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.

Ultrasound diagnosis of serous surface papillary borderline ovarian tumor: A case series with a review of the literature.

Serous surface papillary borderline ovarian tumors (SSPBOTs) are a rare morphologic variant of serous ovarian tumors that are typically confined to the ovarian surface, while the ovaries themselves tend to appear normal in size and shape. In this report, we describe the findings from five premenopausal women diagnosed with SSPBOTs, in whom ultrasound showed grossly normal ovaries that were partially or wholly covered with irregular solid tumors. In all five cases, histologic examination showed evidence of borderline serous tumors. These findings demonstrate that SSPBOTs can be diagnosed on a preoperative sonographic examination, which could facilitate conservative, fertility-sparing surgery in young women affected by this condition.

Natural history of ovarian endometrioma in pregnancy.

BACKGROUND: Ovarian endometriomas are classified as benign ovarian lesions. During pregnancy endometriomas may undergo major morphological changes which are referred to as 'decidualisation'. Decidualised ovarian endometrioma may resemble malignant ovarian tumours on ultrasound examination. The aim was to study variations in the morphology and size of ovarian endometriomas diagnosed on ultrasound during pregnancy. METHODS: We searched our database to identify pregnant women who were diagnosed with ovarian endometriomas on ultrasound in order to study the effect of pregnancy on their morphological characteristics. In women who underwent serial scans during pregnancy we examined the changes in the size of endometriomas with advancing gestation. RESULTS: Twenty four patients with a total of 34 endometriomas were included in the analysis. All women were managed expectantly during pregnancy. On the first ultrasound scan 29/34 (85.3%, 95% CI 73.4 - 97.2) endometriomas appeared unilocular with fine internal echoes ('ground glass' contents) and they were poorly vascularised on Doppler examination. 1/34 (2.9% 95% CI 0.0 - 8.5) endometrioma was multilocular, with regular margins, 'ground glass' contents and it was also poorly vascularised. 4/34 (11.8%, 95% CI 1.0 - 22.6) had sonographic features suggestive of decidualisation such as thick and irregular inner wall, papillary projections and highly vascular on Doppler examination. The endometriomas showed a tendency to decrease in size during pregnancy. CONCLUSIONS: Pregnancy has a major effect on the size and morphological appearances of ovarian endometriomas. Rapid regression of decidualised endometriomas is a helpful feature which could be used to confirm their benign nature.

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.

Fertility preservation provision in the NHS: a national assessment of care policies.

Fertility preservation has gained momentum in recent years. As cancer survival rates improve, late effects of loss of gonadal function have increased the need to consider fertility preservation. NICE recommends offering cryopreservation of gametes or embryos to patients undergoing gonadotoxic therapy, highlighting that this should be extrapolated to those with non-malignant conditions that pose a risk to fertility. We investigated whether variation in fertility preservation provision exists across the United Kingdom, with a view to identifying equitable models of provision. In England, cryopreservation of gametes and embryos is funded for all patients undergoing treatment for cancer, but eligibility criteria and duration of storage funding vary widely. In Scotland, a national policy is applied, with health boards equitably providing funding for cryopreservation of gametes, embryos, and ovarian and testicular tissue for those undergoing treatment for benign and malignant conditions which impair fertility, including gender incongruence. In Wales and Northern Ireland, cryopreservation of gametes and embryos is funded for those undergoing treatment likely to make them infertile, but ovarian tissue cryopreservation is not funded. Funding criteria for fertility preservation in England, Wales, and Northern Ireland deviates from NICE guidance. Standardization of fertility preservation policies is needed to provide equity of access for patients.

Ultrasound-guided retrieval of lost intrauterine devices using very fine grasping forceps: a case series.

AIM: To assess the efficacy of a novel ultrasound-guided procedure for the retrieval of intrauterine contraceptive devices (IUDs) when the threads are not visible at the external cervical os ('lost threads'). METHODS: This was a prospective cohort study of consecutive women referred for ultrasound examination because of lost IUD threads. The procedures were performed under local anaesthesia in the outpatient setting. After injection of local anaesthetic, the anterior cervical lip was grasped with a vulsellum forceps. A 5Fr hysteroscopy grasping forceps was introduced transcervically into the uterine cavity under continuous transabdominal ultrasound guidance. The IUD was then grasped and removed from the uterus. Patients' demographic data, gynaecological history, ultrasound findings, duration of procedure, success rate and pain score were recorded. RESULTS: Twenty-three consecutive women were included in the study. Ultrasound examination showed an IUD correctly sited in the centre of the uterine cavity in 20/23 (87%), in 2/23 (9%) it was partially embedded in the myometrium and in 1/23 (4%) the IUD was partially sited in the cervical canal. In 8/23 (35%) women the IUD threads were not visible on ultrasound scan. Removal of the IUD was successful in 22/23 (96%) cases with a median operating time of 3 (interquartile range 1.25-4.75) minutes. 15/23 (65%) women experienced no or minimal pain (pain score ≤3), 4/23 (17%) reported moderate pain (pain score 4-6) and 4/23 (17%) described the pain as severe (pain score 7-10). No complications were recorded during or immediately after the procedure. CONCLUSIONS: Ultrasound-guided retrieval of lost IUDs using fine hysteroscopy grasping forceps is a highly successful technique and is well tolerated by women.

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.