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INTRODUCTION: Heavy menstrual bleeding (HMB) affects a quarter of all women, with half having no structural cause. Dutch guidelines recommend a stepped care approach to the management of such idiopathic HMB, starting with medication or a levonorgestrel-releasing intrauterine device (LNG-IUD), before progressing to endometrial ablation, and ultimately, hysterectomy. However, practice variation between hospitals could lead to suboptimal health outcomes and increased healthcare costs for some women.OBJECTIVES: To evaluate adherence to stepped care for women with idiopathic HMB and to identify practice variation among Dutch hospitals.STUDY DESIGN: This population-based cross-sectional study used Dutch insurance claims data from primary and secondary care for all women with idiopathic HMB referred to a gynecologist between January 2019 and December 2020. We calculated the average number of treatments in the 3 years before each treatment step at each hospital, making adjustments for age, socioeconomic status, and ethnicity. Variation in medical practice was measured by the coefficient of variation (CV).RESULTS: We studied 20,715 women treated with LNG-IUDs (56%), endometrial ablation (36%), laparoscopic hysterectomy (13%), or vaginal hysterectomy (4%) in 93 hospitals. Before endometrial ablation, on average 47% used medication (hospital range 27%-71%; CV 0.17) and 16% used an LNG-IUD (hospital range 8%-29%, CV 0.32). Before hysterectomy, 52% (hospital range 28%-65%, CV 0.16) used medication, 21% (hospital range 6%-38%, CV 0.35) used an LNG-IUD, and 23% underwent endometrial ablation (hospital range 0%-59%, CV 0.55). On average, women underwent 0.63 (hospital range 0.36-1.00, adjusted rate 0.40-0.98, CV 0.17) and 0.96 (hospital range 0.56-1.45, adjusted rate 0.56-1.44, CV 0.18) treatments before endometrial ablation and hysterectomy, respectively.CONCLUSIONS: Considerable practice variation exists among Dutch hospitals in the stepped care approach to idiopathic HMB. Improving adherence to this approach could improve quality of care and reduce costs.

ObjectiveTo investigate whether a previously performed endometrial ablation is associated with the development and diagnosis of endometrial cancer.MethodsFirst, a systematic review was performed of the articles reporting the incidence of endometrial cancer in patients treated with endometrial ablation. Second, a systematic review was performed to identify all individual cases of endometrial cancer after ablation to evaluate presenting symptoms, diagnostic work-up, potential risk factors, and the type and stage of the endometrial cancer. A systematic search was performed, using Medline, EMBASE, and the Cochrane Library databases, from inception through February 24, 2022.ResultsBased on 11 included studies, the incidence of endometrial cancer in a population of 29 102 patients with a prior endometrial ablation ranged from 0.0% to 1.6%.A total of 38 cases of endometrial cancer after ablation were identified. In 71% of cases (17 of 24 cases), vaginal bleeding was the first presenting symptom. With transvaginal ultrasound it was possible to identify and measure the endometrial thickness in eight cases. Endometrium sampling was successful in 16 of 18 described cases (89%). In 18 of 20 cases (90%) pathologic examination showed early-stage endometrioid adenocarcinoma (International Federation of Gynecology and Obstetrics stage I).ConclusionPrevious endometrial ablation is not associated with the development of endometrial cancer. Diagnostic work-up is not impeded by previous endometrial ablation. In addition, endometrial cancers after endometrial ablation are not detected at an advanced stage.

Hysterosalpingographies (HSGs) have formed an essential part of the fertility workup for more than a century. More recently, tubal flushing, especially with oil-based contrast, has been shown to significantly improve the natural conception rates. Critically, the mechanism of this fertility-enhancing effect during tubal flushing is still unclear. This article postulates hypotheses, based on published and own research, on the potential mechanisms and root cause of tubal flushing fertility enhancement. Possible explanations for the increased fertility rates, especially with oil-based contrast, are divided into the biochemical and interfacial effects derived from the contrast properties. The biochemical effects may include the immunological response of the endometrium or peritoneum, the impact on the endometrial opioid receptors or the iodine content. The interfacial effects may include improvement of interfacial factors due to the lubricant effect or dislodgement of mucus debris within the Fallopian tubes. Impact StatementWhat is already known on this subject? Tubal flushing during hysterosalpingographies (HSGs) increases natural conception rates, and using oil-based over water-based contrast increases that effect even further. However, the underlying mechanism of the observed fertility-enhancing effect is still poorly understood. What do the results of this study add? This article postulates different hypotheses on the potential mechanisms and root cause of the fertility enhancement from tubal flushing. What are the implications of these findings for clinical practice and/or further research? We suggest additional research on the different hypotheses, intending to determine which subfertile women will benefit most from tubal flushing using oil-based contrast and at which stage of their subfertility. Furthermore, we suggest research on administering tubal flushing with oil-based contrast, besides in HSG.

BACKGROUND: Laparoscopic hysterectomy is accepted worldwide as the standard treatment option for early-stage endometrial cancer. However, there are limited data on long-term survival, particularly when no lymphadenectomy is performed. We compared the survival outcomes of total laparoscopic hysterectomy (TLH) and total abdominal hysterectomy (TAH), both without lymphadenectomy, for early-stage endometrial cancer up to 5 years postoperatively.METHODS: Follow-up of a multi-centre, randomised controlled trial comparing TLH and TAH, without routine lymphadenectomy, for women with stage I endometrial cancer. Enrolment was between 2007 and 2009 by 2:1 randomisation to TLH or TAH. Outcomes were disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and primary site of recurrence. Multivariable Cox regression analyses were adjusted for age, stage, grade, and radiotherapy with adjusted hazard ratios (aHR) and 95% confidence intervals (95%CI) reported. To test for significance, non-inferiority margins were defined.RESULTS: In total, 279 women underwent a surgical procedure, of whom 263 (94%) had follow-up data. For the TLH (n = 175) and TAH (n = 88) groups, DFS (90.3% vs 84.1%; aHR[recurrence], 0.69; 95%CI, 0.31-1.52), OS (89.2% vs 82.8%; aHR[death], 0.60; 95%CI, 0.30-1.19), and DSS (95.0% vs 89.8%; aHR[death], 0.62; 95%CI, 0.23-1.70) were reported at 5 years. At a 10% significance level, and with a non-inferiority margin of 0.20, the null hypothesis of inferiority was rejected for all three outcomes. There were no port-site or wound metastases, and local recurrence rates were comparable.CONCLUSION: Disease recurrence and 5-year survival rates were comparable between the TLH and TAH groups and comparable to studies with lymphadenectomy, supporting the widespread use of TLH without lymphadenectomy as the primary treatment for early-stage, low-grade endometrial cancer.

Purpose Although hysterectomy is one of the most frequently performed gynaecological surgeries, there is a dearth of evidence on perioperative care. The aim of the current study was to identify sociodemographic, surgical-related and work-related predictors of recovery following different approaches of hysterectomy. Methods Eligible patients for this retrospective cohort study were women who underwent vaginal, abdominal or laparoscopic hysterectomy for both benign and malignant gynaecological disease in 2014 in Máxima Medical Centre in the Netherlands. The main outcome measure was full return to work (RTW). Data were collected using a patient survey. Potential prognostic factors for time to RTW were examined in univariate Cox regression analyses. The strongest prognostic factors were combined in a multivariable model. Results In total 83 women were included. Median time to full return to work was 8 weeks (interquartile range [IQR] 6–12). The multivariable analysis showed that higher age (hazard ratio [HR] 1.053, 95% confidence interval [CI] 1.012–1.095) and same day removal of indwelling catheter (HR 0.122, 95% CI 0.028–0.539) were predictors of shorter duration until full RTW after hysterectomy. Conclusions This study provided insight in the predictors of recovery after hysterectomy. By identifying patient specific factors, pre-operative counselling can be individualized, changes can be made in perioperative care and effective interventions can be designed to target those factors.

Background It is known that amenorrhea is highly prevalent among female athletes. However, a large percentage of them do not seek help if this complaint occurs. We performed this study to gain more insight into the reasons why female athletes do not seek help when experiencing amenorrhea and how care for these women could be improved. Method Qualitative focus group research. Female athletes were approached to take part in a focus group. They were asked about the main reasons for not reporting amenorrhea and how care for amenorrhea, in their opinion, would ideally be organised. The women were asked to make a list of their top five reasons for both subjects and discuss this among their peers. Results According to the participants, the five main reasons for not reporting the amenorrhea were: (1) normalizing of the subject, (2) the absence of menstruation is not perceived as a problem by the athletes themselves, (3) experienced shame and taboo, (4) prioritisation of sports performance, and (5) denial. Factors to improve care around menstrual cycle problems in female athletes were: (1) informing athletes, coaches, trainers and mentors, (2) informing doctors, (3) conducting more research on long-term consequences, (4) breaking the taboo on menstrual problems, and (5) having a multidisciplinary collaboration between different specialisms. Conclusion By informing athletes, coaches, trainers, and mentors about menstrual cycle problems in athletes, more awareness among those groups can be created. According to the athletes, more research is needed on the long-term consequences of amenorrhea in sports, to enable them to make a better assessment of their possible future health risks. Women experience a taboo on discussing menstrual problems; role models discussing the problem may help in decreasing the taboo. A multidisciplinary collaboration of health care providers may improve care around female athletes with menstrual problems.

Objective To evaluate the costs and non‐inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG‐IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). Design Cost‐effectiveness analysis from a societal perspective alongside a multicentre randomised non‐inferiority trial. Setting General practices and gynaecology departments in the Netherlands. Population In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child. Methods Randomisation to a strategy starting with the LNG‐IUS (n = 132) or EA (n = 138). The incremental cost‐effectiveness ratio was estimated. Main outcome measures Direct medical costs and (in)direct non‐medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)‐score (non‐inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC‐score ≤75 points). Results Total costs per patient were €2,285 in the LNG‐IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC‐scores were 64.8 in the LNG‐IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3–96.7). In the LNG‐IUS group, 87% of women had a PBAC‐score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85–1.01). The ICER was €23 (95% CI €5–111) per PBAC‐point. Conclusions A strategy starting with the LNG‐IUS was cheaper than starting with EA, but non‐inferiority could not be demonstrated. The LNG‐IUS is reversible and less invasive and can be a cost‐effective treatment option, depending on the success rate women are willing to accept. Tweetable abstract Treatment of heavy menstrual bleeding starting with LNG‐IUS is cheaper but slightly less effective than endometrial ablation., Tweetable abstract Treatment of heavy menstrual bleeding starting with LNG‐IUS is cheaper but slightly less effective than endometrial ablation.

Introduction and hypothesis The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP). Methods Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (n=37) or ASC (n=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment. Results We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0–17; ASC: IQR 0–0) on the “genital prolapse” domain of the Urogenital Distress Inventory in both groups (p = 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (n = 11) in the LSC group and 84.6% (n = 11) in the ASC group (p = 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%, p = 0.729). Conclusions At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages. Trial registration Dutch Trial Register NTR6330, 18 January 2017, https://www.trialregister.nl/trial/5964

Objectives: This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows:. To determine and compare the diagnostic accuracy of visual tubal patency tests (hysterosalpingography (HSG), sono-hysterosalpingography (sono-HSG), magnetic resonance hysterosalpingography (MR-HSG), and outpatient transvaginal hydrolaparoscopy (THL)) for the diagnosis of tubal occlusion. Secondary objectives. To determine and compare the diagnostic accuracy of visual tubal patency tests (HSG, sono-HSG, MR-HSG, and outpatient THL) for the diagnosis of hydrosalpinx. To evaluate heterogeneity with regards to population characteristics (population risk stratification) and index test characteristics (contrast media, technology, operator skills).

Objective: The objective of this study was to compare the reintervention rate of women who opted for treatment with the levonorgestrel-releasing intrauterine system (LNG-IUS) to women who opted for endometrial ablation. Furthermore, the difference in reintervention rate between women in this observational cohort and women who were randomised was compared, with the hypothesis that women who actively decide on treatment have lower reintervention rates compared to women in a RCT.Study design: An observational cohort study alongside a multicentre randomised controlled trial (RCT) was conducted between April 2012 and January 2016, with a follow-up time of 24 months, in 26 hospitals and nearby general practices in the Netherlands. Women suffering from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future fertility desire, were eligible for this trial. Women who declined randomisation were asked to participate in the observational cohort. The outcome measure was reintervention rate at 24 months of follow-up.Results: 276 women were followed in the observational cohort of which 87 women preferred an initial treatment with LNG-IUS and 189 women preferred an initial treatment with endometrial ablation. At 24 months of follow-up women in the LNG-IUS-group were more likely to receive a reintervention compared to the women in the ablation group, 28/81 (35 %) versus 25/178 (14 %) (aRR 2.42, CI 1.47-3.98, p-value 0.001). No differences in reintervention rates were found between women in the observational cohort and women in the RCT.Conclusions: Women who receive an LNG-IUS are more likely to undergo an additional intervention compared to women who receive endometrial ablation. Reintervention rates of women in the cohort and RCT population were comparable. The results of this study endorse the findings of the RCT and will contribute to shared decision making in women with heavy menstrual bleeding. (C) 2020 Elsevier B.V. All rights reserved.

Background Symptoms related to endometriosis have a significant impact on the quality of life, and symptoms often recur. The experience sampling method (ESM), a digital questioning method characterized by randomly repeated momentary assessments, has several advantages over traditionally used measurements, including the ability to assess the temporal relationship between variables such as physical, mental, and social factors. Objective The aim of this study is to develop an ESM tool for patients with endometriosis to accurately measure symptoms and their course over time, allowing for personalized treatment and adequate monitoring of treatment efficacy in individual patients. Methods On the basis of international guidelines, items from validated questionnaires were selected through a literature review and during focus groups and multidisciplinary expert meetings. Data analysis was conducted using ATLAS.ti (ATLAS.ti Scientific Software Development GmbH). The feasibility and usability of the newly developed momentary assessment tool were tested for 28 consecutive days in 5 patients with endometriosis-related pain symptoms. Results Momentary assessment items contained questions concerning endometriosis symptoms, general somatic symptoms, psychological symptoms, contextual information, and the use of food and medication. A morning questionnaire on sleep and sexuality was included. In a pilot study, the patients considered the tool easy to use but time consuming. The average compliance rate of momentary assessments was 37.8% (106/280), with the highest completion rate during the first week (39/70, 56%). Therefore, it is advisable to use the ESM for a maximum of 7 days. Conclusions A new digital tool for endometriosis symptom assessment was developed using the ESM, which may help overcome the limitations of current retrospective questionnaires. After validation and testing, future studies will be planned to evaluate the use of this tool in a clinical setting in order to propose a personalized treatment plan for women with endometriosis.

BACKGROUND Social support groups are an important resource for people to cope with problems. Previous studies have reported the different types of support in these groups, but little is known about the type of reactions that sharing of personal experiences induce among members. It is important to know how and to what extent members of support groups influence each other regarding the consumption of medical care. We researched this in an online Facebook group of women sterilized with Essure®. Essure® was a device for permanent contraception. From 2015 onwards, women treated with Essure® for tubal occlusion raised safety concerns and experienced numerous of complaints. OBJECTIVE To evaluate the use of social support in a Facebook community of Essure® Problems Netherlands. METHODS All posts in a closed online Facebook group named: Essure Problems Netherlands between March 8 and May 8 of 2018 were included. In total 3,491 Facebook posts were analysed using a modified version on the social support behaviour code created by Cutrona and Suhr (1992). Posts were abstracted and aggregated into a database. Two investigators evaluated the posts, developed a modified version on the social support behaviour code book, and applied codes to data. RESULTS Results show that 92% messages contained a form of social support. In 68.8% of posting social support was given and in 31.2% social support was received. Informational and emotional support are the most frequently used form of given social support (40.6 and 55.5%, respectively). The same distribution is seen with receiving social support: informational support in 81.5% and emotional in 17.4% of the cases. Analysis showed a strong correlation between giving or taking social support and the main form of social support (P CONCLUSIONS The main purpose of women in the Essure® problems group was to give and receive informational and/or emotional support. CLINICALTRIAL

Study question Is there a difference in fertility-related quality of life (QoL) in subfertile women undergoing transvaginal hydrolaparoscopy (THL) versus hysterosalpingography (HSG) as a first-line tubal-patency test? Summary answer In subfertile women undergoing first-line tubal patency testing, THL and HSG resulted in comparable fertility-related QoL. What is known already Both subfertility itself and subfertility treatment can have a significant impact on QoL. Tubal patency testing as part of fertility work-up is also known as a potential stressor. Pain scores for THL are significantly lower than for HSG (VAS 4.7 vs 5.4 ; SD: 2.5, p 0.038), but acceptability of the procedures was found to be comparable. Fertility-related QoL has not yet been studied in women undergoing tubal patency testing. Study design, size, duration We used data from a randomised clinical trial performed in 4 Dutch teaching hospitals, NTR3462. Between May 2013 and October 2016, we randomly assigned 300 subfertile women to THL or HSG with live birth as primary outcome. We performed a standardized questionnaire study as part of a randomised controlled trial comparing THL and HSG in the work-up for subfertility. Participants/materials, setting, methods Women were eligible if they were undergoing a fertility work-up with an indication for evaluation of tubal patency testing. Fertility-related QoL was measured six weeks after the procedure with the validated FertiQoL questionnaire, which produces a Core (total) score and four subscale domains: Emotional, Relational, Social, and Mind-Body. FertiQoL scores for the Core score and subscales between THL and HSG were compared using Mann-Whitney-U test and multiple linear regression analysis. Main results and the role of chance We allocated 149 women to THL and 151 to HSG. The questionnaire was completed by 84 women in the THL group (response rate 56%) and 96 women in the HSG group (response rate 64%). Core scores were 74.6 ±12.8 for THL and 73.4 ±12.4 for HSG (p = 0.39). Scores for the Emotional domain were 64.5 ±19.0 for THL versus 66.0 ±16.3 (p = 0.67) for HSG. Scores for the ‘Mind-body’ domain for THL were 76.9 ±15.6 versus 74.1 ±18.0 for HSG (p = 0.42), scores for the Relational domain were 79.2 ±12.9 for THL and 76.9 ±15.6 for HSG (p = 0.21). Scores for the Social domain for THL were 77.9 ±15.1 versus 76.7±14.1, (p = 0.42). The optional ‘Treatment FertiQol’ was completed by 156 women. Total scores were 77.5 ±12.1 for THL versus 73.8 ±13.1 (p = 0.08) for HSG. The multiple linear regression analysis showed only a statistical significant positive effect of higher age on the score for the Emotional domain (B:0.90, p = 0.015). Limitations, reasons for caution One of the main limitations of this study was a response rate of 60%. Although this is considered an acceptable rate within questionnaire research, this could lead to selection bias. Wider implications of the findings: In subfertile women, tubal patency testing with THL versus HSG did not result in differences in fertility-related QoL. Trial registration number NTR3462

Recent meta-analyses have shown that a hysterosalpingography (HSG) with oil-based contrast increases pregnancy rates in subfertile women. However, the frequency of complications during or after an HSG with oil-based contrast in subfertile women and/or their offspring is still unclear. This systematic review and meta-analysis, without restrictions on language, publication date or study design, was performed to fill this knowledge gap. The results show that the most frequently reported complication was intravasation of contrast, which occurred in 2.7% with the use of oil-based contrast (31 cohort studies and randomized controlled trials [RCT], 95% CI 1.7–3.8, absolute event rate 664/19,339), compared with 2.0% with the use of water-based contrast (8 cohort studies and RCT, 95% CI 1.2–3.0, absolute event rate 18/1006). In the cohort studies and RCT there were 18 women with an oil embolism (18/19,339 HSG), all without serious lasting consequences. Four cases with serious consequences of an oil embolism were described (retinal oil embolism [n = 1] and cerebral complaints [n = 3]); these reports did not describe the use of adequate fluoroscopy guidance during HSG. In conclusion, the most frequently reported complication after an HSG with oil-based contrast is intravasation occurring in 2.7%. In total four cases with serious consequences of oil embolisms in subfertile women were published.

Objective: The aim of this research was to evaluate uterine-wall integrity 12 months after transcervical fibroid ablation (TFA) of uterine fibroids with the Sonata® system (Gynesonics Inc., Redwood City, CA). Materials and Methods: INTEGRITY is a secondary analysis of the FAST-EU clinical trial, a prospective, longitudinal, multicenter single-armed trial involving women with heavy menstrual bleeding secondary to fibroids who were treated at 7 academic and community hospitals in the United Kingdom, the Netherlands, and Mexico with transcervical, intrauterine, ultrasound-guided radiofrequency ablation (the Sonata system). TFA was performed on up to 5 fibroids per subject ranging from 1–5 cm in diameter as determined by magnetic resonance imaging (MRI). All measurements and comparisons, including uterine-wall thicknesses were derived from baseline and 12-month MRI scans by an independent core MRI center. Scans were analyzed to assess preservation of uterine-wall integrity and reviewed for uterine-wall anomalies after TFA with the Sonata system. Results: Twenty-nine patients had baseline and 12-month MRI with contrast enhancement. Minimum uterine-wall thicknesses in all visible slices were >2.5 mm in diameter. No areas on MRI indicated any loss of uterine-wall integrity, compared with baseline imaging; comparison of baseline and postablation uterine-wall thicknesses revealed no significant changes. Conclusion: Transcervical fibroid ablation with the Sonata system was associated with preservation of uterine-wall integrity in this patient cohort.

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。.

Heavy menstrual bleeding (HMB) affects approximately 10% to 30% of women of reproductive age and is often treated conservatively with insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) or endometrial ablation/ resection (EA). The LNG-IUS induces atrophy of endometrial tissue, whereas EA is a minimally invasive, uteruspreserving procedure that destroys endometrial tissue and superficial myometrium. Approximately 12% to 25% of the women require reintervention with additional surgery 2 to 5 years after EA treatment. Treatment failure after EA presents with persistent or recurrent vaginal bleeding thought to occur because of ongoing bleeding from areas of untreated or regenerated endometrium and can require hysterectomy. Introduction of an LNG-IUS after EA could suppress regeneration and nonablated endometrial tissue resulting in a reduction of symptoms and lower hysterectomy rate.This systematic review aimed to determine whether combined treatment with LNG-IUS insertion immediately after EA can lower the reintervention rate among women with HMB. A systematic search was conducted using the Medline, EMBASE, and Cochrane Library databases from inception through September 16, 2020. Studies reporting the results of this combined treatment with orwithout a control group were included. The primary study outcome was hysterectomy rate after treating with EA and LNG-IUS. Secondary outcomes included reintervention rate, reasons why women required additional treatment, removal rate of LNG-IUS, bleeding pattern, patient satisfaction, and adverse events. Included studies were assessed using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for nonrandomized cohort studies.A total of 7 studies were included in this systematic review, of which 4 were historic cohort studies with a control group, 2 were historic cohort studies without a control group, and 1 was case series. A total of 747 women were included, 472 of whom were treated withEA and LNG-IUS, with a follow-up duration between 6 and 55.2 months. The 4 controlled studies showed a hysterectomy rate in the combined treatment group between 0% and 11%, whereas treatment with EA alone showed a rate between 9.4% and 24%. The 4 studies investigating nonhysteroscopic EA plus LNG-IUS showed hysterectomy rates between 0% and 1%. Four studies reported reintervention rates, with 3 controlled studies showing a lower reintervention rate among the combined treatment cohort (0%8.7%) compared with the EA alone cohort (19%-29.2%). Reintervention rate was significantly lower at 12 and 24 months after combined treatment compared with EA alone. Patient satisfaction was reported in 3 studies, with satisfaction rates in favor of the combined treatment group. The adverse event rate associated with LNG-IUS after combined treatment resulting in removal was 1.6%.The results of this review show that hysterectomy rate after combined treatment with EA and LNG-IUS seems to vary between 0% and 11% compared with a rate between 9.4% and 24% associated with EA alone. The complication rate between the 2 management options seemed the same, whereas the bleeding profile and patient satisfaction both favored the combined treatment group. The data from included studies are limited by its observational nature with low methodological quality, and high-quality prospective research is necessary to guide clinical decision-making regarding HMB management.

Background This study was conducted to identify factors that are associated with failure of treatment using the levonorgestrel releasing intrauterine system (LNG-IUS) in women with heavy menstrual bleeding. Methods For this study, data of a cohort of women treated with an LNG-IUS was used. Women who suffered from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future child wish, were recruited in hospitals and general practices in the Netherlands. Eight potential prognostic baseline variables (age, body mass index, caesarean section, vaginal delivery, previous treatment, anticoagulant use, dysmenorrhea, and pictorial blood assessment score) were analyzed using univariable and multivariable regression models to estimate the risk of failure. The main outcome measure was discontinuation of the LNG-IUS within 24 months of follow up, defined as removal of the LNG-IUS or receiving an additional intervention. Results A total of 209 women received the LNG-IUS, 201 women were included in the analyses. 93 women (46%) discontinued LNG-IUS treatment within 24 months. Multivariable analysis showed younger age (age below 45) (adjusted RR 1.51, 95% CI 1.10–2.09, p = .012) and severe dysmenorrhea (adjusted RR 1.36, 95% CI 1.01–1.82, p = .041) to be associated with a higher risk of discontinuation. Conclusions High discontinuation rates are found in women who receive an LNG-IUS to treat heavy menstrual bleeding. A younger age and severe dysmenorrhea are found to be risk factors for discontinuation of LNG-IUS treatment. These results are relevant for counselling women with heavy menstrual bleeding.

STUDY QUESTIONDoes septum resection improve reproductive outcomes in women with a septate uterus?SUMMARY ANSWERHysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus.WHAT IS KNOWN ALREADYA septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant.STUDY DESIGN, SIZE, DURATIONWe performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018.PARTICIPANTS/MATERIALS, SETTING, METHODSWomen with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12 months after randomization, defined as the birth of a living foetus beyond 24 weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI.MAIN RESULTS AND THE ROLE OF CHANCEWe randomly assigned 80 women with a septate uterus to septum resection (n = 40) or expectant management (n = 40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39 = 2.6%).LIMITATIONS, REASONS FOR CAUTIONAlthough this was a major international trial, the sample size was still limited and recruitment took a long period. Since surgical techniques did not fundamentally change over time, we consider the latter of limited clinical significance.WIDER IMPLICATIONS OF THE FINDINGSThe trial generated high-level evidence in addition to evidence from a recently published large cohort study. Both studies unequivocally do not reveal any improvements in reproductive outcomes, thereby questioning any rationale behind surgery.STUDY FUNDING/COMPETING INTEREST(S)There was no study funding. M.H.E. reports a patent on a surgical endoscopic cutting device and process for the removal of tissue from a body cavity licensed to Medtronic, outside the scope of the submitted work. H.A.v.V. reports personal fees from Medtronic, outside the submitted work. B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. M.G. reports several research and educational grants from Guerbet, Merck and Ferring (location VUMC) outside the scope of the submitted work. The remaining authors have nothing to declare.TRIAL REGISTRATION NUMBERDutch trial registry: NTR 1676TRIAL REGISTRATION DATE18 February 2009DATE OF FIRST PATIENT’S ENROLMENT20 October 2010

Introduction/Background Laparoscopic hysterectomy has been proven to be a safe surgical procedure and is globally accepted as the standard treatment for early-stage endometrial cancer, despite insufficient data on long-term survival. Aim was to provide the five-years outcomes of a randomised Dutch trial on total laparoscopic hysterectomy (TLH) versus total abdominal hysterectomy (TAH) in early-stage low-risk endometrial cancer. Methodology Follow-up of a multi-centre, randomised controlled trial on TLH versus TAH without routine lymphadenectomy. A total of 279 women with stage I endometrial cancer were enrolled between 2007–2009 in a 2:1 randomisation to undergo either TLH (n=185) or TAH (n=94). Primary outcome was disease-free survival. Secondary outcomes were primary site of recurrence, overall and disease-specific survival. The Kaplan-Meier survival curves and Cox proportional hazard ratios were applied. Results Follow-up data of 253/279 patients are available. At a median follow-up time of 5.0 years, disease-free survival was 90.4% after TLH and 83.3% after TAH, HR 0.68 (95% CI 0.31–1.49). There were no port-site metastases and local recurrence rates were comparable. After adjustment for the covariates, overall survival outcomes were comparable between groups HR 0.64 (95% CI 0.33–1.26). Disease-specific survival was comparable between both groups. Conclusion This is the first study reporting on survival among women with early-stage endometrial cancer randomised to TLH or TAH, without routine lymphadenectomy. No significant differences were found in disease-free, overall and disease-specific survival five-years postoperatively. This supports the widespread use of laparoscopic hysterectomy as primary treatment procedure for early-stage, low-grade endometrial cancer. Disclosures None.

Background: The extent of endometriosis is not directly related to the degree of symptoms, and recurrence of symptoms occurs frequently. Given that, an association with psychological distress, as in depression and anxiety disorders, is suggested. Objective: To explore the strength of the associations between endometriosis and depression or anxiety and to review potential correlating factors. Search Strategy: A literature search was carried out using the electronic databases Embase, PubMed, Web-of-science and PsycINFO. Search terms related to depression, anxiety and endometriosis were combined resulting in 1,837 records. Selection criteria: Articles describing an association between endometriosis and depression or anxiety by using validated assessment tools, structured psychiatric interviews or a documented diagnosis were included. Data collection and Analysis: With 47 articles a systematic qualitative review was performed. Seventeen studies were eligible for meta-analysis. Main Results: In the meta-analysis, endometriosis patients experienced significantly more symptoms of depression (SMD of 0.71 (95%CI 0.36, 1.06) and anxiety (SMD 0.60 (95%CI 0.35, 0.84)) compared to healthy controls, but no differences were found comparing endometriosis patients with chronic pelvic pain patients without endometriosis. Besides the effect of pain, other correlating factors included age, quality of life, quality of sleep, fatigue, sexual function, gastrointestinal symptoms, comorbidity, self-esteem, emotional self-efficacy, coping style, social adjustment, pain imagery and pain sensitization. Conclusion: Endometriosis is associated with depression and anxiety. Therefore, an integrated patient-centred approach to medical, psychological and sexual issues is suggested as this may positively influence the perception of symptoms, treatment adherence, quality of life, prognosis and health care costs.

We present a case about Essure® removal surgery in which the third markers of the device have torn off. The woman needed a second surgery for complete removal of the devices. Fluoroscopy during surgery is a good method to visualize the lost fragments. With fluoroscopy, a hysterectomy is not needed for complete removal. It is important to understand the structure of the device and to be aware of the four radiopaque markers during surgery and their removal.

Introduction and hypothesis The objective was to review the long-term prevalence of pelvic organ prolapse (POP) after laparoscopic hysterectomy (LH) compared with vaginal hysterectomy (VH). Methods An observational cohort study was conducted amongst women who underwent an LH or a VH for benign indications during the period 1996–2004: the POP-UP study. The prevalence of POP was inventoried by a questionnaire involving the Pelvic Floor Distress Inventory (PFDI-20) and a pelvic floor examination (POP-Q). Women were divided into groups based on route and indication of hysterectomy: LH, VH-1 (for nonprolapse), and VH-2 (prolapse). Results Four hundred and six of the 706 eligible patients (58%) returned the questionnaire and 247 underwent POP-Q examination. Sixty-eight patients (17%) received treatment for prolapse; 8% LH, 10% VH-1, and 29% VH-2 (Chi-squared test, p p = 0.707); and 23% for VH-2 (VH-2 versus others, p n = 153) in total and in 42% of the LH group, 51% of the VH-1 group, and 84% of the VH-2 group (Chi-squared test, p Conclusions No difference was found in the prevalence of POP between LH and VH for nonprolapse indications. However, POP after VH for prolapse occurs more frequently than after hysterectomy for other indications.

Study question Does septum resection improve reproductive outcomes in women with a septate uterus? Summary answer In women with a septate uterus, septum resection does not increase live birth rate nor does it decrease the rates of pregnancy loss or preterm birth, compared with expectant management. What is known already The septate uterus is the most common uterine anomaly with an estimated prevalence of 0.2–2.3% in women of reproductive age, depending on the classification system. The definition of the septate uterus has been a long-lasting and ongoing subject of debate, and currently two classification systems are used worldwide. Women with a septate uterus may be at increased risk of subfertility, pregnancy loss, preterm birth and foetal malpresentation. Based on low quality evidence, current guidelines recommend removal of the intrauterine septum or, more cautiously, state that the procedure should be evaluated in future studies. Study design, size, duration We performed an international multicentre cohort study in which we identified women mainly retrospectively by searching in electronic patient files, medical records and databases within the time frame of January 2000 until August 2018. Searching of the databases, files and records took place between January 2016 and July 2018. By doing so, we collected data on 257 women with a septate uterus in 21 centres in the Netherlands, USA and UK. Participants/materials, setting, methods We included women with a septate uterus, defined by the treating physician, according to the classification system at that time. The women were ascertained among those with a history of subfertility, pregnancy loss, preterm birth or foetal malpresentation or during a routine diagnostic procedure. Allocation to septum resection or expectant management was dependent on the reproductive history and severity of the disease. We excluded women who did not have a wish to conceive at time of diagnosis. The primary outcome was live birth. Secondary outcomes included pregnancy loss, preterm birth and foetal malpresentation. All conceptions during follow-up were registered but for the comparative analyses, only the first live birth or ongoing pregnancy was included. To evaluate differences in live birth and ongoing pregnancy, we used Cox proportional regression to calculate hazard rates (HRs) and 95% CI. To evaluate differences in pregnancy loss, preterm birth and foetal malpresentation, we used logistic regression to calculate odds ratios (OR) with corresponding 95% CI. We adjusted all reproductive outcomes for possible confounders. Main results and the role of chance In total, 257 women were included in the cohort. Of these, 151 women underwent a septum resection and 106 women had expectant management. The median follow-up time was 46 months. During this time, live birth occurred in 80 women following a septum resection (53.0%) compared to 76 women following expectant management (71.7%) (HR 0.71 95% CI 0.49–1.02) and ongoing pregnancy occurred in 89 women who underwent septum resection (58.9%), compared to 80 women who had expectant management (75.5%) (HR 0.74 (95% CI 0.52–1.06)). Pregnancy loss occurred in 51 women who underwent septum resection (46.8%) versus 31 women who had expectant management (34.4%) (OR 1.58 (0.81–3.09)), while preterm birth occurred in 26 women who underwent septum resection (29.2%) versus 13 women who had expectant management (16.7%) (OR 1.26 (95% CI 0.52–3.04)) and foetal malpresentation occurred in 17 women who underwent septum resection (19.1%) versus 27 women who had expectant management (34.6%) (OR 0.56 (95% CI 0.24–1.33)). Limitations, reasons for caution Our retrospective study has a less robust design compared with a randomized controlled trial. Over the years, the ideas about the definition of the septate uterus has changed, but since the 257 women with a septate uterus included in this study had been diagnosed by their treating physician according to the leading classification system at that time, the data of this study reflect the daily practice of recent decades. Despite correcting for the most relevant patient characteristics, our estimates might not be free of residual confounding. Wider implications of the findings Our results suggest that septum resection, a procedure that is widely offered and associated with financial costs for society, healthcare systems or individuals, does not lead to improved reproductive outcomes compared to expectant management for women with a septate uterus. The results of this study need to be confirmed in randomized clinical trials. Study funding/competing interest(s) A travel for JFWR to Chicago was supported by the Jo Kolk Studyfund. Otherwise, no specific funding was received for this study. The Department of Obstetrics and Gynaecology, University Medical Centre, Groningen, received an unrestricted educational grant from Ferring Pharmaceutical Company unrelated to the present study. BWM reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck, personal fees from Guerbet, other payment from Guerbet and grants from Merck, outside the submitted work. The other authors declare no conficts of interest. Trial registration number N/A

Introduction Laparoscopic myomectomy can be difficult when fibroids are large and numerous. This may result in extensive intraoperative bleeding and the need for a conversion to a laparotomy. Medical pretreatment prior to surgery might reduce these risks by decreasing fibroid size and vascularization of the fibroid. We compared pretreatment with ulipristal acetate (UPA) vs gonadotropin‐releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra‐ and postoperative outcomes. Material and methods We performed a non‐inferiority double‐blind randomized controlled trial in nine hospitals in the Netherlands. Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks. The primary outcome was intraoperative blood loss. Secondary outcomes were reduction of fibroid volume, suturing time, total surgery time and surgical ease. Results Thirty women received UPA and 25 women leuprolide acetate. Non‐inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348‐1025] vs 280 mL[100‐500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28‐48] vs 22 minutes [14‐33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (−7.2% [−35.5 to 54.1] vs −38.4% [−71.5 to −19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa. Conclusions Non‐inferiority of UPA in terms of intraoperative blood loss could not be established, possibly due to the preliminary termination of the study. Pretreatment with GnRHa was more favorable than UPA in terms of fibroid volume reduction, intraoperative blood loss, hemoglobin drop directly postoperatively, suturing time of the first fibroid and several subjective surgical ease parameters.

STUDY QUESTION What is the incidence of complications after hysterosalpingography (HSG) using oil-based contrast versus water-based contrast? SUMMARY ANSWER Among 5165 women undergoing HSG, the most frequently reported complication after HSG with oil- and water-based contrast was intravasation of contrast medium (4.8% versus 1.3%, respectively), which was without further consequences, and pulmonary embolization or death did not occur. WHAT IS KNOWN ALREADY An HSG with oil-based contrast increases pregnancy rates in women with unexplained infertility. However, there have been some concerns regarding complications, including the risks of intravasation of the contrast medium, oil embolism and infection. Here, we present the incidence of complications after HSG with different types of contrast media used in the Netherlands in the year 2017. STUDY DESIGN, SIZE, DURATION In January 2018, an electronic survey was sent to all 73 clinics in the Netherlands that perform HSG. The survey consisted of 12 questions addressing the number of HSGs performed in 2017, the amount and type of contrast medium used, the occurrence of post-procedural complications and what their clinical consequences were. Non-responding clinics were sent multiple reminders. PARTICIPANTS/MATERIALS, SETTING, METHODS We calculated the incidence of the complications and reported on their clinical consequences. Furthermore, we examined the average amount of contrast used as well as the administration of prophylactic antibiotics. MAIN RESULTS AND THE ROLE OF CHANCE The response rate was 96% (67/70) (during the study, one site closed and was not included while two clinics no longer performed HSGs). In the 67 clinics, 3289 HSGs with oil-based contrast and 1876 HSGs with water-based contrast were performed in 2017. The median amount of contrast used was 8.0 ml (interquartile range (IQR) 7.0–10.0) for oil-based contrast and 10.0 ml for water-based contrast (IQR 10.0–10.0). Antibiotic prophylaxis was administered in 61% (41/67) of the clinics. Intravasation occurred in 4.8% of the HSGs performed with oil-based contrast and in 1.3% of the HSGs with water-based contrast (relative risk (RR), 3.6; CI, 2.4–5.4). Pulmonary embolism or death was not reported. Pelvic inflammatory disease (PID) occurred in 0.3% of the HSGs performed with oil-based contrast versus 0.4% with water-based contrast. PID occurred in 0.3% of the HSGs in clinics using antibiotic prophylaxis and 0.2% in clinics not using antibiotic prophylaxis. Allergic reactions were reported in one HSG performed with oil-based contrast (0.03%) compared with two HSGs performed with water-based contrast (0.1%). Anaphylactic reactions did not occur. The overall complication rate was 5.1% in the clinics that used oil-based contrast versus 1.8% in the clinics that used water-based contrast (RR, 2.8; CI, 1.9–4.0; P-value, LIMITATIONS, REASONS FOR CAUTION Half of the clinics did not routinely register complications, and the incidence of the complications in their clinic was based on the recall of the clinician. Estimated complication rates in the clinics with and without systematic registration did not significantly differ. The survey asked about the frequency of intravasation but no classification system is being used in daily practice, which may create differences in reporting. There was no standard screening of post-HSG thyroid function for the mother and the foetus. WIDER IMPLICATIONS OF THE FINDINGS In this nationwide cohort study, the complication rates after HSG were low. Intravasation occurred more frequently with the use of oil-based contrast compared with water-based contrast but did not lead to any problems or symptoms in any of the women. We therefore conclude that safety concerns should not be a reason to deny the use of oil-based contrast in women with unexplained infertility. The data also support that fluoroscopy appears to be an essential safety measure during HSG. STUDY FUNDING/COMPETING INTEREST(S) This work was partly funded by Guerbet, France. I.R. reports receiving travel fee for presenting at the Congress of the American Society for Reproductive Medicine 2019 from Guerbet. V.M. reports receiving travel and speaker’s fee as well as research grants from Guerbet. K.D. reports receiving travel and speaker’s fee from Guerbet. B.W.M. is supported by an National Health and Medical Research Council (NHMRC) Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. The other authors do not report conflicts of interest. TRIAL REGISTRATION NUMBER N19.056.

STUDY QUESTIONS The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (−30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN, SIZE, DURATION This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS, SETTING, METHODS Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTEREST(S) This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE 2 January 2019 DATE OF FIRST PATIENT’S ENROLMENT First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.

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: To investigate Dutch women's attitudes and preferences towards hysterectomy or uterus preservation in surgical treatment of pelvic organ prolapse. Study design: Women's attitude was assessed by a structured questionnaire in one university hospital and one non-university teaching hospital in the Netherlands. Between December 2013 and November 2014, 102 women referred with prolapse complaints, without previous prolapse surgery, responded to the questionnaire received by mail prior to gynaecological consultation. Main outcome was the preference for uterus preserving surgery versus hysterectomy. Furthermore we studied the impact of uterus preservation and hysterectomy on body image and sexual function and the importance of treatment success, risk of urinary incontinence after surgery, complication risk, recovery time, length of hospital stay, costs and the risk of developing endometrial cancer. Results: Assuming that functional and anatomical outcomes after hysterectomy and uterus preserving surgery were equal, more women expressed preference for uterus preservation (43%, 44 out of 102 women) compared to hysterectomy (27%, 27 out of 102 women). The majority of women expected a similar improvement in sexuality and body image after the two treatment modalities. Treatment success, risk for urinary incontinence after surgery and complication risk were the most important factors. Taken the future risk of endometrial cancer into account, 18% of the women preferred hysterectomy because of this risk. Conclusions: This study demonstrated that women referred with prolapse complaints have a preference for uterus preservation in case outcomes after both interventions are expected to be equal. The majority of women expected that body image and sexual function would equally improve after both interventions. (C) 2017 Elsevier B.V. All rights reserved.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to compare the functional outcomes after pessary treatment and after prolapse surgery as primary treatments for pelvic organ prolapse (POP).METHODS: This was a prospective cohort study performed in a Dutch teaching hospital in women with symptomatic POP of stage II or higher requiring treatment. Patients were treated according to their preference with a pessary or prolapse surgery. The primary endpoint was disease-specific quality of life at 12 months follow-up according to the prolapse domain of the Urogenital Distress Inventory (UDI) questionnaire. Secondary outcomes included adverse events and additional interventions. To show a difference of ten points in the primary outcome, we needed to randomize 80 women (power 80%, α 0.05, taking 10% attrition into account).RESULTS: We included 113 women (74 in the pessary group, 39 in the surgery group). After 12 months, the median prolapse domain score was 0 (10th to 90th percentile 0-33) in the pessary group and 0 (10th to 90th percentile 0-0) in the surgery group (p < 0.01). Differences in other domain scores were not statistically significant. In the pessary group, 28% (21/74) of the women had a surgical intervention versus 3% (1/39) reoperations in the surgery group (p = 0.01).CONCLUSIONS: In women with POP of stage II or higher undergoing surgery, prolapse symptoms were less severe than in those who were treated with a pessary, but 72% of women who were treated with a pessary did not opt for surgery.TRIAL REGISTRATION NUMBER: Dutch trial register NTR2856.

Objective: To assess the effectiveness of curettage versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Study design: We conducted a multicenter cohort study alongside a randomized clinical trial (RCT) between June 2012 until July 2014. 27 Dutch hospitals participated. Women with an incomplete evacuation after misoprostol treatment for first trimester miscarriage who declined to participate in the RCT, received treatment of their preference; curettage (n = 65) or expectant management (n = 132). A successful outcome was defined as an empty uterus on sonography at six weeks or uneventful clinical follow-up. We furthermore assessed complication rate and (re)intervention rateResults: Of the 197 women who declined to participate in the RCT, 65 preferred curettage and 132 expectant management. A successful outcome was observed in 62/65 women (95%) in the surgical group versus 112/132 women (85%) in the expectant group (RR 1.1, 95% CI 1.03-1.2), with complication rates of 6.2% versus 2.3%, respectively (RR 2.7, 95% CI 0.6-12).Conclusion: In women with an incomplete evacuation of the uterus after misoprostol treatment, expectant management is an effective and safe option. This finding could restrain the use of curettage in women that have used misoprostol in the treatment of first trimester miscarriage. (C) 2017 Elsevier B.V. All rights reserved.

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.