Acceptability, reliability, and validity of a vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia: a cross-sectional study.

BACKGROUND: Approximately half of people with endometriosis experience deep dyspareunia; however, there is no means of objective self-testing of endometriosis-associated deep dyspareunia. AIM: The aim of this study was to assess the acceptability, test-retest reliability, and validity of a vaginal insert for a self-assessment of endometriosis-associated deep dyspareunia. METHODS: Participants were recruited from a tertiary endometriosis center. Inclusion criteria were: 19 to 49 years of age, self-reported deep dyspareunia of ≥4 of 10, and surgically confirmed endometriosis. Participants completed 2 self-assessments using the vaginal insert to self-assess tenderness at the right and left pelvic floor, bladder, cervix-uterus, and posterior cul-de-sac (vaginal fornix). The participants recorded tenderness at each pelvic site and completed a questionnaire regarding the acceptability of the vaginal insert to assess deep dyspareunia. Test-retest reliability was assessed by correlating the tenderness scores between the 2 assessment dates. Over a 4-week period, the participants also recorded deep dyspareunia severity at each penetrative vaginal sex encounter. Validity was assessed by correlating vaginal insert tenderness to deep dyspareunia severity, and also to tenderness reported on a prior gynecologic pelvic examination. OUTCOMES: The main outcome measures were the acceptability index score, tenderness (0-10) at each pelvic site, and prospective deep dyspareunia scores (0-10) over 4 weeks. RESULTS: There were 19 participants (mean age 34 ± 7 years) who completed the study. The majority identified as female (94.7%), heterosexual (89.5%), and white (89.5%). The median acceptability index score was 0.72 (interquartile range, 0.66-0.81). For test-retest reliability, the intraclass correlation coefficients were 0.79 (P = .001) for the left pelvic floor, 0.82 (P < .001) for the right pelvic floor, 0.54 (P = .07) for the bladder, 0.89 (P < .001) for the cervix-uterus, and 0.77 (P = .003) for the cul-de-sac. The correlation between the highest self-assessed mean tenderness in each participant and self-reported deep dyspareunia over 4 weeks was r = 0.32, but correlations for each pelvic site varied significantly. Tenderness at each site on prior gynecologist pelvic exam was associated with higher self-assessed mean tenderness with the vaginal insert in each participant (effect sizes = 0.42-0.88). CLINICAL IMPLICATIONS: The vaginal insert is acceptable and reliable for the objective self-assessment of endometriosis-associated deep dyspareunia, with initial evidence of validity. STRENGTHS AND LIMITATIONS: A strength was the inclusion of participants who were avoiding sexual activity and a limitation was the small sample size. CONCLUSION: Future studies with larger sample sizes are required to further establish the validity of the vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia.

Understanding Minimally Invasive Gynaecologic Surgery Fellowship Training in Canada: A National Survey of Recent Graduates.

OBJECTIVE: To characterize fellowship training experiences in the 11 Canadian minimally invasive gynaecologic surgery (MIGS) programs and compare the surgical exposure of fellows in these programs to that of the American Association of Gynecologic Laparoscopists (AAGL) accredited fellowship in MIGS (FMIGS). METHODS: In this cross-sectional study, 2017 and 2018 MIGS fellowship graduates across Canada were given a web-based survey via SurveyMonkey software to evaluate 5 key components of postgraduate fellowship curricula: 1) surgical exposure; 2) teaching and evaluation methods; 3) research experience; 4) clinical responsibilities; and 5) pursuit of other academic endeavours. Interest in creating a national standardized curriculum and seeking accreditation for MIGS fellowships were also examined. RESULTS: The survey attained a 91% (20/22) response rate of the target population. All Canadian MIGS programs met the minimum standards for at least 62% (8/13) of the surgical competencies listed by the AAGL, with office hysteroscopy being the procedure with the largest discordance. Half of respondents (10/20) attended a program with an established curriculum, and 75% (15/20) believed there would be a benefit to standardizing training nationwide. Seventy percent (14/20) had published at least one manuscript during their fellowship and 60% (12/20) pursued postgraduate degrees. The majority (55%; 11/20) felt certain that MIGS should become a credentialed fellowship in Canada. CONCLUSION: Canada has made meaningful progress in MIGS training over the past decade with 11 well-established fellowship programs. Although this survey identifies a general interest in standardized training and accreditation for Canadian MIGS programs, more research is needed on how best to accomplish this.

Negative Sliding Sign during Dynamic Ultrasonography Predicts Low Endometriosis Fertility Index at Laparoscopy.

STUDY OBJECTIVE: Endometriosis fertility index (EFI) is a robust tool to predict the pregnancy rate in patients with endometriosis who are attempting non-in vitro fertilization conception. However, EFI calculation requires laparoscopy. Newly established imaging techniques such as sliding sign, which is used to diagnose pouch of Douglas obliteration, could provide a promising alternative. The objective of this study was to investigate the practicality of using ultrasound data to predict a low EFI (score ≤6). DESIGN: Observational study from a prospective registry (Endometriosis Pelvic Pain Interdisciplinary Cohort, clinicaltrials.gov #NCT02911090). Analyzed data were captured from December 2013 to June 2017. SETTING: Tertiary referral center at British Columbia Women's Hospital. PATIENTS: We analyzed data for 2583 participants from the Endometriosis Pelvic Pain Interdisciplinary Cohort. In this cross-sectional study, we included 86 women aged <40 years. INTERVENTIONS: Dynamic ultrasonography for the sliding sign testing and EFI calculation during laparoscopic surgery. MEASUREMENTS AND MAIN RESULTS: Logistic regression was used to obtain receiver operating characteristic area under the curve (AUC) for the prediction models. Significance was p <.05. Patients with a negative sliding sign were older and had severe endometriosis and longer duration of infertility. Patients with a negative sliding sign had significantly lower total EFI scores and lower surgical factors scores than patients with a positive sliding sign. Logistic regression showed that a negative sliding sign and EFI historic factors score can predict an EFI score ≤6 (sensitivity = 87.9%, specificity = 81.1%, AUC = 0.93 [95% confidence interval, 0.88-0.98]). Adding the diagnosis of endometrioma to the previous prediction model resulted in AUC = 0.95 (95% confidence interval, 0.90-0.995), sensitivity = 84.8%, and specificity = 92.5%. CONCLUSION: The sliding sign could be a potential alternative to the EFI surgical factors, and it could be used in combination with EFI historic factors and the diagnosis of endometrioma to predict an EFI score ≤6 for patients who are not scheduled for immediate surgery.

Hospital-Associated Cost of Endometriosis in Canada: A Population-Based Study.

STUDY OBJECTIVE: To describe the hospital-associated cost of endometriosis in Canada from April 2008 to March 2013. DESIGN: Population-based descriptive study. SETTING: Canada, with the exception of the province of Quebec. PATIENTS: All women aged 15 to 59 years discharged with endometriosis between April 2008 and March 2013. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Over 5 years, 47 021 women were admitted for endometriosis, resulting in a total hospital cost of Canadian dollars (CaD) $152.21 million (US dollars [US $] 147.79 million) and per-case cost of CaD $3237 (US $3143). Uterine endometriosis accounted for 28.29% of cases, ovarian endometriosis 27.44%, and other endometriosis 44.27%. Cost for uterine endometriosis was the highest at CaD $4137 (US $4017) per case, followed by ovarian endometriosis (CaD $3506; US $3404) and other endometriosis (CaD $2495; US $2422). The highest number of cases were in the groups aged 35 to 39 years (20.77%) and 40 to 44 years (20.44%). Hysterectomy accounted for 29.57% of surgical procedures. Encounters with hysterectomy were the costliest at CaD $5062 (US $4915) per case, followed by the ones with other surgical procedures at CaD $2477 (US $2405) per case, and admissions with no surgical procedure at CaD $2164 (US $2101) per case. CONCLUSION: The hospital cost associated with endometriosis was approximately CaD $30 million (US $29.56 million) per year, whereas uterine endometriosis, hysterectomy, and older age were found to have a higher average cost per case. Although this study focuses specifically on hospital admission and does not account for outpatient costs or indirect costs, it nonetheless highlights the economic burden of this debilitating disease on Canadian society during the study period.

Hospital-associated Costs of Chronic Pelvic Pain in Canada: A Population-based Descriptive Study.

OBJECTIVE: To determine the hospital-related costs incurred by women requiring surgery or inpatient admission for chronic pelvic pain in Canada. METHODS: We conducted a population-based, cross-sectional study, focusing on women ages 15-59 with a most responsible International Classification of Diseases diagnosis of pelvic and perineal pain, dysmenorrhea, or dyspareunia who had surgery or inpatient admission with a discharge date between April 1, 2008 and March 31, 2012. This study was based on the Canadian Institute for Health Information Discharge Abstract database and the National Ambulatory Care Reporting System. Clinical diagnoses and interventions and resource intensity weights (RIW) were extracted. Hospital costs were estimated by multiplying cost per weighted case (CPWC) calculated at the national level with respective RIWs. RESULTS: Over four years, there were 34 346 cases of surgery or inpatient admission for chronic pelvic pain amounting to $100.5 million with an average cost of $25 million per year. Pelvic and perineal pain accounted for 61.5% (n = 21 127) of the cases, while dysmenorrhea accounted for 31.8% (n = 10 936), and dyspareunia accounted for 6.6% (n = 2283). The vast majority of the cases (92.9%, n = 31 923) were associated with surgical interventions, with the most common surgeries being hysterectomy (47.1%, n = 16 189), followed by laparoscopy (25.8%, n = 8850), adnexal surgery (6.8%, n = 2349), and other procedures (11.6%, n = 3968). CONCLUSION: While these estimates do not take into account non-hospital related costs, such as outpatient treatment, loss of productivity, and impact on quality of life, this study demonstrates that chronic pelvic pain represents a considerable economic burden to Canada's health care system.

Long-term medical management of endometriosis with dienogest and with a gonadotropin-releasing hormone agonist and add-back hormone therapy.

Endometriosis can recur after either surgical or medical therapy. Long-term medical therapy is implemented to treat symptoms or prevent recurrence. Dienogest and gonadotropin-releasing hormone (GnRH) analogues with hormone add-back therapy seem to be equally effective for long-term treatment of pain symptoms associated with endometriosis. There is insufficient evidence to support the superiority of one therapy over the other. However, add-back hormone therapy (HT) is recommended for patients using GnRH agonists. The treatment selection depends on therapeutic effectiveness, tolerability, drug cost, the physician's experience, and expected patient compliance.

Endometrial ablation in the management of abnormal uterine bleeding.

BACKGROUND: Abnormal uterine bleeding (AUB) is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for the problem during their reproductive years. OBJECTIVE: To provide current evidence-based guidelines on the techniques and technologies used in endometrial ablation (EA), a minimally invasive technique for the management of AUB of benign origin. METHODS: Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of both location in Canada and type of practice, as well as subspecialty expertise and general background in gynaecology. The committee reviewed all available evidence in the English medical literature, including published guidelines, and evaluated surgical and patient outcomes for the various EA techniques. Recommendations were established by consensus. EVIDENCE: Published literature was retrieved through searches of MEDLINE and The Cochrane Library in 2013 and 2014 using appropriate controlled vocabulary and key words (endometrial ablation, hysteroscopy, menorrhagia, heavy menstrual bleeding, AUB, hysterectomy). RESULTS were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English from January 2000 to November 2014. Searches were updated on a regular basis and incorporated in the guideline to December 2014. Grey (unpublished) literature was identifies through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). RESULTS: This document reviews the evidence regarding the available techniques and technologies for EA, preoperative and postoperative care, operative set-up, anaesthesia, and practical considerations for practice. BENEFITS, HARMS, AND COSTS: Implementation of the guideline recommendations will improve the provision of EA as an effective treatment of AUB. Following these recommendations would allow the surgical procedure to be performed safely and maximize success for patients. CONCLUSIONS: EA is a safe and effective minimally invasive option for the treatment of AUB of benign etiology. Summary Statements 1. Endometrial ablation is a safe and effective minimally invasive surgical procedure that has become a well-established alternative to medical treatment or hysterectomy to treat abnormal uterine bleeding in select cases. (I) 2. Endometrial preparation can be used to facilitate resectoscopic endometrial ablation (EA) and can be considered for some non-resectoscopic techniques. For resectoscopic EA, preoperative endometrial thinning results in higher short-term amenorrhea rates, decreased irrigant fluid absorption, and shorter operative time than no treatment. (I) 3. Non-resectoscopic techniques are technically easier to perform than resectoscopic techniques, have shorter operative times, and allow the use of local rather than general anaesthesia. However, both techniques have comparable patient satisfaction and reduction of heavy menstrual bleeding. (I) 4. Both resectoscopic and non-resectoscopic endometrial ablation (EA) have low complication rates. Uterine perforation, fluid overload, hematometra, and cervical lacerations are more common with resectoscopic EA; perioperative nausea/vomiting, uterine cramping, and pain are more common with non-resectoscopic EA. (I) 5. All non-resectoscopic endometrial ablation devices available in Canada have demonstrated effectiveness in decreasing menstrual flow and result in high patient satisfaction. The choice of which device to use depends primarily on surgical judgement and the availability of resources. (I) 6. The use of local anaesthetic and blocks, oral analgesia, and conscious sedation allows for the provision of non-resectoscopic EA in lower resource-intense environments including regulated non-hospital settings. (II-2) 7. Low-risk patients with satisfactory pain tolerance are good candidates to undergo endometrial ablation in settings outside the operating room or in free-standing surgical centres. (II-2) 8. Both resectoscopic and non-resectoscopic endometrial ablation are relatively safe procedures with low complication rates. The complications perforation with potential injury to contiguous structures, hemorrhage, and infection. (II-2) 9. Combined hysteroscopic sterilization and endometrial ablation can be safe and efficacious while favouring a minimally invasive approach. (II-2) Recommendations 1. Preoperative assessment should be comprehensive to rule out any contraindication to endometrial ablation. (II-2A) 2. Patients should be counselled about the need for permanent contraception following endometrial ablation. (II-2B) 3. Recommended evaluations for abnormal uterine bleeding, including but not limited to endometrial sampling and an assessment of the uterine cavity, are necessary components of the preoperative assessment. (II-2B) 4. Clinicians should be vigilant for complications unique to resectoscopic endometrial ablation such as those related to fluid distention media and electrosurgical injuries. (III-A) 5. For resectoscopic endometrial ablation, a strict protocol should be followed for fluid monitoring and management to minimize the risk of complications of distension medium overload. (III-A) 6. If uterine perforation is suspected to have occurred during cervical dilatation or with the resectoscope (without electrosurgery), the procedure should be abandoned and the patient should be closely monitored for signs of intraperitoneal hemorrhage or visceral injury. If the perforation occurs with electrosurgery or if the mechanism of perforation is uncertain, abdominal exploration is warranted to obtain hemostasis and rule out visceral injury. (III-B) 7. With resectoscopic endometrial ablation, if uterine perforation has been ruled out acute hemorrhage may be managed by using intrauterine Foley balloon tamponade, injecting intracervical vasopressors, or administering rectal misoprostol. (III-B) 8. If repeat endometrial ablation (EA) is considered following non-resectoscopic or resectoscopic EA, it should be performed by a hysteroscopic surgeon with direct visualization of the cavity. Patients should be counselled about the increased risk of complications with repeat EA. (II-2A) 9. If significant intracavitary pathology is present, resectoscopic endometrial ablation combined with hysteroscopic myomectomy or polypectomy should be considered in a non-fertility sparing setting. (II-3A).

Contexte : Les saignements utérins anormaux (SUA) sont directement à l'origine d'un fardeau de santé considérable que doivent porter les femmes, leur famille et la société en général. Jusqu'à 30 % des femmes chercheront à obtenir l'aide d'un médecin pour contrer ce problème au cours de leurs années de fertilité. Objectif : Fournir des lignes directrices factuelles à jour quant aux techniques et aux technologies utilisées aux fins de l'ablation de l'endomètre (AE), soit une intervention à effraction minimale permettant la prise en charge des SUA d'origine bénigne. Méthodes : Les membres du comité sur la directive clinique ont été sélectionnés en fonction de leurs spécialisations respectives en vue de représenter une gamme d'expériences pratiques et universitaires : le milieu de pratique au Canada, le type de pratique, la sous-spécialité et les antécédents généraux en gynécologie ont donc été pris en considération. Le comité a analysé les données pertinentes issues de la littérature médicale anglophone (y compris les lignes directrices publiées), en plus d'évaluer les issues chirurgicales et les issues qu'ont connues les patientes à la suite de l'utilisation de diverses techniques d'AE. Les recommandations ont été formulées par consensus. Données : La littérature publiée a été récupérée par l'intermédiaire de recherches menées dans MEDLINE et The Cochrane Library en 2013 et en 2014 au moyen d'un vocabulaire contrôlé et de mots clés appropriés (p. ex. « endometrial ablation ¼, « hysteroscopy ¼, « menorrhagia ¼, « heavy menstrual bleeding ¼, « AUB ¼, « hysterectomy ¼). Les résultats ont été restreints aux analyses systématiques, aux études observationnelles et aux essais comparatifs randomisés / essais cliniques comparatifs publiés en anglais entre janvier 2000 et novembre 2014. Les recherches ont été mises à jour de façon régulière et intégrées à la directive clinique jusqu'en décembre 2014. La littérature grise (non publiée) a été identifiée par l'intermédiaire de recherches menées dans les sites Web d'organismes s'intéressant à l'évaluation des technologies dans le domaine de la santé et d'organismes connexes, dans des collections de directives cliniques, dans des registres d'essais cliniques et auprès de sociétés de spécialité médicale nationales et internationales. Valeurs : La qualité des résultats a été évaluée au moyen des critères décrits dans le rapport du Groupe d'étude canadien sur les soins de santé préventifs (Tableau). Résultats : Le présent document passe en revue les données quant aux techniques et aux technologies disponibles en ce qui concerne l'AE, les soins préopératoires et postopératoires, le milieu d'intervention, l'anesthésie et les facteurs pratiques à prendre en considération. Avantages, désavantages et coûts : La mise en œuvre des recommandations de la présente directive clinique entraînera une amélioration de l'offre de l'AE à titre de traitement efficace contre les SUA. Le respect de ces recommandations permettrait l'exécution de l'intervention chirurgicale en cause de façon sûre et en maximiserait la réussite pour les patientes. Conclusions : L'AE est une option à effraction minimale sûre et efficace pour la prise en charge des SUA d'étiologie bénigne. Déclarations sommaires 1. L'ablation de l'endomètre est une intervention chirurgicale à effraction minimale sûre et efficace qui en est venue à constituer, dans certains cas, une solution de rechange bien établie au traitement médical ou à l'hystérectomie pour la prise en charge des saignements utérins anormaux. (I) 2. Une préparation de l'endomètre peut être mise en œuvre pour en faciliter l'ablation résectoscopique et peut également être envisagée dans le cas de certaines techniques non résectoscopiques. Lorsque l'on a recours à l'ablation résectoscopique de l'endomètre, l'amincissement préopératoire de ce dernier donne lieu à une hausse des taux d'aménorrhée à court terme, à une atténuation de l'absorption du liquide de distension et à une réduction de la durée opératoire, par comparaison avec l'absence de traitement. (I) 3. Les techniques non résectoscopiques sont techniquement plus faciles à utiliser que les techniques résectoscopiques, nécessitent des temps opératoires plus courts et permettent l'utilisation d'une anesthésie locale (plutôt que d'avoir recours à une anesthésie générale). Toutefois, ces deux techniques comptent des taux comparables de satisfaction des patientes et d'atténuation des saignements menstruels abondants. (I) 4. Les techniques résectoscopiques et non résectoscopiques d'ablation de l'endomètre comptent toutes de faibles taux de complication. La perforation utérine, la surcharge liquidienne, l'hématomètre et les lacérations cervicales sont plus courantes dans le cas de l'AE résectoscopique; les crampes utérines, la douleur et les nausées / vomissements périopératoires sont plus courants dans le cas de l'AE non résectoscopique. (I) 5. L'efficacité de tous les dispositifs d'ablation non résectoscopique de l'endomètre disponibles au Canada a été démontrée en ce qui concerne l'atténuation du flux menstruel; de plus, ils mènent tous à des taux élevés de satisfaction des patientes. Le choix du dispositif à utiliser dépend principalement de l'opinion du chirurgien et de la disponibilité des ressources. (I) 6. L'utilisation d'anesthésiques et de blocs locaux, d'une analgésie orale et d'une sédation consciente permet la tenue d'une ablation non résectoscopique de l'endomètre au sein de milieux nécessitant des ressources moindres, y compris dans des milieux non hospitaliers réglementés. (II-2) 7. Les patientes n'étant exposées qu'à de faibles risques et présentant une tolérance satisfaisante à la douleur sont de bonnes candidates pour ce qui est de la tenue d'une ablation endométriale dans un milieu autre qu'en salle d'opération ou dans un centre chirurgical autonome. (II-2) 8. Les techniques d'ablation de l'endomètre tant résectoscopiques que non résectoscopiques sont relativement sûres et ne comptent que de faibles taux de complication. Parmi les complications les plus graves, on trouve la perforation (s'accompagnant de lésions potentielles aux structures adjacentes), l'hémorragie et l'infection. (II-2) 9. La tenue concomitante d'une stérilisation hystéroscopique et d'une ablation endométriale peut être sûre et efficace tout en favorisant une approche à effraction minimale. (II-2) Recommandations 1. L'évaluation préopératoire devrait être exhaustive, de façon à pouvoir écarter toute contre-indication à l'ablation de l'endomètre. (II-2A) 2. Les patientes devraient être avisées de la nécessité d'une contraception permanente à la suite de l'ablation de l'endomètre. (II-2B) 3. Les évaluations recommandées en présence de saignements utérins anormaux (dont, entre autres, le prélèvement endométrial et l'évaluation de la cavité utérine) sont des composantes nécessaires de l'évaluation préopératoire. (II-2B) 4. Les cliniciens devraient demeurer à l'affût des complications propres à l'ablation résectoscopique de l'endomètre, comme celles qui sont associées au produit de distension et aux lésions électrochirurgicales. (III-A) 5. Dans le cas de l'ablation résectoscopique de l'endomètre, un protocole strict devrait être respecté pour ce qui est de la surveillance liquidienne et de la prise en charge, et ce, afin de minimiser le risque de voir se manifester des complications associées à la surcharge de produit de distension. (III-A) 6. Lorsque l'on soupçonne qu'une perforation utérine s'est manifestée au cours de la dilatation cervicale ou dans le cadre de l'utilisation du résectoscope (sans électrochirurgie), l'intervention devrait être abandonnée et la patiente devrait faire l'objet d'une surveillance étroite de façon à ce que l'on puisse demeurer à l'affût des signes d'hémorragie intrapéritonéale ou de lésion viscérale. Lorsque la perforation se manifeste dans le cadre d'une électrochirurgie ou lorsque le mécanisme de la perforation demeure incertain, la tenue d'une exploration abdominale est justifiée pour assurer l'hémostase et écarter la présence de lésions viscérales. (III-B) 7. Dans le cas de l'AE résectoscopique, lorsque la présence d'une perforation utérine a été écartée, l'hémorragie aiguë pourrait être prise en charge au moyen d'un tamponnement intra-utérin par sonde de Foley, d'une injection intracervicale de vasopresseurs ou de l'administration de misoprostol par voie rectale. (III-B) 8. Lorsqu'une nouvelle ablation de l'endomètre est envisagée à la suite d'une intervention non résectoscopique ou résectoscopique, elle devrait être menée par un chirurgien hystéroscopique sous visualisation directe de la cavité. Les patientes devraient bénéficier de services de counseling au sujet des risques de complications qui sont associés à la tenue d'une nouvelle ablation de l'endomètre. (II-2A) 9. En présence d'une pathologie intracavitaire considérable, la tenue concomitante d'une ablation résectoscopique de l'endomètre et d'une myomectomie / polypectomie hystéroscopique devrait être envisagée. (II-3A).

The management of uterine leiomyomas.

OBJECTIVES: The aim of this guideline is to provide clinicians with an understanding of the pathophysiology, prevalence, and clinical significance of myomata and the best evidence available on treatment modalities. OPTIONS: The areas of clinical practice considered in formulating this guideline were assessment, medical treatments, conservative treatments of myolysis, selective uterine artery occlusion, and surgical alternatives including myomectomy and hysterectomy. The risk-to-benefit ratio must be examined individually by the woman and her health care provider. OUTCOMES: Implementation of this guideline should optimize the decision-making process of women and their health care providers in proceeding with further investigation or therapy for uterine leiomyomas, having considered the disease process and available treatment options, and reviewed the risks and anticipated benefits. EVIDENCE: Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in February 2013, using appropriate controlled vocabulary (uterine fibroids, myoma, leiomyoma, myomectomy, myolysis, heavy menstrual bleeding, and menorrhagia) and key words (myoma, leiomyoma, fibroid, myomectomy, uterine artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia). The reference lists of articles identified were also searched for other relevant publications. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date limits but results were limited to English or French language materials. Searches were updated on a regular basis and incorporated in the guideline to January 2014. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, and national and international medical specialty societies. BENEFITS, HARMS, AND COSTS: The majority of fibroids are asymptomatic and require no intervention or further investigations. For symptomatic fibroids such as those causing menstrual abnormalities (e.g. heavy, irregular, and prolonged uterine bleeding), iron defficiency anemia, or bulk symptoms (e.g., pelvic pressure/pain, obstructive symptoms), hysterectomy is a definitive solution. However, it is not the preferred solution for women who wish to preserve fertility and/or their uterus. The selected treatment should be directed towards an improvement in symptomatology and quality of life. The cost of the therapy to the health care system and to women with fibroids must be interpreted in the context of the cost of untreated disease conditions and the cost of ongoing or repeat investigative or treatment modalities. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Caadian Task Force on Preventive Health Care (Table 1). Summary Statements 1. Uterine fibroids are common, appearing in 70% of women by age 50; the 20% to 50% that are symptomatic have considerable social and economic impact in Canada. (II-3) 2. The presence of uterine fibroids can lead to a variety of clinical challenges. (III) 3. Concern about possible complications related to fibroids in pregnancy is not an indication for myomectomy except in women who have had a previous pregnancy with complications related to these fibroids. (III) 4. Women who have fibroids detected in pregnancy may require additional maternal and fetal surveillance. (II-2) 5. Effective medical treatments for women with abnormal uterine bleeding associated with uterine fibroids include the levonorgestrel intrauterine system, (I) gonadotropin-releasing hormone analogues, (I) selective progesterone receptor modulators, (I) oral contraceptives, (II-2) progestins, (II-2) and danazol. (II-2) 6. Effective medical treatments for women with bulk symptoms associated with fibroids include selective progesterone receptor modulators and gonadotropin-releasing hormone analogues. (I) 7. Hysterectomy is the most effective treatment for symptomatic uterine fibroids. (III) 8. Myomectomy is an option for women who wish to preserve their uterus or enhance fertility, but carries the potential for further intervention. (II-2) 9. Of the conservative interventional treatments currently available, uterine artery embolization has the longest track record and has been shown to be effective in properly selected patients. (II-3) 10. Newer focused energy delivery methods are promising but lack long-term data. (III) Recommendations 1. Women with asymptomatic fibroids should be reassured that there is no evidence to substantiate major concern about malignancy and that hysterectomy is not indicated. (III-D) 2. Treatment of women with uterine leiomyomas must be individualized based on symptomatology, size and location of fibroids, age, need and desire of the patient to preserve fertility or the uterus, the availability of therapy, and the experience of the therapist. (III-B) 3. In women who do not wish to preserve fertility and/or their uterus and who have been counselled regarding the alternatives and risks, hysterectomy by the least invasive approach possible may be offered as the definitive treatment for symptomatic uterine fibroids and is associated with a high level of satisfaction. (II-2A) 4. Hysteroscopic myomectomy should be considered first-line conservative surgical therapy for the management of symptomatic intracavitary fibroids. (II-3A) 5. Surgical planning for myomectomy should be based on mapping the location, size, and number of fibroids with the help of appropriate imaging. (III-A) 6. When morcellation is necessary to remove the specimen, the patient should be informed about possible risks and complications, including the fact that in rare cases fibroid(s) may contain unexpected malignancy and that laparoscopic power morcellation may spread the cancer, potentially worsening their prognosis. (III-B) 7. Anemia should be corrected prior to proceeding with elective surgery. (II-2A) Selective progesterone receptor modulators and gonadotropin-releasing hormone analogues are effective at correcting anemia and should be considered preoperatively in anemic patients. (I-A) 8. Use of vasopressin, bupivacaine and epinephrine, misoprostol, peri-cervical tourniquet, or gelatin-thrombin matrix reduce blood loss at myomectomy and should be considered. (I-A) 9. Uterine artery occlusion by embolization or surgical methods may be offered to selected women with symptomatic uterine fibroids who wish to preserve their uterus. Women choosing uterine artery occlusion for the treatment of fibroids should be counselled regarding possible risks, including the likelihood that fecundity and pregnancy may be impacted. (II-3A) 10. In women who present with acute uterine bleeding associated with uterine fibroids, conservative management with estrogens, selective progesterone receptor modulators, antifibrinolytics, Foley catheter tamponade, and/or operative hysteroscopic intervention may be considered, but hysterectomy may become necessary in some cases. In centres where available, intervention by uterine artery embolization may be considered. (III-B).

Objectifs : La présente directive clinique a pour objectif d'aider les cliniciens à mieux comprendre la pathophysiologie, la prévalence et l'importance clinique des myomes, et de leur faire part des meilleures données probantes disponibles quant aux modalités de traitement. Options : Dans le cadre de la rédaction de la présente directive clinique, nous avons tenu compte des aspects suivants de la pratique clinique : évaluation, traitements médicaux, traitements conservateurs par myolyse, occlusion sélective de l'artère utérine et solutions de rechange chirurgicales (dont la myomectomie et l'hystérectomie). Le rapport risques-avantages doit faire l'objet d'une analyse personnalisée dans le cadre des discussions menées entre la patiente et son fournisseur de soins. Issues : La mise en œuvre de la présente directive clinique devrait optimiser le processus décisionnel pour les patientes et les fournisseurs de soins en ce qui a trait à la tenue d'autres explorations ou à la façon d'assurer la prise en charge des léiomyomes utérins, en ayant tenu compte du processus pathogénique (et des options disponibles en matière de traitement) et en ayant passé en revue les risques et les avantages anticipés. Résultats : La littérature publiée a été récupérée par l'intermédiaire de recherches menées dans PubMed, CINAHL et Cochrane Systematic Reviews en février 2013 au moyen d'un vocabulaire contrôlé (p. ex. « uterine fibroids ¼, « myoma ¼, « leiomyoma ¼, « myomectomy ¼, « myolysis ¼, « heavy menstrual bleeding ¼ et « menorrhagia ¼) et de mots clés (p. ex. « myoma ¼, « leiomyoma ¼, « fibroid ¼, « myomectomy ¼, « uterine artery embolization ¼, « hysterectomy ¼, « heavy menstrual bleeding ¼, « menorrhagia ¼) appropriés. Des recherches ont également été menées dans les listes de références des articles identifiés en vue d'en tirer d'autres publications pertinentes. Les résultats ont été restreints aux analyses systématiques, aux essais comparatifs randomisés / essais cliniques comparatifs et aux études observationnelles. Aucune restriction n'a été appliquée en matière de date, mais les résultats ont été limités aux documents rédigés en anglais ou en français. Les recherches ont été mises à jour de façon régulière et intégrées à la directive clinique jusqu'en janvier 2014. La littérature grise (non publiée) a été identifiée par l'intermédiaire de recherches menées dans les sites Web d'organismes s'intéressant à l'évaluation des technologies dans le domaine de la santé et d'organismes connexes, dans des collections de directives cliniques, dans des registres d'essais cliniques et auprès de sociétés de spécialité médicale nationales et internationales. Avantages, désavantages et coûts : La majorité des fibromes sont asymptomatiques et ne nécessitent aucune intervention ni aucune autre mesure exploratoire. Dans le cas des fibromes symptomatiques, tels que ceux qui sont à l'origine d'anomalies menstruelles (p. ex. saignements utérins abondants, irréguliers et prolongés), d'une anémie ferriprive ou de symptômes de masse (p. ex. pression / douleur pelvienne, symptômes obstructifs), l'hystérectomie constitue une solution définitive; toutefois, cette solution n'est pas à privilégier pour ce qui est des femmes qui souhaitent préserver leur fertilité et/ou leur utérus. Le traitement choisi devrait viser une amélioration de la symptomatologie et de la qualité de vie. Les coûts du traitement (pour le système de santé et les patientes présentant des fibromes) doivent être interprétés dans le contexte des coûts associés aux pathologies non traitées et à la mise en œuvre continue ou répétée de modalités d'exploration ou de traitement. Valeurs : La qualité des résultats est évaluée au moyen des critères décrits par le Groupe d'étude canadien sur les soins de santé préventifs (Tableau). Déclarations sommaires 1. Les fibromes utérins sont courants (leur incidence étant de 70 % à l'âge de 50 ans). De 20 % à 50 % de ces fibromes sont symptomatiques et exercent des effets sociaux et économiques considérables au Canada. (II-3) 2. La présence de fibromes utérins peut mener à diverses difficultés cliniques. (III) 3. Les préoccupations au sujet de possibles complications associées à la présence de fibromes pendant la grossesse ne constituent pas une indication justifiant la tenue d'une myomectomie, sauf chez les femmes qui ont déjà connu une grossesse ayant présenté des complications associées à ces fibromes. (III) 4. Les femmes chez qui des fibromes sont détectés pendant la grossesse pourraient nécessiter la mise en œuvre de modalités additionnelles de surveillance maternelle et fœtale. (II-2) 5. Parmi les traitements médicaux efficaces pouvant être offerts aux femmes qui connaissent des saignements utérins anormaux associés à la présence de fibromes utérins, on trouve le système intra-utérin à libération de lévonorgestrel, (I) les analogues de la gonadolibérine, (I) les modulateurs sélectifs des récepteurs de la progestérone, (I) les contraceptifs oraux, (II-2) les progestatifs (II-2) et le danazol. (II-2) 6. Parmi les traitements médicaux efficaces pouvant être offerts aux femmes qui connaissent des symptômes de masse associés à la présence de fibromes, on trouve les modulateurs sélectifs des récepteurs de la progestérone et les analogues de la gonadolibérine. (I) 7. L'hystérectomie constitue le moyen le plus efficace d'assurer la prise en charge des fibromes utérins symptomatiques. (III) 8. Bien que la myomectomie constitue une option pour les femmes qui souhaitent conserver leur utérus ou rehausser leur fertilité, elle expose la patiente à un risque de devoir subir d'autres interventions. (II-2) 9. Parmi les traitements interventionnels conservateurs actuellement disponibles, l'embolisation de l'artère utérine est celui pour lequel nous disposons du plus grand nombre de données; de plus, l'efficacité de cette intervention a été démontrée chez des patientes adéquatement sélectionnées. (II-3) 10. Des méthodes novatrices faisant appel à l'application d'énergie focalisée s'avèrent prometteuses; toutefois, nous ne disposons pas de données à long terme à leur sujet. (III) Recommandations 1. Rien n'indique que la présence de fibromes asymptomatiques devrait susciter des préoccupations importantes au sujet de leur malignité potentielle; de plus, le recours à l'hystérectomie dans un tel cas n'est pas indiqué, ce qui devrait rassurer les femmes qui présentent de tels fibromes. (III-D) 2. La prise en charge des femmes qui présentent des léiomyomes utérins doit être personnalisée en fonction de la symptomatologie, de la taille et de l'emplacement des fibromes, de l'âge de la patiente et de ses besoins et souhaits en matière de préservation de la fertilité ou de l'utérus, de la disponibilité du traitement et de l'expérience du thérapeute. (III-B) 3. Chez les femmes qui ne souhaitent pas préserver leur fertilité et/ou leur utérus et qui ont bénéficié de services de counseling à l'égard des solutions de rechange et des risques, l'hystérectomie (menée au moyen de l'approche la moins effractive possible) peut être offerte à titre de traitement définitif contre les fibromes utérins symptomatiques et est associée à un taux élevé de satisfaction. (II-2A) 4. La myomectomie hystéroscopique devrait être considérée comme étant un traitement chirugical conservateur de première intention pour la prise en charge des fibromes endocavitaires symptomatiques. (II-3A) 5. Dans le cas de la myomectomie, la planification de la chirurgie devrait être fondée sur les résultats d'une intervention d'imagerie cherchant à déterminer, de façon précise, l'emplacement, la taille et le nombre des fibromes. (III-A) 6. Lorsqu'il s'avère nécessaire d'avoir recours au morcellement pour retirer un prélèvement, la patiente devrait être avisée des risques et des complications possibles (dont la possibilité, dans de rares cas, d'en venir à constater la présence inattendue d'une tumeur maligne et de voir celle-ci être disséminée par l'utilisation du morcellement motorisé laparoscopique, ce qui pourrait aggraver le pronostic). (III-B) 7. L'anémie devrait être corrigée avant la tenue d'une chirurgie planifiée. (II-2 A) Les modulateurs sélectifs des récepteurs de la progestérone et les analogues de la gonadolibérine constituent des moyens efficaces de corriger l'anémie, et leur utilisation préopératoire devrait être envisagée dans le cas des patientes anémiques. (I-A) 8. L'utilisation de vasopressine, de bupivacaïne et d'épinéphrine, de misoprostol, d'un garrot péricervical ou d'une matrice gélatine-thrombine atténue la perte sanguine au cours de la myomectomie et devrait être envisagée. (I-A) 9. L'occlusion de l'artère utérine par embolisation ou au moyen de méthodes chirurgicales peut être offerte à certaines femmes présentant des fibromes utérins symptomatiques qui souhaitent préserver leur utérus. Les femmes qui choisissent d'avoir recours à l'occlusion de l'artère utérine pour la prise en charge de leurs fibromes devraient être avisées des risques possibles et du fait que les issues en matière de fertilité et de grossesse pourraient en être affectées. (II-3A) 10. Chez les femmes qui connaissent des saignements utérins aigus associés à la présence de fibromes utérins, bien que la mise en œuvre d'une prise en charge conservatrice (œstrogènes, modulateurs sélectifs des récepteurs de la progestérone, antifibrinolytiques, sonde de Foley et/ou intervention hystéroscopique opératoire) puisse être envisagée, la tenue d'une hystérectomie pourrait devenir nécessaire dans certains cas. Au sein des centres qui disposent des capacités nécessaires, la mise en œuvre d'une embolisation de l'artère utérine pourrait être envisagée. (III-B).

SOGC clinical practice guidelines: Oral contraceptives and the risk of venous thromboembolism: an update: no. 252, December 2010.

OBJECTIVE: To provide current and emerging evidence on oral contraceptives and the risk of venous thromboembolism. EVIDENCE: Articles published in English from 2005 were retrieved through searches of PubMed and Medline, using the following terms: venous thromboembolism, VTE, contraception, oral contraceptives, hormonal contraception. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis and incorporated in the guideline to May 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table).

SOGC clinical practice guidelines: Adhesion prevention in gynaecological surgery: no. 243, June 2010.

OBJECTIVES: To review the etiology and incidence of and associative factors in the formation of adhesions following gynaecological surgery. To review evidence for the use of available means of adhesion prevention following gynaecological surgery. OPTIONS: Women undergoing pelvic surgery are at risk of developing abdominal and/or pelvic adhesive disease postoperatively. Surgical technique and commercial adhesion prevention systems may decrease the risk of postoperative adhesion formation. OUTCOMES: The outcomes measured are the incidence of postoperative adhesions, complications related to the formation of adhesions, and further intervention relative to adhesive disease. EVIDENCE: Medline, EMBASE, and The Cochrane Library were searched for articles published in English from 1990 to March 2009, using appropriate controlled vocabulary and key words. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, cohort studies, and meta-analyses specifically addressing postoperative adhesions, adhesion prevention, and adhesive barriers. Searches were updated on a regular basis and incorporated in the guideline to March 2009. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care.

Asymptomatic endometrial thickening.

OBJECTIVE: To formulate clinical recommendations for the assessment of endometrial thickening when it is found on ultrasound in a postmenopausal patient without bleeding. OUTCOMES: Ensure that women with asymptomatic thickening and endometrial polyps found on ultrasound are managed appropriately. EVIDENCE: Published literature was retrieved through searches of English language articles from the EMBASE, Cochrane, and PubMed databases for relevant peer-reviewed articles dating from 1970 to 2009, using appropriate controlled vocabulary (e.g., "asymptomatic endometrial thickness," "endometrial cancer," "postmenopausal bleeding," "transvaginal ultrasonography," "endometrial biopsy" and "endometrial polyp"). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis and incorporated in the guideline to April 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The level of evidence was determined according to the criteria established by the Canadian Task Force on Preventative Health Care (Table). Recommendations are ranked according to this method. BENEFITS, HARMS, AND COSTS: It is anticipated that the adoption of these recommendations would save postmenopausal women unnecessary anxiety, pain, and risk of procedural complication. It is also expected to decrease the cost to the health system by eliminating unnecessary interventions.

SOGC clinical guidelines. Hysterectomy.

OBJECTIVE: To identify the indications for hysterectomy, preoperative assessment, and available alternatives required prior to hysterectomy. Patient self-reported outcomes of hysterectomy have revealed high levels of patient satisfaction. These may be maximized by careful preoperative assessment and discussion of other treatment choices. In most cases hysterectomy is performed to relieve symptoms and improve quality of life. The patient's preference regarding treatment alternatives must be considered carefully. OPTIONS: The areas of clinical practice considered in formulating this guideline are preoperative assessment including alternative treatments, choice of method for hysterectomy, and evaluation of risks and benefits. The risk-to-benefit ratio must be examined individually by the woman and her health practitioners. OUTCOMES: Optimizing the decision-making process of women and their caregivers in proceeding with a hysterectomy having considered the disease process, and available alternative treatments and options, and having reviewed the risks and anticipated benefits. EVIDENCE: Using Medline, PubMed, and the Cochrane Database, English language articles were reviewed from 1996 to 2001 as well as the review published in the 1996 SOGC guidelines. The level of evidence has been determined using the criteria described by the Canadian Task Force on the Periodic Health Examination. BENEFITS, HARMS, AND COSTS: Hysterectomy is the treatment of choice for certain gynaecologic conditions. The predicted advantages must be carefully weighed against the possible risks of the surgery and other treatment alternatives. In the properly selected patient, the result from the surgery should be an improvement in the quality of life. The cost of the surgery to the health care system and to the patient must be interpreted in the context of the cost of untreated conditions. The approach selected for the hysterectomy will impact on the cost of the surgery. RECOMMENDATIONS: Benign Disease 1. Leiomyomas: For symptomatic fibroids, hysterectomy provides a permanent solution to menorrhagia and the pressure symptoms related to an enlarged uterus. (I-A) 2. Abnormal uterine bleeding: Endometrial lesions must be excluded and medical alternatives should be considered as a first line of therapy. (III-B) 3. Endometriosis: Hysterectomy is often indicated in the presence of severe symptoms with failure of other treatments and when fertility is no longer desired. (1-B) 4. Pelvic relaxation: A surgical solution usually includes vaginal hysterectomy, but must include pelvic supporting procedures. (II-B) 5. Pelvic pain: A multidisciplinary approach is recommended, as there is little evidence that hysterectomy will cure chronic pelvic pain. When the pain is confined to dysmenorrhea or associated with significant pelvic disease, hysterectomy may offer relief. (II-C) Preinvasive Disease 1. Hysterectomy is usually indicated for endometrial hyperplasia with atypia. (I-A) 2. Cervical intraepithelial neoplasia in itself is not an indication for hysterectomy. (I-B) 3. Simple hysterectomy is an option for treatment of adenocarcinoma in situ of the cervix when invasive disease has been excluded. (I-B) Invasive Disease 1. Hysterectomy is an accepted treatment or staging procedure for endometrial carcinoma. It may play a role in the staging or treatment of cervical, epithelial ovarian, and fallopian tube carcinoma. (I-A) Acute Conditions 1. Hysterectomy is indicated for intractable postpartum hemorrhage when conservative therapy has failed to control bleeding. (II-B) 2. Tubo-ovarian abscesses that are ruptured or do not respond to antibiotics may be treated with hysterectomy and bilateral salpingo-oophorectomy in selected cases. (I-C) 3. Hysterectomy may be required for cases of acute menorrhagia refractory to medical or conservative surgical treatment. (II-C) Other Indications 1. Consultation with an oncologist or geneticist is recommended when considering hysterectomy and prophylactic oophorectomy for a familial history of ovarian cancer. (III-C) Surgical Approach 1. The vaginal route shoe should be considered as a first choice for all benign indications. The laparoscopic approach should be considered when it reduces the need for a laparotomy. (III-B) VALIDATION: Medline searches were performed in preparing this guideline with input from experts in their field across Canada. The guideline was reviewed and accepted by SOGC Council and Executive. SPONSOR: The Society of Obstetricians and Gynaecologists of Canada.