Redefining the. Management of. The 2015 Canadian Guidelines: the. Uterine Fibroids- The Future. A Focus on Fibristal

Transcription

1 The 2015 Canadian Guidelines: the Redefining the Management of Uterine Fibroids- The Future A Focus on Fibristal ulipristal acetate TM Nicholas A. Leyland, BASc, MD, MHCM, FRCSC Professor and Chair Department of Obstetrics and Gynaecology Faculty of Health Sciences Michael A Symposium G. for DeGroote Canadian Obstetricians/Gynecologists School of Medicine McMaster University

2 Learning Objectives! Review the summary statements and the recommendations from the recently published Society of Obstetricians and Gynaecologists of Canada clinical practice guidelines! Review the various options for the management of uterine fibroids depending on the presenting symptoms and the patient s desire for fertility preservation.

3 MARCH JOGC MARS SOGC CLINICAL PRACTICE GUIDELINE SOGC CLINICAL PRACTICE GUIDELINE SOGC/GOC TECHNICAL UPDATE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas Outcomes: Implementation of this guideline should optimize This clinical practice guideline has been prepared by the the decision-making process of women and their health care providers in proceeding with further investigation or therapy for Clinical Practice Gynaecology, Reproductive Endocrinology uterine leiomyomas, having considered the disease process & Infertility, and Family Physician Advisory Committees, and available treatment options, and reviewed the risks and and approved by the Executive and Board of the Society of Obstetricians and Gynaecologists of Canada. Evidence: Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in PRINCIPAL AUTHORS February 2013, using appropriate controlled vocabulary (uterine George A. Vilos, MD, London ON menstrual bleeding, and menorrhagia) and key words (myoma, Catherine Allaire, MD, Vancouver BC Philippe-Yves Laberge, MD, Quebec QC hysterectomy, heavy menstrual bleeding, menorrhagia). The Nicholas Leyland, MD, MHCM, Hamilton ON relevant publications. Results were restricted to systematic SPECIAL CONTRIBUTORS reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date limits but results were Angelos G. Vilos, MD, London, ON limited to English or French language materials. Searches were Ally Murji, MD, MPH, Toronto, ON updated on a regular basis and incorporated in the guideline Innie Chen, MD, Ottawa, ON through searching the websites of health technology assessment Disclosure statements have been received from all contributors. and health technology related agencies, clinical practice guideline collections, and national and international medical The literature searches and bibliographic support for this specialty societies. guideline were undertaken by Becky Skidmore, Medical Reserch Analyst, Society of Obstetricians and Gynaecologists of Canada. asymptomatic and require no intervention or further menstrual abnormalities (e.g. heavy, irregular, and prolonged Abstract (e.g., pelvic pressure/pain, obstructive symptoms), hysterectomy Objectives: The aim of this guideline is to provide clinicians with an for women who wish to preserve fertility and/or their uterus. The understanding of the pathophysiology, prevalence, and clinical selected treatment should be directed towards an improvement in symptomatology and quality of life. The cost of the therapy treatment modalities. be interpreted in the context of the cost of untreated disease Options: The areas of clinical practice considered in formulating this conditions and the cost of ongoing or repeat investigative or guideline were assessment, medical treatments, conservative treatment modalities. treatments of myolysis, selective uterine artery occlusion, and surgical alternatives including myomectomy and hysterectomy. Values: The quality of evidence in this document was rated using the criteria described in the Report of the Ca adian Task Force woman and her health care provider. on Preventive Health Care (Table 1). Key Words: artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia J Obstet Gynaecol Can 2015;37(2): No. 321, March 2015 The Management of Uterine Fibroids in Women With Otherwise Unexplained Infertility This clinical practice guideline was prepared by the Reproductive Endocrinology and Infertility Committee, reviewed by Family Physician Advisory and Clinical Practice Gynaecology Committees, and approved by the Executive and Board of the Society of Obstetricians and Gynaecologists of Canada. PRINCIPAL AUTHORS Belina Carranza-Mamane, MD, Sherbrooke QC Jon Havelock, MD, Vancouver BC Robert Hemmings, MD, Montreal QC REPRODUCTIVE ENDOCRINOLOGY AND INFERTILITY COMMITTEE Anthony Cheung (Co-chair), MD, Vancouver BC Sony Sierra (Co-chair), MD, Toronto ON Belina Carranza-Mamane, MD, Sherbrooke QC Allison Case, MD, Saskatoon SK Cathie Dwyer, RN, Toronto ON James Graham, MD, Calgary AB Jon Havelock, MD, Vancouver BC Robert Hemmings, MD, Montreal QC Kimberly Liu, MD, Toronto ON Ward Murdock, MD, Fredericton NB Tannys Vause, MD, Ottawa ON Benjamin Wong, MD, Calgary AB SPECIAL CONTRIBUTOR Margaret Burnett, MD, Winnipeg MB Disclosure statements have been received from all contributors. Keywords: Female leiomyoma, myomectomy, uterine artery embolization, in vitro fertilization, ovarian reserve, ulipristal acetate, magnetic resonance-guided focused ultrasound surgery. Abstract Objective: To provide recommendations regarding the best with emphasis on their applicability in women who wish to conceive. Options: surgical, but must be weighed against the evidence of surgical surgical management and approach. Outcomes: The outcomes of primary concern are the improvement women with infertility. Evidence: Published literature was retrieved through searches of PubMed, MEDLINE, the Cochrane Library in November 2013 using appropriate controlled vocabulary (e.g., leiomyoma, infertility, uterine artery embolization, fertilization in vitro) and key systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English and French. There were no date restrictions. Searches were updated on a regular basis and incorporated in the guideline to November websites of health technology assessment and health technologyrelated 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 by the Canadian Task Force on Preventive Health Care (Table). : These recommendations are expected infertility, maximizing their chances of pregnancy by minimizing risks introduced by unnecessary myomectomies. Reducing complications and eliminating unnecessary interventions are also expected to decrease costs to the health care system. J Obstet Gynaecol Can 2015;37(3): Technical Update on Tissue Morcellation During Gynaecologic Surgery: Its Uses, Complications, and Risks of Unsuspected Malignancy This technical update has been prepared by the Clinical Practice Gynaecology Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Executive of the Society of Gynecologic Oncology of Canada (GOC) and approved by the Executive and Board of the SOGC and the Board of Directors of the GOC. PRINCIPAL AUTHORS Sukhbir S. Singh, MD, Ottawa ON Stephanie Scott, MD, Vancouver BC Olga Bougie, MD, Ottawa ON Nicholas Leyland, MD, Hamilton ON SOGC CLINICAL PRACTICE GYNAECOLOGY COMMITTEE Nicholas Leyland, MD (Co-chair), Hamilton ON Wendy Wolfman, MD (Co-chair), Toronto ON Catherine Allaire, MD, Vancouver BC Alaa Awadalla, MD, Winnipeg MB Annette Bullen, RN, Caledonia ON Margaret Burnett, MD, Winnipeg MB Susan Goldstein, MD, Toronto ON Madeleine Lemyre, MD, Quebec QC Violaine Marcoux, MD, Montreal QC Frank Potestio, MD, Thunder Bay ON David Rittenberg, MD, Halifax NS Sukhbir S. Singh, MD, Ottawa ON Grace Yeung, MD, London ON GOC EXECUTIVE COMMITTEE Paul Hoskins, MD, Vancouver BC Dianne Miller, MD, Vancouver BC Walter Gotlieb, MD, Montreal QC Marcus Bernardini, MD, Toronto ON SPECIAL CONTRIBUTOR Laura Hopkins, MD, Ottawa ON Disclosure statements have been received from all contributors. Abstract Objective: To review the use of tissue morcellation in minimally invasive gynaecological surgery. Outcomes: Morcellation may be used in gynaecological surgery to allow removal of large uterine specimens, 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 (leiomyomsarcoma, uterine neoplasm, uterine myomectomy, hysterectomy) and key words (leiomyoma, endometrial cancer, uterine sarcoma, leiomyosarcoma, morcellation, and MRI). 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 August Grey (unpublished) literature technology assessment and health technology assessmentrelated 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) Gynaecologists may 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 Key Words: leiomyoma, uterine sarcoma, leiomyosarcoma, morcellation, complications J Obstet Gynaecol Can 2015;37(1):68 78 This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the SOGC. This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the SOGC. FEBRUARY JOGC FÉVRIER JANUARY JOGC JANVIER 2015

4 Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force on Preventive Health Care Quality of evidence assessment* I: Evidence obtained from at least one properly randomized controlled trial II-1: Evidence from well-designed controlled trials without randomization II-2: Evidence from well-designed cohort (prospective or retrospective) or case control studies, preferably from more than one centre or research group A. There is good evidence to recommend the clinical preventive action B. There is fair evidence to recommend the clinical preventive action C. recommendation for or against use of the clinical preventive action; II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category D. There is fair evidence to recommend against the clinical preventive action E. There is good evidence to recommend against the clinical preventive action III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees decision-making *The quality of evidence reported in here has been adapted from The Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care. 52 on Preventive Health Care. 52

5 Diagnosis of Uterine Fibroids! Clinical history! presentation " Pain (degeneration) " Bulk " Menorrhagia (SOGC 2013)! Determine impact on patient s quality of life! Physical exam,! Appropriate imaging! Remember contiguous structures- R/O Hydronephrosis Khan AT, et al. Int J Womens Health 2014;6:95-114

6 FIGO Classification System 12 Leiomyoma Subclassification System S Submusosal 0 Pedunculated intracavitary 1 < 50% intramural O Other 3 Contacts endometrium; 100% intramural 4 Intramural 6 Subserosal < 50% intramural 7 Subserosal pedunculated 8 Other (specify e.g. cervical, parasitic) Hybrid leiomyomas (impact both endometrium and serosa) Two numbers are listed separated by a hyphen. By convention, the first refers to the relationship with the endometrium while the second refers to the relationship to the serosa. One example is below 2-5 Submusocal and subserosal, each with less than half the diameter in the endometrial and peritoneal cavities, respectively.

7 Classification of Fibroids-Clinical European Society of Hysteroscopy Classification: 1 TYPE 0 Intracavitary TYPE I > 50% in cavity TYPE II < 50% in cavity TYPE III Serosal/intramural Myoma to serosa distance *Endometrium coverage 1. Wamsteker K, et al. Obstet Gynecol 1993;82: Munro MG, et al. Int J Gynaecol Obstet 2011;113:3-13

8 1.. Singh, S., et al. J Obstet Gynaecol Can 2013;35(5 esuppl):s1-s28 2. Singh, Scott, Bougie, Leyland, et al. J Obstet Gynaecol Can 2015;25: ; 2. Brooks SE, et al. Gynecol Oncol 2004;93:204-8; 3. Seidman MA, et al. PLoS One 2012;7:e50058 Diagnostic Work-up! Investigate based on presentation " Abnormal uterine bleeding # Blood work-up (hemoglobin, ferritin) # Endometrial biopsy as per guidelines to rule out pathology! Uterine stromal tumours are rare (1 in 352) 2 # Incidence may be higher in patients undergoing surgery 3 # No diagnostic test determines sarcoma (1 in 500 to 1 in 1000)

9 Diagnostic Work-up (cont d)! Imaging is important to determine location & rule out other pathology- Fibroid Mapping! Pelvic ultrasound: Endovaginal and/or transabdominal! Contrast (gel, saline) infusion sonography- Virtual Hysteroscopy! MRI: Allows determination of location, size, number, and perfusion of fibroids! Hysteroscopy MRI = Magnetic resonance imaging 1. Khan AT, et al. Int J Womens Health 2014;6: Singh, S., et al. J Obstet Gynaecol Can 2013;35(5 esuppl):s1-s28

10 Brölmann H, et al. Internet J Gynecol Obstetrics 2007; /1/6739 Treatment Approaches for Uterine Fibroids! Medical! Surgical! Interventional Uterine artery embolization MRI-guided focused ultrasound

11 Figure 2. Algorithm for the management of uterine myomas Uterine myomas Asymptomatic Symptomatic Clinical surveillance Pre-menopause Post-menopause Enhance fertility Retain fertility Retain uterus Other f Investigations: - Endometrial biopsy - Imaging - Hysteroscopy See SOGC Guideline 19 AUB Medical therapy: - SPRM (Ulipristal) - OC - Danazol - LNG-IUS - Tranexamic acid - GnRH agonist ± add-back Bulk effects ± AUB Medical therapy: - SPRM (Ulipristal) - GnRH-agonist ± add-back Bulk effects ± AUB Interventional therapy: - UAE - MRg-FUS - Myolysis Hysterectomy ± BSO Hysteroscopic myomectomy Surgical therapy: Myomectomy - Hysteroscopic - Laparoscopic - Laparotomic Surgical therapy Myomectomy - Hysteroscopic - Laparoscopic - Laparotomic Surgical therapy: Myomectomy ± EA - Hysteroscopic - Laparoscopic - Laparotomic BSO: bilateral salpingo-oophorectomy; MRg-FUS: Magnetic resonance-guided focused ultrasound; OC: oral contraceptives

12 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas This clinical practice guideline has been prepared by the Clinical Practice Gynaecology, Reproductive Endocrinology & Infertility, and Family Physician Advisory Committees, and approved by the Executive and Board of the Society of Obstetricians and Gynaecologists of Canada. PRINCIPAL AUTHORS George A. Vilos, MD, London ON Catherine Allaire, MD, Vancouver BC Philippe-Yves Laberge, MD, Quebec QC Nicholas Leyland, MD, MHCM, Hamilton ON SPECIAL CONTRIBUTORS Angelos G. Vilos, MD, London, ON Ally Murji, MD, MPH, Toronto, ON Innie Chen, MD, Ottawa, ON Disclosure statements have been received from all contributors. The literature searches and bibliographic support for this guideline were undertaken by Becky Skidmore, Medical Reserch Analyst, Society of Obstetricians and Gynaecologists of Canada. Abstract Objectives: The aim of this guideline is to provide clinicians with an understanding of the pathophysiology, prevalence, and clinical 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. 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 Evidence: Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in February 2013, using appropriate controlled vocabulary (uterine menstrual bleeding, and menorrhagia) and key words (myoma, hysterectomy, heavy menstrual bleeding, menorrhagia). The 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 through searching the websites of health technology assessment and health technology related agencies, clinical practice guideline collections, and national and international medical specialty societies. asymptomatic and require no intervention or further menstrual abnormalities (e.g. heavy, irregular, and prolonged (e.g., pelvic pressure/pain, obstructive symptoms), hysterectomy 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 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 Ca adian Task Force on Preventive Health Care (Table 1). Key Words: artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia J Obstet Gynaecol Can 2015;37(2): This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information FEBRUARY JOGC FÉVRIER

13 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) Recommendations The Management of Uterine Leiomyomas 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 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

14 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas line conservative surgical therapy for the management of 5. Surgical planning for myomectomy should be based on mapping appropriate imaging. (III-A) 6. When morcellation is necessary to remove the specimen, the patient should be informed about possible risks and 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

15 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas line conservative surgical therapy for the management of 5. Surgical planning for myomectomy should be based on mapping appropriate imaging. (III-A) 6. When morcellation is necessary to remove the specimen, the patient should be informed about possible risks and 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

16 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas 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 counselled regarding possible risks, including the likelihood that fecundity and pregnancy may be impacted. (II-3A)

17 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas 10. In women who present with acute uterine bleeding associated 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)

18 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas Summary Statements age 50; the 20% to 50% that are symptomatic have considerable social and economic impact in Canada. (II-3) challenges. (III) pregnancy is not an indication for myomectomy except in women who have had a previous pregnancy with complications related additional maternal and fetal surveillance. (II-2)

19 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas 5. Effective medical treatments for women with abnormal uterine 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 modulators and gonadotropin-releasing hormone analogues. (I) 7. Hysterectomy is the most effective treatment for symptomatic

20 SOGC CLINICAL PRACTICE GUIDELINE No. 318, February 2015 (Replaces, No. 128, May 2003) The Management of Uterine Leiomyomas 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)

21 SOGC CLINICAL PRACTICE GUIDELINE No. 321, March 2015 The Management of Uterine Fibroids in Women With Otherwise Unexplained Infertility This clinical practice guideline was prepared by the Reproductive Endocrinology and Infertility Committee, reviewed by Family Physician Advisory and Clinical Practice Gynaecology Committees, and approved by the Executive and Board of the Society of Obstetricians and Gynaecologists of Canada. PRINCIPAL AUTHORS Belina Carranza-Mamane, MD, Sherbrooke QC Jon Havelock, MD, Vancouver BC Robert Hemmings, MD, Montreal QC REPRODUCTIVE ENDOCRINOLOGY AND INFERTILITY COMMITTEE Anthony Cheung (Co-chair), MD, Vancouver BC Sony Sierra (Co-chair), MD, Toronto ON Belina Carranza-Mamane, MD, Sherbrooke QC Allison Case, MD, Saskatoon SK Cathie Dwyer, RN, Toronto ON James Graham, MD, Calgary AB Jon Havelock, MD, Vancouver BC Robert Hemmings, MD, Montreal QC Kimberly Liu, MD, Toronto ON Ward Murdock, MD, Fredericton NB Tannys Vause, MD, Ottawa ON Benjamin Wong, MD, Calgary AB SPECIAL CONTRIBUTOR Margaret Burnett, MD, Winnipeg MB Disclosure statements have been received from all contributors. Keywords: Female leiomyoma, myomectomy, uterine artery embolization, in vitro fertilization, ovarian reserve, ulipristal acetate, magnetic resonance-guided focused ultrasound surgery. Abstract Objective: To provide recommendations regarding the best with emphasis on their applicability in women who wish to conceive. Options: surgical, but must be weighed against the evidence of surgical surgical management and approach. Outcomes: The outcomes of primary concern are the improvement women with infertility. Evidence: Published literature was retrieved through searches of PubMed, MEDLINE, the Cochrane Library in November 2013 using appropriate controlled vocabulary (e.g., leiomyoma, infertility, uterine artery embolization, fertilization in vitro) and key systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English and French. There were no date restrictions. Searches were updated on a regular basis and incorporated in the guideline to November websites of health technology assessment and health technologyrelated 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 by the Canadian Task Force on Preventive Health Care (Table). : These recommendations are expected infertility, maximizing their chances of pregnancy by minimizing risks introduced by unnecessary myomectomies. Reducing complications and eliminating unnecessary interventions are also expected to decrease costs to the health care system. J Obstet Gynaecol Can 2015;37(3): This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the SOGC. MARCH JOGC MARS

22 SOGC CLINICAL PRACTICE GUIDELINE No. 321, March 2015 The Management of Uterine Fibroids in Women With Otherwise Unexplained Infertility Recommendations 1. In women with infertility, an effort should be made to adequately endometrial cavity, using transvaginal ultrasound, hysteroscopy, hysterosonography, or magnetic resonance imaging. (III-A) uterine cavity, evaluation of the degree of invasion of the cavity and thickness of residual myometrium to the serosa. A combination of hysteroscopy and transvaginal ultrasound or hysterosonography are the modalities of choice. (III-B) managed hysteroscopically, but repeat procedures are often necessary. (III-B)

23 SOGC CLINICAL PRACTICE GUIDELINE No. 321, March 2015 The Management of Uterine Fibroids in Women With Otherwise Unexplained Infertility 4. A hysterosalpingogram is not an appropriate exam to evaluate and 5. In women with otherwise unexplained infertility, submucosal pregnancy rates. (II-2A)

24 SOGC CLINICAL PRACTICE GUIDELINE No. 321, March 2015 The Management of Uterine Fibroids in Women With Otherwise Unexplained Infertility 7. There is fair evidence to recommend against myomectomy in endometrium) and otherwise unexplained infertility, regardless of of myomectomy should be weighed against the risks, and

25 SOGC CLINICAL PRACTICE GUIDELINE No. 321, March 2015 The Management of Uterine Fibroids in Women With Otherwise Unexplained Infertility to use an anterior uterine incision to minimize the formation of postoperative adhesions. (II-2A) 9. Widespread use of the laparoscopic approach to myomectomy selection should be individualized based on the number, size, and 10. Women, fertile or infertile, seeking future pregnancy should not generally be offered uterine artery embolization as a treatment

26 SOGC/GOC TECHNICAL UPDATE Technical Update on Tissue Morcellation During Gynaecologic Surgery: Its Uses, Complications, and Risks of Unsuspected Malignancy This technical update has been prepared by the Clinical Practice Gynaecology Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Executive of the Society of Gynecologic Oncology of Canada (GOC) and approved by the Executive and Board of the SOGC and the Board of Directors of the GOC. PRINCIPAL AUTHORS Sukhbir S. Singh, MD, Ottawa ON Stephanie Scott, MD, Vancouver BC Olga Bougie, MD, Ottawa ON Nicholas Leyland, MD, Hamilton ON SOGC CLINICAL PRACTICE GYNAECOLOGY COMMITTEE Nicholas Leyland, MD (Co-chair), Hamilton ON Wendy Wolfman, MD (Co-chair), Toronto ON Catherine Allaire, MD, Vancouver BC Alaa Awadalla, MD, Winnipeg MB Annette Bullen, RN, Caledonia ON Margaret Burnett, MD, Winnipeg MB Susan Goldstein, MD, Toronto ON Madeleine Lemyre, MD, Quebec QC Violaine Marcoux, MD, Montreal QC Frank Potestio, MD, Thunder Bay ON David Rittenberg, MD, Halifax NS Sukhbir S. Singh, MD, Ottawa ON Grace Yeung, MD, London ON GOC EXECUTIVE COMMITTEE Paul Hoskins, MD, Vancouver BC Dianne Miller, MD, Vancouver BC Walter Gotlieb, MD, Montreal QC Marcus Bernardini, MD, Toronto ON SPECIAL CONTRIBUTOR Laura Hopkins, MD, Ottawa ON Disclosure statements have been received from all contributors. Abstract Objective: To review the use of tissue morcellation in minimally invasive gynaecological surgery. Outcomes: Morcellation may be used in gynaecological surgery to allow removal of large uterine specimens, 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 (leiomyomsarcoma, uterine neoplasm, uterine myomectomy, hysterectomy) and key words (leiomyoma, endometrial cancer, uterine sarcoma, leiomyosarcoma, morcellation, and MRI). 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 August Grey (unpublished) literature technology assessment and health technology assessmentrelated 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) Gynaecologists may 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 Key Words: leiomyoma, uterine sarcoma, leiomyosarcoma, morcellation, complications J Obstet Gynaecol Can 2015;37(1):68 78 This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the SOGC. 68 JANUARY JOGC JANVIER 2015

27 SOGC/GOC TECHNICAL UPDATE Technical Update on Tissue Morcellation During Gynaecologic Surgery: Its Uses, Complications, and Risks of Unsuspected Malignancy Summary Statements The risk of an unexpected uterine sarcoma following surgery for presumed benign uterine leiomyoma is approximately 1 in 350, and the rate of leiomyosarcoma is 1 in 500. (II-2) This risk increases with age. (II-2) 2. An unexpected uterine sarcoma treated by primary surgery involving tumour disruption, including morcellation of the tumour, has the potential for intra-abdominal tumour-spread and a worse prognosis. (II-2) 3. Uterus-sparing surgery remains a safe option for patients with symptomatic leiomyomas who desire future fertility. (II-1)

28 SOGC/GOC TECHNICAL UPDATE Recommendations Technical Update on Tissue Morcellation During Gynaecologic Surgery: Its Uses, Complications, and Risks of Unsuspected Malignancy 1. Techniques for morcellation of a uterine specimen vary, and physicians should consider employing techniques that minimize specimen disruption and intra-abdominal spread. (III-C) 2. Each patient presenting with uterine leiomyoma should be assessed for the possible presence of malignancy, based on her risk factors and preoperative imaging, although the value of these is limited. (III-C) 3. Preoperative endometrial biopsy and cervical assessment to avoid morcellation of potentially detectable malignant and premalignant conditions is recommended. (II-2A) 4. Hereditary cancer syndromes that increase the risk of uterine malignancy should be considered a contraindication to uncontained uterine morcellation. (III-C)

29 SOGC/GOC TECHNICAL UPDATE Technical Update on Tissue Morcellation During Gynaecologic Surgery: Its Uses, Complications, and Risks of Unsuspected Malignancy 5. Uterine morcellation is contraindicated in women with established or suspected cancer. (II-2A) If there is a high index of suspicion of a uterine sarcoma prior to surgery, patients should be advised to proceed with a total abdominal hysterectomy, bilateral salpingectomy, and possible oophorectomy. (II-2C) A gynaecologic oncology consultation should be obtained. 6. Tissue morcellation techniques require appropriate training and experience. Safe practice initiatives surrounding morcellation technique and the use of equipment should be implemented at the local level. (II-3B) 7. Morcellation is an acceptable option for retrieval of benign

30