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Surgical Tutorial 1: Tissue Extraction

PROGRAM CHAIR

Sarah L. Cohen, MD, MPH

Bernd Bojahr, MD Steve Yu, MD

Professional Education Information Target Audience This educational activity is developed to meet the needs of surgical gynecologists in practice and in training, as well as other healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 Prevalence of Leiomyosarcoma among 10,731 Laparoscopic Supra‐Cervical Hysterectomies B. Bojahr ....................................................................................................................................................... 3 Uncontained Morcellation: Rationale and Technique S. Yu .............................................................................................................................................................. 6 Contained Morcellation S.L. Cohen ...................................................................................................................................................... 9

Cultural and Linguistics Competency ......................................................................................................... 14

Surgical Tutorial 1: Tissue Extraction

Sarah L. Cohen, Chair

Faculty: Bernd Bojahr, Steve Yu The recent controversy concerning the prevalence of leiomyosarcoma (LMS) among women having

surgery for presumed uterine fibroids has focused attention on the risks of tissue extraction in women

with undiagnosed LMS. Methods for both contained and uncontained morcellation have been

developed to reduce intra-peritoneal tumor spread, which might potentially change the patient's

prognosis. The prevalence of LMS, derived from a large study, will be presented, and both contained and

uncontained morcellation techniques will be illustrated with video.

Learning Objectives: At the conclusion of this course, the participant will be able to: 1) Discuss the

prevalence of leiomyosarcoma among women having surgery for presumed uterine fibroids; 2) describe

techniques for both contained and uncontained morcellation.

Course Outline

11:00 Welcome, Introductions and Course Overview S.L. Cohen

11:05 Prevalence of Leiomyosarcoma among 10,731 Laparoscopic Supra-Cervical Hysterectomies B. Bojahr

11:20 Uncontained Morcellation: Rationale and Technique S. Yu

11:35 Contained Morcellation S.L. Cohen

11:50 Questions & Answers All Faculty

12:00 Adjourn

1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop (listed in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* R. Edward Betcher* Amber Bradshaw Speakers Bureau: Myriad Genetics Lab Other: Proctor: Intuitive Surgical Sarah L. Cohen Consultant: Olympus Erica Dun* Joseph (Jay) L. Hudgens Contracted Research: Gynesonics Frank D. Loffer, Medical Director, AAGL* Suketu Mansuria Speakers Bureau: Covidien Linda Michels, Executive Director, AAGL* Karen C. Wang* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Sawsan As-Sanie Consultant: Myriad Genetics Lab Jubilee Brown* Aarathi Cholkeri-Singh Consultant: Smith & Nephew Endoscopy Speakers Bureau: Bayer Healthcare Corp., DySIS Medical, Hologic Other: Advisory Board: Bayer Healthcare Corp., Hologic Jon I. Einarsson* Suketu Mansuria Speakers Bureau: Covidien Andrew I. Sokol* Kevin J.E. Stepp Consultant: CONMED Corporation, Teleflex Stock Ownership: Titan Medical Karen C. Wang* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Bernd Bojahr* Sarah L. Cohen Consultant: Olympus Steve Yu* Content Reviewer has no relationships. Asterisk (*) denotes no financial relationships to disclose.

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Prevalence of Leiomyosarcoma among 10 731 Laparoscopic Supra‐

Cervical Hysterectomies

Prof. Bernd Bojahr

Klinik für MIC Minimally Invasive Center

Berlin, Germany

Prevalence of Leiomyosarcoma among 10 731 Laparoscopic Supra‐Cervical

Hysterectomies

Disclosures:

I have no financial relationships to disclose.

Prof. Bernd Bojahr

Prevalence of Leiomyosarcoma among 10 731 Laparoscopic Supra‐Cervical

Hysterectomies

Objective:

This study aims to evaluate the number of

cases of occult uterine malignancies in all

LASH surgeries at the MIC clinic (Berlin)

and to verify how the operative technique

affects the prognosis of the disease.

Especially the prevalence of

leiomyosarcomas and the results will be

analyzed and discussed.

Statements and Questions

• 600 000 hysterectomies each year (MIS 30% ‐2002 ‐ 63% ‐2012)

• 50 000 ‐150 000 annualy with morcellation

AAGL: Morcellation is contraindicated in presence of documented

or highly suspected malignancy !

(imperative: preoperative screening guidelines – including endometrialbiopsy and cervical cytology)

38‐68% of leiomyosarcomas can be detected in this manner

Data insufficient to discontinue power morcellation in appropriately

screened patients at low risk.

Leiomyosarcomas ‐ aggressive malignancy ! Outcomes are suboptimal with

and without morcellation !

„Decision Analysis Model“ was constructed based on available literature:

Converting all hysterectomies currently performed with morcellation

to abd. hysterectomy – would result in an increase of 17 more women dying

from surgery each year and a substantial morbidity from open surgery.

AAGL:

•Our obligation is not only to patients with

leiomyosarcoma but to all of our patients !

•We must not sacrifice the well‐being of

our patients in response to a rare event !

•We should improve but not abandon power morcellation

•Power morcellation with appropriate informed consent shouldremain available to appropriately screened women at low risk !

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•4864 articles identified – 60 in full evaluated

•Aim: May Morcellation of occult leiomyosarcomas substantially worsen patients outcome ?

•17 with outcome informations: 6 addressed the question of whether morcellation of leiomyosarcomas result in inferior outcomes as compared with en bloc removal.

•Results suggested that en bloc removal may result in improved survival and less recurrence – the data are highly biased and of poor quality.

•There is no evidence from these 17 studies that power morcellation differs in any way from other types of morcellation or even simple myomectomy insofar as patients outcome.

•More investigations are necessary before conclusions are drawn and policies created regarding the danger of morcellation of leiomyosarcomas for the patient.

Malignancy rate of 10,731 uteri morcellated during laparoscopic supracervical hysterectomy (LASH)

Bernd Bojahr, Rudy Leon De Wilde, Garri TchartchianArch Gynecol Obstet (2015) 292: 665‐672

indication patients %

uterine myoma 8720 81.3

bleeding disorder 1015 9.4

suspicion of

adenomyosis/pain

361 3.4

prolaps 635 5.9

n % + SD (range)

uterine malignancies 13 0.13 ± 3.6 (0.128 – 0.133)

sarcoma 6 0.06 ± 2.4 (0.054 - 0.057)

low grade endometrial stromal sarcoma 4 0.04

leiomyosarcoma 2 0.02 ± 1.4 (0.018-0.019)

endometrial cancer 7 0.07 ± 2.7 (0.073 – 0.076)

endometrial cancer in-situ 1 0.01

adenocarcinoma located in a polyp 1 0.01

undifferentiated endometrial carcinoma 1 0.01

endometroid adenocarcinoma 5 0.05





endometrial

cancer sarcoma all uterine

malignomas

Patients age

mean years + SD 51.4 ± 6.1 48.7 ± 5.7 50.2 ± 5.8

range 51.6 - 53.2 48.5 - 49.9 50.1 - 51.1

Patients height

mean cm + SD 171.4 ± 7.0 168.8 ± 3.5 170.4 ± 5.7

range 171.3 - 175.3 168.7 - 173.1 170.3 - 173.2

Patients weight

mean g + SD 88.9 ± 31.6 75.2 ± 12.9 83.0 ± 25.6

range 88.2 - 90.8 74.8 - 77.1 82.6 - 84.4



Sarcomas – Follow up surgery after 51 days (2‐91) after LASH –All patients without residual tumor or metastases

1 patient (Leiomyosarkoma, Uterus 1000gm) 2 month after LASH removal of cervix – no signs of recurrence/metastases; 10 Months after LASH peritoneal carcinomatosis and bone metastases and died after 13 months.

•Follow up: 6/6 patients with sarcomas and 7/8 with endometrial cancer(no follow up informations of the patient endometrial Ca in situ)

•Follow up 65,6 months (13‐169)•All patients with Follow up informations had follow up surgery

Endometrial cancers – no recurrences during follow up surgery within 32 days (11‐56) with a Follow up of 74 months (16‐169)

1 patient with a undifferentiated endometrial cancer and 5 positive lymph nodes ‐ 61 months without signs of recurrences

• The youngest patient with a sarcoma was 43 years old.• Till today we did not find a sarcoma during myomectomies.• 2014: 1499 operations (LASH,LAVH, Myomectomies,

Hysteroscopic Myomresections) – no sarcomas and no atypical myomas !

Aim for the future:

‐Improvement of Morcellation Technique

‐ Evaluation of all cases after morcellation of sarcomas

(Follow up)

‐ Register for all sarcomas (national/international ?)

‐Bag Techniques should be investigated for safety and outcomes.

ESGE, AGE, DGGG,ACOG, AAGL, AUGS, SGO, SGS:

Support the further use of morcellation for patients with appropriate informed consent and low risk.

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• Recommendation:

‐ Abundant lavage at the end of laparoscopy

‐ Removal of all abdominal remnants of myomas and tissues

‐ Careful control of the area of operation (incl. middle and upper abdomen)





•Conclusions

All patients should be informed about the

very low incidence of sarcomas during

preoperative counceling.

(FDA 1/350) own datas 1/1788 ‐ 0,06% !

With a timely follow up surgery according to

the oncologic guidelines our datas suggest a

very good prognosis in terms of survival after LASH with morcellation of malignant tumors in the uterus.

Thank you for your attention!

5

Uncontained Morcellation: Rationale and Technique

Steve Yu, MDAssistant Clinical Professor

Department of Obstetrics and Gynecology

David Geffen School of Medicine

University of California, Los Angeles

I have no financial relationships to disclose.

Objectives

• Explain the rationale for uncontained morcellation.

• Demonstrate the techniques of controlled tissue extraction.

Rationale

• Cells are aerosolized during hysterotomy.

• Blood from the myoma/sarcoma spills into the peritoneal cavity during dissection & repair.

• Morcellation in a bag increases O.R. time.

• Morcellation in a bag has its inherent complications.

Dissemination of Cells Dissemination of Cells

6

20

6

3 samples positivePre‐morcellation &Post‐morcellation

3 samples positivePost‐morcellation

Sample size:

Positive washing:

Sample size: 5

Washing prior myomectomy

0 positive

Washing after myomectomy

3 positive

Technique

• Controlled morcellation

• Extract all visible myoma fragments.

• Copious irrigation

Controlled Morcellation

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Copious Irrigation References

Toubia, Tarek, et al., Peritoneal Washings After Power Morcellation in Laparoscopic Myomectomy: A Pilot Study. Journal of Minimally Invasive Gynecology (2016) 23, 578-581.

Sandberg, EM, et al., Disseminated leiomyoma cells can be identified following conventional myomectomy. BJOG (2016); DOI: 10.1111/1471-0528.14265

Structured Video Abstract:Uncontained Morcellation: Rationale and Technique

Steve Yu, M.D.University of California, Los Angeles

Objective: To explain the rationale for uncontained morcellation and to demonstrate controlled tissue extraction.

Design: Display of myoma cell dissemination during laparoscopic myomectomy prior to morcellation and demonstration of tissue extraction with narrated video footage.

Setting: Advances in minimally invasive surgery (MIS) have significantly improved surgical care in women’s health. In order to remove any tissue considerably larger than the diameter of the secondary trocar requires morcellation. In recent years, there has been considerable scrutiny in power morcellation due to the risk of morcellating an unsuspected uterine leiomyosarcoma, with the potential to disseminate cancer cells. To mitigate this risk, many MIS surgeons have demonstrated techniques to morcellate in a contained bag. However, this is practice has not been shown to prevent dissemination of cells, and it has its inherent complications. Further, due to the technical steps necessary to enucleate a myoma, dissemination of myoma cells occurs prior to morcellation.

Intervention: Minimize the risk of myoma cell dissemination during laparoscopic myomectomy by:

1. Controlled morcellation2. Meticulously removing all visible myoma fragments3. Copious irrigation

Conclusion: Historically, large tissue extraction required a laparotomy, which is associated with more pain, longer hospitalization, increased risk of hemorrhage and increased risk of infection. Power morcellation has significantly advanced MIS in women’s health care. Minimizing the risk of myoma/sarcoma cell dissemination requires improved techniques in tissue extraction outlined previously.

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Surgical Tutorial: Tissue ExtractionContained Morcellation

Sarah L. Cohen, MD MPH

Director of Research

Division of Minimally Invasive Gynecologic Surgery

Brigham and Women’s Hospital

PHS IS2

Disclosures

Consultant: Olympus

Objectives Review options, tips and tricks for contained

morcellation Power

Vaginal

Minilaparotomy

From innovation to possible solution

KA ‘Tony’ Shibley MD Video at AAGL in 2012 detailing tissue isolation

and extraction within artificial pnemoperitoneum

Initially developed for use with single-site laparoscopic supracervical hysterectomy

Single port Shibley VideoContained Power Morcellation

Initial Technique: Cohen et al. Obstet Gynecol. 2014. Collaboration between BWH, MGH, JHH, KA Shibley

Many follow-up studies demonstrating variations on technique, equipment

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PHS IS2 I don't know what the politics are of name ordering! I figured I should be near the end, but the very end seems to be for VIPs... I leave it to youPartners Information Systems, 8/27/2015

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Contained Power Morcellation: Multi-port approach Video

Contained Power Morcellation: How long does it take? Vargas et al. JMIG. 2015

Compared OR time 3 months before and after implementing in bag power morcellation

36 IBM, 49 open morcellation; IBM added 26 minutes to OR time

Winner et al. Obstet Gynecol. 2015

101 uncontained morcellations, 51 contained between 2012-2015

20 minute increase in OR time

Contained Power Morcellation: Is it safe?

Cohen et al. AJOG 2015. Prospective study across 7 sites in Boston

Multi-port approach, varying bags used

Primary outcome: leakage of tissue or blue dye

Enrollment goal 400, early stop at 89 patients due to leakage events

7 cases of dye or tissue leakage on post morcellation survey

Surgical equipment catches up Paul et al. JMIG 2015.

MorSafe Bag, designed with sleeve

Rimbach et al. Arch Gynecol Obstet. 2015

Optic trocar access with sleeve to protect camera

Pig model of 8 cases of LSH

12 mins added OR time

Negative peritoneal cytology washings

FDA approved containment bag Pneumoliner – images and video

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What if I don’t have a power morcellator, or don’t want to use one?

Useful for total hysterectomy cases

Most efficient with parous patients, adequate pelvic outlet or smaller pathology

Vaginal specimen removal:

Contained Vaginal Morcellation

•Insert containment bag of choice •Based on specimen size, use abdominal wall incision (12-15mm) or colpotomy site•Place specimen into bag with cervix directed to opening of bag

Contained Vaginal Morcellation

Exteriorize bag at introitus

May utilize self retaining retractor to facilitate unhindered exposure

Rocking motion during manual morcellation with scalpel

Contained Vaginal Morcellation Video

What if I don’t have a power morcellator, or don’t want to use one?

Useful for myomectomy, supracervical hysterectomy

Large specimens (>16-18 wks)

Minilaparotomy:

Contained Minilaparotomy Morcellation

Umbilicus or suprapubic, 2.5-5cm

Tips to extend port at umbilicus

Insert containment bag of choice

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Single port device helpful to allow for return to LSC view

Place specimen in bag, exteriorize bag at abdominal wall

11 blade scalpel, morcellate in strips allowing specimen to roll

Contained Minilaparotomy Morcellation Minilaparotomy Technique

Contained Minilaparotomy Morcellation Useful Products GelPOINT mini (Applied Medical) – single port device useful for minilap morcellation

Alexis Contained Extraction System (Applied Medical) – bag with stiff rim, 17cm diameter, 6500mL capacity

Alexis Wound Retractors (Applied Medical) – varying sizes, useful to keep bag orifice open

LapSac (Cook Medical)- 8x10cm, 1500mL capacity, comes with optional introducer

EndoCatch (Covidien)- 15mm device with introducer and bag has 12..7cm diameter, 1000mL capacity

EcoSac Specimen Retrieval Bags (Espiner) – varying sizes, capacity upwards of 2000mL

180 bag is 17x24cm

Lahey/Containment bag (3M) – thin material, accommodates very large specimens, 50x50cm

In Summary

Many tissue removal options exist

Contained extraction via vagina, minilaparotomy or with power morcellation

Much of the equipment we are currently using for contained morcellation was not created for this purpose

Further study, technique refinement and work with industry required for continued improvement

U.S. Food and Drug Administration. UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA SafetyCommunication. November 14, 2014.

Park JY, Park SK, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. The impact of tumor morcellation during surgery on the prognosis ofpatients with apparently early uterine leiomyosarcoma. Gynecol Oncol. 2011; 122(2):255-9.

Perri T, Korach J, Sadetzki S, Oberman B, Fridman E, Ben-Baruch G. Uterine leiomyosarcoma: does the primary surgical procedure matter? Int J Gynecol Cancer. 2009;19(2):257-60.

George S, Barysauskas C, Serrano C, Oduyebo T, Rauh-Hain JA, Del Carmen MG, Demetri GD, Muto MG. Retrospective cohort study evaluating the impact of intraperitoneal morcellation on outcomes of localized uterine leiomyosarcoma. Cancer. 2014;120(20):3154-8.

Einarsson, JI, Cohen SL, Fuchs-Weizman N, Wang KC. In bag morcellation. J Minim Invasive Gynecol. 2014; 21(5):951-3.

Cohen SL, Einarsson JI, Wang KC, Brown DN, Boruta D, Scheib SA, Fader AN, Shibley KA. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014; 124(3):491-7.

Cohen SL, Greenberg JA, Wang KC, Srouji SS, Gargiulo AR, Pozner CN, Hoover N, Einarsson JI. Risk of leakage and tissue dissemination with various contained tissue extraction (CTE) techniques: an in vitro pilot study. J Minim Invasive Gynecol. 2014; 21(5):935-9.

Vargas MV, Cohen SL, Fuchs-Weizman N, Wang KC, Manoucheri E, Vitonis AF, Einarsson JI. Open power morcellation versus contained power morcellation within an insufflated isolation bag: comparison of perioperative outcomes. J Minim Invasive Gynecol. 2015 ;22(3):433-8.

Winner B, Porter A, Velloze S, Biest S. Uncontained Compared With Contained Power Morcellation in Total Laparoscopic Hysterectomy. Obstet Gynecol. 2015; 126(4):834-8.

Cohen SL, Morris SN, Brown DN, Greenberg JA, Walsh BW, Gargiulo AR, Isaacson KB, Wright K, Srouji SS, Anchan RM, Vogell AB, Einarsson JI. Contained Tissue Extraction using Power Morcellation: Prospective Evaluation of Leakage Parameters. Am J Obstet Gynecol. 2015; in press.

Akdemir A, Taylan E, Zeybek B, Ergenoglu AM, Sendag F. Innovative technique for enclosed morcellation using a surgical glove. Obstet Gynecol. 2015 ;125(5):1145-9.

Paul PG, Thomas M, Das T, Patil S, Garg R. Contained morcellation for laparoscopic myomectomy within a specially designed bag. J Minim Invasive Gynecol. 2015. pii: S1553-4650(15)00611-1

Rimbach S, Holzknecht A, Nemes C, Offner F, Craina M. A new in-bag system to reduce the risk of tissue morcellation: development and experimental evaluation during laparoscopic hysterectomy. Arch Gynecol Obstet. 2015 Dec;292(6):1311-20.

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CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

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http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

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