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Be a Surgical “Multiplier” in MIGS Inspire Brilliance Through Teamwork
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Scientific Program ChairJubilee Brown, MD
Honorary ChairBarbara S. Levy, MD
PresidentMarie Fidela R. Paraiso, MD
SYLLABUSSURGICAL TUTORIAL 4:
Controversies and Approaches to Tissue Extraction
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. Anti-Harassment Statement AAGL encourages its members to interact with each other for the purposes of professional development and scholarly interchange so that all members may learn, network, and enjoy the company of colleagues in a professional atmosphere. Consequently, it is the policy of the AAGL to provide an environment free from all forms of discrimination, harassment, and retaliation to its members and guests at all regional educational meetings or courses, the annual global congress (i.e. annual meeting), and AAGL-hosted social events (AAGL sponsored activities). Every individual associated with the AAGL has a duty to maintain this environment free of harassment and intimidation. AAGL encourages reporting all perceived incidents of harassment, discrimination, or retaliation. Any individual covered by this policy who believes that he or she has been subjected to such an inappropriate incident has two (2) options for reporting:
1. By toll free phone to AAGL’s confidential 3rd party hotline: (833) 995-AAGL (2245) during the AAGL Annual or Regional Meetings.
2. By email or phone to: The Executive Director, Linda Michels, at [email protected] or (714) 503-6200.
All persons who witness potential harassment, discrimination, or other harmful behavior during AAGL sponsored activities may report the incident and be proactive in helping to mitigate or avoid that harm and to alert appropriate authorities if someone is in imminent physical danger. For more information or to view the policy please go to: https://www.aagl.org/wp-content/uploads/2018/02/AAGL-Anti-Harassment-Policy.pdf
Table of Contents Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 Epidemiology and Evidence regarding Occult Leiomyosarcoma E.A. Pritts ...................................................................................................................................................... 3 Vaginal Extraction: Options for Vaginal Hysterectomy and Laparoscopic or Robotic Hysterectomy M. Wasson .................................................................................................................................................... 7 Myomectomy: Limitations of Containment Systems and Techniques for Post Extraction Irrigation W.H. Parker ................................................................................................................................................. 12 Alternatives for Specimen Removal: Minilaparotomy, Posterior Cul-de-sac, Laparotomy and Power Morcellation S.L. Cohen ................................................................................................................................................... 17 Cultural and Linguistics Competency .......................................................................................................... 22
Surgical Tutorial 4: Controversies and Approaches to Tissue Extraction
Chair: Sarah L. Cohen Faculty: William H. Parker, Elizabeth A. Pritts, Megan N. Wasson
Course Description This session provides a comprehensive look at the topic of tissue extraction at the time of surgery for presumed benign fibroid disease. Beginning with an overview of the epidemiologic evidence surrounding the issue of occult leiomyosarcoma, the faculty will then present techniques for approaches to tissue extraction at time of hysterectomy or myomectomy, including a discussion of tips and tricks for contained extraction. The faculty will discuss evidence-based recommendations, as well as limitations to our current knowledge on this topic.
Course Objectives At the conclusion of this activity, the participant will be able to: 1) Select and perform the appropriate modality of tissue extraction for a variety of clinical scenarios.
Course Outline
2:00 Welcome, Introductions, and Course Overview S.L. Cohen2:05 Epidemiology and Evidence regarding Occult Leiomyosarcoma E.A. Pritts2:15 Vaginal Extraction: Options for Vaginal Hysterectomy and
Laparoscopic or Robotic Hysterectomy M. Wasson
2:25 Myomectomy: Limitations of Containment Systems and Techniques for Post Extraction Irrigation
W.H. Parker
2:35 Alternatives for Specimen Removal: Minilaparotomy, Posterior Cul-de-sac, Laparotomy and Power Morcellation
S.L. Cohen
2:45 Unanswered Questions in Tissue Containment. Question & Answers All Faculty 3:00 Adjourn
Page 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 Director, AAGL* Linda D. Bradley, Medical Director, AAGL* Erin T. Carey Consultant: MedIQ Mark W. Dassel Contracted Research: Myovant Sciences Erica Dun* Adi Katz* Linda Michels, Executive Director, AAGL* Erinn M. Myers Speakers Bureau: Laborie Medical Technologies, Teleflex Medical Other: Unrestricted educational grant to support NC FPMRS Fellow Cadaver Lab: Boston Scientific Corp. Inc. Amy Park* Grace Phan, Professional Education Specialist, AAGL* Harold Y. Wu* Linda C. Yang Other: Ownership Interest: KLAAS LLC Sarah L. Cohen Consultant: Boston Scientific Corp. Inc.
SCIENTIFIC PROGRAM COMMITTEE Linda D. Bradley, Medical Director, AAGL* Jubilee Brown* Nichole Mahnert* Shanti Indira Mohling* Fariba Mohtashami Consultant: Hologic Marie Fidela R. Paraiso* Shailesh P. Puntambekar* Matthew T. Siedhoff Consultant: Applied Medical, Caldera Medical, CooperSurgical, Olympus Amanda C. Yunker Consultant: Olympus Linda Michels, Executive Director, AAGL*
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). Sarah L. Cohen Consultant: Boston Scientific Corp. Inc. William H. Parker Consultant: Abbvie Elizabeth A. Pritts Speakers Bureau: AbbVie Megan N. Wasson*
Content Reviewer has nothing to disclose.
Asterisk (*) denotes no financial relationships to disclose.
Page 2
Elizabeth A. Pritts, MD
Supreme Commander, Wisconsin Fertility Institute
Disclosure Speakers Bureau: AbbVie
Objective Discuss the epidemiology and evidence regardingoccult leiomyosarcoma
Can you take? # LMS# of fibroid surgeries
Single populations, data on everyone? YES
Small studies with heterogeneity? NO
To aggregate multiple smaller heterogeneous studies to answer a question about a population…
*meta‐analytic techniques are required to correct forstudy heterogeneity
Ascertainment
Publication
RetrospectiveIndex case inclusionTertiary care center inclusion
Administrative databases (Grimes 2010)Based upon ICD‐9 codes
( clinical inaccuracies)NOT validated w/ medical records
For meta‐analysis
Page 3
64 Prospective (26 RCT) with 5233 women (3 LMS)
70 Retrospective with 24,970 women (29 LMS)
All data: predicted prevalence LMS
0.51/1,000 cases (95% CrI: 0.16‐0.98)
1/2000
Prospective data: predicted prevalence LMS
0.12/1,000 cases (95% CrI: <0.01 to 0.75)
1/8300
Pritts 2015
FDA ( 1/498) Pritts et al. (1/8300)
Computerized search; “uterine cancer” AND
“hysterectomy or myomectomy” AND “incidental cancer “ etc.
Computerized search;“myoma”, “leiomyoma”, etc.
…OR, then AND
41 papers: 9 included
(8/9 with LMS)
4864 papers identified:133 included
(15/133 with LMS)
9160 surgeries : 19 LMS 30,193 surgeries : 32 LMS
30,193 to 136,195 women
BUT: only used Prospective data
(68 studies: 40,000 women)
Range of Occult Leiomyosarcoma:
1/1111 to < 1/10,000
“It has been established that motorizedmorcellation of uterine leiomyosarcoma during surgery adversely affects disease free survival and overall survival “
Gynecologic Oncology 2014;132:360‐365Impact factor 3.687
Author Power Non –power or unknown En bloc
Einstein/2008 2 1 (Abd fragmentation) 2
George/2014 ? 19? (scalpel or power Hyst) 39
Liebsohn/1990 0 1 (Abd Myom) 4
Morice/2003 ? 17 ? (Bx, HSC, Myom, Hyst) 36
Park/2011 1 24 (18 LAVH, 1 VH,5 mini‐lapMyom)
31
Perri/2009 0 16 (2 LH, 4 HSC, 4 SCH, 2 “injury”, 4 Myom)
21
3/81: Power42/81: Hand36/81: Mixed or Unknown
1 = Power
2 = Hand
Months
Systematic review of published cases (33):
Power 9/24 deceased
Hand 2/9 deceased
Difference in SurvivalPower vs Hand
Life table survival analysis P=NS
Page 4
11/27 women upstaged:
•5 early (within 2 mo)
•6 late or ? ( up to 36 months) (P = NS)
Power Morcellation
•Early : 4/19 (21%)
•All : 8/19 (42%)
Hand Morcellation
•Early : 1/6 (17%)
•All : 2/6 (33%)
5 Year Survival; 384 women Survival TablePower 30%
Scalpel 59% P=NS
Intact 60%
5 more studies:
74 women outcomes
90 women = outcomes
•12 atypical tumors/1091 surgeries w/ power morcellation
• For those with f/u laparoscopy (in house and consult cases)• 64%were disseminated
• 57% of the LMS cases
• Only LMS was associated with mortality
•“… uterine morcellation … associated in mortality…”
In house dissemination
4/7 that had surgery
In house sarcoma dissemination:
0/2 (1 LMS, 1 ESS
In house sarcoma recurrence
0/2
In house ANY mortality
0/12 that were power morcellated
Peritoneal dissemination complicating morcellation of uterine mesenchymalneoplasms
Seidman 2012
>4000 hysterectomies over 10 years
• Endometrial biopsy
• MRI
• Discussion at surgical conferences.
• No occult epithelial and only 1 occultSarcoma were diagnosed
Ricci 2015
Tumor Type
# patients Morcellation Type
Disseminated Recur ? Follow upmo’s
ESS 44*1 in bag power morcellation = dissemination
•4 morcellation cases diagnosed pre‐op
17 power 7 1/17 NED 100
7 hand 0 2/7 1: DOD @ 90NED 18‐90
1 vaginal 0 0/1 NED 24
19 unknown 0 6/19 1: DOD @ 73NED 38‐124
Page 5
Tumor Type
# patients Morcellation Type
Disseminated Recur ? Follow upmo’s
STUMP 19 19 power 10 1/15 (LMS) 2.8‐93(LMS AED @ 20)
Tumor Type
# patients Morcellation Type
Disseminated Recur ? Follow upmo’s
EM CA 19*1 power
morcellationdiagnosedpre‐op
1 vaginal 2 1/1 NED 90
18 power0/17 2‐93.7
•Efficacy of preoperative diagnostics leiomyosarcoma
Method Sensitivity/Specificity (%)
N Author
Endometrial sampling
86/67 72 Bansal
Endometrial sampling
52/45 68 Hinchcliff
MRI (contrastEnhanced)
94/96 8 Lin
MRI 100/93 10 Goto
PET 100 5 Umesaki
MultimodalPRESS
80/85 15 Nagal
EITHER:
Continue to litigate cases
OR:
Dedicate our woman/man power and monies into development of accurate preoperative diagnostic modalities
Author Rates Initiated review using path reports
Billing database
Validated data
Brown 2014 (R) 1/807
Bojhar ‘15 (R) 1/4359 X
Brohl ‘15 (R) 1/1037 X
Graziano ‘15 (R) 0/270
Mahnert ‘15 (P) 1/2575 X
Oduyebo ‘15 (R)(prev reported)
1/524 X
Picerno ‘15 (R) 0/1004
Winner ‘15 (P) 1/142 X
Lieng (R) ‘15 1/798 X X
Author Rates Initiated review using path reports
Billing database
Validated data
Kho ’16 (R) 1/2023
Yang ’17 (R) 1/2594
Lange ’17 (R) 1/603 X
Pados ’17 (R) 0/2582 X
Tanos ’17 (R) 1/1944
Wu ’18 (R) 1/853 X X
Ludwin ‘18(R) 1/1178 X
Mori ’18 (R) 1/281
Multini ’19 (R) 1/1058 X X
Desai ‘19 (R) 1/663 X X
Page 6
©2013 MFMER | slide-1
Vaginal Extraction: Options for Vaginal Hysterectomy, as well as Laparoscopic or Robotic Hysterectomy
Megan N. Wasson, DOAssistant Professor of Obstetrics and GynecologyDivision of Gynecologic SurgeryMayo Clinic Arizona
©2013 MFMER | slide-2
Disclosure
• I have no financial relationships to disclose
©2013 MFMER | slide-3
Goals and Objectives
• Discuss impact of vaginal morcellation onleiomyosarcoma
• Perform adequate preoperative evaluation andcounseling prior to vaginal morcellation
• Describe techniques to facilitate vaginal tissueextraction
©2013 MFMER | slide-4
©2013 MFMER | slide-5
Dissemination of Disease
• Leiomyosarcoma• Morcellation (n=15)
• Myomectomy (n=6)• LAVH (n=18)• TVH (n=1)
• Non-morcellation (n=31)
©2013 MFMER | slide-6
Dissemination of Disease
• Tumor Morcellation• ↑ Abdomino-pelvic dissemination
• Peritoneal sarcomatosis• Vaginal apex recurrence
• ↓ Disease-free survival• ↓ Overall survival
Page 7
©2013 MFMER | slide-7 ©2013 MFMER | slide-8
Total Vaginal Hysterectomy
• 2296 TVH cases• Non-morcellation (n=1685)• Morcellation (n=611)
• Occult malignancy• 12.23% non-morcellation• 0.82% morcellation
• 0.49% Stage IA, grade I endometrialadenocarcinoma
• 0.33% low-grade stromal sarcoma
©2013 MFMER | slide-9 ©2013 MFMER | slide-10
“Scalpel morcellation of an enlarged uterus also may be used to assist with the extraction of the uterus at the time of vaginal hysterectomy…morcellation in these circumstances, in theory, also may result in the spread of undetected malignant cells. However, data regarding this risk and its effect on survival are extremely limited.”
©2013 MFMER | slide-11
ACOG Committee Opinion 770
• Preoperative Evaluation• Imaging• Cervical cancer screening• Endometrial sampling• Leiomyosarcoma Specific
• Dynamic MRI• Lactate dehydrogenase isoenzyme
©2013 MFMER | slide-12
Dynamic MRI
• Specificity 93.8%
• PPV 83.3%
• NPV 100%
• Diagnostic accuracy 95.2%
Goto A, Takeuchi S, Sugimura K, Maruo T. Usefulness of Gd-DTPA contrast-enhanced dynamic MRI and serum determination of LDH and its isoenzymes in the differential diagnosis of leiomyosarcoma from degenerated leiomyoma of the uterus. Int J Gynecol Cancer. 2002;12(4):354-61.
Page 8
©2013 MFMER | slide-13
Dynamic MRI and LDH Levels
• Specificity 100%
• PPV 100%
• NPV 100%
• Diagnostic accuracy 100%
Goto A, Takeuchi S, Sugimura K, Maruo T. Usefulness of Gd-DTPA contrast-enhanced dynamic MRI and serum determination of LDH and its isoenzymes in the differential diagnosis of leiomyosarcoma from degenerated leiomyoma of the uterus. Int J Gynecol Cancer. 2002;12(4):354-61.
©2013 MFMER | slide-14
Prognosis after Morcellation of LMS
• 5 year survival• 30% power morcellation (95% BCI, 13-61%)• 59% scalpel morcellation (95% BCI, 33-84%)• 60% no morcellation (95% BCI, 24-98%)
Hartmann KE, Fonnesbeck C, Surawicz T, Krishnaswami S, Andrews JC, Wilson JE, et al. Management of uterine fibroids. Comparative Effectiveness Review No. 195. AHRQ Publication No. 17(18)-EHC028-EF. Rockville (MD): Agency for Healthcare Research and Quality; 2017. Available at: https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/cer-195-uterine-fibroids-final-revision.pdf. Retrieved August 4, 2019.
©2013 MFMER | slide-15
Prognosis after Morcellation of LMS
Hartmann KE, Fonnesbeck C, Surawicz T, Krishnaswami S, Andrews JC, Wilson JE, et al. Management of uterine fibroids. Comparative Effectiveness Review No. 195. AHRQ Publication No. 17(18)-EHC028-EF. Rockville (MD): Agency for Healthcare Research and Quality; 2017. Available at: https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/cer-195-uterine-fibroids-final-revision.pdf. Retrieved August 4, 2019.
©2013 MFMER | slide-16
Shared Decision Making
• Informed consent• Risk of dissemination
• Occult malignancy• Benign uterine tissue
• Unexpected leiomyosarcoma• <1/770 to 1/10,000• Method of removal affects morbidity and
mortality• Surgical risks
Committee on Gynecologic Practice. ACOG Committee Opinion Number 770: Uterine Morcellation for Presumed Leiomyomas. Obstet Gynecol. 2019;133(3):e238-248.
©2013 MFMER | slide-17
Vaginal Morcellation
• TVH-access to uterine vessels during
• TLH or RATLH-in-bag vaginal morcellation
©2013 MFMER | slide-18
Vaginal Morcellation
• Intramyometrial coring
• “Wedge resection”
• Myomectomy
• Uterine hemisection
Page 9
©2013 MFMER | slide-19
Intramyometrial Coring
R. Lee. Difficult Vaginal Hysterectomy. Atlas of Gynecologic Surgery. W. B. Saunders Company. 1992:154. ©2013 MFMER | slide-20
Intramyometrial Coring
©2013 MFMER | slide-21
Wedge Resection
R. Lee. Difficult Vaginal Hysterectomy. Atlas of Gynecologic Surgery. W. B. Saunders Company. 1992:154. ©2013 MFMER | slide-22
Anterior Wedge Resection
©2013 MFMER | slide-23
Myomectomy
©2013 MFMER | slide-24
Conclusions
• Evidence regarding risk of dissemination ofdisease with vaginal and scalpel morcellation islimited
• Leiomyomas and need for morcellation are nota contraindication to vaginal hysterectomy ormorcellation
• Morcellation should be avoided in patients withknown or suspected hyperplasia or carcinoma
• Shared decision making is essential
Page 10
Myomectomy: Limitations of Containment Systems and Techniques for Post
Extraction and Irrigation
William H. Parker, MD
Clinical Professor
UC San Diego School of Medicine
Consultant: Abbvie
Disclosure
Discuss the limitations of containment systems and techniques for post extraction and irrigation.
Objective
“Everyone is entitled to their own opinion,
but not to their own facts.”
― Daniel Patrick Moynihan
Senator, New York
Morcellation
Sequelae of Morcellation
5154 LSH, Uncontained Morcellation
Reoperation within 58 months (median = 24 months)
65 (1.2%) re‐operations for Endometriosis
57 (86%) ‐ not previously documented
18 (0.4%) – disseminated leiomyomatosis
2 (0.04% ‐ LMS (1/2,577)
Zhang H. JMIG 2019;26:434
Total Hysterectomy Without Morcellation
N = 35
Robotic – 14
Laparoscopic – 12
LAVH – 3
Open – 5
Vaginal ‐ 1Chen J et al. JMIG 2019
Page 12
Pre‐Hysterectomy
1/34 Positive for Smooth Muscle
Post‐Hysterectomy
2/28 Positive for Smooth Muscle
Both Robotic cases
? Related to use of manipulator ?
Chen J et al. JMIG 2019
Cells In Pelvic Washings
Laparoscopic Myomectomy
Harmonic Scalpel – aerosolize cells and cell fluid
Dissection – tenaculum trauma
Place myoma in RLQ while suturing
? Now place myoma in a bag??
Vaginal v Mini‐lap Contained Morcellation
5 ml of Methylene blue or Indigo Carmine placed in bag before morcellation
No standardized bag used
Inspection for blue dye, tissue in pelvis or tears, leaks in bag
32 – vaginal contained
41% bag leakage
36 – mini‐lap contained
8% bag leakage
Cohen S, JMIG 2019;26:702‐8
Page 13
Video – Vaginal MorcellationControlled Morcellation
“No Residual Disease”
Large bore morcellator (20 mm) = less tissue spread
Pulse morcellator – limits rotational forces
Uncontained morcellation = ‐ 26 min
Careful Collection & Copious Irrigation – 3 L
van den Haak L. JMIG 2016;23:107–112
Video – Irrigation Protocol
Copious Irrigation Protocol
200 ml fluid samples collected
After myoma enucleation
After uncontained electro‐mechanical morcellation and removal of visible tissuefragments
After irrigation with 3 L (saline or water) –Trendelenburg / reverse Trendelenburg
No Residual Disease
myomas Mean range
# removed 5 1‐14
Largest 7 cm 4‐12 cm
No Residual Disease
Time Benign Spindle Cells
After Hysterotomy Repair 6/16
After Morcellation 5/16
After 3L Irrigation 0
Page 14
Does Any of This Matter ?
Immunostains
LG ESS ‐ intravascular tumor foci surrounded by endothelial cells
26/28 LGESS with vascular intrusion, only 1/26 dead of disease, 16/26 NED
LMS ‐ intravascular tumor cells in direct contact with blood cells18/21 – true invasion – 6 dead of disease, only 6 NED
Roma A. Human Pathology 2015;46:1712–1721
“profound implications”
…. intravascular clusters of tumor cells: manipulation by the surgeon or transection of the uterine veins could induce detachment of these clusters and potentially be responsible for recurrences or metastasis.
Roma A. Human Pathology 2015;46:1712–1721
Re‐visit Tissue Biopsy
Needle Biopsies – Uterine Smooth Muscle Tumors
33 ‐ Cytologic Atypia 7/10 – LMS
7/7 ‐ STUMP
32 – 1‐9 mitosis/hpf 5/10 – LMS
1/7 – STUMP
34 – coagulative tumor cell necrosis (CTCN)
8/10 – LMS
1/7 – STUMP
ALL 17 women with LMS or STUMP had either atypia, mitosis or CTCN
ALL 280 women with NO atypia, mitosis or CTCN had fibroids
Murakami M. Oncol Lett 2018;15:8647‐51
US‐Guided Transcervical Biopsy
Page 15
Thoughts
Copious Irrigation after all morcellation
Vaginal, Mini‐lap, Electro‐mechanical
Contained or Uncontained
Future Studies
Study washings after vaginal and contained morcellation
? Time needed to implant LMS cells (rodent model)
Thank you
Chen J, Wield A, Bose S, Savilo E, Mahnert N, Siedhoff M, Wright K. Smooth Muscle Cells in Pelvic Washings at Time of Benign Hysterectomy. J Minim Invasive Gynecol. 2018 Nov 29.
Cohen SL, Clark NV, Ajao MO, Brown DN, Gargiulo AR, Gu X, Einarsson JI. Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach. J Minim Invasive Gynecol. 2019;26:702‐708.
Hashimoto M, Kobayashi T, Tashiro H, Kuroda S, Mikuriya Y, Abe T, Tanaka Y, Ohdan H. Viability of Airborne Tumor Cells during Excision by Ultrasonic Device. Surg Res Pract. 2017:4907576.
Murakami M, Ichimura T, Kasai M, et al. Examination of the use of needle biopsy to perform laparoscopic surgery safely on uterine smooth muscle tumors. Oncol Lett. 2018;15:8647‐8651.
Park JY, Park SK, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. The impact of tumor morcellation during surgery on the prognosis of patients with apparently early uterine leiomyosarcoma. Gynecol Oncol. 2011;122:255‐9.
Roma AA, Barbuto DA, Samimi SA, et al . Vascular invasion in uterine sarcomas and its significance. A multi‐institutional study. Hum Pathol. 2015;46:1712‐21.
Tamura R, Kashima K, Asatani M, et al. Preoperative ultrasound‐guided needle biopsy of 63 uterine tumors having high signal intensity upon T2‐weighted magnetic resonance imaging. Int J Gynecol Cancer. 2014;24:1042‐7.
van den Haak L, Arkenbout EA, Sandberg EM, Jansen FW. Power Morcellator Features Affecting Tissue Spill in Gynecologic Laparoscopy: An In‐Vitro Study. J Minim Invasive Gynecol. 2016;23:107‐12
Yu S, Lee B, Han M, et al. Irrigation after Laparoscopic Power Morcellation and the Dispersal of Leiomyoma Cells: A Pilot Study. J Minim Invasive Gynecol. 2018;25:632‐637.
Zhang HM, Christianson LA, Templeman CL, Lentz SE. Non‐malignant Sequelae after Unconfined Power Morcellation. J Minim Invasive Gynecol. 2019 Mar ‐ Apr;26(3):434‐440.
References
Page 16
Alternatives for Specimen removal
Sarah L. Cohen, MD MPHMinimally Invasive Gynecologic Surgery
Brigham and Women’s HospitalBoston, MA USA
Disclosure
Consultant: Boston Scientific Corp. Inc.
Objectives
● Review limitations in knowledge surrounding tissue extraction, use of containment bags
● Offer practical tips for efficient tissue extraction
○ Power morcellation
○ Contained minilaparotomy morcellation
○ Posterior culd-de-sac extraction
○ Hybrid approach with laparotomy for intact removal
Uncontained power morcellation video
Background
Intraperitoneal morcellation can result in spread of tissue
Benign and malignant
Image from Einarsson. Rev Obstet Gynecol. 2010
Review of 51 articles
Up to 1% incidence of iatrogenic endometriosis, adenomyosis, endometrial hyperplasia, parasitic myoma
JMIG. 2016
Page 17
Uncontained power morcellation looks worse
No evidence that any uncontained morcellation is safe
What should we be doing in clinical practice?
All laparotomy
No myomectomy
All laparotomy
No myomectomy
Open power morcellationOpen power morcellation
What should we be doing in clinical practice?
All laparotomy
No myomectomy
All laparotomy
No myomectomy
Open power morcellationOpen power morcellation
TISSUE CONTAINMENT
● Allow patients benefits of minimally invasive surgery
● Minimize risk of tissue dissemination- both for benign and malignant tissue
Is a power morcellator an option?
○ Consider with containment devices
○ Be aware of limitations per FDA safety communications
■ Premenopausal fibroids patients
■ Non-fibroid indication
Page 18
Contained power morcellation video
Contained Vaginal Morcellation:
● Useful for total hysterectomy cases
● Most efficient with parous patients, adequate pelvic outlet or smaller pathology
● Posterior culdesac extraction*
What if I don’t have power morcellator, or don’t want to use one?
Post Culdesac videoWhat if I don’t have power morcellator, or don’t want to use one?
● Contained Minilaparotomy Morcellation:
● Useful for myomectomy, supracervical hysterectomy
● Larger specimens (>18 wks)
Minilap videoOther resources
● Salway, Advincula (EXcite) videos on YouTube, SurgeryU
Page 19
If patient declines morcellation…
● Consider hybrid procedure
○ Laparoscopic hysterectomy
○ Small Pfannensteil for intact removal
● Avoids large vertical incision
○ Anecdotally minimally increased pain/recovery over MIS
■ One night stay, often return to activities 3 wks
What is the incidence of leiomyosarcoma?
Critical in order to counsel about risk, design studies to detect disease or predict outcomes
Textbook teaching: exceedingly rare, 1:10,000
Now quoting as high as 1:300
AHRQ document
Updated meta‐analysis
• corrected data• 27 new studies
Lack of granular data to provide age‐specific estimates
Cases of LMS per 10,000 fibroid surgeries
1:4,761
1:1,176
How much protection do bags provide?
Leakage happens
Solima et al. JMIG 2015
Vaginal morcellation at time of TLH: 33% leakage
7 sites in Boston
Multi‐port approach, varying bags
76 cases
No bag tears during morcellation
7 cases of dye or tissue leakage on post morcellation survey
9% leakage
Leakage with contained manual morcellation
Bag integrity post-morcellation
○ Vaginal: 13 bags with leakage (40.6%)
○ Minilaparotomy: 3 bags with leakage (8.3%)
Page 20
How much protection do bags provide?
Unclear clinical significance of bag leakage
? how much better than uncontained morcellation
Continued research and evolution of surgical equipment needed
Contained tissue extraction is feasible, quickly becomes efficient
and may help mitigate risks of morcellation
Counseling
● Patients need to understand:
○ Risk of occult malignancy
■ Taking into account their workup and history
○ Risk/benefit of open versus MIS approach
■ Complications, blood loss, recovery
○ How contained morcellation works
■ It is logical solution but not guarantee
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 **FDA labeled for contained manual morcellation
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
References● Einarsson JI, Greenberg JA. Abdominal leiomyomatosis. Rev Obstet Gynecol. 2010; 3(4):149.
● Tulandi T. Nonmalignant Sequelae of Unconfined Morcellation at Laparoscopic Hysterectomy or Myomectomy. JMIG 2016.
● Hartmann KE et al. Management of Uterine Fibroids. Comparative Effectiveness Review No 195. AHRQ Publication No 17 (18)-EHC028-EF. Rockville, MD: Agency for Healthcare Research and Quality; December 2017.
● 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 Sep 6. pii: S0002-9378(15)01024-8.
● Solima E, Scagnelli G, Austoni V, Natale A, Bertulessi C, Busacca M, Vignali MVaginal Uterine Morcellation Within a Specimen Containment System: A Study of Bag Integrity. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1244-6.
● Cohen SL et al. Prospective Evaluation of Manual Morcellation Techniques. JMIG. 2019; 26 (4):702-708.
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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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