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The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and International Deep Endometriosis Analysis (IDEA) group, the European Endometriosis League (EEL), the European Society for Gynaecological Endoscopy (ESGE), the European Society of Human Reproduction and Embryology (ESHRE), the International Society for Gynecologic Endoscopy (ISGE), the American Association of Gynecologic Laparoscopists (AAGL) and the European Society of Urogenital Radiology (ESUR) elected an international, multidisciplinary panel of gynecological surgeons, sonographers and radiologists, including a steering committee, which searched the literature for relevant articles in order to review the literature and provide evidence-based and clinically relevant statements on the use of imaging techniques for non-invasive diagnosis and classification of pelvic deep endometriosis. Preliminary statements were drafted based on review of the relevant literature. Following two rounds of revisions and voting orchestrated by chairs of the participating societies, consensus statements were finalized. A final version of the document was then resubmitted to the society chairs for approval. Twenty statements were drafted, of which 14 reached strong and three moderate agreement after the first voting round. The remaining three statements were discussed by all members of the steering committee and society chairs and rephrased, followed by an additional round of voting. At the conclusion of the process, 14 statements had strong and five statements moderate agreement, with one statement left in equipoise. This consensus work aims to guide clinicians involved in treating women with suspected endometriosis during patient assessment, counseling and planning of surgical treatment strategies. © 2024 The Authors. Published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology, by Universa Press, by The International Society for Gynecologic Endoscopy, by Oxford University Press on behalf of European Society of Human Reproduction and Embryology, by Elsevier Inc. on behalf of American Association of Gynecologic Laparoscopists and by Elsevier B.V.
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Endometriosis , Humanos , Endometriosis/diagnóstico por imagen , Endometriosis/clasificación , Femenino , Pelvis/diagnóstico por imagen , Ultrasonografía/métodos , Consenso , Imagen por Resonancia Magnética/métodos , Sociedades MédicasRESUMEN
STUDY QUESTION: What outcomes should be reported in all studies investigating uterus-sparing interventions for treating uterine adenomyosis? SUMMARY ANSWER: We identified 24 specific and 26 generic core outcomes in nine domains. WHAT IS KNOWN ALREADY: Research reporting adenomyosis treatment is not patient-centred and shows wide variation in outcome selection, definition, reporting and measurement of quality. STUDY DESIGN, SIZE, DURATION: An international consensus development process was performed between March and December 2021. Participants in round one were 150 healthcare professionals, 17 researchers and 334 individuals or partners with lived experience of adenomyosis from 48 high-, middle- and low-income countries. There were 291 participants in the second round. PARTICIPANTS/MATERIALS, SETTING, METHODS: Stakeholders included active researchers in the field, healthcare professionals involved in diagnosis and treatment, and people and their partners with lived experience of adenomyosis. The core component of the process was a 2-step modified Delphi electronic survey. The Steering Committee analysed the results and created the final core outcome set (COS) in a semi-structured meeting. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 241 outcomes was identified and distilled into a 'long list' of 71 potential outcomes. The final COS comprises 24 specific and 26 generic core outcomes across nine domains, including pain, uterine bleeding, reproductive outcomes, haematology, urinary system, life impact, delivery of care, adverse events and reporting items, all with definitions provided by the Steering Committee. Nineteen of these outcomes will apply only to certain study types. Although not included in the COS, the Steering Committee recommended that three health economic outcomes should be recorded. LIMITATIONS, REASONS FOR CAUTION: Patients from continents other than Europe were under-represented in this survey. A lack of translation of the survey might have limited the active participation of people in non-English speaking countries. Only 58% of participants returned to round two, but analysis did not indicate attrition bias. There is a significant lack of scientific evidence regarding which symptoms are caused by adenomyosis and when they are related to other co-existent disorders such as endometriosis. As future research provides more clarity, the appropriate review and revision of the COS will be necessary. WIDER IMPLICATIONS OF THE FINDINGS: Implementing this COS in future studies on the treatment of adenomyosis will improve the quality of reporting and aid evidence synthesis. STUDY FUNDING/COMPETING INTEREST(S): No specific funding was received for this work. T.T. received a grant (grant number 2020083) from the South Eastern Norwegian Health Authority during the course of this work. T.T. receives personal fees from General Electrics and Medtronic for lectures on ultrasound. E.R.L. is the chairman of the Norwegian Endometriosis Association. M.G.M. is a consultant for Abbvie Inc and Myovant, receives research funding from AbbVie and is Chair of the Women's Health Research Collaborative. S.-W.G. is a board member of the Asian Society of Endometriosis and Adenomyosis, on the scientific advisory board of the endometriosis foundation of America, previous congress chair for the World Endometriosis Society, for none of which he received personal fees. E.S. received outside of this work grants for two multicentre trials on endometriosis from the National Institute for Health Research UK, the Rosetrees Trust, and the Barts and the London Charity, he is a member of the Medicines and Healthcare Products Regulatory Agency (MHRA), Medicines for Women's Health Expert Advisory Group, he is an ambassador for the World Endometriosis Society, and he received personal fees for lectures from Hologic, Olympus, Medtronic, Johnson & Johnson, Intuitive and Karl Storz. M.H. is member of the British Society for Gynaecological Endoscopy subcommittee. No other conflict of interest was declared. TRIAL REGISTRATION NUMBER: N/A.
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Adenomiosis , Endometriosis , Adenomiosis/terapia , Consenso , Técnica Delphi , Endometriosis/terapia , Femenino , Humanos , Masculino , Evaluación de Resultado en la Atención de Salud , ÚteroRESUMEN
OBJECTIVE: To assess the prevalence and morphological appearance of deep endometriosis and ovarian endometrioma using pelvic ultrasound examination in women attending for an early pregnancy assessment. METHODS: This was a prospective observational study set within a dedicated early pregnancy unit. The study included 1341 consecutive women who attended for an early pregnancy assessment for reassurance or because of suspected early pregnancy complications. All women underwent a transvaginal scan to assess the location and viability of their pregnancy. In addition, a detailed examination of pelvic organs was carried out to detect the presence of endometriosis and other gynecological abnormalities. Data analysis was performed using logistic regression and multivariable analysis. RESULTS: The prevalence of deep endometriosis and/or ovarian endometrioma in women attending our early pregnancy unit was 4.9% (95% CI, 3.8-6.2%). In 33/66 (50.0% (95% CI, 37.9-62.1%)) women with endometriosis, this was a new diagnosis that was made during their early pregnancy scan. On multivariable analysis, the presence of endometriosis was strongly associated with a history of subfertility (odds ratio (OR), 3.15 (95% CI, 1.63-6.07)) and presence of a congenital uterine anomaly (OR, 5.69 (95% CI, 2.17-14.9)) and uterine fibroids (OR, 2.37 (95% CI, 1.31-4.28)). Morphological changes typical of decidualization were seen in 11/33 (33.3% (95% CI, 17.2-49.4%)) women with ovarian endometrioma and 18/57 (31.6% (95% CI, 19.5-43.7%)) women with deep endometriotic nodules. CONCLUSIONS: Deep endometriosis and ovarian endometrioma were present in a significant proportion of women attending for early pregnancy assessment. The prevalence varied depending on a history of subfertility, and therefore is likely to differ significantly among populations, depending on their characteristics. Ultrasound is a useful tool for the detection of endometriosis in early pregnancy and the identification of women who may benefit from specialist antenatal care. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.
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Endometriosis/epidemiología , Enfermedades del Ovario/epidemiología , Complicaciones del Embarazo/epidemiología , Ultrasonografía Prenatal , Adulto , Endometriosis/diagnóstico por imagen , Endometriosis/patología , Femenino , Humanos , Infertilidad Femenina/complicaciones , Infertilidad Femenina/epidemiología , Oportunidad Relativa , Enfermedades del Ovario/diagnóstico por imagen , Enfermedades del Ovario/patología , Embarazo , Complicaciones del Embarazo/diagnóstico por imagen , Complicaciones del Embarazo/patología , Prevalencia , Estudios Prospectivos , Anomalías Urogenitales/diagnóstico por imagen , Anomalías Urogenitales/epidemiología , Útero/anomalías , Útero/diagnóstico por imagenRESUMEN
OBJECTIVE: To describe the clinical and ultrasound characteristics of accessory cavitated uterine malformations (ACUMs). METHODS: This was a single-center observational study of consecutive patients diagnosed with an ACUM, who had undergone an ultrasound examination by an experienced ultrasound examiner between January 2013 and May 2019, identified retrospectively from medical records. ACUM was diagnosed when a cavitated lesion with a myometrial mantle and echogenic contents was seen within the anterolateral wall of the myometrium beneath the insertion of the round ligament. In all women, presenting symptoms and clinical history were recorded along with detailed descriptions of the lesions and any concomitant pelvic abnormalities. RESULTS: Twenty patients diagnosed with an ACUM were identified. Median age was 29.2 (interquartile range, 25.0-35.8) years. None of the women was premenarchal or postmenopausal. All of the women reported painful periods or pelvic pain and none of them reported subfertility. Twelve of the ACUMs were in the right anterolateral myometrium and eight were in the left anterolateral myometrium. Both a myometrial mantle and a fluid-filled cavity were considered to be defining features on ultrasound. The fluid contained within the cavity was either echogenic with a ground-glass appearance or hyperechoic. All of the lesions were spherical in shape. The Doppler flow seen in the outer rim was not markedly different from that of the surrounding myometrium, and the content of the cavity was avascular on Doppler examination. The mean outer cavity diameter of the ACUMs was 22.8 (95% CI, 20.9-24.8) mm and the mean internal cavity diameter was 14.1 (95% CI, 12.2-16.1) mm. Four women opted for transvaginal ultrasound-guided alcohol sclerotherapy. Surgical excision was carried out in eight cases, and the diagnosis was confirmed on histopathological examination in all of them. CONCLUSIONS: ACUMs are a uterine abnormality with a distinct ultrasound appearance, which are associated with dysmenorrhea and chronic pelvic pain. Knowledge of their typical appearance on ultrasound could facilitate early detection and treatment. There are several treatment options for ACUM, ranging from simple analgesia to complete excision. Further prospective and longitudinal studies are required to study the prevalence and natural history of this condition. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.
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Ecocardiografía Doppler , Miometrio/anomalías , Anomalías Urogenitales/diagnóstico por imagen , Útero/anomalías , Adulto , Dolor Crónico/congénito , Dolor Crónico/diagnóstico por imagen , Dismenorrea/congénito , Dismenorrea/diagnóstico por imagen , Femenino , Humanos , Miometrio/diagnóstico por imagen , Dolor Pélvico/congénito , Dolor Pélvico/diagnóstico por imagen , Estudios Retrospectivos , Ligamento Redondo del Útero/diagnóstico por imagen , Anomalías Urogenitales/complicaciones , Útero/diagnóstico por imagenRESUMEN
OBJECTIVES: To identify uterine measurements that are reliable and accurate to distinguish between T-shaped and normal/arcuate uterus, and define T-shaped uterus, using Congenital Uterine Malformation by Experts (CUME) methodology, which uses as reference standard the decision made most often by several independent experts. METHODS: This was a prospectively planned multirater reliability/agreement and diagnostic accuracy study, performed between November 2017 and December 2018, using a sample of 100 three-dimensional (3D) datasets of different uteri with lateral uterine cavity indentations, acquired from consecutive women between 2014 and 2016. Fifteen representative experts (five clinicians, five surgeons and five sonologists), blinded to each others' opinions, examined anonymized images of the coronal plane of each uterus and provided their independent opinion as to whether it was T-shaped or normal/arcuate; this formed the basis of the CUME reference standard, with the decision made most often (i.e. that chosen by eight or more of the 15 experts) for each uterus being considered the correct diagnosis for that uterus. Two other experienced observers, also blinded to the opinions of the other experts, then performed independently 15 sonographic measurements, using the original 3D datasets of each uterus. Agreement between the diagnoses made by the 15 experts was assessed using kappa and percent agreement. The interobserver reliability of measurements was assessed using the concordance correlation coefficient (CCC). The diagnostic test accuracy was assessed using the area under the receiver-operating-characteristics curve (AUC) and the best cut-off value was assessed by calculating Youden's index, according to the CUME reference standard. Sensitivity, specificity, negative and positive likelihood ratios (LR- and LR+) and post-test probability were calculated. RESULTS: According to the CUME reference standard, there were 20 T-shaped and 80 normal/arcuate uteri. Individual experts recognized between 5 and 35 (median, 19) T-shaped uteri on subjective judgment. The agreement among experts was 82% (kappa = 0.43). Three of the 15 sonographic measurements were identified as having good diagnostic test accuracy, according to the CUME reference standard: lateral indentation angle (AUC = 0.95), lateral internal indentation depth (AUC = 0.92) and T-angle (AUC = 0.87). Of these, T-angle had the best interobserver reproducibility (CCC = 0.87 vs 0.82 vs 0.62 for T-angle vs lateral indentation depth vs lateral indentation angle). The best cut-off values for these measurements were: lateral indentation angle ≤ 130° (sensitivity, 80%; specificity, 96%; LR+, 21.3; LR-, 0.21), lateral indentation depth ≥ 7 mm (sensitivity, 95%; specificity, 77.5%; LR+, 4.2; LR-, 0.06) and T-angle ≤ 40° (sensitivity, 80%; specificity, 87.5%; LR+, 6.4; LR-, 0.23). Most of the experts diagnosed the uterus as being T-shaped in 0% (0/56) of cases when none of these three criteria was met, in 10% (2/20) of cases when only one criterion was met, in 50% (5/10) of cases when two of the three criteria were met, and in 93% (13/14) of cases when all three criteria were met. CONCLUSIONS: The diagnosis of T-shaped uterus is not easy; the agreement among experts was only moderate and the judgement of individual experts was commonly insufficient for accurate diagnosis. The three sonographic measurements with cut-offs that we identified (lateral internal indentation depth ≥ 7 mm, lateral indentation angle ≤ 130° and T-angle ≤ 40°) had good diagnostic test accuracy and fair-to-moderate reliability and, when applied in combination, they provided high post-test probability for T-shaped uterus. In the absence of other anomalies, we suggest considering a uterus to be normal when none or only one criterion is met, borderline when two criteria are met, and T-shaped when all three criteria are met. These three CUME criteria for defining T-shaped uterus may aid in determination of its prevalence, clinical implications and best management and in the assessment of post-surgical morphologic outcome. The CUME definition of T-shaped uterus may help in the development of interventional randomized controlled trials and observational studies and in the diagnosis of uterine morphology in everyday practice, and could be adopted by guidelines on uterine anomalies to enrich their classification systems. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
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Ultrasonografía/estadística & datos numéricos , Anomalías Urogenitales/diagnóstico por imagen , Útero/anomalías , Adulto , Área Bajo la Curva , Femenino , Humanos , Funciones de Verosimilitud , Variaciones Dependientes del Observador , Embarazo , Estudios Prospectivos , Estándares de Referencia , Reproducibilidad de los Resultados , Proyectos de Investigación , Sensibilidad y Especificidad , Ultrasonografía/normas , Útero/diagnóstico por imagenRESUMEN
OBJECTIVE: To determine whether significant hemoperitoneum could be a precursor of deep pelvic endometriosis in non-pregnant premenopausal women presenting with severe acute lower abdominal pain. METHODS: This was a prospective observational cohort study carried out at a dedicated gynecological diagnostic unit over a period of 18 months. We included consecutive non-pregnant, premenopausal women who attended with severe acute lower abdominal pain and underwent a pelvic ultrasound examination. Women were triaged for surgical or conservative management depending on the cause of pain and severity of their symptoms. Those who were selected for conservative management were invited for follow-up ultrasound scans. The main outcome measure was evidence of newly developed deep endometriosis at follow-up examination. RESULTS: Of 118 non-pregnant women who attended our unit with severe acute lower abdominal pain, 20 underwent emergency surgery and 17 had a history of endometriosis, or evidence of endometriosis on the initial scan, and were excluded from the study. Therefore, conservative management was employed in 81 women, eight of whom had evidence of significant hemoperitoneum at presentation. A total of 35 women attended for all follow-up ultrasound scans. At the completion of follow-up, four of six (67% (95% CI, 22-96%)) women who presented initially with significant intra-abdominal bleeding had developed new evidence of deep endometriosis, compared with one of 29 (3% (95% CI, 0-18%)) of those without hemoperitoneum (relative risk, 19.3 (95% CI, 3-144); P < 0.001). CONCLUSION: In some women, the presence of significant hemoperitoneum that is managed conservatively precedes the development of deep endometriosis. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
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Dolor Abdominal/patología , Endometriosis/patología , Hemoperitoneo/patología , Dolor Abdominal/diagnóstico por imagen , Adolescente , Adulto , Tratamiento Conservador , Endometriosis/diagnóstico por imagen , Femenino , Hemoperitoneo/diagnóstico por imagen , Humanos , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Radiografía Abdominal , Adulto JovenRESUMEN
STUDY QUESTION: What would be a potential impact of implementing the new ESHRE/European Society of Gynaecological Endoscopy (ESGE) female genital anomalies classification system on the management of women with previous diagnosis of arcuate uteri based on the modified American Society for Reproductive Medicine (ASRM) criteria? SUMMARY ANSWER: A significant number of women with previous diagnosis of arcuate uteri are reclassified as having partial septate uteri according to the new ESHRE/ESGE classification system which may increase the number of remedial surgical procedures. WHAT IS KNOWN ALREADY: The ESHRE/ESGE classification system has defined measurement techniques, reference points and specific cut-offs to facilitate the differentiation between normal and septate uteri. These criteria have been arbitrarily defined and they rely on the measurement of uterine wall thickness and depth of distortion of uterine fundus. STUDY DESIGN, SIZE, DURATION: This was a retrospective cohort study. We searched our ultrasound clinic database from January 2011 to December 2014 to identify all women diagnosed with arcuate uterus on three-dimensional ultrasound according to the modified ASRM criteria. PARTICIPANTS/MATERIALS, SETTING, METHODS: For each woman, the ultrasound images were stored in our clinical database and they were re-examined according to ESHRE/ESGE specifications. The presence and location of all acquired uterine anomalies, such as fibroids or adenomyosis was noted. We applied the two diagnostic approaches as specified by the ESHRE/ESGE classification: the main option (MO) and the alternative option (AO). We used the Kappa statistic to quantify the agreement between the two approaches. We also compared the number of previous miscarriages in women with normal and partial septate uteri according to the ESHRE/ESGE classification. Non-parametric Mann-Whitney and Kruskal-Wallis tests were used for the analyses and receiver-operating characteristic curves were constructed to assess the predictive values of the calculated uterine distortion indices for the detection of women at risk of suffering multiple pregnancy losses. MAIN RESULTS AND THE ROLE OF CHANCE: We included 270 women diagnosed with arcuate uterus in the study. In all, 77 women (28.5%, 95% confidence interval (CI) 23.1-33.9) had evidence of fibroids or adenomyosis. These abnormalities precluded the application of either proposed ESHRE/ESGE techniques to assess uterine morphology in 25 women (9.3%, 95% CI 5.8-12.7). When using the MO, 138/237 (58.2%, 95% CI 51.9-64.3) women were diagnosed with partial septate uterus compared to 61/230 (26.5%, 95% CI 21.2-32.6) women when using the AO. In 222 women in whom we were able to apply both MO and AO, there was agreement in the diagnosis of septate uterus between the two techniques in 146/222 cases (65.8%, 95% CI 59.3-71.7; Kappa 0.42, 95%CI 0.35-0.5). There was no statistical difference in the proportion of women with history of previous multiple miscarriages between those diagnosed with normal or partial septate uteri using either MO (6.2%, 95% CI 2.9-12.9 vs. 9.5%, 95% CI 5.6-15.6; P = 0.47) or AO (7.2%, 95% CI 4.2-12.1 vs. 11.7%, 95% CI 5.8-22.2; P = 0.29). LIMITATIONS, REASONS FOR CAUTION: This study was retrospective in nature and the definition of arcuate uterus used in the study is not universally accepted. The reproductive history data were collected retrospectively and therefore may be prone to bias. WIDER IMPLICATIONS OF THE FINDINGS: There are methodological weaknesses in the new ESHRE/ESGE classification system which would need to be addressed in future revisions. There was no significant difference in the past reproductive outcomes between women diagnosed with normal and anomalous uteri and the clinicians should exercise caution when offering surgical correction to women diagnosed with partial septate uteri using the new ESHRE/ESGE classification. STUDY FUNDING/COMPETING INTEREST(S): No study funding was received and no competing interests are present. TRIAL REGISTRATION NUMBER: N/A.
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Anomalías Urogenitales/diagnóstico por imagen , Útero/anomalías , Adulto , Bases de Datos Factuales , Femenino , Humanos , Estudios Retrospectivos , Ultrasonografía , Útero/diagnóstico por imagenRESUMEN
OBJECTIVES: To assess the level of agreement between experts in distinguishing between septate and normal/arcuate uterus using their subjective judgment when reviewing the coronal view of the uterus from three-dimensional ultrasound. Another aim was to determine the interobserver reliability and diagnostic test accuracy of three measurements suggested by recent guidelines, using as reference standard the decision made most often by experts (Congenital Uterine Malformation by Experts (CUME)). METHODS: Images of the coronal plane of the uterus from 100 women with suspected fundal internal indentation were anonymized and provided to 15 experts (five clinicians, five surgeons and five sonologists). They were instructed to indicate whether they believed the uterus to be normal/arcuate (defined as normal uterine morphology or not clinically relevant degree of distortion caused by internal indentation) or septate (clinically relevant degree of distortion caused by internal indentation). Two other observers independently measured indentation depth, indentation angle and indentation-to-wall-thickness (I:WT) ratio. The agreement between experts was assessed using kappa, the interobserver reliability was assessed using the concordance correlation coefficient (CCC), the diagnostic test accuracy was assessed using the area under the receiver-operating characteristics curve (AUC) and the best cut-off value was assessed using Youden's index, considering as the reference standard the choice made most often by the experts (CUME). RESULTS: There was good agreement between all experts (kappa, 0.62). There were 18 septate and 82 normal/arcuate uteri according to CUME; European Society of Human Reproduction and Embryology (ESHRE)-European Society for Gynaecological Endoscopy (ESGE) criteria (I:WT ratio > 50%) defined 80 septate and 20 normal/arcuate uteri, while American Society for Reproductive Medicine (ASRM) criteria defined five septate (depth > 15 mm and angle < 90°), 82 normal/arcuate (depth < 10 mm and angle > 90°) and 13 uteri that could not be classified (referred to as the gray-zone). The agreement between ESHRE-ESGE and CUME was 38% (kappa, 0.1); the agreement between ASRM criteria and CUME for septate was 87% (kappa, 0.39), and considering both septate and gray-zone as septate, the agreement was 98% (kappa, 0.93). Among the three measurements, the interobserver reproducibility of indentation depth (CCC, 0.99; 95% CI, 0.98-0.99) was better than both indentation angle (CCC, 0.96; 95% CI, 0.94-0.97) and I:WT ratio (CCC, 0.92; 95% CI, 0.90-0.94). The diagnostic test accuracy of these three measurements using CUME as reference standard was very good, with AUC between 0.96 and 1.00. The best cut-off values for these measurements to define septate uterus were: indentation depth ≥ 10 mm, indentation angle < 140° and I:WT ratio > 110% . CONCLUSIONS: The suggested ESHRE-ESGE cut-off value overestimates the prevalence of septate uterus while that of ASRM underestimates this prevalence, leaving in the gray-zone most of the uteri that experts considered as septate. We recommend considering indentation depth ≥ 10 mm as septate, since the measurement is simple and reliable and this criterion is in agreement with expert opinion. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.
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Aborto Espontáneo/prevención & control , Medicina Reproductiva , Ultrasonografía , Anomalías Urogenitales/diagnóstico por imagen , Enfermedades Uterinas/diagnóstico por imagen , Útero/anomalías , Adulto , Femenino , Humanos , Histeroscopía , Embarazo , Estudios Prospectivos , Estándares de Referencia , Anomalías Urogenitales/fisiopatología , Enfermedades Uterinas/fisiopatología , Útero/diagnóstico por imagen , Útero/fisiopatologíaRESUMEN
STUDY QUESTION: Which essential items should be recorded before, during and after endometriosis surgery and in clinical outcome based surgical trials in patients with deep endometriosis (DE)? SUMMARY ANSWER: A DE surgical sheet (DESS) was developed for standardized reporting of the surgical treatment of DE and an international expert consensus proposal on relevant items that should be recorded in surgical outcome trials in women with DE. WHAT IS KNOWN ALREADY: Surgery is an important treatment for symptomatic DE. So far, data have been reported in such a way that comparison of different surgical techniques is impossible. Therefore, we present an international expert proposal for standardized reporting of surgical treatment and surgical outcome trials in women with DE. STUDY DESIGN, SIZE, DURATION: International expert consensus based on a systematic review of literature. PARTICIPANTS/MATERIALS, SETTING, METHODS: Taking into account recommendations from Consolidated Standards of Reporting Trials (CONSORT), the Innovation Development Exploration Assessment and Long-term Study (IDEAL), the Initiative on Methods, Measurement and Pain Assessment in Clinical trials (IMMPACT) and the World Endometriosis Research Foundation Phenome and Biobanking Harmonisation Project (WERF EPHect), a systematic literature review on surgical treatment of DE was performed and resulted in a proposal for standardized reporting, adapted by contributions from eight members of the multidisciplinary Leuven University Hospitals Endometriosis Care Program, from 18 international experts and from audience feedback during three international meetings. MAIN RESULTS AND THE ROLE OF CHANCE: We have developed the DESS to record in detail the surgical procedures for DE, and an international consensus on pre-, intra- and post-operative data that should be recorded in surgical outcome trials on DE. LIMITATIONS, REASONS FOR CAUTION: The recommendations in this paper represent a consensus among international experts based on a systematic review of the literature. For several items and recommendations, high-quality RCTs were not available. Further research is needed to validate and evaluate the recommendations presented here. WIDER IMPLICATIONS OF THE FINDINGS: This international expert consensus for standardized reporting of surgical treatment in women with DE, based on a systematic literature review and international consensus, can be used as a guideline to record and report surgical management of patients with DE and as a guideline to design, execute, interpret and compare clinical trials in this patient population. STUDY FUNDING/COMPETING INTERESTS: None of the authors received funding for the development of this paper. M.A. reports personal fees and non-financial support from Bayer Pharma outside the submitted work; H.T. reports a grant from Pfizer and personal fees for being on the advisory board of Perrigo, Abbvie, Allergan and SPD. TRIAL REGISTRATION NUMBER: N/A.
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Endometriosis/cirugía , Procedimientos Quirúrgicos Ginecológicos/métodos , Protocolos Clínicos , Consenso , Testimonio de Experto , Femenino , Humanos , Resultado del TratamientoRESUMEN
STUDY QUESTION: Is there any benefit to including the routine examination by ultrasound of the bladder, ureters and kidneys of women with endometriosis? SUMMARY ANSWER: The benefit of examination of the complete urinary tract of women with suspected endometriosis is that ureteric endometriosis, with or without hydronephrosis, can be detected which facilitates early intervention to prevent nephropathy. WHAT IS ALREADY KNOWN: Women with endometriosis can get ureteric obstruction but there is no clear consensus on the correct diagnostic technique. Ultrasound is accurate at detecting women with bladder endometriosis but ureteric involvement has not been assessed previously. STUDY DESIGN, SIZE, DURATION: This was a prospective observational study, conducted at a teaching hospital over a period of 14 months. A total of 848 women presenting with chronic pelvic pain were included into the study. PARTICIPANTS/MATERIALS, SETTING, METHODS: All women with chronic pelvic pain underwent a detailed transvaginal and transabdominal pelvic ultrasound examination to investigate possible causes of their symptoms. This included a systematic assessment of the urinary bladder, pelvic sections of the ureters and kidneys. The ultrasound findings were compared with findings at surgery and the results of targeted urological imaging and interventions. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 848 women presenting with chronic pelvic pain were included into the study. 28/848 women (3.3% 95% CI 2.1-4.5) had evidence of urinary tract abnormalities on initial ultrasound scan. Among these 17/848 (2.0% 95% CI 1.06-2.94) had evidence of urinary tract endometriosis, whilst 11/848 (1.3% 95% CI 0.54-2.06) women had other urinary tract abnormalities. Among women with urinary tract endometriosis 11/17 (65%) had evidence of ureteric involvement, 3/17 (18%) had both ureteric and bladder disease and 3/17 (18%) had bladder disease only. 12/17 (59%) women with urinary tract endometriosis also had evidence of hydronephrosis. The diagnosis of ureteral endometriosis had a sensitivity of 12/13 (92%) (95% CI 63.9-99.8), specificity 151/151 100% (95% CI 97.6-100), PPV 100% (95% CI 73.5-100), NPV 99.3% (95% CI 96.3-99.9%) LR- 0.08 (95% CI 0.01-0.39). LIMITATIONS, REASONS FOR CAUTION: The routine examination of the complete urinary tract including the distal ureters is a novel technique that should be evaluated in different populations. WIDER IMPLICATIONS OF THE FINDINGS: Ultrasound is an accurate test to diagnose urinary tract involvement in women with suspected pelvic endometriosis and examination of the complete urinary tract should become an integral part of ultrasound assessment of women with suspected endometriosis.
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Endometriosis/diagnóstico por imagen , Sistema Urinario/diagnóstico por imagen , Enfermedades Urológicas/diagnóstico por imagen , Adulto , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , UltrasonografíaRESUMEN
STUDY QUESTION: What is the optimal management of women with endometriosis based on the best available evidence in the literature? SUMMARY ANSWER: Using the structured methodology of the Manual for ESHRE Guideline Development, 83 recommendations were formulated that answered the 22 key questions on optimal management of women with endometriosis. WHAT IS KNOWN ALREADY: The European Society of Human Reproduction and Embryology (ESHRE) guideline for the diagnosis and treatment of endometriosis (2005) has been a reference point for best clinical care in endometriosis for years, but this guideline was in need of updating. STUDY DESIGN, SIZE, DURATION: This guideline was produced by a group of experts in the field using the methodology of the Manual for ESHRE Guideline Development, including a thorough systematic search of the literature, quality assessment of the included papers up to January 2012 and consensus within the guideline group on all recommendations. To ensure input from women with endometriosis, a patient representative was part of the guideline development group. In addition, patient and additional clinical input was collected during the scoping and review phase of the guideline. PARTICIPANTS/MATERIALS, SETTING, METHODS: NA. MAIN RESULTS AND THE ROLE OF CHANCE: The guideline provides 83 recommendations on diagnosis of endometriosis and on the treatment of endometriosis-associated pain and infertility, on the management of women in whom the disease is found incidentally (without pain or infertility), on prevention of recurrence of disease and/or painful symptoms, on treatment of menopausal symptoms in patients with a history of endometriosis and on the possible association of endometriosis and malignancy. LIMITATIONS, REASONS FOR CAUTION: We identified several areas in care of women with endometriosis for which robust evidence is lacking. These areas were addressed by formulating good practice points (GPP), based on the expert opinion of the guideline group members. WIDER IMPLICATIONS OF THE FINDINGS: Since 32 out of the 83 recommendations for the management of women with endometriosis could not be based on high level evidence and therefore were GPP, the guideline group formulated research recommendations to guide future research with the aim of increasing the body of evidence. STUDY FUNDING/COMPETING INTEREST(S): The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, with the literature searches and with the implementation of the guideline. The guideline group members did not receive payment. All guideline group members disclosed any relevant conflicts of interest (see Conflicts of interest). TRIAL REGISTRATION NUMBER: NA.
Asunto(s)
Endometriosis/terapia , Infertilidad Femenina/terapia , Adulto , Anticonceptivos Hormonales Orales/uso terapéutico , Endometriosis/diagnóstico , Femenino , Humanos , Laparoscopía , Dolor Pélvico/diagnóstico , Técnicas Reproductivas AsistidasRESUMEN
Background: The LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial comparing laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH) closed prematurely on the grounds of futility. Here we identify the challenges faced and lessons learnt. Objectives: To explore the views and experiences of clinical/research staff in order to understand how these might act as barriers to trial participation and recruitment. Materials and Methods: Review of the trial progress and collation of the views and experiences of clinical/ research staff on all aspects of the trial. Data were collected from transcribed conversations, email, phone, or video conferencing interactions and analysed descriptively. Main outcome measures: Site set-up milestones, recruitment rates and reasons provided by clinical/research staff for site's declining to participate. Opinions, preferences and experiences of clinicians/researchers and challenges to participation and recruitment. Results: The mean time from initial site contact to opening was 253 days and 68 days to randomise their first participant. 265 patients were screened from 13 sites over 13 months, 154 were eligible, and 75 (59%) were randomised. Of the 53 not randomised, 23 (43%) women preferred LH whilst 6 (11%) preferred AH. The main reasons given for failure to recruit or activate set-up in the 21 sites open or in set-up, were lack of research/ clinical capacity imposed by the COVID-19 pandemic and lack of clinician equipoise. Conclusions: The main reasons for the LAVA trial failure were lack of equipoise amongst surgeons and the adverse impact of the COVID-19 pandemic on clinical/research services. What is new?: Surgeons' preference for laparoscopic hysterectomy is not shared by most patients. Many patients prefer an open hysterectomy to a laparoscopic one.
RESUMEN
Endometriosis is a complex and chronic gynaecological disorder that affects millions of women worldwide, leading to significant morbidity and impacting reproductive health. This condition affects up to 10% of women of reproductive age and is characterised by the presence of endometrial-like tissue outside the uterus, potentially leading to symptoms such as chronic pelvic pain, dysmenorrhoea, dyspareunia, and infertility. The Montreux summit brought a number of experts in this field together to provide a platform for discussion and exchange of ideas. These proceedings summarise the six main topics that were discussed at this summit to shed light on future directions of endometriosis classification, diagnosis, and therapeutical management. The first question addressed the possibility of preventing endometriosis in the future by identifying risk factors, genetic predispositions, and further understanding of the pathophysiology of the condition to develop targeted interventions. The clinical presentation of endometriosis is varied, and the correlation between symptoms severity and disease extent is unclear. While there is currently no universally accepted optimal classification system for endometriosis, several attempts striving towards its optimisation - each with its own advantages and limitations - were discussed. The ideal classification should be able to reconcile disease status based on the various diagnostic tools, and prognosis to guide proper patient tailored management. Regarding diagnosis, we focused on future tools and critically discussed emerging approaches aimed at reducing diagnostic delay. Preserving fertility in endometriosis patients was another debatable aspect of management that was reviewed. Moreover, besides current treatment modalities, potential novel medical therapies that can target underlying mechanisms, provide effective symptom relief, and minimise side effects in endometriotic patients were considered, including hormonal therapies, immunomodulation, and regenerative medicine. Finally, the question of hormonal substitution therapy after radical treatment for endometriosis was debated, weighing the benefits of hormone replacement.
RESUMEN
The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and International Deep Endometriosis Analysis (IDEA) group, the European Endometriosis League (EEL), the European Society for Gynaecological Endoscopy (ESGE), the European Society of Human Reproduction and Embryology (ESHRE), the International Society for Gynecologic Endoscopy (ISGE), the American Association of Gynecologic Laparoscopists (AAGL) and the European Society of Urogenital Radiology (ESUR) elected an international, multidisciplinary panel of gynecological surgeons, sonographers and radiologists, including a steering committee, which searched the literature for relevant articles in order to review the literature and provide evidence-based and clinically relevant statements on the use of imaging techniques for non-invasive diagnosis and classification of pelvic deep endometriosis. Preliminary statements were drafted based on review of the relevant literature. Following two rounds of revisions and voting orchestrated by chairs of the participating societies, consensus statements were finalized. A final version of the document was then resubmitted to the society chairs for approval. Twenty statements were drafted, of which 14 reached strong and three moderate agreement after the first voting round. The remaining three statements were discussed by all members of the steering committee and society chairs and rephrased, followed by an additional round of voting. At the conclusion of the process, 14 statements had strong and five statements moderate agreement, with one statement left in equipoise. This consensus work aims to guide clinicians involved in treating women with suspected endometriosis during patient assessment, counseling and planning of surgical treatment strategies. This Consensus Statement should be cited as: 'G. Condous, B. Gerges, I. Thomassin-Naggara, C. Becker, C. Tomassetti, H. Krentel, B.J. van Herendael, M. Malzoni, M. S. Abrao, E. Saridogan, J. Keckstein, G. Hudelist and Collaborators. Non-invasive imaging techniques for diagnosis of pelvic deep endometriosis and endometriosis classification systems: An International Consensus Statement. Eur. J. Radiol. 2024. https://doi.org/10.1016/j.ejrad.2024.111450.'
Asunto(s)
Endometriosis , Endometriosis/diagnóstico por imagen , Endometriosis/clasificación , Humanos , Femenino , Consenso , Pelvis/diagnóstico por imagen , Ultrasonografía/métodos , Imagen por Resonancia Magnética/métodosRESUMEN
The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and International Deep Endometriosis Analysis (IDEA) group, the European Endometriosis League (EEL), the European Society for Gynaecological Endoscopy (ESGE), the European Society of Human Reproduction and Embryology (ESHRE), the International Society for Gynecologic Endoscopy (ISGE), the American Association of Gynecologic Laparoscopists (AAGL) and the European Society of Urogenital Radiology (ESUR) elected an international, multidisciplinary panel of gynecological surgeons, sonographers and radiologists, including a steering committee, which searched the literature for relevant articles in order to review the literature and provide evidence-based and clinically relevant statements on the use of imaging techniques for non-invasive diagnosis and classification of pelvic deep endometriosis. Preliminary statements were drafted based on a review of the relevant literature. Following two rounds of revisions and voting orchestrated by chairs of the participating societies, consensus statements were finalized. A final version of the document was then resubmitted to the society chairs for approval. Twenty statements were drafted, of which 14 reached strong and three moderate agreement after the first voting round. The remaining three statements were discussed by all members of the steering committee and society chairs and rephrased, followed by an additional round of voting. At the conclusion of the process, 14 statements had strong and five statements moderate agreement, with one statement left in equipoise. This consensus work aims to guide clinicians involved in treating women with suspected endometriosis during patient assessment, counselling and planning of surgical treatment strategies.
RESUMEN
The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and International Deep Endometriosis Analysis (IDEA) group, the European Endometriosis League (EEL), the European Society for Gynaecological Endoscopy (ESGE), ESHRE, the International Society for Gynecologic Endoscopy (ISGE), the American Association of Gynecologic Laparoscopists (AAGL) and the European Society of Urogenital Radiology (ESUR) elected an international, multidisciplinary panel of gynecological surgeons, sonographers, and radiologists, including a steering committee, which searched the literature for relevant articles in order to review the literature and provide evidence-based and clinically relevant statements on the use of imaging techniques for non-invasive diagnosis and classification of pelvic deep endometriosis. Preliminary statements were drafted based on review of the relevant literature. Following two rounds of revisions and voting orchestrated by chairs of the participating societies, consensus statements were finalized. A final version of the document was then resubmitted to the society chairs for approval. Twenty statements were drafted, of which 14 reached strong and three moderate agreement after the first voting round. The remaining three statements were discussed by all members of the steering committee and society chairs and rephrased, followed by an additional round of voting. At the conclusion of the process, 14 statements had strong and five statements moderate agreement, with one statement left in equipoise. This consensus work aims to guide clinicians involved in treating women with suspected endometriosis during patient assessment, counselling, and planning of surgical treatment strategies.
Asunto(s)
Endometrio/diagnóstico por imagen , Histeroscopía , Adherencias Tisulares/diagnóstico por imagen , Enfermedades Uterinas/diagnóstico por imagen , Útero/diagnóstico por imagen , Adulto , Amenorrea , Endometrio/patología , Femenino , Humanos , Adherencias Tisulares/patología , Ultrasonografía Doppler Dúplex , Enfermedades Uterinas/patologíaRESUMEN
OBJECTIVE: To examine the reproducibility of assessment of severity of pelvic endometriosis by transvaginal sonography (TVS). METHODS: This was a prospective observational study conducted from August 2006 to July 2009 in two academic departments of obstetrics and gynecology. Women with clinically suspected or proven pelvic endometriosis were invited to join the study. All patients included underwent TVS performed by two observers and a laparoscopic assessment of pelvic endometriosis. The ultrasound observers were blinded to each other's results. The reproducibility of TVS was examined by evaluation of interobserver agreement for the American Society of Reproductive Medicine (ASRM) score by Bland-Altman analysis and the stage and the diagnosis of deeply infiltrating endometriosis (DIE) by calculation of kappa coefficients. Agreement between the findings on TVS for each observer and those on laparoscopy was also evaluated. RESULTS: Thirty-four patients were recruited to the study, and TVS was performed by two ultrasound observers. Of these patients, one did not undergo laparoscopy and was therefore excluded from the final analysis. No endometriosis was found in 12 (36.4%) patients. One patient (3%) had minimal disease, one (3%) had mild disease, five (15.2%) had moderate disease and 14 (42.4%) had severe disease. Interobserver agreement was very good for disease classification on TVS (Cohen's kappa, 0.931). Agreement between TVS and laparoscopy findings was also very good (Cohen's kappa, 0.955 and 0.966 for the two examiners). For ASRM score on TVS, the interobserver 95% limits of agreement were -16.6 to 12.7, with a mean difference of -1.9 (95% CI, -4.35 to 0.71). CONCLUSION: TVS is a reproducible method for assessment of the severity of pelvic endometriosis and shows good agreement with findings on laparoscopy.