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In women with postmenopausal bleeding, endometrial polyps are a frequent finding and the risk of a focal (pre)malignancy in a polyp is up to 6%. Because of this reported risk, the detection of polyps in these women, preferably by a minimally invasive method, is important. The aim of this systematic review was to assess the accuracy of saline contrast sonohysterography (SCSH) for diagnosis of endometrial polyps in women with postmenopausal bleeding.In August 2018, an electronic search was performed of MEDLINE, EMBASE and Web of Science databases to identify all diagnostic studies in which SCSH was used to detect endometrial polyps in postmenopausal women. Studies were included if SCSH was performed to detect endometrial polyps in women with postmenopausal bleeding and if detection of a polyp on hysteroscopy or diagnosis on histopathology was used as a reference standard. Two reviewers assessed methodological quality using the quality assessment of diagnostic accuracy studies (QUADAS-2) tool. Two separate analyses were performed for each reference standard. Pooled sensitivity and specificity were calculated using the hierarchical summary receiver-operating characteristics (HSROC) model and HSROC curves were plotted.After selection and quality assessment, five studies were included. Using 'polyps diagnosed with histopathology' as the reference standard, the pooled sensitivity of SCSH was 86.5% (95% CI, 63.6-100%) and the pooled specificity was 91.1% (95% CI, 63.2-100%). Using 'polyps seen on hysteroscopy' as the reference standard, the pooled sensitivity of SCSH was 85.1% (95% CI, 66.9-100%) and the pooled specificity was 84.5% (95% CI, 68.1-100%). Excluding the one study that included women in whom the SCSH examination was reported to be suboptimal, the pooled sensitivity increased to 90.7% (95% CI, 72.8-100%) using hysteroscopy as the reference standard. The sensitivity of hysteroscopy to detect polyps, as reported in two studies, was 81-98%.Provided that the SCSH examination is of optimal quality, it can be considered as a method to stratify women with postmenopausal bleeding for further diagnostic workup and treatment with hysteroscopy. In women without suspicion of a polypoid lesion on SCSH, and with a benign endometrial sample, expectant management should be considered. Copyright © 2019 ISUOG. Published by John WileySons Ltd.Precisión del diagnóstico de la sonohisterografía con contraste salino en la detección de pólipos endometriales en mujeres con hemorragia postmenopáusica: revisión sistemática y metaanálisis OBJETIVO: En las mujeres con hemorragia postmenopáusica, los pólipos endometriales son frecuentes y el riesgo de una (pre)malignidad focal en un pólipo es de hasta el 6%. Debido a este riesgo reportado, es importante la detección de pólipos en estas mujeres, preferiblemente por un método mínimamente invasivo. El objetivo de esta revisión sistemática fue evaluar la precisión de la sonohisterografía con contraste salino (SCSH, por sus siglas en inglés) para el diagnóstico de pólipos endometriales en mujeres con hemorragia postmenopáusica. MÉTODOS: En agosto de 2018 se realizó una búsqueda electrónica en las bases de datos MEDLINE, EMBASE y Web of Science para identificar todos los estudios diagnósticos en los que se utilizó la SCSH para detectar pólipos endometriales en mujeres postmenopáusicas. Los estudios se incluyeron cuando la SCSH se realizó para detectar pólipos endometriales en mujeres con hemorragia postmenopáusica o cuando la detección de un pólipo en la histeroscopia o el diagnóstico sobre la histopatología se utilizó como estándar de referencia. Dos revisores evaluaron la calidad metodológica mediante la evaluación de calidad de la herramienta de estudios de precisión diagnóstica (QUADAS-2). Se realizaron dos análisis separados para cada estándar de referencia. La sensibilidad y especificidad combinadas se calcularon utilizando el modelo jerárquico de resumen de las características operativas del receptor (HSROC, por sus siglas en inglés) y se trazaron las curvas HSROC. RESULTADOS: Después de la selección y la evaluación de calidad, se incluyeron cinco estudios. Utilizando los ‘pólipos diagnosticados con histopatología’ como estándar de referencia, la sensibilidad combinada de la SCSH fue del 86,5% (IC 95%, 63,6-100%) y la especificidad combinada fue del 91,1% (IC 95%, 63,2-100%). Utilizando como estándar de referencia los ‘pólipos observados en la histeroscopia’, la sensibilidad combinada de la SCSH fue del 85,1% (IC 95%: 66,9-100%) y la especificidad combinada fue del 84,5% (IC 95%: 68,1-100%). Excluyendo el único estudio que incluyó mujeres en las que se reportó que el examen por SCSH no fue adecuado, la sensibilidad combinada aumentó al 90,7% (IC 95%: 72,8-100%), usando la histeroscopia como estándar de referencia. La sensibilidad de la histeroscopia para detectar pólipos, tal y como se informó en dos estudios, fue del 81-98%. CONCLUSIONES: Siempre que el examen por SCSH sea de calidad óptima, puede considerarse como un método para estratificar a las mujeres con hemorragia postmenopáusica para su posterior diagnóstico y tratamiento con histeroscopia. En mujeres sin sospecha de una lesión polipoide mediante SCSH y con una muestra endometrial benigna, se debe considerar el tratamiento expectante. Copyright © 2019 ISUOG. Published by John WileySons Ltd.盐水增强超声造影在检测绝经后出血妇女子宫内膜息肉时诊断的准确性:系统回顾及Meta分析 目的: 在绝经后出血的妇女中，子宫内膜息肉为常见原因，而息肉发生局灶性(前期)恶化的风险高达6%。因为报告的风险，所以在这些妇女中检测息肉时，最好采用微创方法，这非常重要。本系统回顾的目的是评估盐水增强超声造影(SCSH)诊断绝经后出血妇女子宫内膜息肉的准确性。 方法: 2018年8月，对 MEDLINE、EMBASE 和 WebofScience 数据库进行电子检索，以确定所有诊断性研究，其中SCSH用于检测绝经后妇女子宫内膜息肉。研究包括:是否对绝经后出血的妇女进行SCSH检测子宫内膜息肉，是否将宫腔镜检查或组织病理学诊断中的息肉检测作为参考标准。两位评审员使用诊断准确性研究(QUADAS-2)的质量评估工具对方法学质量进行了评估。每个参考标准分别进行了两次分析。采用分层汇总接受者-操作特征(HSROC)模型计算综合敏感性和特异性，绘制HSROC曲线。 结果: 经过筛选和质量评估，共纳入5项研究。以组织病理学诊断的息肉为参考标准，SCSH的综合敏感性为86.5%(95% CI，63.6%-100%)，综合特异性为91.1%(95% CI，63.2%-100%)。以宫腔镜所见息肉为参考标准，SCSH的综合敏感性为85.1%(95%CI，66.9%~100%)，综合特异性为84.5%(95%CI，68.1%~100%)。一项报告纳入女性SCSH检查结果不理想的研究除外，以宫腔镜检查为参照，综合敏感度提高到90.7%(95% CI，72.8%-100%)。根据两项研究报告，宫腔镜检查息肉的敏感性为81%-98%。 结论: 只要SCSH检查质量最佳，可将其作为对绝经后出血妇女进行分层的一种方法，以进一步进行诊断性检查和宫腔镜治疗。对于不怀疑SCSH上有息肉样病变且子宫内膜样本为良性的女性，应考虑预期治疗。.

Objective: To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation.Study design: A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure (R) endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods.Results: Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% Cl -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women).Conclusion: This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office. (C) 2020 Elsevier B.V. All rights reserved.

ObjectiveTo compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. DesignMulticentre randomised controlled trial. SettingEleven hospitals collaborating in a consortium for women's health research in the Netherlands. PopulationWomen reporting postmenstrual spotting after a caesarean section who had a niche with a residual myometrium of 3 mm, measured during sonohysterography. MethodsWomen were randomly allocated to hysteroscopic niche resection or expectant management for 6 months. Main outcome measuresThe primary outcome was the number of days of postmenstrual spotting 6 months after randomisation. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, surgical parameters, quality of life, women's satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, except for niche measurements, also at 6 months after randomisation. ResultsWe randomised 52 women to hysteroscopic niche resection and 51 women to expectant management. The median number of days of postmenstrual spotting at baseline was 8 days in both groups. At 6 months after randomisation, the median number of days of postmenstrual spotting was 4 days (interquartile range, IQR 2-7 days) in the intervention group and 7 days (IQR 3-10 days) in the control group (P = 0.04); on a scale of 0-10, discomfort as a result of spotting had a median score of 2 (IQR 0-7) in the intervention group, compared with 7 (IQR 0-8) in the control group (P = 0.02). ConclusionsIn women with a niche with a residual myometrium of 3 mm, hysteroscopic niche resection reduced postmenstrual spotting and spotting-related discomfort. Tweetable abstractA hysteroscopic niche resection is an effective treatment to reduce niche-related spotting. Tweetable abstract A hysteroscopic niche resection is an effective treatment to reduce niche-related spotting.

Objective The aim of this study was to evaluate the incidence of endometrial carcinoma, proven after hysterectomy, in patients diagnosed with atypical endometrial hyperplasia confined to a polyp. A secondary aim was to establish factors associated with (pre-)malignant alterations in a polyp.Design A retrospective cohort study.Setting Maastricht University Medical Centre (MUMC+) and Maxima Medical Centre in Eindhoven/Veldhoven (Maxima MC).Population Women who underwent a hysteroscopic polyp resection between 2008 and 2016.Methods Patient characteristics and histopathology results of the polyp and, in the case of a hysterectomy, uterus were collected from patients' charts.Results A total of 1445 complete hysteroscopic polyp resections were included. Of those, 1390 polyps showed benign histopathology results, 39 polyps contained atypical hyperplasia and 16 polyps contained endometrial carcinoma. A hysterectomy was performed in 35 women who were diagnosed with atypical hyperplasia confined to a polyp after hysteroscopic polyp resection. Histopathological assessment showed no additional (pre-)malignant changes of the endometrium in 12 women (30.8%), atypical hyperplasia in 11 women (28.2%) and endometrial carcinoma in 12 women (30.8%). None of the prognostic factors under consideration were significantly associated with (pre-)malignant changes in a polyp.Conclusion The incidence of endometrial carcinoma in the surrounding endometrium after complete resection of a polyp with atypical hyperplasia is 30.8% in this study. This supports the current advice to perform a hysterectomy and bilateral salpingo-oophorectomy. No prognostic factor for (pre-)malignant changes in a polyp was established. Tweetable abstract The incidence of endometrial carcinoma after complete resection of a polyp with atypical hyperplasia is high.

Introduction/Background Preoperative risk stratification in endometrial cancer (EC) is mainly based on the histological diagnosis of endometrial biopsies. Yet, easily accessible clinical biomarkers sampled prior to surgery, might contribute to improved risk stratification. Previous studies demonstrated the prognostic value of haematological parameters. Cancer antigen 125 (CA-125) has been widely accepted as tumour marker in EC, yet so far not studied in relation to pre-operative haematological parameters. Our aim is to investigate the prognostic value of preoperative haematological parameters in relation with CA-125. Methodology Data collection was performed out of available samples of the prospective multicentre PIPENDO cohort. A total of 285 patients (66%) had complete available serum analysis of at least one. Anaemia ( 390 × 109platelets/L), leucocytosis (>10 × 109/L) were related to CA-125 (>35 kU/L), patients, histopathological characteristics and outcome. Results Preoperative anaemia was present in 9.8% (n=28), leucocytosis in 10.9% (n=31) and thrombocytosis in 7.4% (n=21). Anaemia, thrombocytosis and leucocytosis were associated with BMI, comorbidity of diabetes and hypertension. Age was only associated with anaemia. Histopathological characteristics showed no association between anaemia, thrombocytosis and leucocytosis. In multivariate Cox regression analysis anaemia and increased CA-125 were associated as risk factor for recurrence with hazard ratio (HR) of 2.50 (95% CI, 1.20–5.24 p=0.016) and 2.02 (95% CI 1.10–3.71 p=0.024). Only increased CA-125 was associated as risk factor for overall survival with HR of 2.12 (95% CI 1.21–3.72 p=0.008). Conclusion Preoperative anaemia and increased CA-125 are associated with a two times increased risk of recurrence in women with EC. Disclosure Nothing to disclose.

Objective To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation. Design Multicentre, open-label, randomised controlled trial. Setting Eighteen hospitals in the Netherlands and one hospital in England. Population Women with a symptomatic cyst or abscess of the Bartholin gland. Methods Women were randomised to treatment with Word catheter or marsupialisation. Main outcome measures The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10-point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention-to-treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2). Results One hundred and sixty-one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline characteristics were comparable. Recurrence occurred in 10 women (12%) allocated to Word catheter versus eight women (10%) allocated to marsupialisation: relative risk (RR) 1.1, 95% confidence interval (CI) 0.64–1.91; P = 0.70. Pain scores after treatment were also comparable. In the first 24 hours after treatment, 33% used analgesics in the Word catheter group versus 74% in the marsupialisation group (P

OBJECTIVE: To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling.DESIGN: Multicentre, randomised controlled trial.SETTING: Three academic hospitals and nine non-academic teaching hospitals in the Netherlands.POPULATION: Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling.METHODS: Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management.MAIN OUTCOMES: The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered.RESULTS: Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer.CONCLUSION: In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling.TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.

Background Endometrial ablation has been widely implemented in the outpatient setting. Many different protocols of local anaesthesia during endometrial ablation are used and described. However, prospective studies to assess and evaluate these protocols appear to be scarce. Objectives To evaluate systematically the different local anaesthesia techniques in relation to pain perception during endometrial ablation. Search strategy Medline and Embase were systematically searched and reference lists of selected articles were checked for missed publications. Selection criteria All types of studies reporting the performance of endometrial ablation under local anaesthesia in ten or more women were included. Data collection and analysis Data about the procedure, the protocol of local anaesthesia, the acceptability and side-effects were extracted. Main results Twenty-five studies, involving 2013 women, were included. Applied anaesthesia techniques included intracervical, paracervical and intrauterine anaesthesia or a combination of these techniques. Women who received a combination of either intra- or paracervical anaesthesia and intrauterine injections reported significantly lower pain scores than those who received no local anaesthesia or intra- or paracervical anaesthesia alone (P = 0.000), but the quality of evidence is low. The acceptability of endometrial ablation under local anaesthesia was high (77–94%). Conclusion Endometrial ablation under local anaesthesia is a safe, feasible and acceptable procedure. The combination of either intra- or paracervical anaesthesia with intrauterine injections seems to be promising, but has to be investigated more thoroughly. Tweetable abstract Systematic review of local anaesthesia techniques during endometrial ablation.

Objectives: Up to 60% of women remove their levonorgestrel-releasing Intrauterine System (LNG-IUS) prematurely, mostly because of irregular bleeding disturbances up to six months after insertion. Assuming ongoing bleeding is due to atrophic bleeding of the endometrium, treatment with ooestrogen could be effective. No study in literature supports ooestrogen therapy for irregular bleeding in LNG-IUS users. Study design: A prospective cohort study was conducted in two hospitals to evaluate the effect of oral ooestradiol (started six months after LNG-IUS insertion) on irregular bleeding days. The participating women received 2mg ooestradiol daily for six weeks. We observed the discontinuation rate, the occurrence of adverse events and side effects due to ooestradiol. Women completed questionnaires at baseline and three months after start of the treatment. Results: Nineteen women were included. A median of 21 irregular bleeding days per month at baseline decreased to a median of five irregular bleeding days per month (p=0.003) after the use of ooestradiol for six weeks. Three out of nineteen women had their LNG-IUS removed at three months follow-up because of persistent irregular bleeding. No adverse events were reported, however, 68% of the participants reported side effects. Conclusion: In this study we observed a decrease in the number of irregular bleeding days in LNG-IUS users with ongoing irregular bleeding (>6 months after insertion), after administering oral ooestradiol for six weeks. We propose to conduct a larger prospective trial to evaluate ooestradiol as treatment option for irregular bleeding.

ObjectiveTo evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women. DesignRandomised multicentre double-blind placebo controlled trial. SettingTwo Dutch teaching hospitals and one Dutch university medical centre. PopulationPostmenopausal and premenopausal nulliparous women undergoing office hysteroscopy. MethodsPatients were randomised to receive either 400 microgram misoprostol or placebo 12 and 24 hours before hysteroscopy. Pain was quantified by the use of real time pain measurement using the continuous pain score meter (CPSM) and VAS scores. Main outcome measuresPrimary outcome was pain measured by the CPSM during passage of the hysteroscope through the cervical canal, quantified by the area under the curve (AUC). Secondary outcomes included VAS scores, other CPSM parameters, failures and side effects. ResultsIn all, 149 patients were randomly assigned to either misoprostol (n = 74) or placebo (n = 75). The AUC during introduction did not significantly differ between the intervention and the placebo group. The VAS score during introduction, however, demonstrated a significant difference in premenopausal nulliparous women favouring misoprostol: 2.9 (95% CI 1.3-4.4) versus placebo 5.5 (95% CI 3.9-7.1), P = 0.02, as well as the AUC during the entire procedure: 618 (95% CI 410-827) versus 1126 (95% CI 671-1580), P = 0.04. Failures were equally distributed between the misoprostol (16%) and placebo group (13%). Intestinal side effects occurred significantly more frequently in the misoprostol group (67%) than in the placebo group (32%) [OR 4.2 (95% CI 2.1-8.3), P < 0.01]. ConclusionMisoprostol prior to hysteroscopy reduces pain in premenopausal nulliparous women but not in postmenopausal women. It does cause side effects. Tweetable abstractRCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters. Tweetable abstract RCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters.

OBJECTIVE: The Pictorial Blood Loss Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the effect of its score and its relationship with outcome could have implications for using the PBAC as an outcome measurement in future HMB studies, and as a tool to evaluate the treatment effect in research and clinical practice. Our aim was to relate PBAC scores to other measures of success after endometrial ablation for HMB.DESIGN: Analysis of individual patient data (IPD) of randomised controlled trials studying women with HMB.SETTING: Women with HMB consulting their gynecologists.POPULATION OR SAMPLE: Individual patient data (IPD) of randomised controlled trials studying women with HMB.METHODS: We included studies if they had studied second-generation endometrial ablation techniques and had collected PBAC scores for both baseline and follow-up. The effectiveness of treatment was scored as satisfaction or re-intervention (yes/no) 12 months after treatment. We related these outcomes to the PBAC score at 12 months after treatment, and to PBAC decrease between baseline and 12 months of follow-up.RESULTS: We studied data for 900 patients included in nine studies. The median PBAC score at 12 months was 7 (0-2500). The overall satisfaction rate was 89% and the overall re-intervention rate was 7.2%. A clear association was found between absolute PBAC score at the 12-month follow-up and satisfaction (odds ratio, OR 0.16; 95% confidence interval, 95% CI 0.11-0.24) and surgical re-intervention (OR 2.3, 95% CI 1.8-2.8). A change in PBAC score was also associated with satisfaction (OR 2.0, 95% CI 1.7-2.3) and surgical re-intervention (OR 0.69, 95% CI 0.63-0.75). Both the absolute PBAC scores and the changes in score show high accuracy for both treatment outcomes.CONCLUSIONS: PBAC scores at 12 months after treatment are significantly associated with satisfaction and re-intervention rates. We propose to use the PBAC in research as a primary end point in studies on HMB, and in clinical practice as a measure to assess the effectiveness of treatment.TWEETABLE ABSTRACT: PBAC scores 12 months after treatment are significantly associated with satisfaction and reintervention rates.

Item does not contain fulltext STUDY QUESTION: Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage? SUMMARY ANSWER: Curettage leads to a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. WHAT IS KNOWN ALREADY: In 5-50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage. STUDY DESIGN, SIZE, DURATION: From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated to expectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization. MAIN RESULTS AND THE ROLE OF CHANCE: Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03-1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21-4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy. LIMITATIONS, REASONS FOR CAUTION: Due to a strong patient preference, mainly for expectant management, the targeted sample size could not be included and the trial was stopped prematurely. WIDER IMPLICATIONS OF THE FINDINGS: In women suspected of incomplete evacuation of the uterus after misoprostol, curettage is more effective than expectant management. However, expectant management is equally safe and prevents curettage for most of the women. This finding could further restrain the use of curettage in the treatment of first trimester miscarriage. STUDY FUNDING/COMPETING INTERESTS: This study was funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR3310, http://www.trialregister.nl TRIAL REGISTRATION DATE: 27 February 2012. DATE OF FIRST PATIENT'S ENROLMENT: 12 June 2012.

BACKGROUND: A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. METHODS/DESIGN: We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. DISCUSSION: This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. TRIAL REGISTRATION: Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.

Objective. We recently showed that frozen section diagnosis has an almost perfect specificity for the diagnosis of malignancy in an adnexal mass, whereas the sensitivity was, though good, not perfect. The aim of the present study was to examine whether the accuracy of frozen section diagnosis is affected by the size of the adnexal masses. Methods. We included women that underwent frozen section diagnosis for adnexal mass surgery. For each patient we recorded serum CA 125 level, menopausal status, tumour size, and histologic classification both at frozen section diagnosis and at definite histological examination. We calculated sensitivity and specificity of frozen section diagnoses, both in tumours below and above 10 cm diameter. Results. We included 257 patients, of whom 142 had a benign tumour, 28 had a borderline tumour and 87 had a malignant tumour at definitive histological assessment. In case frozen section diagnosis showed malignancy, this was always confirmed at final histological assessment. In women with a tumour = 10 cm. The corresponding likelihood ratios of a benign diagnosis for presence of malignancy were .15 for tumours >= 10 cm and 0.03 for tumours = 10 cm, a benign result of the frozen section diagnosis is less reliable than in women with a tumour