SYLLABUS · 2020-01-30 · SYLLABUS SURGICAL TUTORIAL 4: Controversies and Approaches to Tissue Extraction. Professional Education Information . Target Audience . This educational

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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:

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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



STUMP 19 19 power 10 1/15 (LMS) 2.8‐93(LMS AED @ 20)

Tumor Type



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


Disclosure

• I have no financial relationships to disclose


Goals and Objectives

• Discuss impact of vaginal morcellation onleiomyosarcoma

• Perform adequate preoperative evaluation andcounseling prior to vaginal morcellation

• Describe techniques to facilitate vaginal tissueextraction



Dissemination of Disease

• Leiomyosarcoma• Morcellation (n=15)

• Myomectomy (n=6)• LAVH (n=18)• TVH (n=1)

• Non-morcellation (n=31)


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.”


ACOG Committee Opinion 770

• Preoperative Evaluation• Imaging• Cervical cancer screening• Endometrial sampling• Leiomyosarcoma Specific

• Dynamic MRI• Lactate dehydrogenase isoenzyme


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


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.


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.


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.


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.


Vaginal Morcellation

• TVH-access to uterine vessels during

• TLH or RATLH-in-bag vaginal morcellation


Vaginal Morcellation

• Intramyometrial coring

• “Wedge resection”

• Myomectomy

• Uterine hemisection

Page 9


Intramyometrial Coring

R. Lee. Difficult Vaginal Hysterectomy. Atlas of Gynecologic Surgery. W. B. Saunders Company. 1992:154. ©2013 MFMER | slide-20

Intramyometrial Coring


Wedge Resection

R. Lee. Difficult Vaginal Hysterectomy. Atlas of Gynecologic Surgery. W. B. Saunders Company. 1992:154. ©2013 MFMER | slide-22

Anterior Wedge Resection


Myomectomy


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


Questions

Page 11

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.

Page 21

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%

Page 22

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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SYLLABUS · 2020-01-30 · SYLLABUS SURGICAL TUTORIAL 4: Controversies and Approaches to Tissue Extraction. Professional Education Information . Target Audience . This educational