Preoperative Mechanical Bowel Preparation for Gynecologic Surgeries: A Systematic Review with Meta-analysis.

OBJECTIVE: To assess the efficacy and safety of mechanical bowel preparation (MBP) before benign laparoscopic or vaginal gynecologic surgeries. DATA SOURCES: Database searches of MEDLINE (PubMed), Embase (OVID), Cochrane Central Register of Controlled Trials, and Web of Sciences and citations and reference lists published up to December 2021. METHODS OF STUDY SELECTION: Randomized clinical trials in any language comparing MBP with no preparation were included. Two reviewers independently screened 925 records and extracted data from 12 selected articles and assessed the risk of bias with the Cochrane risk-of-bias tool for randomized trials tool. A random-effects model was used for the analysis. Surgeon findings (surgical field view, quality of bowel handling and bowel preparation), operative outcomes (blood loss, operative time, length of stay, surgical site infection), and patient's preoperative symptoms and satisfaction were collected. TABULATION, INTEGRATION, AND RESULTS: Thirteen studies (1715 patients) assessing oral and rectal preparations before laparoscopic and vaginal gynecologic surgeries were included. No significant differences were observed with or without MBP on surgical field view (primary outcome, risk ratio [RR] 1.01, 95% confidence interval [CI] 0.97-1.05, p = .66, I2 = 0%), bowel handling (RR 1.01, 95% CI 0.95-1.08, p = .78, I2 = 67%), or bowel preparation. In addition, there were no statistically significant differences in perioperative findings. MBP was associated with increased pain (mean difference [MD] 11.62[2.80-20.44], I2 = 76, p = .01), weakness (MD 10.73[0.60-20.87], I2 = 94, p = .04), hunger (MD 17.52 [8.04-27.00], I2 = 83, p = .0003), insomnia (MD 10.13[0.57-19.68], I2 = 82, p = .04), and lower satisfaction (RR 0.68, 95% CI 0.53-0.87, I2 = 76%, p = .002) compared with controls. CONCLUSIONS: MBP has not been associated with improved surgical field view, bowel handling, or operative outcome. However, in view of the adverse effects induced, its routine use before benign gynecologic surgeries should be abandoned.

Predictive Factors for Morcellation during Total Laparoscopic Hysterectomy: A Cohort Study.

OBJECTIVES: Our objective was to identify predictors of morcellation during a total laparoscopic hysterectomy (TLH). METHODS: A retrospective cohort study (Canadian Task Force classification II-2) taking place in a university hospital center in Quebec, Canada. Participants were women undergoing a TLH for a benign gynaecologic pathology from January 1, 2017, to January 31, 2019. All women underwent a TLH. If the uterus was too voluminous to be removed vaginally, surgeons favoured in-bag morcellation by laparoscopy. Uterine weight and characteristics were assessed before surgery by ultrasound or magnetic resonance imaging to predict morcellation. RESULTS: A total of 252 women underwent a TLH and the mean age was 46 ± 7 (30-71) years old. The main indications for surgery were abnormal uterine bleeding (77%), chronic pelvic pain (36%) and bulk symptoms (25%). Mean uterine weight was 325 (17-1572) ± 272 grams, with 11/252 (4%) uterus being >1000 grams and 71% of women had at least 1 leiomyoma. Among women with a uterine weight <250 grams, 120 (95%) did not require morcellation. On the opposite, among women with a uterine weight >500 grams, 49 (100%) required morcellation. In addition to the estimated uterine weight (≥250 vs. <250 grams; OR 3.7 [CI 1.8 to 7.7, P < 0.01]), having ≥ 1 leiomyoma (OR 4.1, CI 1.0 to 16.0, P = 0.01) and leiomyoma of ≥5 cm (OR 8.6, CI 4.1 to 17.9, P < 0.01) were other significant predictors morcellation in multivariate logistic regression analysis. CONCLUSIONS: Uterine weight estimated by preoperative imaging as well as the size and number of leiomyomas are useful predictors of the need for morcellation.

Evaluation of a Standardized Questionnaire for Initial Assessment of Abnormal Uterine Bleeding in Premenopausal Women.

OBJECTIVE: To assess the effect of a standardized questionnaire for premenopausal women with abnormal uterine bleeding (AUB) on clinical information collection and duration of consultation. METHODS: We conducted a before and after study involving 100 premenopausal women undergoing consultation for AUB. During stage 1, 50 consultations were recorded on a consultation sheet with no specific template. During stage 2, 50 women completed a 26-item auto-administered standardized questionnaire before the consultation, which was then reviewed with the consultant and added to the medical record. The duration of consultation was assessed in subgroups of 27 women in each stage. Two independent evaluators assessed the quality and completeness of data collected in the medical records using a score sheet developed by experts. Outcomes from both stages were compared using the t test. RESULTS: The descriptive characteristics were similar in both groups. The mean global scores of the quality and completeness of data collected improved significantly between stages 1 and 2, from 67% ± 12% to 95% ± 5% (P < 0.0001), as did medical background scores (54% ± 29% vs. 85% ± 13%; P < 0.0001) and AUB-related symptoms scores (69% ± 13% vs. 97% ± 5%; P < 0.0001). A mean reduction in duration of consultation of nearly 4 minutes was observed (24.6 ± 4.3 min vs. 20.7 ± 4.8 min; P < 0.0001). CONCLUSION: The AUB-specific standardized questionnaire improves quality and completeness of data collected in medical records and reduces duration of consultation.

Technicity in Canada: A Nationwide Whole-Population Analysis of Temporal Trends and Variation in Minimally Invasive Hysterectomies.

STUDY OBJECTIVE: The objective of our study was to provide a contemporary description of hysterectomy practice and temporal trends in Canada. DESIGN: A national whole-population retrospective analysis of data from the Canadian Institute for Health Information. SETTING: Canada. PATIENTS: All women who underwent hysterectomy for benign indication from April 1, 2007, to March 31, 2017, in Canada. INTERVENTIONS: Hysterectomy. MEASUREMENTS AND MAIN RESULTS: A total of 369 520 hysterectomies were performed in Canada during the 10-year period, during which the hysterectomy rate decreased from 313 to 243 per 100 000 women. The proportion of abdominal hysterectomies decreased (59.5% to 36.9%), laparoscopic hysterectomies increased (10.8% to 38.6%), and vaginal hysterectomies decreased (29.7% to 24.5%), whereas the national technicity index increased from 40.5% to 63.1% (p <.001, all trends). The median length of stay decreased from 3 (interquartile range 2-4) days to 2 (interquartile range 1-3), and the proportion of patients discharged within 24 hours increased from 2.1% to 7.2%. In year 2016-17, women aged 40 to 49 years had significantly increased risk of abdominal hysterectomy compared with women undergoing hysterectomy in other age categories (p <.001). Comparing women with menstrual bleeding disorders, women undergoing hysterectomy for endometriosis (adjusted relative risk [aRR] 1.36; 95% confidence interval [CI], 1.28-1.44) and myomas (aRR 2.01; 95% CI, 1.94-2.08) were at increased risk of abdominal hysterectomy, whereas women undergoing hysterectomy for pelvic organ prolapse and pelvic pain (aRR 1.47; 95% CI, 1.41-1.53) were at decreased risk. Using Ontario as the comparator, Nova Scotia (aRR 1.35; 95% CI, 1.27-1.43), New Brunswick (aRR 1.25; 95% CI, 1.18-1.32]), Manitoba (aRR 1.35; 95% CI, 1.28-1.43), and Newfoundland and Labrador (aRR 1.18; 95% CI, 1.10-1.27) had significantly higher risks of abdominal hysterectomy. In contrast, Saskatchewan (aRR 0.75; 95% CI, 0.74-0.77) and British Columbia (aRR 0.86; 95% CI, 0.85-0.88) had significantly lower risks, whereas Prince Edward Island, Quebec, and Alberta were not significantly different. CONCLUSION: The proportion of minimally invasive hysterectomies for benign indication has increased significantly in Canada. The declining use of vaginal approaches and the variation among provinces are of concern and necessitate further study.

Guideline No. 412: Laparoscopic Entry for Gynaecological Surgery.

OBJECTIVE: To evaluate the benefits and risks of laparoscopic surgery and provide clinical direction on entry techniques, technologies, and their associated complications in gynaecological surgery. TARGET POPULATION: All patients, including pregnant women and women with obesity, undergoing laparoscopic surgery for various gynaecological indications. OPTIONS: The laparoscopic entry techniques and technologies reviewed in formulating this guideline included the closed (Veress needle-pneumoperitoneum-trocar) technique, direct trocar insertion, open (Hasson) technique, visual entry systems, and disposable shielded and radially expanding trocars. OUTCOMES: Implementation of this guideline should optimize decision-making in the selection of entry technique for laparoscopic surgery. EVIDENCE: We searched English-language articles from September 2005 to December 2019 in PubMed/MEDLINE, Embase, Science Direct, Scopus, and Cochrane Library using the following MeSH search terms alone or in combination: laparoscopic entry, laparoscopy access, pneumoperitoneum, Veress needle, open (Hasson), direct trocar, visual entry, shielded trocars, radially expanded trocars, and laparoscopic complications. VALIDATION METHODS: The authors rated the quality of evidence and strength of recommendations using the Canadian Task Force on Preventive Health Care approach (Appendix A). INTENDED AUDIENCE: Surgeons performing laparoscopic gynaecological surgery. SUMMARY STATEMENTS: RECOMMENDATIONS.

Diagnostic Accuracy of Intraoperative Tools for Detecting Endometriosis: A Systematic Review and Meta-analysis.

OBJECTIVE: To evaluate the diagnostic accuracy of intraoperative laparoscopic imaging tools in reference to that of histopathology for detecting endometriotic lesions and to compare them with conventional white-light inspection by performing a systematic review with meta-analysis. DATA SOURCES: We searched the MEDLINE, EMBASE, and CENTRAL databases in addition to citations and reference lists until the end of February 2019. METHODS OF STUDY SELECTION: Two authors screened 1038 citations for eligibility. We included randomized controlled trials or prospective cohort studies published in English, assessing the accuracy of intraoperative imaging tools for diagnosing endometriosis during laparoscopy. We considered studies using histopathologic evaluation as a standard criterion. TABULATION, INTEGRATION, AND RESULTS: Seven studies were eligible, including 472 women and 1717 histopathologic specimens, and they involved study of the use of narrow-band imaging (2 studies), 5-aminolevulinic acid-induced fluorescence (2 studies), autofluorescence imaging (1 study), indocyanine green (1 study), and a 3-dimensional robotic laparoscopy (1 study). Two authors extracted data and assessed the validity of the included studies. Bivariate random-effects models and McNemar's test were used to compare the tests and evaluate sources of heterogeneity. Four studies were attributed a high risk of bias, and biopsies of normal-looking peritoneum were not performed to verify the results in 3 studies; both factors were identified as significant sources of heterogeneity, leading to the overestimation of the sensitivity and underestimation of the specificity of imaging tools. In all studies, additional endometriotic lesions were diagnosed with the enhanced imaging tool compared with white-light inspection alone. In the 4 studies that appropriately performed control biopsies (171 women, 448 specimens), enhanced imaging techniques were associated with a higher sensitivity and specificity compared with white-light inspection (0.84 and 0.89 compared with 0.75 and 0.76, respectively, p ≤.001). Adverse events were uncommon (n = 5) and reported only with the use of exogeneous photosensitizers. There were no reports of long-term changes in patient-reported outcomes arising from better detection of endometriosis lesions. CONCLUSION: Studies report that enhanced imaging allows for the detection of additional endometriotic lesions missed by conventional white-light laparoscopy. The benefits of finding these additional lesions using enhanced imaging compared with white-light inspection alone on long-term postoperative outcomes have not been determined, and these tools should be considered only in a research context at this time.

Minimally Invasive Hysterectomy Rates in Québec: Trends Over the Last Decade and Predictors of Technicity.

OBJECTIVE: To assess trends and predictors of a high technicity index for hysterectomies performed in the province of Québec. METHODS: We conducted a retrospective study using the ADAM database to determine the annual number hysterectomies performed for a suspected benign condition and the surgical approach used across 81 hospitals in the province of Québec from 2007 to 2017. We calculated the technicity index for each hospital and analyzed trends in surgical approach using the Cochran-Armitage test. We used logistic regression to assess potential predictors of a high technicity index (>70%), including academic centre, urban area, high volume of hysterectomies performed, and greater number of gynaecologists per hospital. RESULTS: Fifty-nine hospitals were eligible for inclusion, representing 96 431 hysterectomies during the study period. Over the decade, the technicity index increased from 43% to 66% (P < 0.001, with a 198% increase in laparoscopic hysterectomies (from 685 to 2039 per year; P < 0.001), a 50% decrease in abdominal hysterectomies (from 5528 to 2790 per year; P < 0.001), and a 8% decrease in vaginal hysterectomies (form 3551 to 3257 per year; P < 0.001). Meanwhile, the total number of hysterectomies per year declined by 17% (P < 0.001). Being an academic centre was the only significant predictor of a high technicity index >70% (68% vs. 38%; OR 7.5; P = 0.047). CONCLUSION: Technicity is increasing in the province of Québec and the majority of hysterectomies are now performed using a minimally invasive approach. This shift has mainly occurred through an increase in the laparoscopic approach and a decrease in the abdominal approach. Academic centres are more likely to have high technicity indexes.

Morcellation During Total Laparoscopic Hysterectomies: Implications of the Use of a Contained Bag System.

OBJECTIVE: This study sought to report the feasibility and clinical implications of in-bag morcellation for total laparoscopic hysterectomy (TLH). METHODS: Women who required uterine morcellation during TLH from January 2017 to December 2018 (at the Centre Hospitalier Universitaire de Québec - CHUL, Québec, QC) were included. Women with a preoperative suspicion of malignancy were excluded (Canadian Task Force classification II-2). RESULTS: During the 2-year study period, uterine morcellation was required in 42% (106 of 252) of women undergoing TLH. Mean uterine weight of morcellated uterus was 541 ± 291 g, with 11 of 106 uteri weighing >1000 g. In-bag morcellation was attempted in 84 of 106 (79%) and successfully performed in 79 of 84 (94%) women. Failures resulted from inability to insert the specimen into the bag or apparent perforation. Uncontained morcellation was chosen for 22 of 106 (21%) women, most of whom underwent vaginal morcellation of the uterus. Total operative time was 40 minutes longer for the in-bag morcellation group (170 ± 48 vs. 130 ± 43 min; P < 0.001), although this difference can be partly explained by the higher mean uterine size compared with the uncontained morcellation group (580 ± 309 vs. 391 ± 122 g; P = 0.01). In a subgroup analysis of 16 women, the mean times of installation and extraction of the bag were estimated to be 17 ± 9 and 4 ± 3 minutes, respectively. Complications were infrequent (2 of 106) and occurred in the in-bag morcellation group. CONCLUSION: In-bag morcellation is feasible in a high proportion of women undergoing laparoscopic hysterectomy and is associated with an increase in operative time. Larger studies will be required in order to better assess the risk of complications with in-bag morcellation and the potential benefits of this technique, namely, reducing the spread of tissue.

Contained Morcellation of Very Large Uterus.

A 38-year-old woman was referred to our centre for symptomatic leiomyoma. The patient had a large uterus, heavy menstrual bleeding, and compressive symptoms refractory to medical treatments. The patient was then scheduled for total laparoscopic hysterectomy with contained morcellation. After circular colpotomy completion, a strong, folded, 4-L bag with an additional sleeve for the optics was inserted into the abdominal cavity through the vagina. The colored tabs on the edge of the bag mouth served as landmarks during bag deployment. After ensuring optimal positioning, the entire bag was fully deployed, and the specimen was placed inside. Thereafter, the coloured tabs were joined together, and a monofilament drawstring was cinched to close the bag and pulled out through the suprapubic trocar. Next, the small extra sleeve was brought up through the umbilical incision. The bag was then insufflated, and the power morcellator was inserted through the suprapubic incision. After completing the morcellation, the pneumo bag was evacuated, and knots were made in both openings of the bag to avoid spillage. The closed bag was finally removed through the vagina, with final laparoscopic closure of the vaginal vault.

Interventional Uterine-Sparing Therapies for Leiomyomas: A Commentary on Myolysis.

Uterine leiomyomas (myomas, fibroids) are very common in premenopausal women and frequently are associated with abnormal uterine bleeding, bulk effects, and reproductive issues. In women who wish to retain their uterus and/or to enhance or retain fertility, interventional therapies have been introduced, including radiofrequency, laser (chromo), cryotherapy, and magnetic resonance (MR)-guided high-intensity focused ultrasound (MRgHIFU) myolysis. In formulating this commentary, all modalities of myolysis from systematic reviews, randomized controlled clinical trials, and observational studies through December 2018 were reviewed. There are only two treatment modalities available in Canada: the laparoscopic radiofrequency volumetric thermal ablation of fibroids (RFVTA) and MRgHIFU systems. In women who wish to enhance or retain their fertility, the safety and efficacy of radiofrequency and HIFU myolysis have not been clearly established, and these treatments should be offered only after extensive counselling and informed consent. Given the recent concerns regarding the incidence of undiagnosed malignant tumours, the lack of histological confirmation before or after these therapies for symptomatic fibroids mandates a thorough process of informed patient consent before any such interventions.

Pyomyoma After Uterine Artery Embolization: Laparotomy Avoided by In-Bag Morcellation.

We report a case of a pyomyoma in which in-bag morcellation allowed for a total laparoscopic hysterectomy instead of laparotomy, which has been recognized as the standard of care to avoid the spread of infection from morcellation. A 45-year-old multiparous woman presented with sepsis, pelvic pain, and leukocytosis at 1 month after undergoing uterine artery embolization for symptomatic uterine leiomyoma. Pelvic computed tomography scan revealed a 9-cm suspected pyomyoma. A total hysterectomy was performed using a laparoscopic approach with in-bag morcellation. The intervention was successful, and the postoperative course was uneventful. The patient was discharged on postoperative day 1 and was well at 2 months after surgery.

N° 244 - Endométriose : Diagnostic et prise en charge (résumé/déclarations sommaires et recommandations).

OBJECTIF: Améliorer la compréhension de l'endométriose et fournir une directive clinique factuelle pour ce qui est du diagnostic et de la prise en charge de l'endométriose. ISSUES: Parmi les issues évaluées, on trouve les effets de la prise en charge médicale et chirurgicale de l'endométriose sur la morbidité et l'infertilité que connaissent les femmes. MéTHODES: Les membres du comité voué à la présente directive clinique ont été sélectionnés en fonction de leur expertise respective, et ce, en vue de représenter une gamme d'expériences pratiques et universitaires tant au niveau de la représentation géographique au Canada que du type de pratique (nous avons également cherché à nous assurer de représenter l'expertise des sous-spécialités et l'expérience en gynécologie générale). Le comité a analysé toutes les données disponibles issues de la littérature médicale (en anglais et en français), ainsi que les données disponibles issues d'un sondage mené auprès de Canadiennes. Les recommandations ont été formulées sous forme de déclarations de consensus. Le document final a été analysé et approuvé par le comité exécutif et le Conseil de la Société des obstétriciens et gynécologues du Canada. RéSULTATS: Le présent document offre un résumé des derniers résultats en ce qui concerne le diagnostic, les explorations et la prise en charge médicale et chirurgicale de l'endométriose. Les recommandations qui en résultent peuvent être adaptées par chacun des fournisseurs de soins de santé offrant ses services à des femmes qui présentent cette pathologie. CONCLUSIONS: L'endométriose est une pathologie courante et parfois débilitante qui affecte les femmes en âge de procréer. Une approche multidisciplinaire mettant en jeu une combinaison de modifications du mode de vie, de médicaments et de services paramédicaux devrait être utilisée pour limiter les effets de cette pathologie sur les activités de la vie quotidienne et la fertilité. Dans certaines circonstances, le recours à la chirurgie s'avère nécessaire pour confirmer le diagnostic et fournir un traitement cherchant à atteindre l'objectif visé en matière de soulagement de la douleur ou d'amélioration de la fertilité. Les femmes qui obtiennent une stratégie acceptable de prise en charge de cette pathologie peuvent connaître une amélioration de leur qualité de vie ou atteindre leur objectif quant à l'obtention d'une grossesse réussie. DONNéES: Des recherches ont été menées dans les bases de données Medline et Cochrane en vue d'en tirer les articles publiés, en anglais et en français, entre janvier 1999 et octobre 2009 sur les sujets liés à l'endométriose, à la douleur pelvienne et à l'infertilité, et ce, en vue de la rédaction d'une directive clinique de consensus canadienne sur la prise en charge de l'endométriose. VALEURS: La qualité des résultats a été évaluée au moyen des critères décrits par le Groupe d'étude canadien sur les soins de santé préventifs. Les recommandations quant à la pratique ont été classées en fonction de la méthode décrite par le groupe d'étude. Reportez-vous au Tableau 1. AVANTAGES, DéSAVANTAGES ET COûTS: La mise en œuvre des recommandations de la présente directive clinique entraînera l'amélioration des soins offerts aux femmes dont les douleurs et l'infertilité sont associées à l'endométriose.

Directive clinique No 389 - Prise en charge médicamenteuse des léiomyomes utérins symptomatiques - Addenda.

OBJECTIFS: Les directives du présent addenda visent à fournir aux cliniciens une mise à jour de la directive clinique de 2015 sur la prise en charge des fibromes utérins. Comme de nouveaux renseignements et de nouvelles données probantes ont vu le jour depuis 2015, le comité de pratique clinique - gynécologie de la Société des obstétriciens et gynécologues du Canada a déterminé qu'un addenda à ce document était désormais nécessaire pour informer les membres des modalités de traitement des fibromes utérins. RéSULTATS: La mise en application de la présente mise à jour de la directive clinique devrait contribuer à optimiser le processus de décision des femmes et de leurs fournisseurs de soins de santé pour ce qui est de poursuivre les examens diagnostiques ou les traitements relatifs aux léiomyomes utérins après avoir tenu compte de l'évolution de la maladie ainsi que des options thérapeutiques et analysé les risques et les bienfaits anticipés. DONNéES PROBANTES: La littérature publiée a été repérée entre février 2015 et avril 2018 à l'aide de recherches effectuées dans les bases de données PubMed, CINAHL et Cochrane Database of Systematic Reviews au moyen d'une terminologie contrôlée appropriée (uterine fibroids, myoma, leiomyoma, myomectomy, myolysis, heavy menstrual bleeding, menorrhagia) et des mots clés (myoma, leiomyoma, fibroid, myomectomy, uterine artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia). Les listes de références des articles repérés ont aussi fait l'objet de recherche pour en tirer des publications pertinentes. Seuls les résultats des revues systématiques, d'essais cliniques randomisés ou comparatifs et d'études observationnelles ont été retenus. Aucune date limite n'a été appliquée, mais les résultats ont été limités aux contenus en anglais ou en français. Les recherches ont été régulièrement mises à jour et leurs résultats ont été incorporés à la directive clinique jusqu'en avril 2018. La plupart des données non publiées n'ont pas fait l'objet d'évaluation scientifique. Les monographies de produit ont aussi été analysées jusqu'au 31 décembre 2018. AVANTAGES, PRéJUDICES ET COûTS: La majorité des fibromes sont asymptomatiques et ne nécessitent aucune intervention ni aucun examen diagnostique supplémentaire. Pour les fibromes symptomatiques, tels que ceux qui entraînent des anomalies menstruelles (p. ex. saignements utérins abondants, irréguliers ou prolongés), une anémie ferriprive ou des symptômes liés au volume des fibromes (p. ex. pression ou douleur pelvienne, symptômes d'obstruction), l'hystérectomie constitue une solution définitive. Par contre, elle n'est pas la solution à privilégier pour les femmes qui souhaitent préserver leur fertilité ou leur utérus. Le traitement choisi devrait viser une amélioration de la symptomatologie et de la qualité de vie. Le coût du traitement pour le système de soins de santé et pour la femme atteinte de fibromes doit être interprété par rapport au coût des affections pathologiques non traitées et au coût des examens diagnostiques et modalités de traitement continus ou répétés. CRITèRES: La qualité des données probantes contenues dans le présent document a été évaluée en fonction des critères décrits dans le rapport du Groupe d'étude canadien sur les soins de santé préventifs. RECOMMANDATIONS.

Guideline No. 389-Medical Management of Symptomatic Uterine Leiomyomas - An Addendum.

OBJECTIVES: The aim of this guideline is to provide clinicians with an update to the 2015 Clinical Practice Guideline on the Management of Uterine Fibroids. As new information and evidence has become available since 2015, the Gynaecology Clinical Practice Committee of the Society for Obstetricians and Gynaecologists of Canada has determined that an addendum to that document was necessary to inform members about treatment modalities for uterine fibroids. OUTCOMES: Implementation of this guideline update 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 2015 to April 2018, 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 controlled trials or 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 April 2018. Most of the unpublished data have not been evaluated scientifically. The product monograph was also reviewed up to December 31st, 2018. 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 deficiency 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 Canadian Task Force on Preventive Health Care.

No. 371-Morcellation During Gynaecologic Surgery: Its Uses, Complications, and Risks of Unsuspected Malignancy.

OBJECTIVE: This guideline provides guidance to gynaecologists regarding the use of tissue morcellation in gynaecologic surgery. OUTCOMES: Morcellation may be used in gynaecologic surgery to allow removal of large uterine specimens, thus providing women with a minimally invasive surgical option. Adverse oncologic outcomes of tissue morcellation should be mitigated through improved patient selection, preoperative investigations, and novel techniques that minimize tissue dispersion. EVIDENCE: Published literature was retrieved through searches of PubMed and Medline in the spring of 2014 using appropriate controlled vocabulary (leiomyosarcoma, uterine neoplasm, uterine myomectomy, hysterectomy) and key words (leiomyoma, endometrial cancer, uterine sarcoma, leiomyosarcoma, and morcellation). 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 July 2017. 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 in this document was rated using the criteria described in the report of the Canadian Task Force on Preventive Health Care. BENEFITS, HARMS, AND COSTS: Gynaecologists offer women minimally invasive surgery, and this may involve tissue morcellation and the use of a power morcellator for specimen retrieval. Women should be counselled that in the case of unexpected uterine (sarcoma, endometrial), cervical, and/or tubo-ovarian cancer, the use of a morcellator is associated with increased risk of tumour dissemination. Tissue morcellation should be performed only after complete investigation, appropriate patient selection, and informed consent and by surgeons with appropriate training in the safe practices of tissue morcellation. SUMMARY STATEMENTS: RECOMMENDATIONS.

No 371 - Le morcellement durant la chirurgie gynécologique: Son utilisation, ses complications et les risques liés à la présence de tumeurs malignes insoupçonnées.

OBJECTIF: La présente directive clinique conseille les gynécologues quant au recours au morcellement tissulaire pendant une chirurgie gynécologique. RéSULTATS: Le morcellement effectué au cours d'une chirurgie gynécologique peut permettre l'ablation de masses utérines volumineuses, offrant ainsi aux femmes une solution chirurgicale à effraction minimale. Les conséquences oncologiques indésirables du morcellement tissulaire devraient être atténuées par l'amélioration de la sélection des patientes, la tenue d'examens préopératoires et l'adoption de techniques novatrices réduisant au minimum la dispersion tissulaire. ÉVIDENCE: La littérature publiée a été récupérée au moyen de recherches menées dans PubMed et Medline au printemps 2014 à l'aide d'une terminologie contrôlée (« leiomyosarcoma ¼, « uterine neoplasm ¼, « uterine myomectomy ¼, « hysterectomy ¼) et de mots-clés (« leiomyoma ¼, « endometrial cancer ¼, « uterine sarcoma ¼, « leiomyosarcoma ¼, « morcellation ¼). Les résultats retenus provenaient de revues systématiques, d'essais cliniques randomisés, d'essais cliniques contrôlés et d'études observationnelles de langue anglaise ou française. Aucune restriction de date n'a été imposée. Les recherches ont été refaites régulièrement, et les résultats ont été incorporés à la directive clinique jusqu'en juillet 2017. Nous avons également tenu compte de la littérature grise (non publiée) trouvée sur les sites Web d'organismes d'évaluation des technologies de la santé et d'autres organismes liés aux technologies de la santé, dans des collections de directives cliniques et dans des registres d'essais cliniques, et obtenue auprès d'associations nationales et internationales de médecins spécialistes. VALEURS: La qualité des données probantes a été évaluée en fonction des critères décrits dans le rapport du Groupe d'étude canadien sur les soins de santé préventifs. AVANTAGES, INCONVéNIENTS ET COûTS: Les gynécologues offrent aux femmes une chirurgie à effraction minimale pouvant comprendre le recours à un morcellateur électromécanique pour faciliter le retrait des tissus. Les femmes devraient être informées que l'utilisation d'un morcellateur en présence de tumeurs utérines (sarcomes, tumeurs endométriales), cervicales ou tubo-ovariennes jusque-là insoupçonnées est associée à un risque accru de dissémination. Le morcellement tissulaire devrait être précédé d'une évaluation complète, d'une sélection appropriée des patientes et de l'obtention du consentement éclairé de ces dernières, et devrait être effectué par des chirurgiens ayant une formation adéquate en matière de pratiques de morcellement tissulaire sûres. DéCLARATIONS SOMMAIRES: RECOMMANDATIONS.

A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

STUDY OBJECTIVE: To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women. DESIGN: Multicenter, randomized, controlled, international study (Canadian Task Force classification I). SETTING: Thirteen academic and private medical centers. PATIENTS: Premenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O). INTERVENTION: Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation. MEASUREMENTS AND MAIN RESULTS: At 1-year post-treatment, study success (alkaline hematin ≤80 mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1 minutes for Minerva and 17.2 minutes for rollerball. There were no intraoperative adverse events and/or complications reported. CONCLUSION: The results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures.

No. 193-Laparoscopic Entry: A Review of Techniques, Technologies, and Complications.

OBJECTIVE: To provide clinical direction, based on the best evidence available, on laparoscopic entry techniques and technologies and their associated complications. OPTIONS: The laparoscopic entry techniques and technologies reviewed in formulating this guideline include the classic pneumoperitoneum (Veress/trocar), the open (Hasson), the direct trocar insertion, the use of disposable shielded trocars, radially expanding trocars, and visual entry systems. OUTCOMES: Implementation of this guideline should optimize the decision-making process in choosing a particular technique to enter the abdomen during laparoscopy. EVIDENCE: English-language articles from Medline, PubMed, and the Cochrane Database published before the end of September 2005 were searched, using the key words laparoscopic entry, laparoscopy access, pneumoperitoneum, Veress needle, open (Hasson), direct trocar, visual entry, shielded trocars, radially expanded trocars, and laparoscopic complications. VALUES: The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on the Periodic Health Examination. RECOMMENDATIONS AND SUMMARY STATEMENT.