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Redefining the Management of Uterine Fibroids

A Focus on FibristalTM

ulipristal acetate

A Symposium for Canadian Obstetricians/Gynecologists

The 2015 Canadian

Guidelines: the Management of

Uterine Fibroids- “The Future”

Nicholas A. Leyland, BASc, MD, MHCM, FRCSC Professor and Chair Department of Obstetrics and Gynaecology Faculty of Health Sciences Michael G. DeGroote School of Medicine McMaster University

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.

MARCH JOGC MARS 2015 z 277

No. 321, March 2015

SOGC CLINICAL PRACTICE GUIDELINE

The Management of Uterine Fibroids in Women With Otherwise Unexplained Infertility

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 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


Allison Case, MD, Saskatoon SK

Cathie Dwyer, RN, Toronto ON

James Graham, MD, Calgary AB



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 LQIHUWLOLW\��XQH[SODLQHG�LQIHUWLOLW\��¿EURLG��leiomyoma, myomectomy, uterine artery embolization, in vitro fertilization, ovarian reserve, ulipristal acetate, magnetic resonance-guided focused ultrasound surgery.

J Obstet Gynaecol Can 2015;37(3):277–285

Abstract

Objective: To provide recommendations regarding the best PDQDJHPHQW�RI�¿EURLGV�LQ�FRXSOHV�ZKR�SUHVHQW�ZLWK�LQIHUWLOLW\��8VXDO�DQG�QRYHO�WUHDWPHQW�RSWLRQV�IRU�¿EURLGV�ZLOO�EH�UHYLHZHG�with emphasis on their applicability in women who wish to conceive.

Options:�0DQDJHPHQW�RI�¿EURLGV�LQ�ZRPHQ�ZLVKLQJ�WR�FRQFHLYH�¿UVW�LQYROYHV�GRFXPHQWDWLRQ�RI�WKH�SUHVHQFH�RI�WKH�¿EURLG�DQG�GHWHUPLQDWLRQ�RI�OLNHOLKRRG�RI�WKH�¿EURLG�LPSDFWLQJ�RQ�WKH�DELOLW\�WR�FRQFHLYH��7UHDWPHQW�RI�¿EURLGV�LQ�WKLV�LQVWDQFH�LV�SULPDULO\�surgical, but must be weighed against the evidence of surgical PDQDJHPHQW�LPSURYLQJ�FOLQLFDO�RXWFRPHV��DQG�ULVNV�VSHFL¿F�WR�surgical management and approach.

Outcomes: The outcomes of primary concern are the improvement LQ�SUHJQDQF\�UDWHV�DQG�RXWFRPHV�ZLWK�PDQDJHPHQW�RI�¿EURLGV�LQ�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 ZRUGV��H�J��¿EURLG��P\RPHFWRP\��5HVXOWV�ZHUH�UHVWULFWHG�WR�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 2013. *UH\��XQSXEOLVKHG�OLWHUDWXUH��ZDV�LGHQWL¿HG�WKURXJK�VHDUFKLQJ�WKH�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 by the Canadian Task Force on Preventive Health Care (Table).

%HQH¿WV��KDUPV��DQG�FRVWV: These recommendations are expected WR�DOORZ�DGHTXDWH�PDQDJHPHQW�RI�ZRPHQ�ZLWK�¿EURLGV�DQG�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.

68 z JANUARY JOGC JANVIER 2015

1R��-DQXDU\��

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 ONStephanie Scott, MD, Vancouver BCOlga Bougie, MD, Ottawa ONNicholas Leyland, MD, Hamilton ON

SOGC CLINICAL PRACTICE–GYNAECOLOGY COMMITTEE

Nicholas Leyland, MD (Co-chair), Hamilton ONWendy Wolfman, MD (Co-chair), Toronto ONCatherine Allaire, MD, Vancouver BCAlaa Awadalla, MD, Winnipeg MBAnnette Bullen, RN, Caledonia ONMargaret Burnett, MD, Winnipeg MBSusan Goldstein, MD, Toronto ONMadeleine Lemyre, MD, Quebec QCViolaine Marcoux, MD, Montreal QCFrank Potestio, MD, Thunder Bay ONDavid Rittenberg, MD, Halifax NSSukhbir S. Singh, MD, Ottawa ONGrace Yeung, MD, London ON

GOC EXECUTIVE COMMITTEE

Paul Hoskins, MD, Vancouver BCDianne Miller, MD, Vancouver BCWalter Gotlieb, MD, Montreal QCMarcus Bernardini, MD, Toronto ON

SPECIAL CONTRIBUTOR

Laura Hopkins, MD, Ottawa ONDisclosure statements have been received from all contributors.

Key Words: leiomyoma, uterine sarcoma, leiomyosarcoma, morcellation, complications


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 2014. Grey (unpublished) literature ZDV�LGHQWL¿HG�WKURXJK�VHDUFKLQJ�WKH�ZHEVLWHV�RI�KHDOWK�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. (Table 1)

%HQH¿WV��KDUPV��DQG�FRVWV� 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

FEBRUARY JOGC FÉVRIER 2015 z 157

No. 318, February 2015 (Replaces, No. 128, May 2003)


The Management of Uterine Leiomyomas

This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information VKRXOG�QRW�EH�FRQVWUXHG�DV�GLFWDWLQJ�DQ�H[FOXVLYH�FRXUVH�RI�WUHDWPHQW�RU�SURFHGXUH�WR�EH�IROORZHG��/RFDO�LQVWLWXWLRQV�FDQ�GLFWDWH�DPHQGPHQWV�WR�WKHVH�RSLQLRQV��7KH\�VKRXOG�EH�ZHOO�GRFXPHQWHG�LI�PRGLILHG�DW�WKH�ORFDO�OHYHO��1RQH�RI�WKHVH�FRQWHQWV�PD\�EH�UHSURGXFHG�LQ�DQ\�IRUP�ZLWKRXW�SULRU�ZULWWHQ�SHUPLVVLRQ�RI�WKH�62*&�

This clinical practice guideline has been prepared by the 8WHULQH�/HLRP\RPDV�:RUNLQJ�*URXS��UHYLHZHG�E\�WKH�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


The literature searches and bibliographic support for this guideline were undertaken by Becky Skidmore, Medical Reserch Analyst, Society of Obstetricians and Gynaecologists of Canada.

Key Words:�0\RPD��OHLRP\RPD��¿EURLG��P\RPHFWRP\��XWHULQH�artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia J Obstet Gynaecol Can 2015;37(2):157–178

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 DQWLFLSDWHG�EHQH¿WV�

Evidence: Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in February 2013, using appropriate controlled vocabulary (uterine ¿EURLGV��P\RPD��OHLRP\RPD��P\RPHFWRP\��P\RO\VLV��KHDY\�menstrual bleeding, and menorrhagia) and key words (myoma, OHLRP\RPD��¿EURLG��P\RPHFWRP\��XWHULQH�DUWHU\�HPEROL]DWLRQ��hysterectomy, heavy menstrual bleeding, menorrhagia). The UHIHUHQFH�OLVWV�RI�DUWLFOHV�LGHQWL¿HG�ZHUH�DOVR�VHDUFKHG�IRU�RWKHU�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 WR�-DQXDU\��*UH\��XQSXEOLVKHG��OLWHUDWXUH�ZDV�LGHQWL¿HG�through searching the websites of health technology assessment and health technology–related agencies, clinical practice guideline collections, and national and international medical specialty societies.

%HQH¿WV��+DUPV��DQG�&RVWV��7KH�PDMRULW\�RI�¿EURLGV�DUH�asymptomatic and require no intervention or further LQYHVWLJDWLRQV��)RU�V\PSWRPDWLF�¿EURLGV�VXFK�DV�WKRVH�FDXVLQJ�menstrual abnormalities (e.g. heavy, irregular, and prolonged XWHULQH�EOHHGLQJ��LURQ�GHI¿FLHQF\�DQHPLD��RU�EXON�V\PSWRPV�(e.g., pelvic pressure/pain, obstructive symptoms), hysterectomy LV�D�GH¿QLWLYH�VROXWLRQ��+RZHYHU��LW�LV�QRW�WKH�SUHIHUUHG�VROXWLRQ�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 WR�WKH�KHDOWK�FDUH�V\VWHP�DQG�WR�ZRPHQ�ZLWK�¿EURLGV�PXVW�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 CaQadian Task Force on Preventive Health Care (Table 1).

Abstract

Objectives: The aim of this guideline is to provide clinicians with an understanding of the pathophysiology, prevalence, and clinical VLJQL¿FDQFH�RI�P\RPDWD�DQG�WKH�EHVW�HYLGHQFH�DYDLODEOH�RQ�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. 7KH�ULVN�WR�EHQH¿W�UDWLR�PXVW�EH�H[DPLQHG�LQGLYLGXDOO\�E\�WKH�woman and her health care provider.

278 z MARCH JOGC MARS 2015


ABBREVIATIONSCPR clinical pregnancy rates

FSH follicle-stimulating hormone

IR implantation rates

IVF in vitro fertilization

LBR live birth rates

MR miscarriage rates

MRGfUS magnetic resonance-guided focused ultrasound surgery

MRI magnetic resonance imaging

OBR ongoing pregnancy rates

RCT randomized control trial

UAE uterine artery emolization

Summary Statements

� ��6XEVHURVDO�¿EURLGV�GR�QRW�DSSHDU�WR�KDYH�DQ�LPSDFW�RQ�IHUWLOLW\��WKH�HIIHFW�RI�LQWUDPXUDO�¿EURLGV�UHPDLQV�XQFOHDU��,I�LQWUDPXUDO�¿EURLGV�GR�KDYH�DQ�LPSDFW�RQ�IHUWLOLW\��LW�DSSHDUV�WR�EH�VPDOO�DQG�WR�EH�HYHQ�OHVV�VLJQL¿FDQW�ZKHQ�WKH�HQGRPHWULXP�LV�QRW�involved. (II-3)

� ��%HFDXVH�FXUUHQW�PHGLFDO�WKHUDS\�IRU�¿EURLGV�LV�DVVRFLDWHG�ZLWK�suppression of ovulation, reduction of estrogen production, or disruption of the target action of estrogen or progesterone at the receptor level, and it has the potential to interfere in endometrial development and implantation, there is no role for medical WKHUDS\�DV�D�VWDQG�DORQH�WUHDWPHQW�IRU�¿EURLGV�LQ�WKH�LQIHUWLOH�population. (III)

� ��3UHRSHUDWLYH�DVVHVVPHQW�RI�VXEPXFRVDO�¿EURLGV�LV�HVVHQWLDO�WR�the decision on the best approach for treatment. (III)

4. There is little evidence on the use of Foley catheters, estrogen, or intrauterine devices for the prevention of intrauterine adhesions following hysteroscopic myomectomy. (II-3)

5. In the infertile population, cumulative pregnancy rates by the laparoscopic and the minilaparotomy approaches are similar, but the laparoscopic approach is associated with a quicker recovery, less postoperative pain, and less febrile morbidity. (II-2)

6. There are lower pregnancy rates, higher miscarriage rates, and more adverse pregnancy outcomes following uterine artery embolization than after myomectomy. (II-3) Studies also suggest that uterine artery embolization is associated with loss of ovarian reserve, especially in older patients. (III)

Recommendations

1. In women with infertility, an effort should be made to adequately HYDOXDWH�DQG�FODVVLI\�¿EURLGV��SDUWLFXODUO\�WKRVH�LPSLQJLQJ�RQ�WKH�endometrial cavity, using transvaginal ultrasound, hysteroscopy, hysterosonography, or magnetic resonance imaging. (III-A)

��3UHRSHUDWLYH�DVVHVVPHQW�RI�VXEPXFRVDO�¿EURLGV�VKRXOG�LQFOXGH��LQ�DGGLWLRQ�WR�DQ�DVVHVVPHQW�RI�¿EURLG�VL]H�DQG�ORFDWLRQ�ZLWKLQ�WKH�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)

��6XEPXFRVDO�¿EURLGV�DUH�PDQDJHG�K\VWHURVFRSLFDOO\��7KH�¿EURLG�VL]H�VKRXOG�EH��FP��DOWKRXJK�ODUJHU�¿EURLGV�KDYH�EHHQ�managed hysteroscopically, but repeat procedures are often necessary. (III-B)

4. A hysterosalpingogram is not an appropriate exam to evaluate and FODVVLI\�¿EURLGV��,,,�'�

5. In women with otherwise unexplained infertility, submucosal ¿EURLGV�VKRXOG�EH�UHPRYHG�LQ�RUGHU�WR�LPSURYH�FRQFHSWLRQ�DQG�pregnancy rates. (II-2A)

��5HPRYDO�RI�VXEVHURVDO�¿EURLGV�LV�QRW�UHFRPPHQGHG��,,,�'�

7. There is fair evidence to recommend against myomectomy in ZRPHQ�ZLWK�LQWUDPXUDO�¿EURLGV��K\VWHURVFRSLFDOO\�FRQ¿UPHG�LQWDFW�endometrium) and otherwise unexplained infertility, regardless of WKHLU�VL]H��,,��'��,I�WKH�SDWLHQW�KDV�QR�RWKHU�RSWLRQV��WKH�EHQH¿WV�of myomectomy should be weighed against the risks, and PDQDJHPHQW�RI�LQWUDPXUDO�¿EURLGV�VKRXOG�EH�LQGLYLGXDOL]HG��,,,�&�

Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force on Preventive Health CareQuality of evidence assessment* &ODVVL¿FDWLRQ�RI�UHFRPPHQGDWLRQV�

I: Evidence obtained from at least one properly randomized controlled trial

A. There is good evidence to recommend the clinical preventive action

II-1: Evidence from well-designed controlled trials without randomization

B. There is fair evidence to recommend the clinical preventive action

II-2: Evidence from well-designed cohort (prospective or retrospective) or case–control studies, preferably from more than one centre or research group

C. 7KH�H[LVWLQJ�HYLGHQFH�LV�FRQÀLFWLQJ�DQG�GRHV�QRW�DOORZ�WR�PDNH�D�recommendation for or against use of the clinical preventive action; KRZHYHU��RWKHU�IDFWRUV�PD\�LQÀXHQFH�GHFLVLRQ�PDNLQJ

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

/��7KHUH�LV�LQVXI¿FLHQW�HYLGHQFH��LQ�TXDQWLW\�RU�TXDOLW\��WR�PDNH�D�UHFRPPHQGDWLRQ��KRZHYHU��RWKHU�IDFWRUV�PD\�LQÀXHQFH�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

�5HFRPPHQGDWLRQV�LQFOXGHG�LQ�WKHVH�JXLGHOLQHV�KDYH�EHHQ�DGDSWHG�IURP�WKH�&ODVVL¿FDWLRQ�RI�5HFRPPHQGDWLRQV�FULWHULD�GHVFULEHG�LQ�WKH�&DQDGLDQ�7DVN�)RUFH�on Preventive Health Care.52

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

FIGO Classification System

160 z FEBRUARY JOGC FÉVRIER 2015


myometrium), and or submucosal (projecting into the cavity RI �WKH�XWHUXV��$�QHZHU��PRUH�GHWDLOHG�FODVVLÀFDWLRQ�V\VWHP�has been devised and advocated by FIGO (Figure 1).12

5HFRJQL]HG�ULVN�IDFWRUV�IRU�GHYHORSPHQW�RI �XWHULQH�ÀEURLGV�include nulliparity, early menarche, increased frequency of menses, history of dysmenorrhea, family history of uterine ÀEURLGV��$IULFDQ�GHVFHQW��REHVLW\��DQG�DJH��SHDN�LQFLGHQFH�at 40 to 50). Clinical conditions that seem to increase risk RI �ÀEURLGV�LQFOXGH�K\SHUWHQVLRQ�DQG�GLDEHWHV�13

Clinical Presentation7KH�SUHVHQFH�RI �XWHULQH�ÀEURLGV�FDQ�OHDG�WR�YDULRXV�FOLQLFDO�challenges. The need for and choice of intervention must be individualized to the clinical situation.

The most common symptom of uterine leiomyoma is AUB. In a published series of myomectomies, 30% of women suffered from heavy menstrual bleeding.14–15 The mechanism of leiomyoma-associated AUB is unknown. Increased endometrial surface area, vascular dysregulation, and interference with endometrial hemostasis have been offered as possible explanations.16 Clinicians with patients presenting with AUB should refer to the SOGC clinical practice guideline on the management of AUB.17

3HOYLF� SDLQ� LV� UDUH� ZLWK� ÀEURLGV� DQG� XVXDOO\� VLJQLÀHV�degeneration, torsion, or possibly associated adenomyosis and/or endometriosis. Pelvic pressure, bowel dysfunction, and bladder symptoms such as urinary frequency and XUJHQF\� PD\� EH� SUHVHQW� ZLWK� ODUJHU� ÀEURLGV�� 8ULQDU\�symptoms should be investigated prior to surgical

PDQDJHPHQW�RI �ÀEURLGV�WR�H[FOXGH�RWKHU�SRVVLEOH�FDXVHV�15 In the postmenopausal woman presenting with new RQVHW�RI �SDLQ�DQG�RU�EOHHGLQJ�LQ�QHZ�RU�H[LVWLQJ�ÀEURLGV��leiomyosarcoma should be considered.18

Fibroids and FertilityA new SOGC guideline on the management of uterine ÀEURLGV� LQ�ZRPHQ�ZLWK� RWKHUZLVH� XQH[SODLQHG� LQIHUWLOLW\�will be published in the spring of 2015.19

Fibroids in Pregnancy(VWLPDWHV�RI �WKH�SUHYDOHQFH�RI �ÀEURLGV�LQ�SUHJQDQF\�YDU\�depending on the quality of the ultrasound study and the race and age of the women being studied. A recent ultrasound study found the prevalence to be 18% in African-American women, 8% in white women, and 10% in Hispanic women.20

0RVW� XOWUDVRXQG� VWXGLHV� IRXQG� WKDW� ÀEURLGV� UHPDLQ� WKH�same size or become smaller during pregnancy.21–23 In a �� UHSRUW�� SUHJQDQW� ZRPHQ� ZLWK� ÀEURLGV� ZHUH�followed by serial ultrasound. Postpartum, 36% of women KDG�QR�LGHQWLÀDEOH�ÀEURLG�DQG��RI �UHPDLQLQJ�ÀEURLGV�had decreased in size.24 One study reported an increase in myoma size during pregnancy.25

Several large retrospective studies of ultrasounds and medical records of pregnant women have reported on WKH� LPSDFW� RI � ÀEURLGV� RQ� SUHJQDQF\� RXWFRPHV�26–30 A 2008 meta-analysis found an overall increased risk of malpresentation (OR 2.9; 95% CI 2.6 to 3.2), Caesarean delivery (OR 3.7; 95% CI 3.5 to 3.9), and preterm delivery

LeiomyomaSubclassification System

S – Submusosal 0 Pedunculated intracavitary

1 < 50% intramural

�� LQWUDPXUDO

3 Contacts endometrium; 100% intramural

4 Intramural

�� 6XEVHURVDO��LQWUDPXUDO

6 Subserosal < 50% intramural

7 Subserosal pedunculated

8 Other (specify e.g. cervical, parasitic)

2-5 Submusocal and subserosal, each with less

than half the diameter in the endometrial

and peritoneal cavities, respectively.

Hybridleiomyomas(impact both

endometrium

and serosa)

O – Other

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

)LJXUH��7KH�),*2�OHLRP\RPD�VXEFODVVL¿FDWLRQ�V\VWHP12

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

1. Wamsteker K, et al. Obstet Gynecol 1993;82:736-40 2. Munro MG, et al. Int J Gynaecol Obstet 2011;113:3-13

*Endometrium coverage

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 surgery3

#  No diagnostic test determines sarcoma (1 in 500 to 1 in 1000)

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;25:396-418

; 2. Brooks SE, et al. Gynecol Oncol 2004;93:204-8; 3. Seidman MA, et al. PLoS One 2012;7:e50058

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

1. Khan AT, et al. Int J Womens Health 2014;6:95-114

2. Singh, S., et al. J Obstet Gynaecol Can 2013;35(5 eSuppl):S1-S28 MRI = Magnetic resonance imaging

Treatment Approaches for Uterine Fibroids

! Medical ! Surgical

!  Interventional

Uterine artery embolization MRI-guided focused ultrasound

Brölmann H, et al. Internet J Gynecol Obstetrics 2007;10. http://ispub.com/IJGO/10/1/6739



evidence that progestin add-back negatively impacts the HIIHFWLYHQHVV�RI �*Q5+�DJRQLVWV�RQ�ÀEURLG�VL]H�65,66

*Q5+�DJRQLVWV�DUH�XVHIXO�SUHRSHUDWLYHO\�WR�VKULQN�ÀEURLGV�and to reduce anemia related to uterine bleeding.47,67

Gonadotropin-Releasing Hormone AntagonistsWhile GnRH agonists work by down-regulation and desensitization of the GnRH receptors, GnRH antagonists work via the classical competitive blockage mechanism. The main advantage of using GnRH antagonists is their ODFN�RI �WKH� LQLWLDO�´ÁDUHµ�HIIHFW�VHHQ�ZLWK�*Q5+�DJRQLVW�stimulation and supraphysiological amounts of follicle stimulating hormone, luteinizing hormone, and estradiol, and hence have a much shorter onset of action and treatment period.68,69

7KH�XVH�RI �*Q5+�DQWDJRQLVWV�DV�D�WUHDWPHQW�IRU�ÀEURLGV�requires further evaluation.

Androgens (Danazol)'DQD]RO�LV�FKHPLFDOO\�UHODWHG�WR��ơ�HWKLQ\O�WHVWRVWHURQH��It competes with natural androgens, progesterone, and

glucocorticoids in receptor binding and acts at different levels of the hypothalamic-pituitary-ovarian-uterine axis. Aside from its androgenic effects, it also lowers estrogen levels by suppressing gonadotropin secretion at the levels of the hypothalamus and inhibits ovarian steroidogenesis.70

Danazol has been associated with a reduction in volume RI �ÀEURLGV� LQ� WKH�RUGHU�RI ��WR��71 Although the XVH�RI �GDQD]RO� IRU� WKH� VKULQNDJH�RI �XWHULQH�ÀEURLGV�KDV�been described in cohort studies, a systematic review did QRW�ÀQG�DQ\�UDQGRPL]HG�WULDOV�FRPSDULQJ�LWV�HIÀFDF\�ZLWK�placebo or other treatments.72

Although the long-term response to danazol is modest, it may offer an advantage in reducing myoma associated heavy menstrual bleeding.71

Aromatase Inhibitors (Letrozole)Myometrial cultured cells overexpress aromatase P450 DQG�V\QWKHVL]H�VXIÀFLHQW�HVWUDGLRO�WR�DFFHOHUDWH�WKHLU�RZQ�cell growth. Aromatase inhibitors may serve to block the aromatase activity and growth of leiomyomata.73

f

Uterine myomas

Asymptomatic Symptomatic

Clinical surveillance Pre-menopause Post-menopause

Enhance fertility Retain fertility Retain uterus Other Investigations:

- Endometrial biopsy - Imaging - Hysteroscopy

Hysterectomy ±BSO

Hysteroscopic myomectomy

See SOGC Guideline19

AUB

Medical therapy: - SPRM (Ulipristal) - OC - Danazol - LNG-IUS - Tranexamic acid - GnRH agonist ±

add-back Surgical therapy: Myomectomy - Hysteroscopic - Laparoscopic - Laparotomic

Bulk effects ± AUB

Medical therapy: - SPRM (Ulipristal) - GnRH-agonist ±

add-back Surgical therapy Myomectomy - Hysteroscopic - Laparoscopic - Laparotomic

Bulk effects ± AUB

Interventional therapy: - UAE - MRg-FUS - Myolysis Surgical therapy: Myomectomy ± EA - Hysteroscopic - Laparoscopic - Laparotomic

Figure 2. Algorithm for the management of uterine myomas

BSO: bilateral salpingo-oophorectomy; MRg-FUS: Magnetic resonance-guided focused ultrasound; OC: oral contraceptives







PRINCIPAL AUTHORS
















Abstract





Summary Statements

� �� 8WHULQH�¿EURLGV�DUH�FRPPRQ��DSSHDULQJ�LQ��RI�ZRPHQ�E\�age 50; the 20% to 50% that are symptomatic have considerable social and economic impact in Canada. (II-3)

� �� 7KH�SUHVHQFH�RI�XWHULQH�¿EURLGV�FDQ�OHDG�WR�D�YDULHW\�RI�FOLQLFDO�challenges. (III)

� �� &RQFHUQ�DERXW�SRVVLEOH�FRPSOLFDWLRQV�UHODWHG�WR�¿EURLGV�LQ�pregnancy is not an indication for myomectomy except in women who have had a previous pregnancy with complications related WR�WKHVH�¿EURLGV��,,,�

� �� :RPHQ�ZKR�KDYH�¿EURLGV�GHWHFWHG�LQ�SUHJQDQF\�PD\�UHTXLUH�additional maternal and fetal surveillance. (II-2)

5. Effective medical treatments for women with abnormal uterine EOHHGLQJ�DVVRFLDWHG�ZLWK�XWHULQH�¿EURLGV�LQFOXGH�WKH�OHYRQRUJHVWUHO�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 DVVRFLDWHG�ZLWK�¿EURLGV�LQFOXGH�VHOHFWLYH�SURJHVWHURQH�UHFHSWRU�modulators and gonadotropin-releasing hormone analogues. (I)

7. Hysterectomy is the most effective treatment for symptomatic XWHULQH�¿EURLGV��,,,�

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

� �� :RPHQ�ZLWK�DV\PSWRPDWLF�¿EURLGV�VKRXOG�EH�UHDVVXUHG�WKDW�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 ¿EURLGV��DJH��QHHG�DQG�GHVLUH�RI�WKH�SDWLHQW�WR�SUHVHUYH�IHUWLOLW\�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 EH�RIIHUHG�DV�WKH�GH¿QLWLYH�WUHDWPHQW�IRU�V\PSWRPDWLF�XWHULQH�¿EURLGV�DQG�LV�DVVRFLDWHG�ZLWK�D�KLJK�OHYHO�RI�VDWLVIDFWLRQ��,,��$�

� �� +\VWHURVFRSLF�P\RPHFWRP\�VKRXOG�EH�FRQVLGHUHG�¿UVW�line conservative surgical therapy for the management of V\PSWRPDWLF�LQWUDFDYLWDU\�¿EURLGV��,,��$�

5. Surgical planning for myomectomy should be based on mapping WKH�ORFDWLRQ��VL]H��DQG�QXPEHU�RI�¿EURLGV�ZLWK�WKH�KHOS�RI�appropriate imaging. (III-A)

6. When morcellation is necessary to remove the specimen, the patient should be informed about possible risks and FRPSOLFDWLRQV��LQFOXGLQJ�WKH�IDFW�WKDW�LQ�UDUH�FDVHV�¿EURLG�V��PD\�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 ¿EURLGV�ZKR�ZLVK�WR�SUHVHUYH�WKHLU�XWHUXV��:RPHQ�FKRRVLQJ�XWHULQH�DUWHU\�RFFOXVLRQ�IRU�WKH�WUHDWPHQW�RI�¿EURLGV�VKRXOG�EH�counselled regarding possible risks, including the likelihood that fecundity and pregnancy may be impacted. (II-3A)

Table 1. Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force on Preventive Health CareQuality of evidence assessment* &ODVVL¿FDWLRQ�RI�UHFRPPHQGDWLRQV�
















Summary Statements











Recommendations






























PRINCIPAL AUTHORS
















Abstract





Summary Statements











Recommendations






























PRINCIPAL AUTHORS
















Abstract





10. In women who present with acute uterine bleeding associated ZLWK�XWHULQH�¿EURLGV��FRQVHUYDWLYH�PDQDJHPHQW�ZLWK�HVWURJHQV��VHOHFWLYH�SURJHVWHURQH�UHFHSWRU�PRGXODWRUV��DQWL¿EULQRO\WLFV��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)

INTRODUCTION

Clinical Importance of Uterine Fibroids

TKH� WHUPV� ÀEURLG�� P\RPD�� DQG� OHLRP\RPD� DUH�synonymous and are the commonest gynaecological

tumours, with a prevalence of 70% to 80% in women who have reached the age of 50.1 In 95 061 US nurses, aged 25 to 44 years, the incidence was 8.9/1000 for white women and 30.9/1000 for black women.2 The prevalence increases with age, peaking in women in their 40s. A hysterectomy study has found leiomyomas in 77% of uterine specimens.3

In many women, myomas may be asymptomatic and are diagnosed incidentally on clinical examination or imaging. +RZHYHU��P\RPDV�FDQ�FDXVH�VLJQLÀFDQW�PRUELGLW\�LQFOXGLQJ�menstrual abnormalities (e.g. heavy, irregular, and prolonged XWHULQH�EOHHGLQJ�� LURQ�GHIÀFLHQF\�DQHPLD��EXON�V\PSWRPV�(e.g. pelvic pressure/pain, obstructive symptoms), and IHUWLOLW\� LVVXHV�� 6\PSWRPDWLF� ÀEURLGV� KDYH� D� FRQVLGHUDEOH�

impact on women’s quality of life as well as their productivity: in one survey of more than 21 000 women from 8 different countries, including 2500 from Canada, these symptoms had a negative impact on sexual life (43%), performance at work (28%), and relationship, and family (27%).4–6

Of 11 880 screened Canadian women, aged 20 to 49 years, 12.0% indicated they had been diagnosed with uterine ÀEURLGV��LQFOXGLQJ��UHSRUWLQJ�FXUUHQW�ÀEURLGV��7KRVH�ZLWK�PRGHUDWH�WR�VHYHUH�ÀEURLG�V\PSWRPV�H[SHULHQFHG�D�VLJQLÀFDQWO\�KHDYLHU�EXUGHQ�RI �LOOQHVV��ZLWK�ORVW�SURGXFWLYLW\�and reduced QoL.7

8WHULQH�ÀEURLGV�DUH�FXUUHQWO\�WKH�PRVW�FRPPRQ�LQGLFDWLRQ�for hysterectomy worldwide, and in Canada they account for 30% of all hysterectomies, the second most common surgery for women after Caesarean section.8 Hysterectomy LV� DVVRFLDWHG� ZLWK� VLJQLÀFDQW� PRUELGLW\�� PRUWDOLW\�� DQG�economic burden on the health care system,9–10 and 1 in 4 Canadian women over age 45 have had a hysterectomy.8 7KH� VRFLDO� DQG� HFRQRPLF� LPSDFW� RI � XWHULQH� ÀEURLGV� LV�therefore considerable.

Summary Statement��8WHULQH�ÀEURLGV�DUH�FRPPRQ��DSSHDULQJ�LQ��

of women by age 50; the 20% to 50% that are symptomatic have considerable social and economic impact in Canada. (II-3)

Pathophysiology of Myomas8WHULQH�ÀEURLGV�DUH�PRQRFORQDO� WXPRXUV� WKDW�DULVH�IURP�the uterine smooth muscle tissue (i.e. the myometrium). They are benign neoplasms composed of disordered ´P\RÀEUREODVWVµ� EXULHG� LQ� DEXQGDQW� TXDQWLWLHV� RI �extracellular matrix that accounts for a substantial portion RI �WXPRXU�YROXPH��7KH�LQLWLDWLQJ�HYHQWV�IRU�ÀEURLG�JHQHVLV�remain speculative.

The cells proliferate at a modest rate and their growth is dependant on the ovarian steroids estrogen and SURJHVWHURQH� DQG� WKHUHIRUH� PRVW� ÀEURLGV� VKULQN� DIWHU�menopause. The biologically potent estrogen estradiol LQGXFHV� WKH� SURGXFWLRQ� RI � 35� E\� PHDQV� RI � (5�ơ��35� LV� HVVHQWLDO� IRU� WKH� UHVSRQVH� RI � ÀEURLG� WLVVXH� WR�progesterone secreted by the ovaries. Progesterone and PR are indispensable to tumour growth, increasing cell proliferation and survival and enhancing extracellular matrix formation. In the absence of progesterone and PR, HVWURJHQ�DQG�(5�ơ�DUH�QRW�VXIÀFLHQW�IRU�ÀEURLG�JURZWK�11

Myomas can be single or multiple and can vary in size, ORFDWLRQ��DQG�SHUIXVLRQ��0\RPDV�DUH�FRPPRQO\�FODVVLÀHG�into 3 subgroups based on their location: subserosal (projecting outside the uterus), intramural (within the

ABBREVIATIONSAAGL American Association of Gynecologic Laparoscopists

AUB abnormal uterine bleeding

EA endometrial ablation

(5�Į�� HVWURJHQ�UHFHSWRU�DOSKD

FDA United States Food and Drug Administration

FIGO International Federation of Gynecology and Obstetrics

GnRH gonadotropin-releasing hormone

HRT hormone replacement therapy

LNG-IUS levonorgestrel intrauterine system

MRg-FUS magnetic resonance-guided focused ultrasound


NETA norethindrone acetate

PR progesterone receptor

QoL quality of life

RF radio frequency

RFVTA radio frequency volumetric thermal ablation

SERM selective estrogen receptor modulator

SPRM selective progesterone receptor modulator

UAE uterine artery embolization

UAO uterine artery occlusion

UPA ulipristal acetate







PRINCIPAL AUTHORS
















Abstract





Summary Statements











Recommendations






























PRINCIPAL AUTHORS
















Abstract




No. 321, March 2015





PRINCIPAL AUTHORS

















SPECIAL CONTRIBUTOR





Abstract








No. 321, March 2015





PRINCIPAL AUTHORS

















SPECIAL CONTRIBUTOR





Abstract







278 z MARCH JOGC MARS 2015


ABBREVIATIONSCPR clinical pregnancy rates

FSH follicle-stimulating hormone

IR implantation rates

IVF in vitro fertilization

LBR live birth rates

MR miscarriage rates

MRGfUS magnetic resonance-guided focused ultrasound surgery


OBR ongoing pregnancy rates

RCT randomized control trial

UAE uterine artery emolization

Summary Statements

� ��6XEVHURVDO�¿EURLGV�GR�QRW�DSSHDU�WR�KDYH�DQ�LPSDFW�RQ�IHUWLOLW\��WKH�HIIHFW�RI�LQWUDPXUDO�¿EURLGV�UHPDLQV�XQFOHDU��,I�LQWUDPXUDO�¿EURLGV�GR�KDYH�DQ�LPSDFW�RQ�IHUWLOLW\��LW�DSSHDUV�WR�EH�VPDOO�DQG�WR�EH�HYHQ�OHVV�VLJQL¿FDQW�ZKHQ�WKH�HQGRPHWULXP�LV�QRW�involved. (II-3)

� ��%HFDXVH�FXUUHQW�PHGLFDO�WKHUDS\�IRU�¿EURLGV�LV�DVVRFLDWHG�ZLWK�suppression of ovulation, reduction of estrogen production, or disruption of the target action of estrogen or progesterone at the receptor level, and it has the potential to interfere in endometrial development and implantation, there is no role for medical WKHUDS\�DV�D�VWDQG�DORQH�WUHDWPHQW�IRU�¿EURLGV�LQ�WKH�LQIHUWLOH�population. (III)

� ��3UHRSHUDWLYH�DVVHVVPHQW�RI�VXEPXFRVDO�¿EURLGV�LV�HVVHQWLDO�WR�the decision on the best approach for treatment. (III)

4. There is little evidence on the use of Foley catheters, estrogen, or intrauterine devices for the prevention of intrauterine adhesions following hysteroscopic myomectomy. (II-3)

5. In the infertile population, cumulative pregnancy rates by the laparoscopic and the minilaparotomy approaches are similar, but the laparoscopic approach is associated with a quicker recovery, less postoperative pain, and less febrile morbidity. (II-2)

6. There are lower pregnancy rates, higher miscarriage rates, and more adverse pregnancy outcomes following uterine artery embolization than after myomectomy. (II-3) Studies also suggest that uterine artery embolization is associated with loss of ovarian reserve, especially in older patients. (III)

Recommendations

1. In women with infertility, an effort should be made to adequately HYDOXDWH�DQG�FODVVLI\�¿EURLGV��SDUWLFXODUO\�WKRVH�LPSLQJLQJ�RQ�WKH�endometrial cavity, using transvaginal ultrasound, hysteroscopy, hysterosonography, or magnetic resonance imaging. (III-A)

��3UHRSHUDWLYH�DVVHVVPHQW�RI�VXEPXFRVDO�¿EURLGV�VKRXOG�LQFOXGH��LQ�DGGLWLRQ�WR�DQ�DVVHVVPHQW�RI�¿EURLG�VL]H�DQG�ORFDWLRQ�ZLWKLQ�WKH�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)

��6XEPXFRVDO�¿EURLGV�DUH�PDQDJHG�K\VWHURVFRSLFDOO\��7KH�¿EURLG�VL]H�VKRXOG�EH��FP��DOWKRXJK�ODUJHU�¿EURLGV�KDYH�EHHQ�managed hysteroscopically, but repeat procedures are often necessary. (III-B)

4. A hysterosalpingogram is not an appropriate exam to evaluate and FODVVLI\�¿EURLGV��,,,�'�

5. In women with otherwise unexplained infertility, submucosal ¿EURLGV�VKRXOG�EH�UHPRYHG�LQ�RUGHU�WR�LPSURYH�FRQFHSWLRQ�DQG�pregnancy rates. (II-2A)

��5HPRYDO�RI�VXEVHURVDO�¿EURLGV�LV�QRW�UHFRPPHQGHG��,,,�'�

7. There is fair evidence to recommend against myomectomy in ZRPHQ�ZLWK�LQWUDPXUDO�¿EURLGV��K\VWHURVFRSLFDOO\�FRQ¿UPHG�LQWDFW�endometrium) and otherwise unexplained infertility, regardless of WKHLU�VL]H��,,��'��,I�WKH�SDWLHQW�KDV�QR�RWKHU�RSWLRQV��WKH�EHQH¿WV�of myomectomy should be weighed against the risks, and PDQDJHPHQW�RI�LQWUDPXUDO�¿EURLGV�VKRXOG�EH�LQGLYLGXDOL]HG��,,,�&�

Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force on Preventive Health CareQuality of evidence assessment* &ODVVL¿FDWLRQ�RI�UHFRPPHQGDWLRQV�















No. 321, March 2015





PRINCIPAL AUTHORS

















SPECIAL CONTRIBUTOR





Abstract









� ��,I�¿EURLGV�DUH�UHPRYHG�DEGRPLQDOO\��HIIRUWV�VKRXOG�EH�PDGH�to use an anterior uterine incision to minimize the formation of postoperative adhesions. (II-2A)

9. Widespread use of the laparoscopic approach to myomectomy PD\�EH�OLPLWHG�E\�WKH�WHFKQLFDO�GLI¿FXOW\�RI�WKLV�SURFHGXUH��3DWLHQW�selection should be individualized based on the number, size, and ORFDWLRQ�RI�XWHULQH�¿EURLGV�DQG�WKH�VNLOO�RI�WKH�VXUJHRQ��,,,�$�

10. Women, fertile or infertile, seeking future pregnancy should not generally be offered uterine artery embolization as a treatment RSWLRQ�IRU�XWHULQH�¿EURLGV��,,��(�

INTRODUCTION

UWHULQH� ÀEURLGV�� P\RPDV�� RU� OHLRP\RPDWD� DUH� VPRRWK�muscle cell tumours and are the most common benign

gynaecologic tumour in women of reproductive age.1 They are often found as part of the investigation of a couple presenting with infertility, and their origin is monoclonal.2 They are rarely found before menarche and usually regress after menopause.3 They are hormonally responsive, and estrogens appear to promote their growth.4,5 Local estrogen concentrations have been shown to be higher in myomas than in the surrounding myometrium, possibly because of a higher concentration of aromatase.6 Hormonal responsiveness appears to be greater in submucosal than subserosal myomas.7

EVALUATION AND CLASSIFICATION OF FIBROIDS

6XEPXFRVDO� ÀEURLGV� KDYH� D� QHJDWLYH� LPSDFW� RQ� UDWHV� RI �implantation, clinical pregnancy, ongoing pregnancy, PLVFDUULDJH��DQG�OLYH�ELUWK��$Q�LPSRUWDQW�IHDWXUH�RI �ÀEURLG�FODVVLÀFDWLRQ�V\VWHPV�LV�WKH�HYDOXDWLRQ�RI �WKH�XWHULQH�FDYLW\�LQ�RUGHU� WR�GHÀQH�D�ÀEURLG�DV�VXEPXFRVDO��0DQ\�VWXGLHV�have not included proper evaluation of the cavity, and therefore potential biases can be expected in their results. Imaging is now recognized as a necessary tool in the preoperative evaluation of myomas, especially for uterus-sparing procedures.8

Ultrasound has been shown to be an adequate, rapid, safe, and cost-effective means of evaluating the size, number, and ORFDWLRQ� RI � ÀEURLGV�9 Transvaginal ultrasound may identify ÀEURLGV� RI � XS� WR� �� WR� ��PP� LQ� GLDPHWHU�10 Ultrasound PD\��KRZHYHU��EH� VXERSWLPDO� IRU�PXOWLSOH�ÀEURLGV��EHFDXVH�of acoustic shadowing, and for the proper evaluation of endometrial impingement. Interobserver variation has also been found to be greater with this technique than with MRI.11

05,� KDV� EHHQ� ZHOO� VWXGLHG� LQ� WKH� HYDOXDWLRQ� RI � ÀEURLG�XWHUXVHV�� HVSHFLDOO\� IRU� ÀEURLG�PDSSLQJ� DQG� VXEPXFRVDO�penetration. It was shown to be the most reliable method of evaluation when compared with vaginal ultrasound, hysterosonography, and hysteroscopy, with �� VHQVLWLYLW\� DQG� �� VSHFLÀFLW\� �JROG� VWDQGDUG�ZDV�

pathological examination).9 The main drawbacks of MRI evaluation are lack of accessibility and high cost.8

Hysterosalpingography is often performed to assess tubal patency in women with infertility and to exclude intrauterine pathology. However, the sensitivity and SRVLWLYH�SUHGLFWLYH�YDOXH�RI �WKLV�WHVW�IRU�WKH�LGHQWLÀFDWLRQ�of intrauterine lesions can be as low as 50% and 28.6% respectively.12 Hysterosalpingography cannot therefore be considered reliable to exclude endometrial distortion secondary to submucosal myomas.

Hysterosonography, which has the advantages of pelvic ultrasound, has been advocated as superior to transvaginal ultrasound alone13 and equal to hysteroscopy in the evaluation of endometrial impingement.14 It has EHHQ� VKRZQ� WR� EH� KLJKO\� VHQVLWLYH� DQG� VSHFLÀF� LQ� WKH�LGHQWLÀFDWLRQ�RI �VXEPXFRVDO�P\RPDV��,WV�PDLQ�GUDZEDFNV�are the risk of infection (approximately 1%) and the discomfort associated with the injection of sterile saline.13

No studies to date have evaluated the optimal mode of evaluating uterine myoma in women presenting with infertility. It is also unclear whether all women with infertility should have the integrity of their endometrial cavity evaluated. However, it seems clear that part of the heterogeneity in the results of studies attempting to clarify WKH� UHODWLRQVKLSV�EHWZHHQ�ÀEURLGV� DQG� LQIHUWLOLW\� DQG� WKH�impact of treatment on conception is due to inadequate FODVVLÀFDWLRQ�RI �ÀEURLGV��DQG�LQ�SDUWLFXODU�WKHLU�LPSDFW�RQ�the endometrial cavity.

Recommendations1. In women with infertility, an effort should be PDGH�WR�DGHTXDWHO\�HYDOXDWH�DQG�FODVVLI\�ÀEURLGV��particularly those impinging on the endometrial cavity, using transvaginal ultrasound, hysteroscopy, hysterosonography, or magnetic resonance imaging. (III-A)

��3UHRSHUDWLYH�DVVHVVPHQW�RI �VXEPXFRVDO�ÀEURLGV�should include, in addition to an assessment of ÀEURLG�VL]H�DQG�ORFDWLRQ�ZLWKLQ�WKH�XWHULQH�FDYLW\��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)

��6XEPXFRVDO�ÀEURLGV�DUH�PDQDJHG�K\VWHURVFRSLFDOO\��7KH�ÀEURLG�VL]H�VKRXOG�EH�� 5 cm, although larger ÀEURLGV�KDYH�EHHQ�PDQDJHG�K\VWHURVFRSLFDOO\��EXW�repeat procedures are often necessary. (III-B)

4. A hysterosalpingogram is not an appropriate exam to HYDOXDWH�DQG�FODVVLI\�ÀEURLGV��,,,�'�







PRINCIPAL AUTHORS






SPECIAL CONTRIBUTOR




Abstract






JANUARY JOGC JANVIER 2015 z 69


SOGC TECHNICAL UPDATE

ABBREVIATIONSBRCA breast cancer

ESS endometrial stromal sarcoma

FDA Food and Drug Administration

LDH lactic dehydrogenase

LESS laparoendoscopic single site morcellation

LMS leiomyosarcoma

MIS minimally invasive surgery

MRI magnetic resonance imagery

unexpected uterine sarcoma or endometrial cancer, the use of a morcellator is associated with increased risk of tumour dissemination. Appropriate training and safe practices should be in place before offering tissue morcellation.

Summary Statements

�� 8WHULQH�VDUFRPDV�PD\�EH�GLI¿FXOW�WR�GLDJQRVH�SUHRSHUDWLYHO\��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)

Recommendations

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)

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 uterine specimens and may facilitate a minimally invasive surgical approach, which is associated with decreased perioperative risks. Each patient should be counselled about the possible risks associated with the use of morcellation, including the risks associated with underlying malignancy. (III-C)

INTRODUCTION

Tissue morcellation during gynaecologic surgery has been widely practiced to facilitate removal of large

uteri or uterine myomas through less invasive incisions than those used in a traditional laparotomy.1�7KH�ÀUVW�HOHFWURQLF�













*The quality of evidence reported in these guidelines has been adapted from The Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care.59








PRINCIPAL AUTHORS






SPECIAL CONTRIBUTOR




Abstract














LMS leiomyosarcoma




Summary Statements




Recommendations








INTRODUCTION

























LMS leiomyosarcoma




Summary Statements




Recommendations








INTRODUCTION























PRINCIPAL AUTHORS






SPECIAL CONTRIBUTOR




Abstract














LMS leiomyosarcoma




Summary Statements




Recommendations








INTRODUCTION























PRINCIPAL AUTHORS






SPECIAL CONTRIBUTOR




Abstract






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