ESGO/ESHRE/ESGE Guidelines for the fertility-sparing treatment of patients with endometrial carcinoma.

The standard surgical treatment of endometrial carcinoma, consisting of total hysterectomy with bilateral salpingo-oophorectomy, drastically affects the quality of life of patients and creates a challenge for clinicians. Recent evidence-based guidelines of the European Society of Gynaecological Oncology (ESGO), the European SocieTy for Radiotherapy and Oncology (ESTRO), and the European Society of Pathology (ESP) provide comprehensive information on all relevant issues of diagnosis and treatment in endometrial carcinoma in a multidisciplinary setting. While addressing also work-up for fertility preservation treatments and the management and follow-up for fertility preservation, it was considered relevant to further extend the guidance on fertility-sparing treatment.A collaboration was set up between the ESGO, the European Society of Human Reproduction and Embryology (ESHRE), and the European Society for Gynaecological Endoscopy (ESGE), aiming to develop clinically relevant and evidence-based guidelines focusing on key aspects of fertility-sparing treatment (patient selection, tumor clinicopathological characteristics, treatment, special issues) in order to improve the quality of care for women with endometrial carcinoma across Europe and worldwide.ESGO/ESHRE/ESGE nominated an international multidisciplinary development group consisting of practicing clinicians and researchers who have demonstrated leadership and expertise in the care and research of endometrial carcinoma (11 experts from across Europe). To ensure that the guidelines are evidence-based, the literature published since 2016, identified by a systematic search, was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the development group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 95 independent international practitioners in cancer care delivery and patient representatives.

ESGO/ESHRE/ESGE Guidelines for the fertility-sparing treatment of patients with endometrial carcinoma.

STUDY QUESTION: How should fertility-sparing treatment of patients with endometrial carcinoma be performed? SUMMARY ANSWER: Forty-eight recommendations were formulated on fertility-sparing treatment of patients with endometrial carcinoma. WHAT IS KNOWN ALREADY: The standard surgical treatment of endometrial carcinoma consisting of total hysterectomy with bilateral salpingo-oophorectomy drastically affects the quality of life of patients and creates a challenge for clinicians. Recent evidence-based guidelines of the European Society of Gynaecological Oncology (ESGO), the European SocieTy for Radiotherapy & Oncology (ESTRO) and the European Society of Pathology (ESP) provide comprehensive guidelines on all relevant issues of diagnosis and treatment in endometrial carcinoma in a multidisciplinary setting. While addressing also work-up for fertility preservation treatments and the management and follow-up for fertility preservation, it was considered relevant to further extend the guidance on fertility-sparing treatment. STUDY DESIGN SIZE DURATION: A collaboration was set up between the ESGO, the European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE), aiming to develop clinically relevant and evidence-based guidelines focusing on key aspects of fertility-sparing treatment in order to improve the quality of care for women with endometrial carcinoma across Europe and worldwide. PARTICIPANTS/MATERIALS SETTING METHODS: ESGO/ESHRE/ESGE nominated an international multidisciplinary development group consisting of practising clinicians and researchers who have demonstrated leadership and expertise in the care and research of endometrial carcinoma (11 experts across Europe). To ensure that the guidelines are evidence-based, the literature published since 2016, identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgement was based on the professional experience and consensus of the development group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 95 independent international practitioners in cancer care delivery and patient representatives. MAIN RESULTS AND THE ROLE OF CHANCE: The multidisciplinary development group formulated 48 recommendations in four sections; patient selection, tumour clinicopathological characteristics, treatment and special issues. LIMITATIONS REASONS FOR CAUTION: Of the 48 recommendations, none could be based on level I evidence and only 16 could be based on level II evidence, implicating that 66% of the recommendations are supported only by observational data, professional experience and consensus of the development group. WIDER IMPLICATIONS OF THE FINDINGS: These recommendations provide guidance to professionals caring for women with endometrial carcinoma, including but not limited to professionals in the field of gynaecological oncology, onco-fertility, reproductive surgery, endoscopy, conservative surgery and histopathology, and will help towards a holistic and multidisciplinary approach for this challenging clinical scenario. STUDY FUNDING/COMPETING INTERESTS: All costs relating to the development process were covered from ESGO, ESHRE and ESGE funds. There was no external funding of the development process or manuscript production. G.S. has reported grants from MSD Italia S.r.l., advisory boards for Storz, Bayer, Astrazeneca, Metronic, TESARO Bio Italy S.r.l and Johnson & Johnson, and honoraria for lectures from Clovis Oncology Italy S.r.l. M.G. has reported advisory boards for Gedeon Richter and Merck. The other authors have reported no conflicts of interest. DISCLAIMER: This document represents the views of ESHRE, ESGO and ESGE which are the result of consensus between the relevant stakeholders and where relevant based on the scientific evidence available at the time of preparation. The recommendations should be used for informational and educational purposes. They should not be interpreted as setting a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. They do not replace the need for application of clinical judgement to each individual presentation, nor variations based on locality and facility type.

Particulate matter generated during monopolar and bipolar hysteroscopic human uterine tissue vaporization.

STUDY OBJECTIVE: To characterize the insoluble particulate matter generated during hysteroscopic monopolar and bipolar electrosurgery. DESIGN: In vitro comparative study (Canadian Task Force Classification II-1). SETTING: Teaching hospital. PATIENTS: Eight patients undergoing hysterectomy with benign indications. INTERVENTION: Tissue blocks were divided, and 1g of tissue was vaporized using a monopolar and a bipolar vaporizing electrode. MEASUREMENTS AND MAIN RESULTS: The particles were examined at light microscopy to study their morphologic features. Particle analysis was carried out using a laser diffraction particle analyser. Monopolar uterine tissue vaporization generated particles of a smaller median diameter than did bipolar vaporization (0.13 microm and 0.25 microm, respectively). The distribution by particle surface area in both instruments seems to be complex, with peaks at 0.35 and 4.0 microm for monopolar-generated particles and 0.5 and 5.0 microm for bipolar-generated particles. Another smaller peak with larger particles produced by both instruments was identified at 30 microm. During monopolar uterine tissue vaporization, 9.96% of particles generated were smaller than 5 microm, whereas during bipolar vaporization, 3.81% of particles were smaller than 5 microm (p = .01). CONCLUSION: Particulate matter generated during hysteroscopic electrosurgical vaporization using monopolar and bipolar instruments is heterodisperse and complex in shape. Monopolar vaporization results in particles of a smaller median diameter compared with bipolar vaporization. Both instruments generate 2 distinct populations of particles by surface area. The distribution of particles by volume during hysteroscopic electrosurgery is complex.

Rate, type, and cost of invasive interventions for uterine myomas in Germany, France, and England.

STUDY OBJECTIVE: The objective of our study was to quantify the rate, type, and cost of interventions for uterine myomas to payers in Germany, France, and England. DESIGN: Computations using data from national hospital activity databases. DESIGN CLASSIFICATION: II-3. SETTING: Hospital admissions in Germany, France, and England. PATIENTS: Women admitted for a surgical or radiologic intervention for uterine myomas. INTERVENTIONS: Surgical or radiologic interventions for uterine myomas. MEASUREMENTS AND MAIN RESULTS: We identified the number and type of hospital admissions involving surgical or radiologic interventions for uterine myomas, through the analysis of national hospital activity databases from each country. We calculated the costs of these hospitalizations to payers in these countries using the diagnosis-related group reimbursement rates. In 2005, the number (rate) of hospital admissions involving interventions for uterine myomas was 64 299 (1.53/1000 women) in Germany, 37 787 (1.17/1000 women) in France, and 18 274 (0.71/1000 women) in England. The annual costs of these interventions to payers were euro212 313 090 in Germany, euro73 278 270 in France (excluding surgeon and anesthetist fees for interventions in the private sector), and euro52 674 672 in England. The percentage of interventions for uterine myomas that included a hysterectomy was 84.9% in Germany, 59.7% in France, and 64.1% in England. CONCLUSION: The number of admissions and costs associated with interventions for uterine myomas are substantial in the 3 European countries studied. Hysterectomy is the most frequent surgical intervention used to treat uterine myomas. The results in this article provide useful information for policy makers wishing to evaluate the cost effectiveness and budget impact of new, less invasive interventions.

Balloon endometrial ablation under hysteroscopic control of septate uterus complicated by postcesarean scar defect.

Use of second-generation endometrial ablation devices has largely supplanted hysteroscopic resection and rollerball ablation for treatment of menorrhagia. Pathology of the uterus may be diagnosed immediately before endometrial ablation procedure using these newer instruments, making the chosen device inappropriate and requiring a change in planned procedure. Preprocedural assessment with 1 or a combination of transvaginal ultrasound (TVS), saline-infusion sonography, and hysteroscopy is necessary to identify suitability for preferred technique. TVS is frequently used as the only investigation to assess uterine cavity, and undiagnosed or missed pathology on TVS may render chosen endometrial ablation procedure inappropriate. Previously undiagnosed septate uterus and postcesarean scar defect were diagnosed at hysteroscopy immediately before endometrial ablation, but missed by routine TVS. Balloon endometrial ablation in the septate uterus was used.

Hysteroscopic endometrial ablation using the Hydro ThermAblator in an outpatient hysteroscopy clinic: feasibility and acceptability.

STUDY OBJECTIVE: To assess the feasibility and patient acceptability of global endometrial ablation using the Hydro ThermAblator (HTA) in an outpatient hysteroscopy clinic setting under local anaesthesia. DESIGN: A prospective cohort study (Canadian Task Force classification II-2). SETTING: University hospital in the United Kingdom. PATIENTS: Forty patients with medication-resistant menorrhagia. INTERVENTION: Oral mefenamic acid was administered 8 hours before the procedure. A combined cervical/paracervical block using lignocaine 1% adrenaline 1:200,000 was used before hysteroscopic endometrial ablation using the HTA device. MEASUREMENTS AND MAIN RESULTS: A successful procedure was defined as a completed HTA treatment cycle. Failure was defined as premature termination or inability to carry out the HTA procedure after scheduling the patient. Pain scores were estimated at three stages during and after the procedure using a visual-analog scale. A questionnaire was used before discharge to assess acceptability. Forty patients were successfully treated. The median pain score during the ablation was 6.4 (range 4.0-8.9). Eighty-eight percent of patients found the procedure acceptable. No serious complications occurred. All patients were discharged home within 2 hours of the procedure. CONCLUSION: Selected patients suffering from menorrhagia may be treated with the HTA device using local anesthesia in an outpatient setting.

Intraoperative and postoperative lower genital tract changes after global endometrial ablation using the Hydro ThermAblator device.

OBJECTIVE: To identify any heat transfer areas in the lower genital tract during a Hydro ThermAblator (HTA) (BEI Medical Systems) procedure and to characterize the changes in the cervix that occur in the immediate weeks after an HTA treatment. DESIGN: A prospective cohort study (Canadian Task Force classification II-3). SETTING: A university hospital in the United Kingdom. PATIENT(S): Twenty-five patients with menorrhagia. INTERVENTION(S): All patients underwent global endometrial ablation using the HTA device. Infrared thermal camera imaging of the lower genital tract was performed per-operatively, and colposcopic examinations of the cervix were performed at 2 and 4 weeks after the operation. MAIN OUTCOME MEASURE(S): The surface temperature rise of the cervix and vagina during a procedure. RESULT(S): Thermal temperature measurements of the lower genital tract in five patients and colposcopic examination at 2 and 4 weeks after the procedure. The maximum temperatures recorded during a procedure were those of the cervix, reaching 36.5 degrees C. Colposcopic images at 2 weeks showed that 15% of patients had a whitish discoloration of the cervix. At 4 weeks, the appearance of the cervix was normal. CONCLUSION(S): This study shows that during an HTA treatment cycle using a bivalve speculum to visualize the cervix, no area of the lower genital tract reaches a temperature at which thermal damage may occur. A whitish change in the cervix at 2 weeks is normal, and the lower genital tract should appear normal 4 weeks after the procedure.