest for ADNEX with CA125 (0.94, 95% confidence interval 0.92 to 0.96), ADNEX without CA125 (0.94, 0.91 to 0.95) and SRRisk (0.94, 0.91 to 0.95), and lowest for RMI (0.89, 0.85 to 0.92). Calibration varied among centres for all models, however the ADNEX models and SRRisk were the best calibrated. Calibration of the estimated risks for the tumour subtypes was good for ADNEX irrespective of whether or not CA125 was included as a predictor. Overall clinical utility (net benefit) was highest for the ADNEX models and SRRisk, and lowest for RMI. For patients who received at least one follow-up scan (n=1958), overall area under the receiver operating characteristic curve ranged from 0.76 (95% confidence interval 0.66 to 0.84) for RMI to 0.89 (0.81 to 0.94) for ADNEX with CA125. CONCLUSIONS Our study found the ADNEX models and SRRisk are the best models to distinguish between benign and malignant masses in all patients presenting with an adnexal mass, including those managed conservatively.

Objectives: To compare the performance of ultrasound measurements and subjective ultrasound assessment (SA) in detecting deep myometrial invasion (MI) and cervical stromal invasion (CSI) in women with endometrial cancer, overall and according to whether they had low- or high-grade disease separately, and to validate published measurement cut-offs and prediction models to identify MI, CSI and high-risk disease (Grade-3 endometrioid or non-endometrioid cancer and/or deep MI and/or CSI). Methods: The study comprised 1538 patients with endometrial cancer from the International Endometrial Tumor Analysis (IETA)-4 prospective multicenter study, who underwent standardized expert transvaginal ultrasound examination. SA and ultrasound measurements were used to predict deep MI and CSI. We assessed the diagnostic accuracy of the tumor/uterine anteroposterior (AP) diameter ratio for detecting deep MI and that of the distance from the lower margin of the tumor to the outer cervical os (Dist-OCO) for detecting CSI. We also validated two two-step strategies for the prediction of high-risk cancer; in the first step, biopsy-confirmed Grade-3 endometrioid or mucinous or non-endometrioid cancers were classified as high-risk cancer, while the second step encompassed the application of a mathematical model to classify the remaining tumors. The 'subjective prediction model' included biopsy grade (Grade 1 vs Grade 2) and subjective assessment of deep MI or CSI (presence or absence) as variables, while the 'objective prediction model' included biopsy grade (Grade 1 vs Grade 2) and minimal tumor-free margin. The predictive performance of the two two-step strategies was compared with that of simply classifying patients as high risk if either deep MI or CSI was suspected based on SA or if biopsy showed Grade-3 endometrioid or mucinous or non-endometrioid histotype (i.e. combining SA with biopsy grade). Histological assessment from hysterectomy was considered the reference standard. Results: In 1275 patients with measurable lesions, the sensitivity and specificity of SA for detecting deep MI was 70% and 80%, respectively, in patients with a Grade-1 or -2 endometrioid or mucinous tumor vs 76% and 64% in patients with a Grade-3 endometrioid or mucinous or a non-endometrioid tumor. The corresponding values for the detection of CSI were 51% and 94% vs 50% and 91%. Tumor AP diameter and tumor/uterine AP diameter ratio showed the best performance for predicting deep MI (area under the receiver-operating characteristics curve (AUC) of 0.76 and 0.77, respectively), and Dist-OCO had the best performance for predicting CSI (AUC, 0.72). The proportion of patients classified correctly as having high-risk cancer was 80% when simply combining SA with biopsy grade vs 80% and 74% when using the subjective and objective two-step strategies, respectively. The subjective and objective models had an AUC of 0.76 and 0.75, respectively, when applied to Grade-1 and -2 endometrioid tumors. Conclusions: In the hands of experienced ultrasound examiners, SA was superior to ultrasound measurements for the prediction of deep MI and CSI of endometrial cancer, especially in patients with a Grade-1 or -2 tumor. The mathematical models for the prediction of high-risk cancer performed as expected. The best strategies for predicting high-risk endometrial cancer were combining SA with biopsy grade and the subjective two-step strategy, both having an accuracy of 80%.

Objective: To determine whether the transvaginal ultrasonographic measurement of the cervical volume at 19¿22 weeks could predict a post-term pregnancy. Materials and methods: This work involves a retrospective case¿control study comprising 44 women who delivered beyond 41 weeks and 87 women who delivered at term (37¿40 + 6 weeks), matched by age and parity. All of them had undergone cervical length measurement and cervical volume estimation at 19¿22 weeks. Results: Patients¿ median of age was 35 years in term gestations and 34.5 years in prolonged pregnancies (p= 0.313). The mean of gestational age during delivery in the term gestation group was 275.41 days vs 289.34 days on prolonged gestations (p < 0.001). We did not observe differences in the mean cervical volume between term delivery (37.37 cm3, 95% CI: 34.59¿40.14) and those who had post-term delivery (38.06 cm3, 95% CI: 33.34¿42.77) (p = 0.788). In addition, we did not find differences in the median cervical length (39.0 mm vs 37.0 mm) (p= 0.610). Conclusion: It seems that there is no relationship between the cervical volume measured in the ultrasound of 20-week gestation and the prolongation of pregnancy beyond week 41.

Pertussis vaccination of parents and household contacts ('cocooning') to protect newborn infants is an established strategy in many countries, although uptake may be low. Many aspects may influence such decision-making. We conducted a cross-sectional survey (NCT01890447) of households and other close contacts of newborns aged <= 6 months (or of expectant mothers in their last trimester) in Spain and Italy, using an adaptive discrete-choice experiment questionnaire. Aims were to assess the relative importance of attributes influencing vaccine adoption, and to estimate variation in vaccine adoption rates and the impact of cost on vaccination rates. Six hundred and fifteen participants (Spain, n = 313; Italy, n = 302) completed the survey. Of 144 available questionnaire scenarios, the most frequently selected (14% of respondents in both countries) were infant protection by household vaccination at vaccination center, recommendation by family physician and health authorities, with information available on leaflets and websites. The attribute with highest median relative importance was 'reduction in source of infection' in Spain (23.1%) and 'vaccination location' in Italy (18.8%). Differences between other attributes were low in both countries, with media attributes showing low importance. Over 80% of respondents indicated a definite or probable response to vaccine adoption (at no-cost) with estimated probability of adoption of 89-98%; applying vaccine costs (25euro per person) would reduce the probability of uptake by 7-20% in definite/probable respondents. Awareness of these determinants is helpful in informing Health Authorities and healthcare practitioners implementing a cocooning strategy for those populations where maternal immunization is not a preferred option.

Objectives To assess the feasibility of gastrointestinal endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) for histologic confirmation of cancer recurrence in women with gynecologic cancer. Methods This work was a retrospective cohort study comprising 46 consecutive women treated for gynecologic cancer and suspected of having a deep pelvic or abdominal recurrence on ultrasound imaging, computed tomography, positron emission tomography-computed tomography, or magnetic resonance imaging, evaluated at our institution from January 2010 to December 2017. Primary cancer was ovarian (n = 22), cervical (n = 13), endometrial (n = 4), sarcoma (n = 4), and other (n = 3). All women underwent EUS examinations for locating the lesion and guiding FNA. The results of FNA (benign/malignant) were assessed. Procedure-related complications were recorded. Results The patients' mean age was 57.8 years. A total of 66 procedures were performed. Eleven women underwent 2 procedures; 2 women underwent 3 procedures; and 1 woman underwent 6 procedures at different times during the study period. In 1 case, no lesion was detected on the EUS assessment, and in 2 cases, FNA was not successful. Most lesions were located in the retroperitoneum or involved the intestine. Fine-needle aspiration could be performed in 63 cases (94.5%). Cytologic samples were adequate in 62 of 63 (98.4%). Recurrence was confirmed in 56 cases (90.3%) and ruled out in 6 (9.7%). No patient had any complication related to the procedure. Conclusions Endoscopic ultrasound-guided FNA is a minimally invasive, feasible, and safe technique for confirming pelvic/abdominal recurrence of gynecologic cancer.

Aims: Abdominal hypopressive technique (AHT) is gaining popularity as an alternative to pelvic floor muscle training (PFMT) during postpartum. Although, there is no solid evidence for its recommendation. Methods: We conducted a prospective observational cohort study in a university hospital with 105 primiparae who performed a two-month PFMT or AHT program. The aim was to compare the effectiveness of both treatments in terms of morphofunctional changes in 3D transperineal ultrasound, manometry, dynamometry, and differences in urinary incontinence symptoms (ICIQ-IU-SF) and satisfaction. Results: The average change in levator ani muscle was 1.2 mm higher in AHT group vs PFMT (95% confidence interval [CI], -2.2 to -0.2; P = .017). No statistically significant differences were shown in maximal strength changes between groups. After AHT, basal tone change was 63.0 g/cm(2) higher than PFMT (95% CI, -129 to 2.9; P = .06). A statistically significant reduction in ICIQ-IU-SF was observed after both treatments [(PFMT, -0.8 points; 95% CI, -1.4 to -0.1; P = .015), (AHT, -0.7 points; 95% CI, -1.3 to -0.1; P = .018]. AHT showed a higher median satisfaction score than PFMT (P = .004). Conclusions: This preliminary study is the first that analyses the effect of AHT vs PFMT during postpartum. The results suggest a higher improve for AHT in levator muscle thickness and satisfaction compared to PFMT. These must be considered with caution due to the limitations of the study. Further randomized clinical trials about both techniques during postpartum are required.

Objective To describe the clinical and ultrasound characteristics of uterine sarcomas. Methods This was a retrospective multicenter study. From the databases of 13 ultrasound centers, we identified patients with a histological diagnosis of uterine sarcoma with available ultrasound reports and ultrasound images who had undergone preoperative ultrasound examination between 1996 and 2016. As the first step, each author collected information from the original ultrasound reports from his/her own center on predefined ultrasound features of the tumors and by reviewing the ultrasound images to identify information on variables not described in the original report. As the second step, 16 ultrasound examiners reviewed the images electronically in a consensus meeting and described them using predetermined terminology. Results We identified 116 patients with leiomyosarcoma, 48 with endometrial stromal sarcoma and 31 with undifferentiated endometrial sarcoma. Median age of the patients was 56 years (range, 26-86 years). Most patients were symptomatic at diagnosis (164/183 (89.6%)), the most frequent presenting symptom being abnormal vaginal bleeding (91/183 (49.7%)). Patients with endometrial stromal sarcoma were younger than those with leiomyosarcoma and undifferentiated endometrial sarcoma (median age, 46 years vs 57 and 60 years, respectively). According to the assessment by the original ultrasound examiners, the median diameter of the largest tumor was 91mm (range, 7-321 mm). Visible normal myometrium was reported in 149/195 (76.4%) cases, and 80.0% (156/195) of lesions were solitary. Most sarcomas (155/195 (79.5%)) were solid masses (> 80% solid tissue), and most manifested inhomogeneous echogenicity of the solid tissue (151/195 (77.4%)); one sarcoma was multilocular without solid components. Cystic areas were described in 87/195 (44.6%) tumors and most cyst cavities had irregular walls (67/87 (77.0%)). Internal shadowing was observed in 42/192 (21.9%) sarcomas and fan-shaped shadowing in 4/192 (2.1%). Moderate or rich vascularization was found on color-Doppler examination in 127/187 (67.9%) cases. In 153/195 (78.5%) sarcomas, the original ultrasound examiner suspected malignancy. Though there were some differences, the results of the first and second steps of the analysis were broadly similar. Conclusions Uterine sarcomas typically appear as solid masses with inhomogeneous echogenicity, sometimes with irregular cystic areas but only very occasionally with fan-shaped shadowing. Most are moderately or very well vascularized. Copyright (C) 2019 ISUOG. Published by John Wiley & Sons Ltd.

Objective To assess the learning curves of trainees during a structured offline/hands-on training program for the ultrasonographic diagnosis of deep infiltrating endometriosis (DIE). Methods Four trainees (all Ob/Gyn postgraduates with at least 5 years' experience in ultrasonography in obstetrics and gynecology, but with no experience of sonographic examination of DIE) participated in the study. They underwent a 2-week training program with a single trainer. Day 1 was devoted to theoretical issues and guided offline analysis of 10 three-dimensional ultrasound volumes. During the following days, four sessions of real-time sonographic examinations were performed in a DIE referral center ultrasound unit. In between these sessions, the trainees analyzed four datasets offline, each containing 25 volumes. At the end of each set, misinterpreted volumes were reassessed with the trainer. Presence or absence of DIE at surgery was considered the gold standard. The trainees' learning process was evaluated by learning-curve cumulative summation (LC-CUSUM) and the deviations of the trainees' level of performance at the control stage was assessed by CUSUM (standard CUSUM), for different locations of DIE. Results The trainees reached competence after an average of 17 (range, 14-21) evaluations for bladder, 40 (range, 30-60) for rectosigmoid, 25 (range, 14-34) for forniceal, 44 (range, 25-66) for uterosacral ligament (USL) and 21 (range, 14-43) for rectovaginal septum (RVS) locations of DIE, and then kept the process under control, with error levels of less than 4.5% until the end of the test. The overall accuracy for each trainee in diagnosis of DIE at the different locations ranged from 0.91 to 0.98 for bladder DIE, from 0.80 to 0.94 for rectosigmoid DIE, from 0.90 to 0.94 for forniceal DIE, from 0.79 to 0.82 for USL DIE and from 0.89 to 0.98 for RVS DIE. Conclusions The suggested 2-week training program, based on a mixture of offline and live scanning sessions, is feasible and apparently provides effective training for the ultrasonographic diagnosis of DIE. Copyright (c) 2018 ISUOG. Published by John Wiley & Sons Ltd.

Objective: To compare the diagnostic performance of ultrasound and computed tomography (CT) for detecting pelvic and abdominal tumor spread in women with epithelial ovarian cancer. Methods: An observational cohort study of 93 patients (mean age 57.6 years) with an ultrasound diagnosis of adnexal mass suspected of malignancy and confirmed histologically as epithelial ovarian cancer was undertaken. In all cases, transvaginal and transabdominal ultrasound as well as CT scans were performed to assess the extent of the disease within the pelvis and abdomen prior to surgery. The exploration was systematic, analyzing 12 anatomical areas. All patients underwent surgical staging and/or cytoreductive surgery with an initial laparoscopy for assessing resectability. The surgical and pathological findings were considered as the 'reference standard'. Sensitivity and specificity of ultrasound and CT scanning were calculated for the different anatomical areas and compared using the McNemar test. Agreement between ultrasound and CT staging and the surgical stage was estimated using the weighted kappa index. Results: The tumorous stage was International Federation of Gynecology and Obstetrics (FIGO) stage I in 26 cases, stage II in 11 cases, stage III in 47 cases, and stage IV in nine cases. Excluding stages I and IIA cases (n=30), R0 (no macroscopic residual disease) was achieved in 36 women (62.2%), R1 (macroscopic residual disease <1cm) was achieved in 13 women (25.0%), and R2 (macroscopic residual disease >1cm) debulking surgery occurred in three women (5.8%). Eleven patients (11.8%) were considered not suitable for optimal debulking surgery during laparoscopic assessment. Overall sensitivity of ultrasound and CT for detecting disease was 70.3% and 60.1%, respectively, and specificity was 97.8% and 93.7%, respectively. The agreement between radiological stage and surgical stage for ultrasound (kappa index 0.69) and CT (kappa index 0.70) was good for both techniques. Overall accuracy to determine tumor stage was 71% for ultrasound and 75% for CT. Conclusion: Detailed ultrasound examination renders a similar diagnostic performance to CT for assessing pelvic/abdominal tumor spread in women with epithelial ovarian cancer.

Objectives To perform an external validation of the diagnostic performance of the three-step strategy proposed by the International Ovarian Tumor Analysis (IOTA) group for classifying adnexal masses as benign or malignant, when ultrasound is performed by non-expert sonographers in the first two steps. The second objective was to assess the diagnostic performance of an alternative strategy using simple-rules risk (SRR), instead of simple rules (SR), in the second step. Methods This was a prospective observational study conducted at two university hospitals, from September 2015 to August 2017, of consecutive patients diagnosed with an adnexal mass. All women were evaluated by ultrasound using the IOTA three-step strategy. Non-expert sonographers performed the first step (use of simple descriptors to classify the masses) and the second step (use of SR if the mass could not be classified in the first step); masses that could not be classified in the first two steps were categorized by an expert sonographer based on their subjective assessment (third step). The reference standard was histological diagnosis in patients who underwent surgery or at least 12 months of follow-up in cases managed expectantly. The sensitivity, specificity, positive (LR+) and negative (LR-) likelihood ratios and overall accuracy of the IOTA three-step strategy were estimated. Furthermore, we evaluated retrospectively an alternative two-step strategy using SRR in the second step to categorize the masses not classifiable with simple descriptors, classifying the lesions as being of low, intermediate or high risk for malignancy. The diagnostic performance of this strategy was estimated by calculating its sensitivity and specificity, assuming surgical intervention for intermediate-or high-risk lesions. Results The study included 283 patients (median age, 48 (range, 18-90) years), of whom 165 (58.3%) were premenopausal and 118 (41.7%) postmenopausal. Two hundred and sixteen (76.3%) women underwent surgery (154 benign and 62 malignant masses) and 67 (23.7%) were managed expectantly with serial ultrasound follow-up for at least 12 months. All expectantly managed masses were considered benign because no sonographic changes suggestive of malignancy were observed during follow-up. Simple descriptors could be applied in 126 (44.5%) masses. Of the remaining 157 lesions, 112 (39.6%) could be characterized using SR. Therefore, 238 (84.1%) masses could be classified by non-expert sonographers in the first two steps. Of the remaining 45 (15.9%) masses, all could be classified by an expert sonographer. Overall sensitivity, specificity, LR+ and LR- of the IOTA three-step strategy were 95.2%, 97.7%, 42.1 and 0.05, respectively. The diagnostic accuracy was 97.2%. Following the two-step strategy using SRR in the second step, of the 157 lesions not classified with simple descriptors, 42, 38 and 77 presented low, intermediate or high risk for malignancy, respectively. Based on this method, 210 women would have undergone surgical treatment. The sensitivity and specificity of this two-step strategy were 98.4% and 63.8%, respectively. Conclusions The IOTA three-step strategy shows high accuracy for discriminating between benign and malignant adnexal lesions when used by non-expert sonographers. An alternative strategy using the SRR calculator in the second step might improve on this diagnostic performance by decreasing the number of surgical interventions and increasing sensitivity.

Background Ovarian tumours are usually surgically removed because of the presumed risk of complications. Few large prospective studies on long-term follow-up of adnexal masses exist. We aimed to estimate the cumulative incidence of cyst complications and malignancy during the first 2 years of follow-up after adnexal masses have been classified as benign by use of ultrasonography. Methods In the international, prospective, cohort International Ovarian Tumor Analysis Phase 5 (IOTA5) study, patients aged 18 years or older with at least one adnexal mass who had been selected for surgery or conservative management after ultrasound assessment were recruited consecutively from 36 cancer and non-cancer centres in 14 countries. Follow-up of patients managed conservatively is ongoing at present. In this 2-year interim analysis, we analysed patients who were selected for conservative management of an adnexal mass judged to be benign on ultrasound on the basis of subjective assessment of ultrasound images. Conservative management included ultrasound and clinical follow-up at intervals of 3 months and 6 months, and then every 12 months thereafter. The main outcomes of this 2-year interim analysis were cumulative incidence of spontaneous resolution of the mass, torsion or cyst rupture, or borderline or invasive malignancy confirmed surgically in patients with a newly diagnosed adnexal mass. IOTA5 is registered with ClinicalTrials.gov, number NCT01698632, and the central Ethics Committee and the Belgian Federal Agency for Medicines and Health Products, number S51375/B32220095331, and is ongoing. Findings Between Jan 1, 2012, and March 1, 2015, 8519 patients were recruited to IOTA5. 3144 (37%) patients selected for conservative management were eligible for inclusion in our analysis, of whom 221 (7%) had no follow-up data and 336 (11%) were operated on before a planned follow-up scan was done. Of 2587 (82%) patients with follow-up data, 668 (26%) had a mass that was already in follow-up at recruitment, and 1919 (74%) presented with a new mass at recruitment (ie, not already in follow-up in the centre before recruitment). Median follow-up of patients with new masses was 27 months (IQR 14-38). The cumulative incidence of spontaneous resolution within 2 years of follow-up among those with a new mass at recruitment (n=1919) was 20.2% (95% CI 18.4-22.1), and of finding invasive malignancy at surgery was 0.4% (95% CI 0.1-0.6), 0.3% (< 0.1-0.5) for a borderline tumour, 0.4% (0.1-0.7) for torsion, and 0.2% (< 0.1-0.4) for cyst rupture. Interpretation Our results suggest that the risk of malignancy and acute complications is low if adnexal masses with benign ultrasound morphology are managed conservatively, which could be of value when counselling patients, and supports conservative management of adnexal masses classified as benign by use of ultrasound.

The aim of this study was to describe the clinical and sonographic features of ovarian metastases originating from colorectal cancer (mCRC), and to discriminate mCRC from primary ovarian cancer (OC). We conducted a multi-institutional, retrospective study of consecutive patients with ovarian mCRC who had undergone ultrasound examination using the International Ovarian Tumor Analysis (IOTA) terminology, with the addition of evaluating signs of necrosis and abdominal staging. A control group included patients with primary OC. Clinical and ultrasound data, subjective assessment (SA), and an assessment of different neoplasias in the adnexa (ADNEX) model were evaluated. Fisher's exact and Student's t-tests, the area under the receiver-operating characteristic curve (AUC), and classification and regression trees (CART) were used to conduct statistical analyses. In total, 162 patients (81 with OC and 81 with ovarian mCRC) were included. None of the patients with OC had undergone chemotherapy for CRC in the past, compared with 40% of patients with ovarian mCRC (p < 0.001). The ovarian mCRC tumors were significantly larger, a necrosis sign was more frequently present, and tumors had an irregular wall or were fixed less frequently; ascites, omental cake, and carcinomatosis were less common in mCRC than in primary OC. In a subgroup of patients with ovarian mCRC who had not undergone treatment for CRC in anamnesis, tumors were larger, and had fewer papillations and more locules compared with primary OC. The highest AUC for the discrimination of ovarian mCRC from primary OC was for CART (0.768), followed by SA (0.735) and ADNEX calculated with CA-125 (0.680). Ovarian mCRC and primary OC can be distinguished based on patient anamnesis, ultrasound pattern recognition, a proposed decision tree model, and an ADNEX model with CA-125 levels.

Objectives To assess the level of agreement between experts in distinguishing between septate and normal/arcuate uterus using their subjective judgment when reviewing the coronal view of the uterus from three-dimensional ultrasound. Another aim was to determine the interobserver reliability and diagnostic test accuracy of threemeasurements suggested by recent guidelines, using as reference standard the decision made most often by experts (Congenital Uterine Malformation by Experts (CUME)). Methods Images of the coronal plane of the uterus from 100 women with suspected fundal internal indentation were anonymized and provided to 15 experts (five clinicians, five surgeons and five sonologists). They were instructed to indicate whether they believed the uterus to be normal/arcuate (defined as normal uterine morphology or not clinically relevant degree of distortion caused by internal indentation) or septate (clinically relevant degree of distortion caused by internal indentation). Two other observers independently measured indentation depth, indentation angle and indentation-to-wall-thickness (I: WT) ratio. The agreement between experts was assessed using kappa, the interobserver reliability was assessed using the concordance correlation coefficient (CCC), the diagnostic test accuracy was assessed using the area under the receiver-operating characteristics curve (AUC) and the best cut-off value was assessed using Youden's index, considering as the reference standard the choice made most often by the experts (CUME). Results There was good agreement between all experts (kappa, 0.62). There were 18 septate and 82 normal/arcuate uteri according to CUME; European Society of Human Reproduction and Embryology (ESHRE)-European Society for Gynaecological Endoscopy (ESGE) criteria (I: WT ratio> 50%) defined 80 septate and 20 normal/arcuate uteri, while American Society for Reproductive Medicine (ASRM) criteria defined five septate (depth> 15mm and angle < 90 degrees), 82 normal/arcuate (depth< 10mm and angle > 90 degrees) and 13 uteri that could not be classified (referred to as the gray-zone). The agreement between ESHRE-ESGE and ASRM criteria and CUME for septate was 87% (kappa, 0.39), and considering both septate and gray-zone as septate, the agreement was 98% (kappa, 0.93). Among the three measurements, the interobserver reproducibility of indentation depth (CCC, 0.99; 95% CI, 0.98-0.99) was better than both indentation angle (CCC, 0.96; 95% CI, 0.94-0.97) and I: WT ratio (CCC, 0.92; 95% CI, 0.90-0.94). The diagnostic test accuracy of these three measurements using CUME as reference standard was very good, with AUC between 0.96 and 1.00. The best cut-off values for these measurements to define septate uterus were: indentation depth >= 10 mm, indentation angle < 140 degrees and I: WT ratio > 110%. Conclusions The suggested ESHRE-ESGE cut-off value overestimates the prevalence of septate uterus while that of ASRM underestimates this prevalence, leaving in the gray-zone most of the uteri that experts considered as septate. We recommend considering indentation depth >= 10mmas septate, since the measurement is simple and reliable and this criterion is in agreement with expert opinion. Copyright (C) 2017 ISUOG. Published by John Wiley & Sons Ltd.

This Consensus Opinion summarizes the main aspects of several techniques for performing ovarian antral follicle count (AFC), proposes a standardized report and provides recommendations for future research. AFC should be performed using a transvaginal ultrasound (US) probe with frequency >= 7 MHz. For training, we suggest a minimum of 20-40 supervised examinations. The operator should be able to adjust the machine settings in order to achieve the best contrast between follicular fluid and ovarian stroma. AFC may be evaluated using real-time two-dimensional (2D) US, stored 2D-US cine-loops and stored three-dimensional (3D) US datasets. Real-time 2D-US has the advantage of permitting additional maneuvers to determine whether an anechoic structure is a follicle, but may require a longer scanning time, particularly when there is a large number of follicles, resulting in more discomfort to the patient. 2D-US cine-loops have the advantages of reduced scanning time and the possibility for other observers to perform the count. The 3D-US technique requires US machines with 3D capability and the operators to receive additional training for acquisition/analysis, but has the same advantages as cine-loop and also allows application of different imaging techniques, such as volume contrast imaging, inversion mode and semi-automated techniques such as sonography-based automated volume calculation. In this Consensus Opinion, we make certain recommendations based on the available evidence. However, there is no strong evidence that any one method is better than another; the operator should choose the best method for counting ovarian follicles based on availability of resources and on their own preference and skill. More studies evaluating how to improve the reliability of AFC should be encouraged. Copyright (c) 2017 ISUOG. Published by John Wiley & Sons Ltd.

ObjectivesTo evaluate the diagnostic accuracy of 2-dimensional (2D) and 3-dimensional (3D) transvaginal ultrasonography (US) in comparison with magnetic resonance imaging (MRI) for identification of deep infiltrating endometriosis. MethodsIn this prospective observational study, 159 premenopausal women who underwent surgery for a clinical suspicion of deep infiltrating endometriosis were prospectively enrolled. All women underwent 2DUS, 3DUS, and MRI. The following 3 locations of deep endometriosis were considered: (1) intestinal; (2) other posterior lesions (retrocervical septum, rectovaginal septum, uterosacral ligaments, and vaginal fornix); and (3) anterior. The sensitivity, specificity, positive predictive value, and negative predictive value of 2D and 3D transvaginal US in comparison with MRI were determined. ResultsIntestinal deep infiltrating endometriosis was identified by 2DUS in 56 of 66 patients, by 3DUS in 59 of 66, and by MRI in 61 of 66. A receiver operating characteristic curve analysis showed optimal results for 2DUS, 3DUS, and MRI (areas under the curve, 0.86, 0.915, and 0.935, respectively) with a statistically significant difference between 2DUS and MRI (P=.0103), even when the 95% confidence interval showed an overlap. Other posterior deep infiltrating endometriosis was identified by 2DUS in 55 of 75 patients, by 3DUS in 65 of 75, and by MRI in 66 of 75. A receiver operating characteristic curve analysis showed very good results for 2DUS, 3DUS, and MRI (areas under the curve, 0.801, 0.838, and 0.857) with no statistically significant differences. In the 12 women with deep infiltrating endometriosis in the anterior location, the nodules were correctly identified by 2DUS in 3 of 12 patients, by 3DUS in 5 of 12, and by MRI in 6 of 12. ConclusionsOur results seem to suggest that there is a statistically significant difference between 2DUS and MRI for the intestinal location of deep infiltrating endometriosis, whereas no differences were found among the techniques for the other locations.

Objectives. The aim is to estimate agreement between two-dimensional transvaginal ultrasound (2D-TVS) and three-dimensional volume contrast imaging (3D-VCI) in diagnosing deep myometrial invasion (MI) and cervical stromal involvement (CSI) of endometrial cancer and to compare the two methods regarding inter-rater reliability and diagnostic accuracy. Methods. Fifteen ultrasound experts assessed off-line de-identified 3D-VCI volumes and 2D-1VU video clips from 58 patients with biopsy-confirmed endometrial cancer regarding the presence of deep (>= 50%) MI and CSI. Video clips and 3D volumes were assessed independently. Interrater reliability was measured using kappa statistics. Histological diagnosis after hysterectomy served as gold standard. Accuracy measurements were correlated to rater experience using Spearman's rank correlation coefficient (rho). Results. Agreement between 2D-TVU and 3D-VCI for diagnosing MI was median 76% (range 64-93%) and for CSI median 88% (range 79-97%). Interrater reliability was better for 2D-TVU than for 3D-VCI (Fleiss' kappa 0.41 vs. 0.31 for MI and 0.55 vs. 0.45 for CSI). Median accuracy for diagnosing deep MI was 76% (range 59-84%) with 2D-TVU and 69% (range 52-83%) for 3D-VCI; the corresponding figures for CSI were 88% (range 81-93%) and 86% (range 72-95%). Accuracy was significantly correlated to how many cases the raters assessed annually. Conclusions. Off-line assessment of MI and CSI in women with endometrial cancer using 3D-VCI has lower interrater reliability and lower accuracy than 2D-1VU video clip assessment. Since accuracy was correlated to the number of cases assessed annually it is advised to centralize these examinations to high-volume centres. (C) 2018 Elsevier Inc. All rights reserved.

PURPOSE: To determine the long-term results of a Phase II trial of perioperative high-dose-rate brachytherapy (PHDRB) in primary advanced or recurrent gynecological cancer. METHODS AND MATERIALS: Fifty patients with locally advanced and recurrent gynecological cancer suitable for salvage surgery were included. Unirradiated patients (n = 25) received preoperative chemoradiation followed by surgery and PHDRB (16-24 Gy). Previously irradiated patients (n = 25) received surgery and PHDRB alone (32-40 Gy). RESULTS: Median followup was 11.5 years. Eight unirradiated patients (32%) developed Grade >= 3 toxic events including two fatal events. Local and locoregional control rates at 16 years were 87.3% and 78.9%, respectively. Sixteen-year disease-free and overall survival rates were 42.9% and 46.4%, respectively. Ten previously irradiated patients (40.0%) developed Grade >= 3 adverse events, including four fatal events. Local and locoregional control rates at 14 years were 59.6% and 42.6%, respectively. Fourteen-year disease-free and overall survival rates were 16.0% and 19.2%, respectively. CONCLUSIONS: PHDRB allows effective salvage of a subset of unfavorable gynecological tumors with high-risk surgical margins. Toxicity was unacceptable at the initial dose levels but deescalation resulted in the absence of severe toxicity without a negative impact on locoregional control. A substantial percentage of patients remain alive and controlled at >10 years including a few previously irradiated cases with positive margins. (C) 2018 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Purpose To evaluate the risk of endometrial cancer and/or endometrial hyperplasia with atypia in asymptomatic postmenopausal women with endometrial thickness >= 11 mm. Methods Results Systematic review of literature using database search (PubMed and Web of Science) of articles published between January 1990 and December 2016 evaluating the correlation between endometrial thickness as measured by transvaginal ultrasound (double layer) and histopathological findings in asymptomatic postmenopausal women, using the following terms: "endometrial thickness," "postmenopausal," "postmenopause," and "asymptomatic." Inclusion criteria were prospective or retrospective studies of more than 150 cases that provided information on endometrial thickness and its correlation with histopathological data. Studies that included patients with hormone replacement therapy, tamoxifen, or aromatase inhibitors were excluded. The overall relative risk (RR) for EC/EHA was calculated, stratifying the patients into two groups according to endometrial thickness (<11 mm and >= 11 mm). Heterogeneity was assessed by calculating I-2. The search identified 289 studies. After exclusions, nine articles that met all the inclusion criteria were included, comprising data from 4751 women. The prevalence of endometrial cancer and/or endometrial hyperplasia with atypia was 2.4%. The relative risk of endometrial cancer and/or endometrial hyperplasia with atypia in the >= 11 mm group was 2.59 (95% CI: 1.66-4.05). High heterogeneity was observed between studies (I-2: 57.3%, P = .016). Conclusions Overall the risk for EC/EHA was 2.6 times greater in women with ET >= 11 mm vs women with ET 5-10 mm, although there was significant heterogeneity in estimates across studies.

Objective To describe the sonographic features of endometrial cancer in relation to tumor stage, grade and histological type, using the International Endometrial Tumor Analysis (IETA) terminology. Methods This was a prospective multicenter study of 1714 women with biopsy-confirmed endometrial cancer undergoing standardized transvaginal grayscale and Doppler ultrasound examination according to the IETA study protocol, by experienced ultrasound examiners using high-end ultrasound equipment. Clinical and sonographic data were entered into a web-based database. We assessed how strongly sonographic characteristics, according to IETA, were associated with outcome at hysterectomy, i.e. tumor stage, grade and histological type, using univariable logistic regression and the c-statistic. Results In total, 1538 women were included in the final analysis. Median age was 65 (range, 27-98) years, median body mass index was 28.4 (range 16-67) kg/m(2), 1377 (89.5%) women were postmenopausal and 1296 (84.3%) reported abnormal vaginal bleeding. Grayscale and color Doppler features varied according to grade and stage of tumor. High-risk tumors, compared with low-risk tumors, were less likely to have regular endometrial-myometrial junction (difference of -23%; 95% CI, -27 to -18%), were larger (mean endometrial thickness; difference of +9%; 95% CI, +8 to +11%), and were more likely to have non-uniform echogenicity (difference of +7%; 95% CI, +1 to +13%), a multiple, multifocal vessel pattern (difference of +21%; 95% CI, +16 to +26%) and a moderate or high color score (difference of +22%; 95% CI, +18 to +27%). Conclusion Grayscale and color Doppler sonographic features are associated with grade and stage of tumor, and differ between high- and low-risk endometrial cancer. Copyright (c) 2017 ISUOG. Published by John Wiley & Sons Ltd.

OBJECTIVE: To compare the uterine transverse diameter (UTD) in women with normal uteri and women with uterine canalization defects as well as to assess its performance for ruling out such defects. STUDY DESIGN: Retrospective analysis of prospectively collected data in a series of selected women with primary or secondary infertility. Measurement of UTD and 3D volume acquisition subsequent off-line analysis was performed in order to identify possible canalization defects. UTD of the normal uterus, measured by 2D ultrasound, was compared to that of arcuate, subseptate, and septate uteri. ROC curve was plotted to determine the best UTD cutoff for differentiating normal from abnormal uteri. RESULTS: A total of 421 women were ultimately evaluated. UTD was significantly larger in women with (53.3 mm, SD 6.3, p <0.05), subseptate (55.0 mm, SD 6.7, p <0.05), and septate (56.0 mm, SD 4.8, <0.05) uterus as compared with the normal uterus (45.9 mm, SD 7.1). ROC curve showed that the best UTD cutoff for ruling out the presence of a uterine canalization defect was 45 mm (AUC 0.809, 95% CI 0;768-0.849). CONCLUSION: Measurement of UTD may be a simple and practical method for ruling out a uterine canalization defect in infertile women.

Objective: To compare clinical and sonographic features of benign, borderline, and malignant invasive mucinous ovarian tumors (MOTs). Materials and Methods: Retrospective observational multicenter study comprising 365 women (mean age: 46.1 years) with a histologically confirmed benign, borderline or malignant invasive MOT. Clinical data (patient's age, patient's complaints), tumor markers (CA-125 and CA-19.9), and sonographic data (tumor size, bilaterality, morphology unilocular, multilocular, unilocular-solid, multilocular-solid and solid-, and IOTA color score) were reviewed and compared among these three groups. Women with ultrasound evidence on intra-abdominal disease spread were excluded. Results: Three hundred seventy-eight MOTs (14 women had bilateral lesions) were analyzed. Histologically, 287 tumors were benign, 51 were borderline, and 40 were malignant. No difference in patient's mean age was observed. Women with borderline or invasive tumors were less frequently asymptomatic. Tumors were larger in case of invasive lesions. Borderline and invasive tumors showed solid components and exhibited IOTA color score 3 or 4, more frequently than benign lesions (p < 0.001). However, the authors discovered that 16 out of 51 (31.4%) of borderline tumors and six out of 40 (15.0%) of invasive cancers had no solid components and a color score 1 or 2, and were considered as a benign lesion by the sonologist. On the other hand, 96 out of 287 (33.4%) benign mucinous cystadenoma exhibited solid components and/or a color score of 3 or 4. Conclusions: In spite of statistical differences, the authors observed significant overlapping in ultrasound features among benign, borderline, and invasive ovarian mucinous tumors that renders a difficult accurate preoperative discrimination among these lesions.

OBJECTIVE: To assess the natural history of ultrasonographically diagnosed benign ovarian teratomas in asymptomatic women. METHODS: We conducted a retrospective observational cohort study of 408 women (mean age 36.6 years, range 14-81 years) diagnosed as having an ovarian teratoma by transvaginal ultrasonography (except eight who only had a transabdominal study done) between January 2003 and December 2013 at a single tertiary care institution. Six hundred thirteen women were diagnosed with ovarian teratoma of whom 205 were promptly treated surgically, leaving 408 patients followed conservatively with follow-up scans at 3 and 6 months from diagnosis and then yearly. The ultrasonographic diagnosis of a benign ovarian teratoma required at least one of the following features: a cystic mass with mixed echogenicity, thick band-like echoes, a fat-fluid level, or echogenic tubercle with posterior shadowing. Clinical, ultrasonographic, and histologic data (in case of surgery) were retrieved for analysis. RESULTS: During follow-up, 130 of 408 (31.8%) women underwent surgery. The main reason for surgery was the physician's recommendation according to our protocol (n=115). One patient had adnexal torsion. Most surgeries (112/130 [86.2%]) were performed within the first 5 years after diagnosis. The remainder (278/408) is still being followed (median time 45.6 months, range 6-147 months). The vast majority of these lesions had no change and women remain asymptomatic. Histologic diagnosis of tumors removed surgically revealed a benign ovarian teratoma in 103 of 130 (79.2%) of the women. There were two borderline tumors, four endometriomas, three fibromas, seven serous cysts, two mucinous cysts, two stroma ovarii, seven other benign, and no case of malignant tumor. CONCLUSION: Our results demonstrate that expectant management might be a reasonable option for managing asymptomatic women who receive a ultrasonographic diagnosis of a benign ovarian teratoma. The risk of undergoing surgery for this lesion decreases significantly after 5 years to follow-up. With careful observation, the risk of missing a diagnosis of malignancy is low.

Objective: To assess the natural history of benign appearing purely solid ovarian lesions in asymptomatic postmenopausal women. Methods: Retrospective observational cohort study comprising 99 women (mean age, 58.2 years, ranging from 50 to 77 years) diagnosed as having a purely solid ovarian lesion at transvaginal ultrasound between April 2001 and October 2015. Inclusion criteria were as follows: asymptomatic postmenopausal women with a well-defined purely solid ovarian lesion with International Ovarian Tumor Analysis color score 1 or 2, without ascites and/or signs of carcinomatosis. Clinical, sonographic, biochemical (CA-125), and histologic data (in case of surgery) were retrieved for analysis. Patients who were managed conservatively were assessed by transvaginal sonography every 6 months for a minimum of a year. In case of bilateral lesions we used the largest one for analysis. Results: Five women (5.1%) had bilateral lesions. Mean size of the lesion was 2.9cm (range, 1.0-7.8 cm). Most lesions were homogeneous (96.0%). Acoustic shadowing was present in 59.6% of cases. International Ovarian Tumor Analysis color score was 1 in 77.8% and 2 in 22.2% of the cases, respectively. Median CA-125 was 10.8 IU/mL (range, 3.0-403.0 IU/mL). Forty-two women underwent surgery after diagnosis (histologic diagnoses were as follows: fibroma (n = 26), fibrothecoma (n = 5), dermoid (n = 3), Brenner tumor (n = 3), endometrioma (n = 2), thecoma (n = 1), primary invasive cancer (n = 2). One case of invasive cancer CA-125 was 403.0 IU/mL and in the other case CA-125 was 6.0 IU/mL. They both were stage 1. Fifty-seven women were managed with serial follow-up. With a median follow-up time of 36 months (range, 12-142 months) all these lesions had no change and women remain asymptomatic. Considering all 99 cases the risk of malignancy is 2% (95% CI, 0.1-7.5). Conclusions: The risk of malignancy of benign appearing purely solid adnexal masses in asymptomatic postmenopausal women is low. Conservative management of these lesions might be an option.

ObjectivesTo estimate intraobserver and interobserver reproducibility for assigning an International Endometrial Tumor Analysis (IETA) group color score for endometrial vascularization on color Doppler imaging. MethodsSixty-eight endometrial 3-dimensional volumes from endometrial color Doppler assessments of women with different endometrial disorders were evaluated by 8 different examiners (4 skilled examiners and 4 obstetric and gynecologic trainees). One skilled examiner who did not participate in the assessments selected the 68 volumes from a database to select a balanced number of each IETA score. Each examiner evaluated the 68 endometrial volumes to assign the IETA color score (1, absence of vascularization; 2, low vascularization; 3, moderate vascularization; or 4, abundant vascularization) using tomographic ultrasound imaging. The analysis was repeated 4 weeks later, and interobserver and intraobserver reproducibility was analyzed by calculating the weighted index. The second of the measurements made by each observer was used to estimate interobserver reproducibility. ResultsThe intraobserver reproducibility was very good for all examiners, with a weighted index ranging from 0.84 to 0.91. The interobserver reproducibility was good or very good for all estimated comparisons, with a weighted index ranging from 0.77 to 0.96, regardless of experience level. ConclusionsThe reproducibility of assigning the IETA color score for assessing endometrial vascularization using 3-dimensional volumes is good or very good regardless of the experience of the examiner.

Objective: To evaluate the utility of transvaginal ultrasound-guided thrombin injection (UGTI) to treat uterine artery pseudoaneurysms (UAPs) as an alternative to emergency arterial embolization. Methods: Two females presenting with heavy vaginal bleeding were diagnosed with UAPs by pelvic CT scan. After UAP identification by transvaginal ultrasound, 2 cm3 of thrombin (Tissucol®; Baxter Healthcare Corporation, Munich, Germany) was slowly injected into the UAPs using a 30-cm long 22-gauge needle through a needle guide attached to the vaginal probe. The same procedure was performed in both cases, and the Doppler sign disappeared immediately and the bleeding stopped. Results: We describe two cases of UAPs treated with transvaginal UGTI: one after intrauterine tandem and vaginal colpostat insertion for brachytherapy after diagnosis of cervical cancer (Case 1) and the other after the insertion of a levonorgestrel-releasing intrauterine device (Case 2). Conclusion: Transvaginal UGTI could be a minimally invasive tool to treat selected cases of UAPs with severe vaginal bleeding. Advances in knowledge: Transvaginal UGTI could avoid the need for uterine embolization and emergency hysterectomy in selected cases of UAPs diagnosed by CT scan.

OBJECTIVE: To compare diagnostic performance of preoperative transvaginal ultrasound (TVS) and intraoperative macroscopic examination for determining myometrial infiltration in women with low-risk endometrial cancer, and to estimate the agreement between the two methods. METHODS: This was a single-center observational study comprising women with preoperative diagnosis of well- or moderately differentiated endometrioid carcinoma of the endometrium. All women underwent preoperative TVS by a single examiner. According to the examiner's subjective impression, myometrial infiltration was stated as¿¿¿50% or¿<¿50%. Surgical staging was performed in all cases. Intraoperative macroscopic examination of the removed uterus was performed by pathologists who were unaware of the ultrasound findings, and myometrial infiltration was stated as¿¿¿50% or¿<¿50%. Definitive histological diagnosis of myometrial infiltration was made by frozen section analysis and was used as the gold standard. Sensitivity and specificity with 95% CIs were calculated for TVS and intraoperative macroscopic inspection and compared using McNemar's test. Agreement between TVS and intraoperative macroscopic inspection was estimated using Cohen's kappa index (¿) and percentage of agreement. RESULTS: Of 209 eligible women, 152 were ultimately included. Mean (±¿SD) age was 60.9¿±¿10.2¿years, with a range of 32-91¿years. Definitive histological diagnosis revealed that myometrial infiltration was <¿50% in 114 women and ¿¿50% in 38 women. Sensitivity and specificity of TVS for detecting deep myometrial infiltration were 81.6% and 89.5%, respectively, whereas the respective values for intraoperative macroscopic examination were 78.9% and 90.4% (McNemar's test, P¿>¿0.05 when comparing TVS and intraoperative macroscopic examination). Agreement between methods was moderate with ¿¿=¿0.54 (95%¿CI, 0.39-0.69) and percentage of agreement of 82%. CONCLUSIONS: Although the agreement between preoperative TVS and intraoperative macroscopic examination for detecting deep myometrial infiltration was only moderate, both methods had similar accuracy when compared with frozen section histology. Preoperative TVS might reasonably be proposed as a method for assessing myometrial infiltration as an alternative to intraoperative macroscopic examination, especially when performed by an experienced examiner and image quality is not poor.

Objective To assess the diagnostic performance of a three-step strategy proposed by the International Ovarian Tumor Analysis (IOTA) Group for discriminating between benign and malignant adnexal masses. Methods This was a prospective observational study, performed at two tertiary-care university hospitals, of women diagnosed with an adnexal mass on transvaginal or transabdominal ultrasound between December 2012 and December 2014. Women were scheduled for an ultrasound evaluation, which was initially performed by non-expert examiners. The examiner had to classify the mass using `simple descriptors¿ (first step) and, if not possible, using `simple rules¿ (second step). For inconclusive masses, an expert examiner classified the mass according to their subjective impression (third step). Masses were managed expectantly, with serial follow-up examinations, or surgically, according to ultrasound findings and clinical symptoms. Histology was used as the reference standard. Masses that were managed expectantly with at least 1 year of follow-up were considered as benign for analytical purposes. Women with less than 1 year of follow-up were not included in the study. Results Six hundred and sixty-six women were included (median age, 41 (range, 18¿81)¿years) of whom 514 were premenopausal and 152 were postmenopausal. Based on the three-step strategy, 362 women had surgical removal of the mass (53 malignant and 309 benign), 71 masses resolved spontaneously and 233 persisted. Four hundred and forty-eight (67.3%) of 666 masses could be classified using simple descriptors and, of the 218 that could not, 147 (67.4%) were classified using simple rules. Of the remaining 71 masses, the expert examiner classified 45 as benign, 12 as malignant and 14 as uncertain. Overall sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of the three-step strategy were 94.3%, 94.9%, 18.6 and 0.06, respectively. Conclusion The IOTA three-step strategy, based on the sequential use of simple descriptors, simple rules and expert evaluation, performs well for classifying adnexal masses as benign or malignant.

Objectives-To evaluate the agreement of clinical examination, 2-dimensional (2D) sonography, and 3-dimensional (3D) sonography with magnetic resonance imaging (MRI) for local staging of cervical cancer. Methods-We conducted a prospective study including women with a diagnosis of carcinoma of the cervix. All women were staged clinically and underwent 2D and 3D transvaginal sonography and MRI before treatment for assessing tumor size and parametrial, bladder, and rectal involvement using the examiner's subjective impression. Agreement between sonography and MRI was assessed by calculating the. index and percentage of agreement. Results-Forty women were included (mean age +/- SD, 46.6 +/- 11.4 years). Eleven had early-stage (IA and IB1) disease, and 29 had advanced-stage (IB2-IVB) disease. A significant correlation for tumor size estimation was found between MRI and pelvic examination (r = 0.754; P < .001), MRI and 2D sonography (r = 0.649; P < .001), and MRI and 3D sonography (r = 0.657; P<.001). Agreement for parametrial infiltration between MRI and pelvic examination was fair (kappa = 0.26; 95% confidence interval [CI], 0.10-0.54; 62.5% agreement), between MRI and 2D sonography was moderate (kappa = 0.41; 95% CI, 0.15-0.66; 70.0% agreement), and between MRI and 3D sonography was good (kappa = 0.60; 95% CI, 0.35-0.85; 80.0% agreement). Agreement for bladder involvement between MRI and pelvic examination was moderate (kappa = 0.48; 95% CI, 0.10-0.99; 95.0% agreement), between MRI and 2D sonography was moderate (kappa = 0.48; 95% CI, 0.10-0.99; 95.0% agreement), and between MRI and 3D sonography was very good (kappa = 0.84; 95% CI, 0.55-1.0; 97.5% agreement). Agreement for rectal involvement was not calculated because of the very small number of cases. Conclusions-Three-dimensional sonography showed good agreement with MRI for assessing parametrial infiltration and bladder involvement in cervical cancer.

The discrimination between benign and malignant adnexal masses in ultrasound images represents one of the most challenging problems in gynecologic practice. In the study described here, a new method for automatic discrimination of adnexal masses based on a neural networks approach was tested. The proposed method first calculates seven different types of characteristics (local binary pattern, fractal dimension, entropy, invariant moments, gray level co-occurrence matrix, law texture energy and Gabor wavelet) from ultrasound images of the ovary, from which several features are extracted and collected together with the clinical patient age. The proposed technique was validated using 106 benign and 39 malignant images obtained from 145 patients, corresponding to its probability of appearance in general population. On evaluation of the classifier, an accuracy of 98.78%, sensitivity of 98.50%, specificity of 98.90% and area under the curve of 0.997 were calculated.

Fundamento. La validación externa de un modelo predictivo de predicción de preeclampsia tardía en un centro de bajo volumen obstétrico en gestantes de bajo riesgo obstétrico. Métodos. Estudio prospectivo de 174 gestaciones únicas de 11+0 a 13+6 semanas de gestación en la Clínica Universidad de Navarra desde septiembre 2011 a marzo de 2013, que fue considerado como una cohorte de validación de un modelo descrito anteriormente para preeclampsia tardía en el hospital Clínic de Barcelona). Resultados: Un total de 7 (4%) mujeres desarrollaron PE tardía. En la cohorte de validación el área bajo la curva del modelo fue de 0,69 (IC del 95% 0,45 a 0,93). Las tasas de detección para un 5, 10 y 15% de tasas de falsos positivos fueron 21,9, 31,4 y 38,6%. Al comparar las áreas bajo la curva de la cohorte de validación con la cohorte de la construcción, no se encontraron diferencias estadísticamente significativas (p = 0,68). Conclusión. La combinación de la historia clínica materna, la proteína placentaria A-asociada al embarazo y presión arterial media es moderadamente útil para predecir preeclampsia tardía en gestantes de bajo riesgo y en un centro de bajo volumen obstétrico. El modelo predictivo del hospital Clinic de Barcelona es una herramienta válida para predecir preeclampsia tardía en este entorno.

Levator avulsion is associated with lower manometric squeeze pressure (p¿=¿0.032).

ObjectiveTo evaluate the contribution of three-dimensional (3D) power Doppler angiography (3D-PDA) to the differential diagnosis of adnexal masses. MethodsThis was a prospective study in women diagnosed with a persistent adnexal mass and subsequently scheduled for surgery in a tertiary university hospital. All women were evaluated by transvaginal/transrectal ultrasound according to a predetermined three-step protocol, with transabdominal ultrasound being performed in some cases. First, morphological evaluation of the mass was performed using gray-scale pattern recognition' (first step). Lesions diagnosed as having a benign pattern were considered as being at low risk of malignancy whereas tumors with solid components, ascites and/or signs of carcinomatosis were considered as being at high risk of malignancy. In both cases no further test was performed and a decision regarding clinical management, either for follow-up or surgery, was taken. Tumors with solid components but without signs of ascites or carcinomatosis were considered as being at intermediate risk of malignancy. These lesions were assessed by two-dimensional (2D) PDA to evaluate tumor vascularity (color score) (second step). Solid tumors with a color score of 1 or 2 were considered as benign and no further test was performed, while tumors with a color score of 2, 3 or 4 within solid components or a color score of 3 or 4 in the case of a solid tumor were considered as malignant. The latter group underwent 3D-PDA a

Introduction: Simulation enables medical students to practice clinical skills in a safe environment. Graduates in medicine must be able to correctly perform an examination on a pregnant woman using Leopold maneuvers. Learning curves-cumulative summation (LC-CUSUM) may help determine when the student has achieved a specific skill. Our objective was to perform the LC-CUSUM test regarding the ability of students to correctly carry out Leopold maneuvers; a pregnancy simulator was used, transferring the results to a clinical setting. Methods: Five medical students were trained to carry out Leopold maneuvers using the simulator. Each student performed maneuvers for 50 cases of different fetus positions; a LC-CUSUM was plotted for each student. Afterward, the students performed the Leopold maneuvers on 5 pregnant women. Results: Of the 5 students, 3 achieved a level of proficiency; the attempts needed for reaching this level were 13, 13, and 37, respectively. The other 2 students did not reach proficiency level. Of the students who became successfully proficient with the simulator, one of them attained a 100% success rate in pregnant patients, whereas the other two had success rates of 80%. The students who did not achieve a level of competency with the simulator had only a 60% success rate with patients. Conclusions: Because of the differences observed between students in the number of attempts needed for achieving proficiency in Leopold maneuvers, we believe that each student should build his/her own learning curve. Achieving competency in carrying out Leopold maneuvers using the simulator could be transferable to patients. Copyright © 2015 by the Society for Simulation in Healthcare.

Objetivo Diseñar una técnica novedosa de adquisición ex-vivo para establecer un marco común de validación de diferentes técnicas de segmentación para imágenes PET oncológicas. Evaluar sobre estas imágenes el funcionamiento de varios algoritmos de segmentación automática. Material y métodos En 15 pacientes oncológicos se realizaron estudios PET ex-vivo de las piezas quirúrgicas extraídas durante la cirugía, previa inyección de 18F-FDG, adquiriéndose imágenes en 2 tomógrafos: un PET/CT clínico y un tomógrafo PET de alta resolución. Se determinó el volumen tumoral real en cada paciente, generándose una imagen de referencia para la segmentación de cada tumor. Las imágenes se segmentaron con 12 algoritmos automáticos y con un método estándar para PET (umbral relativo del 42%) y se evaluaron los resultados mediante parámetros cuantitativos. Resultados La segmentación de imágenes PET de piezas quirúrgicas ha demostrado que para imágenes PET de alta resolución 8 de las 12 técnicas de segmentación evaluadas superan al método estándar del 42%. Sin embargo, ninguno de los algoritmos superó al método estándar en las imágenes procedentes del PET/CT clínico. Debido al gran interés de este conjunto de imágenes PET, todos los estudios se han publicado a través de Internet con el fin de servir de marco común de validación y comparación de diferentes técnicas de segmentación. Conclusiones Se ha propuesto una técnica novedosa para validar técnicas de segmentación para imágenes PET oncológicas, adquiriéndose estudios ex-vivo de piezas quirúrgicas. Se ha demostrado la utilidad de este conjunto de imágenes PET mediante la evaluación de varios algoritmos automáticos.

To determine the degree of confidence of students regarding obstetric examination before and after training with simulators, and assess their satisfaction with the use of simulation as a tool for acquiring skills. METHODS:Training groups involved 10 students per lecturer. Students learned how to perform Leopold's manoeuvres and measure uterine height with a simulator. The instructor supervised each physical exam. Surveys by those students who had previously done an internship at the Department of Obstetric & Gynecology were not taken into account. RESULTS:Students' confidence in performing the procedures improved significantly (p¿0.001) after the intervention.

The diagnosis rate of deep pelvic endometriosis is increasing. Endometrial stromal sarcoma (ESS) is a rare neoplasm. Extragenital ESS is an extremely uncommon event. Very few cases of extragenital ESS have been reported to date. The diagnosis of this entity is very difficult in some instances. Knowledge about its management is also limited. In this paper, we review the current literature on the clinical management, histology, immunohistochemistry, treatment and outcome of ESS arising in pelvic endometriosis.

Three-dimensional ultrasound is an imaging technique that is being introduced into clinical practice in several medical specialties. Although this technique is unlikely to replace the two-dimensional ultrasound, its role as a diagnostic tool is being explored. In fact, in the field of gynecology there has been a steady increase in the number of papers published in the last few years. These applications include: imaging the uterus, uterine cavity, adnexa, and pelvic floor as well as reproductive medicine, such as the prediction of IVF success or ovarian hyperstimulation syndrome. The aim of this paper is to review the current status of three-dimensional ultrasound in clinical practice in gynecology.

Off-line 3D volume analysis may be a useful method for assessing adnexal masses, showing a good agreement with real-time ultrasound and having a similar diagnostic performance.

Cancer antigen 125 screening does not add useful information for specific diagnosis of benign adnexal tumors, except for endometrioma. An elevated CA-125 level significantly increases the probability of such a lesion..

To assess the clinical usefulness of a structured reporting system based on ultrasound findings for management of adnexal masses. Methods This was a prospective multicenter study comprising 432 adnexalmasses in 372 women (mean age, 44.0 (range, 13¿78) yea

The mode of delivery does not affect survival. Cesarean section provides lower morbidity and better prognosis for neurodevelopment long-term outcome in ELBW infants.

To assess whether the analysis of cyst content using mean gray value (MGV) can discriminate ovarian endometriomas from other unilocular ovarian cysts in premenopausal women.

Objective: To estimate the diagnostic value of transvaginal ultrasonography in the detection of pelvic adhesions in women suspected of having endometriomas at ultrasonography. Design: Prospective observational study. Setting: Academic Department of Obstetrics and Gynecology. Patient(s): One hundred thirteen women who underwent surgery for an endometrioma. Intervention(s): All patients underwent transvaginal ultrasonography before surgery, and at ultrasonography the presence of fixation of the ovary to the uterus was considered characteristic of the presence of pelvic adhesions. Main Outcome Measure(s): Sensitivity, specificity, and likelihood ratios were calculated with 95% confidence intervals (CIs). Result(s): The sensitivity and specificity of the fixation to the uterus of at least one ovary were respectively 89% (95% CI 84%-92%) and 90% (95% CI 76%-97%). The likelihood ratio for fixation of at least one ovary to the uterus was 8.92 (95% CI 3.04-26) and for a "normal" ultrasound examination 0.12 (95% CI 0.06-0.23). The pretest probability of pelvic adhesions was 74%, and this probability increased to 96% when fixation of at least one ovary to the uterus was present and fell to 27% when this ultrasonographic finding was absent. Conclusion(s): Transvaginal ultrasonography seems to be able to detect or exclude the presence of adhesions in women with ultrasonographic suspicion of endometrioma.

Objective: To assess whether, when using spherical sampling with Virtual Organ Computer-Aided Analysis (VOCAL) for calculating three-dimensional (3D) power Doppler angiography (PDA) indices, the sphere volume affects performance in the prediction of malignancy in vascularized cystic-solid or solid adnexal masses. Methods: One hundred and thirty-eight women (mean +/- SD age, 51.8 +/- 14.1 years) diagnosed as having vascularized cystic-solid or solid adnexal masses on B-mode and two-dimensional (2D) power Doppler ultrasound were evaluated by 3D-PDA prior to surgery. Five women had bilateral masses, giving a total number of 143 masses analyzed. Vascularization was assessed using VOCAL software. 3D-PDA vascular indices (vascularization index (VI), flow index (FI) and vascularization flow index (VFI)) from the most vascularized area within papillary projections and solid areas were calculated automatically using spherical sampling. Five different volumes of sphere were used (1 cm(3), 2 cm(3), 3 cm(3), 4 cm(3) and 5 cm(3)) in each case. A definitive histological diagnosis was obtained in each case after surgical tumor removal. Results: One hundred and seventeen (82%) masses were malignant and 26 (18%) were benign. Morphological evaluation revealed 34 (24%) unilocular solid masses, 49 (34%) multilocular solid masses and 60 (42%) mostly solid masses. The 1-cm(3) sphere could be used in 100% of the cases, the 2-cm(3) sphere could be used in 98.2% of the cases and the 3-5-cm(3) spheres could be used in 97.2% of the cases. The median VI, FI and VFI for all sphere volumes were significantly higher in malignant compared with non-malignant tumors. Receiver-operating characteristics curve analysis showed that VI and VFI, independently of sphere volume, were better predictors of malignancy than was FI. The best cut-off values for the 3D-PDA indices differed depending on sphere volume. VI was significantly more specific than were VFI and FI. Conclusions: Sphere volume does not affect the performance of 3D-PDA. We recommend the use of different cut-off values for 3D-PDA indices for discriminating between benign and malignant adnexal masses, depending on the sphere volume used. Use of VI is preferable due to its higher specificity.

Objective: To determine whether interleukin-8 (IL-8) serum levels are correlated with pelvic pain in patients with ovarian endometriomas. Design: Prospective study. Setting: Tertiary-care university hospital. Patient(s): Interleukin-8 serum levels were prospectively analyzed in 51 patients (group A, asymptomatic patients or patients with mild dysmenorrhea; group B, severe dysmenorrhea and/or chronic pelvic pain and/or dyspareunia) who underwent surgery for cystic ovarian endometriosis to asses whether a correlation exists between IL-8 serum levels and pelvic pain. Intervention(s): Interleukin-8 serum levels determination. Main Outcome Measure(s): Interleukin-8 serum levels and pelvic pain. Result(s): From 56 patients, five cases were ultimateley excluded because the histologic diagnosis was not cystic ovarian endometriosis (2 teratomas and 3 haemorragic cysts). The mean (+/- SD) IL-8 serum levels in group A were 6.41 +/- 12.17 pg/mL and in group B were 6.52 +/- 8.73 pg/mL. Conclusion(s): Pain symptoms in ovarian endometriosis is not correlated with IL-8 serum levels.

Objective (1) To determine the accuracy of a standard clinical and radiological assessment of resectability in patients with previously irradiated recurrent cervical cancer (PIRCC), and (2) to report the outcome and prognostic factors in this high-risk population treated with an exenterative procedure. Methods Forty-eight patients with centrally located (n=20, 41.7%) or lateralized (n=28, 58.3%) PIRCC treated with exenterative procedures were analyzed. All patients underwent standard assessment of resectability with pelvic exam and radiological studies. Patients with centrally located tumors were considered as resectable and lateralized tumors were deemed unresectable. Results Complete surgical resection with negative margins (R0) was achieved in 28.6% of the patients with lateral recurrences and in 65.0% of the patients with central recurrences (p<0.019). After a median follow-up of 114.6 months (3.0¿244.9 months), the 10-year local control rate for the whole group was 36.3%, 43.1% in the central PIRCC group and 31.5% in the lateral PIRCC group, respectively (p=0.290). Multivariate analysis showed that improved local control was significantly associated with the presence of negative margins (p=0.004). The 10-year distant failure rate was 69%, 56.6% in the central PIRCC group and 83.2% in the lateral PIRCC group (p=0.178), respectively. Multivariate analysis showed that the development of distant metastases was significantly correlated with the absence of local control (p=0.01). The 10-year disease-specific survival (DSS) for central and lateral PIRCC was 27.2% and 14.9%, respectively (p=0.239). Multivariate analysis showed that negative margins (p=0.001), local control (p=0.001) and distant control (p=0.006) were all significantly associated with improved DSS. Location of PIRCC (central vs. lateral) was irrelevant for DSS in completely resected (R0) patients. Overall morbidity rate was 65.0% and 73.3% for central and lateral PIRCC patients, respectively (p=0.528). Conclusion About one-third of the patients with lateral PIRCC classified as unresectable with non-surgical means may ultimately undergo complete (R0) resections and about one-third of the patients with centrally located PIRCC and judged as resectable will undergo non-curative (R1) resections. A curative (R0) resection significantly impacts local control rates, distant metastases-free rates and DSS.

Objective To assess the correlation between intratumoral vascularization using three-dimensional power Doppler angiography (3D-PDA) and several histological tumor characteristics in a series of patients with endometrial carcinoma. Methods Ninety-nine women (mean age, 61.7 (range, 31-84) years) diagnosed as having endometrial cancer were assessed by transvaginal 3D-PDA before surgical staging. Endometrial volume (E V,) and 3D-PDA vascular indices (vascularization index (VI), flow index (FI) and vascularization flow index (VFI)) were calculated using the Virtual Organ Computer-aided AnaLysis (VOCAL (TM)) method. All patients were surgically staged. Individual tumor features such as histological type, tumor grade, myometrial infiltration depth, lymph-vascular space involvement, cervical involvement, lymph node metastases and tumor stage were considered for analysis. Multivariate logistic regression (MLR) analysis was used to determine which 3D-PDA parameters were independently associated with each histological characteristic. Results MLR analysis showed that only EV and VI were independently associated with myometrial infiltration (EV: odds ratio (OR), 1.119 (95% CI, 1.025-1.221), P = 0.012; VI: OR, 1.127 (95% CI, 1.063-1.195), P = 0.001) and tumor stage (EV: OR, 1.103 (95% CI, 1.012-1.202), P = 0.025; VI: OR, 1.120 (95% CI, 1.057-1.187), P = 0.001), only VI was independently associated with tumor grade (OR, 1.056 (95% CI, 1.023-1.091), P = 0.001) and only EV was independently associated with lymph node metastases (OR, 1.086 (95% CI, 1.017-1.161), P = 0.001). Conclusion 3D-PDA analysis of tumor vascularization in endometrial cancer correlates with some prognostic histological characteristics.

Objective: The purpose of this study was to determine whether there are differences in 3-dimensional (3D) vascular indices when calculated using high-definition flow imaging (HDF) and power Doppler imaging (PD). Methods: Twenty-five consecutive asymptomatic premenopausal women (mean age, 31 years; range, 28-33 years) without a history of gynecologic disease who attended routine gynecologic checkups were included in the study. All women had regular menstrual cycles, and none had uterine or myometrial disease detected on basal transvaginal sonography. All women underwent 3D transvaginal sonography. In each patient, a first volume using conventional PD was obtained, immediately followed by a second volume using HDF. Volumes were stored and subsequently analyzed for calculating 3D vascular indices (vascularization index [VI], flow index [FI], and vascularization-flow index [VFI]) from the endometrium. Results: The median VI, FI, and VFI were significantly higher when calculated using HDF compared with conventional PD (P < .05). Conclusions: Three-dimensional vascular indices calculated using HDF are higher than those calculated using conventional PD.

Introduction: The aim of the study was to compare the diagnostic accuracy of grayscale sonography and that of color Doppler imaging in the diagnosis of ovarian malignancy in a prospective study by the Sardinia-Navarra group. Methods: The study was performed as a collaborative work at the 2 European university departments of obstetrics and gynecology between 1997 and 2007. A total of 2148 pelvic masses in 1997 women on whom transvaginal sonography were performed before surgical exploration were included in the study. An adnexal mass was first studied in grayscale sonography, and any cystic mass in which the echo architecture was not suggestive of benign tumor was categorized as malignant. Second, any solid excrescences or solid portions of the tumor were evaluated with color/power Doppler sonography. A mass was graded malignant if flow was shown within the excrescences or the solid areas and benign if there was no flow or if flow was only peripheral. Results: Four hundred sixty-eight masses were malignant. Color Doppler evaluation was more accurate in the diagnosis of adnexal malignancies in comparison with grayscale sonography because of a significantly higher specificity (94% vs 89%, P - 0.001), with similar sensitivity (95% vs 98%, P = 0.44). The pretest probability of ovarian cancer was 22%, and this probability rose to 82% when the diagnosis was suggested by color Doppler evaluation. The diagnostic accuracy of the tests was also dependent on menopausal status. Conclusions: The evaluation of vessel distribution by color Doppler sonography in adnexal masses increases the diagnostic accuracy of grayscale sonography in the detection of adnexal malignancies in a large study population.

Objective: To evaluate whether tumor vascularity as assessed by 3-dimensional power Doppler angiography (3D-PDA) correlates with some tumor features in cervical cancer. Methods: Clinical, sonographic, and histologic data on 56 women (mean age, 47.8 years; range, 27-81 years) with a diagnosis of carcinoma in the uterine cervix were analyzed. Tumor volume and 3D-PDA indexes (vascularization index, flow index, and vascularization flow index) were calculated in all cases. These data were correlated with some tumoral features such as histologic type, histologic grade, lymphovascular space involvement, lymph node metastases, and tumor stage. Results: Intratumoral blood flow was found in all cases. No correlation was found between tumor volume and 3D-PDA indexes with histologic type, lymphovascular space involvement, and lymph node metastases. Moderately and poorly differentiated tumors and advanced-stage tumors had larger volume and 3D-PDA indexes (P < 0.05). Conclusions: Our data indicate that tumor vascularization as assessed by 3D-PDA correlates with some tumor features in cervical cancer.