N. Nunes

Inter‐ and intraobserver variability in three‐dimensional ultrasound assessment of the endometrial–myometrial junction and factors affecting its visualization

To assess the inter‐ and intraobserver variability of three‐dimensional (3D) ultrasound assessment of the endometrial–myometrial junction (EMJ), and to assess demographic and physiological factors that affect the quality of its imaging.

Use of IOTA simple rules for diagnosis of ovarian cancer: meta-analysis

To present data on prospective evaluation of the International Ovarian Tumor Analysis (IOTA) ‘simple‐rules’ tool for the diagnosis of ovarian cancer and to perform a meta‐analysis of studies that utilized the same diagnostic method.

A Prospective Validation of the IOTA Logistic Regression Models (LR1 and LR2) in Comparison to Subjective Pattern Recognition for the Diagnosis of Ovarian Cancer

Objectives This study aimed to assess the accuracy of the International Ovarian Tumour Analysis (IOTA) logistic regression models (LR1 and LR2) and that of subjective pattern recognition (PR) for the diagnosis of ovarian cancer. Methods and Materials This was a prospective single-center study in a general gynecology unit of a tertiary hospital during 33 months. There were 292 consecutive women who underwent surgery after an ultrasound diagnosis of an adnexal tumor. All examinations were by a single level 2 ultrasound operator, according to the IOTA guidelines. The malignancy likelihood was calculated using the IOTA LR1 and LR2. The women were then examined separately by an expert operator using subjective PR. These were compared to operative findings and histology. The sensitivity, specificity, area under the curve (AUC), and accuracy of the 3 methods were calculated and compared. Results The AUCs for LR1 and LR2 were 0.94 [95% confidence interval (CI), 0.92–0.97] and 0.93 (95% CI, 0.90–0.96), respectively. Subjective PR gave a positive likelihood ratio (LR+ve) of 13.9 (95% CI, 7.84–24.6) and a LR−ve of 0.049 (95% CI, 0.022–0.107). The corresponding LR+ve and LR−ve for LR1 were 3.33 (95% CI, 2.85–3.55) and 0.03 (95% CI, 0.01–0.10), and for LR2 were 3.58 (95% CI, 2.77–4.63) and 0.052 (95% CI, 0.022–0.123). The accuracy of PR was 0.942 (95% CI, 0.908–0.966), which was significantly higher when compared with 0.829 (95% CI, 0.781–0.870) for LR1 and 0.836 (95% CI, 0.788–0.872) for LR2 (P < 0.001). Conclusions The AUC of the IOTA LR1 and LR2 were similar in nonexpert’s hands when compared to the original and validation IOTA studies. The PR method was the more accurate test to diagnose ovarian cancer than either of the IOTA models.

Endometrial cancer and ultrasound: why measuring endometrial thickness is sometimes not enough

Endometrial cancer is the commonest cancer of the female genital tract in the developed world. Ultrasound measurement of endometrial thickness is commonly used to triage patients with postmenopausal bleeding for histological sampling. The sensitivity of ultrasound in diagnosing endometrial cancer is high, but it has a small, well‐defined false‐negative rate. In this report we describe two cases, with histological confirmation, of postmenopausal women without any vaginal bleeding, who were subsequently diagnosed with advanced endometrial cancer. They were found to have a thin, normal endometrium on ultrasound. In both cases, histological examination was suggestive of endometrial cancer originating from foci of adenomyosis. These findings suggest that a proportion of the false‐negative diagnoses of endometrial cancer on ultrasound could be caused by the disease being confined to the myometrium rather than as a result of suboptimal performance of ultrasound examination. Copyright

A randomised controlled trial comparing surgical intervention rates between two protocols for the management of asymptomatic adnexal tumours in postmenopausal women

Introduction Detection of asymptomatic adnexal tumours in postmenopausal women has increased due to wider use of diagnostic ultrasound and imaging quality improvements. Reliable methods to differentiate between benign and malignant tumours are required to avoid delays in treating ovarian cancer and to prevent unnecessary interventions for benign lesions. In the UK, the Royal College of Obstetricians and Gynaecologists has issued guidance for the management of adnexal cysts in postmenopausal women, which is considered standard in routine clinical practice. The protocol utilises the Risk of Malignancy Index to assess the risk of adnexal lesion being malignant. This protocol has a relatively high intervention rate in order to avoid a delay in a cancer diagnosis. The Simple Rules Protocol designed by International Ovarian Tumour Analysis Group reports a low false-positive rate in the diagnosis of ovarian cancer without a loss of sensitivity and therefore has the potential to reduce unnecessary interventions in asymptomatic postmenopausal women with benign cysts. Methods and analysis 140 postmenopausal women aged 40–80, with incidentally detected adnexal tumours on ultrasound scan will be recruited to this study. They will be randomly allocated, to be assessed and managed according to either of the two protocols under investigation. In both arms of the study the tumours will be classified into three groups: high, intermediate or low risk of malignancy. Women with high risk of malignancy will be referred for management in a tertiary cancer centre, women with low-risk tumours will be managed expectantly, while those with intermediate risk findings have surgery in their local hospital units. Analysis will be on an intention-to-treat basis. Ethics and dissemination Research ethical approval was granted by the North London Research Ethical Committee 2 (10/H0724/48). Trial results will be published according to the CONSORT statement. Trial registration number Registration at http://www.controlled-trials.com/ISRCTN89034131/. ISRCTN89034131

Single‐dose systemic methotrexate vs expectant management for treatment of tubal ectopic pregnancy: a placebo‐controlled randomized trial

Methotrexate is used routinely worldwide for the medical treatment of clinically stable women with a tubal ectopic pregnancy. This is despite the lack of robust evidence to show its superior effectiveness over expectant management. The aim of our multicenter randomized controlled trial was to compare success rates of methotrexate against placebo for the conservative treatment of tubal ectopic pregnancy.

Comparison of two protocols for the management of asymptomatic postmenopausal women with adnexal tumours - a randomised controlled trial of RMI/RCOG vs Simple Rules

Background:Adnexal tumours are frequently diagnosed in asymptomatic postmenopausal women due to more liberal use of modern high-resolution imaging. This study’s objective was to determine if there would be a difference in the intervention rates when using the Simple Rules Management Protocol (SRMP) as compared to the Risk of Malignancy Index in the Royal College of Obstetricians and Gynaecologists guideline (RMI/RCOG).Methods:This was a prospective randomised controlled trial with the participants and the researchers non-blinded, and the surgeons and pathologists blinded. We recruited pain-free postmenopausal women who were diagnosed with an adnexal tumour on ultrasound scan. Women were randomised to either of the two protocols, which then determined if they were offered conservative or surgical management. An intention-to-treat analysis was performed. The primary outcome measure was rate of surgical interventions for ovarian cysts up to 12 months after randomisation. The secondary outcome measures were the number of staging surgical procedures, surgical complications and number of delayed diagnoses of ovarian cancer.Results:A total of 148 women were randomised over 39 months with 73 in the RMI/RCOG arm and 75 in the SRMP arm with outcome data for 136 at 12 months. The two groups were balanced in terms of age, length of time since menopause and use of hormone replacement therapy. There were 18 out of 68 (28.1%) women in the RMI/RCOG arm who had surgery vs 7 out of 68 (10.3%) women in the SRMP arm (P=0.015, χ2-test). The difference in these proportions was 16.2% (95% confidence interval (CI): 3.4–28.9%) and the relative risk was 2.57 (95% CI: 1.15–5.76). There were no significant differences in the number of staging surgical procedures and the surgical complications between the two groups and there were no delayed diagnoses of ovarian cancer at 12 months.Conclusions:Surgical intervention rates in asymptomatic postmenopausal women with an ultrasound diagnosis of adnexal tumours are significantly lower when the novel SRMP protocol is used for triaging compared to the standard RMI/RCOG protocol without an increase in delayed malignant diagnoses.

A prospective evaluation of the IOTA Logistic Regression Models (LR1 and LR2) in comparison to Subjective Pattern Recognition for the diagnosis of ovarian cancer in the outpatient setting

To determine whether International Ovarian Tumor Analysis (IOTA) logistic regression models LR1 and LR2 developed for the preoperative diagnosis of ovarian cancer could also be used to differentiate between benign and malignant adnexal tumors in the population of women attending gynecology outpatient clinics.

OP24.02: A prospective evaluation of two protocols for the management of postmenopausal women with adnexal tumors: analysis of potential intervention rates

indication was increased NT. We excluded 24 cases of failed of cell culture or loss of follow up. Of these 174 procedures, a complete follow-up was obtained by a review of medical records and phonecall. Addition to fetal karyotyping these patients were managed with follow-up scans at 20–22 weeks, fetal echocardiography and in selected cases by infection screening. Especially our data set substantiates that additional MLPA analyses for further genetic syndrome. Results: Overall 69 (69/174, 39.66%) cases of chromosomal abnormalities were detected. In 105 (60.34%) with the normal karyotyping results, there were 8 (7.61%) abortions or FUID and 6 (5.71%) terminations of pregnancy. In the 91 (86.66%) survivors, 9 (8.57%) had abnormalities requiring medical or surgical treatment. The chance of a live-birth with no defects in the group with normal ultrasonographic findings was 71 (67.62%), for those with abnormal or suspicious ultrasonographic findings was 11 (10.48%). Moreover, microdeletions rate is 1.90%(2/105), all cases terminated of pregnancy. Conclusions: Grossly 47.13% (82/174) of cases with increased NT had a live-birth with no defects and chromosomal abnormality. Offering the parents the option for fetal karyotyping, the finding of increased translucency should stimulate the search for other fetal defects by detailed ultrasonography and special microdeletions study. If these results are normal features, physicians give a relief to parents and postnatal pediatric follow up should be arranged.