Treatment of women with heavy menstrual bleeding:Results of a prospective cohort study alongside a randomised controlled trial

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

Women’s preference for laparoscopic or abdominal hysterectomy

In the present study, women’s preferences on advantages and disadvantages of laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH) have been studied. Patients’ preferences were evaluated in individual, structured interviews in women scheduled for hysterectomy and questionnaires in nurses. Forty-three patients and 39 nurses were included. After general information, 84% of patients and 74% of nurses preferred LH over AH. This preference did not change after supplying more detailed information or after hysterectomy. The avoidance of complications was indicated as the most important factor in the decision. More than half of the women evaluated a difference of 1% as the maximum acceptable risk of major complications. When confronted with scenarios based on current evidence, both patients and nurses prefer LH over AH. This study supports further implementation of LH in clinical practice. The actual major complication rate in hysterectomy, however, is perceived as high

Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

Acknowledgments: We thank all the women who participated in this trial; the participating general practitioners, gynecologists, and hospitals; the research nurses; and the staff of the Dutch Consortium for Studies in Women’s Health and Reproduction.Peer reviewedPublisher PD

Pregnancy in a Patient with an Intra-Abdominal Levonorgestrel-Releasing Intrauterine System

Background: The levonorgestrel-releasing-intrauterine system (LNG-IUS) is a frequently used method of contraception worldwide. A rare, but bothersome complication of the LNG-IUS is a perforation of the uterus after insertion. Knowledge about the preferred management option in case of an intra-abdominally situated LNG-IUS during pregnancy is lacking. Case: This case report concerns a 33-year-old patient who became pregnant despite having an intra-abdominally situated LNG-IUS. The patient was counseled about the management options. The advantages and disadvantages of expectant management versus laparoscopic removal of the LNG-IUS were discussed, and the patient preferred removal of the IUS. The procedure was performed laparoscopically at 15 weeks of pregnancy. Results: The IUS was removed without complications, and the patient's pregnancy proceeded uneventfully. Conclusions: Considering the degree of evidence, it is important to make a tailor-made decision in case of a pregnancy with a perforated LNG-IUS

Endometrial SamPling befoRe or aftEr Saline infusion SOnography (ESPRESSO Trial):a national survey and a study protocol of a multicenter RCT

Postmenopausal bleeding can be the first clinical sign of an endometrial abnormality. Because of an increased risk of malignancy, evaluation is advocated. Polyps are reported up to 40% in women with postmenopausal bleeding. These polyps carry a risk of 6% for a focal (pre-) malignancy. To perform complete diagnostic work-up, recent guidelines recommend endometrial sampling and a saline infusion sonography if a previous transvaginal ultrasound shows an endometrial thickness of more than 4 mm. The current guideline shows no consensus of the sequence of both diagnostic procedures. Hypothetically, the fluid of the saline infusion sonography (SIS) could affect the quality of the endometrial sample. We designed a randomized trial (the ESPRESSO Trial; Trial Registration No. NTR5690) to investigate the quality of the endometrial sample (Pipelle®) when performed before or after SIS in postmenopausal women. We will perform a randomized trial comparing two diagnostic work-ups (SIS and subsequent Pipelle® versus Pipelle® and subsequent SIS) in women with postmenopausal bleeding. The study will be performed in one teaching and one Academic hospital in the Netherlands. Women with postmenopausal bleeding and an endometrial thickness of more than 4 mm are eligible. The gynecologist will evaluate quality of the SIS and the quality of the Pipelle® will be evaluated by a pathologist (possible to diagnose or not). Furthermore, the incidence and intensity of pain will be evaluated. The results will give insight whether the quality of the Pipelle® is influenced by the SIS or not

The pre-operative assessment of the adnexal mass: the accuracy of clinical estimates versus clinical prediction rules

Objective To evaluate the reproducibility of the clinical judgement of gynaecologists, gynaecologists in training and gynaecologic oncologists and to compare the predictive performance of the offhand assessment with the predictive performance of existing mathematical models for the pre-operative assessment of the adnexal mass. Design Questionnaire with paper cases of women operated on for an adnexal mass. Setting Gynaecological unit in a teaching hospital in the South of The Netherlands. Population Women who underwent surgery for adnexal mass between January 1991 and December 1998. Methods We offered 45 gynaecologists five different sets of 34 cases, with data on female age and menopausal status, a written description of the sonography, Doppler flow measurement and serum CA125 measurement. Nine observers for every set were asked to estimate the probability of malignancy. Main outcome measures The reproducibility of the risk estimates as made by the participants was expressed with an intraclass correlation coefficients. The accuracy of the judgement of the clinicians and the result of mathematical models in the prediction of malignancy were expressed with sensitivity, specificity and receiver-operating characteristic curves. Results Neither clinically relevant nor statistically significant differences could be found between the accuracy of the risk assessments made by the clinicians and the accuracy of the risk assessments made by prediction models. Conclusion This study demonstrates that at this moment there is no need to introduce complicated predictive scoring systems such as neural networks or logistic regression models for the pre-operative assessment of the adnexal masse

Patients' preferences in mode of surgery of an adnexal mass

Objective. We assessed the preferences of women with an adnexal mass for the mode of surgery. Methods. A structured interview was designed in which women, scheduled for surgery for an adnexal mass, were confronted with fictive scenarios of the different approaches. Women were asked at what probability of a false negative test result of frozen section diagnosis they would prefer frozen section diagnosis over primary radical surgery. Furthermore, the women were asked at what probability of ovarian malignancy they would prefer laparoscopy over laparotomy. Results. We interviewed 43 women. When the probability of frozen section diagnosis being false negative was set at 90%, 97% of the women preferred primary radical surgery. The mean threshold at which women switched their preference from primary radical surgery to frozen section diagnosis was at a risk of 49% on a false negative test result of frozen section diagnosis. In the choice between laparoscopy over laparotomy, the mean threshold at which the women switched their preference from laparoscopy to laparotomy was at a risk of 55% on ovarian malignancy. Conclusion. Women scheduled for surgery of an adnexal mass at low risk of ovarian malignancy, prefer frozen section diagnosis over primary radical surgery and prefer laparoscopy over laparotom

Predictive factors for failure of the levonorgestrel releasing intrauterine system in women with heavy menstrual bleeding

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