Fibroids: Myomectomy and New Approaches (Didactic)

Transcription

Fibroids: Myomectomy and New
Approaches (Didactic)
PROGRAM CHAIR
Tommaso Falcone, MD
Ted L. Anderson, MD
Jon I. Einarsson, MD
Sponsored by
AAGL
Advancing Minimally Invasive Gynecology Worldwide
Professional Education Information Target Audience Educational activities are developed to meet the needs of surgical gynecologists in practice and in training, as well as, other allied healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 3.75 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 ...................................................................................................................................................... 3 Which Myomas Require Intervention? T. Falcone ..................................................................................................................................................... 5 Hysteroscopic Approach to Myomas T.L. Anderson ............................................................................................................................................. 11 What Limits a Conventional Laparoscopic Approach? J.I. Einarsson ............................................................................................................................................... 21 Robotic Myomectomy ‐‐ Surgical Tips T. Falcone ................................................................................................................................................... 27 Myoma Ablation and Uterine Artery Occlusion Techniques for the Management of Leiomyomas J.I. Einarsson ............................................................................................................................................... 36 Single Port Myomectomy – Surgical Tips J.I. Einarsson ............................................................................................................................................... 43 Tips to Prevent Excessive Blood Loss at Myomectomy T. Falcone ................................................................................................................................................... 47 Abdominal Myomectomy as a Minimally Invasive Alternative to Hysterectomy for Large Fibroids T.L. Anderson ............................................................................................................................................. 51 Cultural and Linguistics Competency ......................................................................................................... 55 PG 113
Fibroids: Myomectomy and New Approaches (Didactic)
Tommaso Falcone, Chair
Faculty: Ted L. Anderson, Jon I. Einarsson
Course Description
This course is designed for all gynecologists who wish to expand their experience in the management of
myomas. The course is designed to be case-based and each presentation will include several illustrative
cases. The program will emphasize practical information with multiple video demonstrations of surgical
techniques. The program will begin with a fundamental review of preoperative evaluation of patients
with leiomyomas and appropriate selection of patients for intervention. Minimally invasive surgical and
non-surgical approaches will be presented. Case presentations will show when medical or radiologicbased approaches may be acceptable. Conventional, robotic and single port laparoscopic approaches as
well as laparotomy will be discussed within the context of specific cases.
Course Objectives
At the conclusion of this course, the participant will be able to: 1) Identify the concepts of selecting
patients appropriately for surgery or other intervention; 2) analyze the role of different surgical and
non-surgical minimally invasive techniques for the treatment of uterine fibroids; 3) assess techniques to
safely perform laparoscopic myomectomy; 4) appraise the surgical approach to single port
myomectomy; and 5) identify when myomectomy by laparotomy is indicated.
Course Outline
8:00
Welcome, Introductions and Course Overview
T. Falcone
8:05
Which Myomas Require Intervention?
T. Falcone
8:30
Hysteroscopic Approach to Myomas
8:55
What Limits a Conventional Laparoscopic Approach?
9:20
Robotic Myomectomy -- Surgical Tips
T. Falcone
9:45
Questions & Answers
All Faculty
9:55
Break
T.L. Anderson
J.I. Einarsson
10:10 Myoma Ablation and Uterine Artery Occlusion Techniques for the Management
of Leiomyomas
J.I. Einarsson
10:35 Single Port Myomectomy – Surgical Tips
J.I. Einarsson
11:00 Tips to Prevent Excessive Blood Loss at Myomectomy
1
T. Falcone
11:25 Abdominal Myomectomy as a Minimally Invasive Alternative to Hysterectomy
for Large Fibroids
11:50 Questions & Answers
T.L. Anderson
All Faculty
12:00 Course Evaluation
2
PLANNER DISCLOSURE
The following members of AAGL have been involved in the educational planning of this workshop and
have no conflict of interest to disclose (in alphabetical order by last name).
Art Arellano, Professional Education Manager, AAGL*
Viviane F. Connor
Consultant: Conceptus Incorporated
Frank D. Loffer, Executive Vice President/Medical Director, AAGL*
Linda Michels, Executive Director, AAGL*
Jonathan Solnik
Other: Lecturer - Olympus, Lecturer - Karl Storz Endoscopy-America
SCIENTIFIC PROGRAM COMMITTEE
Arnold P. Advincula
Consultant: CooperSurgical, Ethicon Women's Health & Urology, Intuitve Surgical
Other: Royalties - CooperSurgical
Linda Bradley
Grants/Research Support: Elsevier
Consultant: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharmaceuticals
Speaker's Bureau: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharm
Keith Isaacson
Consultant: Karl Storz Endoscopy
Rosanne M. Kho
Other: Honorarium - Ethicon Endo-Surgery
C.Y. Liu*
Javier Magrina*
Ceana H. Nezhat
Consultant: Intuitve Surgical, Lumenis, Karl Storz Endoscopy-America
Speaker's Bureau: Conceptus Incorporated, Ethicon Women's Health & Urology
William H. Parker
Grants/Research Support: Ethicon Women's Health & Urology
Consultant: Ethicon Women's Health & Urology
Craig J. Sobolewski
Consultant: Covidien, CareFusion, TransEnterix
Stock Shareholder: TransEnterix
Speaker's Bureau: Covidien, Abbott Laboratories
Other: Proctor - Intuitve Surgical
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).
Tommaso Falcone*
Jon I. Einarsson
Consultant: Ethicon Endo-Surgery
Ted L. Anderson*
Georgine Marie Lamvu*
3
Asterisk (*) denotes no financial relationships to disclose.
4
Financial Disclosure
Indications for
Myomectomy
I
have no financial relationships to
di l
disclose
Tommaso Falcone, M.D
Professor & Chair
Department of Obstetrics & Gynecology
Cleveland Clinic
Leiomyoma related hospitalization
Learning Objectives
 Wechter
et al AJOG
AJOG-- 2011
 2007 data from Nationwide inpatient
sample (NIS)
 Analyze
the data on the impact of fibroids
on obstetric outcomes
 List
Li t th
the b
benefits
fit off myomectomy
t
on ffertility
tilit
outcomes
 Discuss the impact of pregnancy on fibroid
growth



355, 135 women were h
355
hospitalized
it li d
Excludes all minimally invasive interventions
Rates of myomectomy
• BlackBlack- 9.2/10,000 women years
• WhiteWhite- 1.3/ 10,00 women years
• By 20502050-31 % increase in myomectomies
Impact of Race
Natural History of Fibroids
 Maverlos
 Huyck

et al. Ultrasound Obstet Gynecol
2010
et al AJOG 2008

Black women p
present earlier ( 5.3 yyears)) and
more severe disease


5
Women examined at least twice by a single
sonographer at least 8 months apart (median
21 months)
Median age was 40 years; majority were
under 5 cm
21 % of fibroids showed evidence of
spontaneous regression.
Myomectomy: Refuted reasons
Indication for Surgery
ASRM practice committee 2008
 Abnormal
Uterine Bleeding
pressure and pain
 Urinary or rectal symptoms
 Infertility
Infertility-- exclude other causes
 Recurrent Pregnancy Loss
Loss--exclude other
causes
 Adverse pregnancy outcome
 Size
(>12 weeks)
 Cannot palpate the adnexae
 Symptoms will develop
 Surgery could be more difficult if surgery
delayed
 Possible leiomyosarcoma
 Pelvic

Fibroids and Pregnancy loss
Fibroids and Pregnancy loss
 Klatsky
et al AJOG 20082008- Systematic
review
 Submucosal fibroids
fibroids-- associated with
increased Spontaneous abortion rate




 Saravelos


fibroidsfibroids-

OR 1.34 ( 1.041.04-1.65)
Early first trimester u/s OR 1.82 (1.43(1.43-2.3)
Number was more important than size
Non
Non--cavity distorting fibroids
fibroids--no surgery &
unexplained RPL
• Live birth rate was 70 %
Leiomyomas and Infertility

et al Hum Reprod 2011
8 % prevalence in patients with RPL (n=966)
Cavity distorting fibroidfibroid• Early lossloss- no change
• Mid
Mid--trimester losses
losses-- reduced significantlysignificantly-Live
birth 52 %
OR 3.85 ( 1:121:12-13.27)
 Intramural
Sarcoma does not relate to size or rate of
growth and more related to age ( over 60)
Leiomyomas and Infertility
Casini et al Gynecological Endocrinology 20062006Infertile patients

Only RCT of surgery vs. no surgery & fertility outcome

SubMucous (SM) fibroidsfibroids- P<.05
 Submucosal
• with surgerysurgery-PRPR-43%
• Without surgerysurgery- PRPR-27 %


• Goldberg F&S 1995
• Hart Br J Obstet & Gynecol 1999
• Bernard Eur J Obstet Gynecol Reprod Biol 2000
Intramural (IM) fibroidsfibroids- NS
• Without surgerysurgery- PRPR-41 %

fibroids
PR after hysteroscopic
y
p resection up
p to 43%
SM--IM
SM
IM-- P<.05
• Without surgerysurgery- PRPR-15%
PR = pregnancy rate
PR = pregnancy rate
6
Cavity Distorting Intramural
Myomas
Hysteroscopic myomectomy:
 Shokeir





et al. 2010 Fertil Steril 2010
 Systematic
Review – Pritts, Parker and
Olive F&S 2009
Randomized matched trial
Unexplained infertility
Type 0 and Type 1 myomas
Hysteroscopic surgery was performed
PR significantly improved (63% vs. 28%)



Clinical Pregnancy rate/ Implantation
rate/ongoing pregnancy rate/live birth rateratedecreased
Spontaneous abortion rate is increased
Myomectomy vs. women with no fibroids
• Clinical pregnancy rate is similar
Impact of Subserosal Fibroids on
Fertility outcome
Systematic Review – Fibroids and
Fertility
 Pritts,

 Systematic
Review – Pritts, Parker and
Olive F&S 2009
 Uniquely Subserosal fibroids have no
impact on fertility or spontaneous abortion
rates
•
•
•
•

Parker and Olive 2009
Effect on fertility – no intracavitary involvement
Pregnancy rate ( 24 studies): RR .89 (.8(.8-1.0)
Implantation rate ( 14 studies): RR .79 (.69
(.69--.9)
Live--birth rate ( 16 studies): RR .78 ( .69Live
.69-.88)
Spontaneous abortion (16 studies): RR 1.8 (1.47(1.47-2.4)
Myomectomy for intramural fibroids (controls(controlsfibroids in situ) ( nonnon-cavity distorting)
• Pregnancy rate ( 2 studies ): RR 3.7 ( .47.47-30)
• Live
Live--birth rate (1 study): RR .75 ( .29.29-1.9)
RR = relative risk
Effect of Intramural Fibroids on IVF
Outcome
Impact of Fibroids on IVF






 Sunkara
Variables that explain differences in results:
Location of the fibroids
Size of leiomyoma: large (>5(>5-7cm) often excluded
Case--control studies: retrospective
Case
p
bias
Assessment of fibroids HSG vs. US vs. hysteroscopy
(SIS was not used in the studies)




Contribution of the fibroid that does not distort
the cavity may not be appreciated if there is a
low PR or implantation rate

HSG = hysterosalpingogram; US = ultrasound; SIS = saline-infusion sonogram
7
et al. HR 2010
Meta-analysis
MetaIntramural fibroids without cavity distortion
19 studies: 6087 cycles
y
Significant decrease in livelive-birth (RR 0.79,
95% CI -.70
.70--.88) and clinical pregnancy rates
(RR 0.85, 95% CI .77.77-.94)
This does not mean that removal will restore
PR to the levels expected in women without
fibroids
Impact of Fibroids on IVF:
Conclusions
Myomas & Pregnancy
 Growth
 Because
of the lack of consistent or wellwelldesigned studies and high reported PR,
prophylactic
p
p y
myomectomy
y
yp
pre--IVF if the
pre
cavity is normal should be individualized
and not routine. No data for fibroids >5>5-7
cm.
of Myomas during pregnancy
• 49
49--60 % no change
• 22
22--32% increase in size
• 8-27 % decrease in size



Adapted from Stout et al Leiomyomas at second trimester
u/s Obstet Gynecol 2010
Most of the growth is in the first trimester
Mean increase is 12 %
90 % of women with fibroids detected in the
first trimester will have regression of volume
postpartum
Adapted from Stout et al Leiomyomas at second trimester
u/s Obstet Gynecol 2010
Nomenclature of Professional Communication
International Consensus Meeting 2005…
Klatsky et al AJOG 2007
8
Acute versus Chronic AUB
AUB- Recommended Descriptive
AUBNomenclature for Symptoms
For nonpregnant women of reproductive age



Fraser IS, Critchley HOD, Munro MG, et al
Hum Reprod 2007;22
2007;22::635635-43 and Fertil Steril 2007;87:466
2007;87:466--76
Chronic Abnormal Uterine Bleeding
Bleeding from the uterine corpus, that is abnormal in
duration, volume, regularity, and/or frequency and
has been present for the majority of the last six (6)
months
months.
Acute Abnormal Uterine Bleeding

is an episode of bleeding that is of sufficient quantity
to require immediate intervention to prevent further
blood loss.
Hum Reprod 2007;22:635
2007;22:635--43 and Fertil Steril 2007;87:466
2007;87:466--76
Hum Reprod 2007;22:635
2007;22:635--43 and Fertil Steril 2007;87:466
2007;87:466--76
 Unresolved

Issues
Volume
• Since the volumetric measurement of 55-80 mL is
NOT practical in the clinical environment, what are
practicable measures of menstrual volume?

Regularity
• Is ± 2-20 days a practical definition of a group who
is primarily ovulatory?
ovulatory?
Coagulopathy
Polyp
Adenomyosis
Leiomyoma
Polyp
Adenomyosis
Leiomyoma
Malignancy & Hyperplasia
Structural Abnormality
Coagulopathy
Ovulatory Dysfunction
Endometrial
Iatrogenic
Not Yet Classified
Dysfunctional Uterine
O
vulatory Dysfunction
Bleeding
Leiomyoma
Subclassification
System
Endometrial
Iatrogenic
NNo
ot Yet Classified
Structural Abnormality
S M‐ Submucous
0
Pedunculated Intracavitary
O ‐ Other
O 1
2
3
<50% Intramural
≥ 50% Intramural
Contacts endometrium; 100% Intramural
Contacts
endometrium; 100% Intramural
Hybrid
Leiomyomas (impact both endometrium and serosa)
9
4
5
Intramural
Subserous ≥50% Intramural
6
Subserous < 50% Intramural
7
Subserous Pedunculated
8
Other (specify eg. cervical, parasitic)
Two numbers are listed separated by a dash. By convention, the first refers to the relationship with the endometrium while the second refers to the relationship to the serosa. One example is below
2‐5
Submucosal and subserosal, each with less than half the diameter in the endometrial and peritoneal cavities respectively.
Classification Categorization
Single Entity Examples
Polyp
Adenomyosis
Leiomyoma
Coagulopathy
Ovulatory Dysfunction
P0 A0 L1(SM) M0 - C0 O0 E 0 I0 N0
Endometrial
Iatrogenic
Not Yet Classified
P0 A1 L0 M0 - C0 O0 E 0 I0 N0
How could / should FIGO’s
PALM
PALM--COEIN system be used?
P1 A0 L0 M0 - C0 O0 E 0 I0 N0
P0 A0 L0 M0 - C0 O0 E 0 I0 N0
Classification Categorization
References
Multiple Entity Examples
P0 A0 L1 (SM) M1 - C0 O0 E 0 I0 N0

AUB-M


P1 A1 L0 M0 - C0 O0 E 0 I0 N0
AUB-P, -A

P1 A0 L1(O) M0 - C0 O0 E 0 I0 N0
AUB-P, -Lo

P0 A1 L1(O) M0 - C1 O0 E 0 I0 N0
AUB-A, -Lo, -C
References





Klatsky P, Tran N, Caughey A, Fujimoto V. Fibroids and
reproductive outcomes: a systematic literature review from
conception to delivery. Am J Obstet Gynecol 2008;198:3572008;198:357-366.
Mavrelos D, Ben
Ben--Nagi J, Holland T, Hoo W, Naftalin J, Jurkovic D.
The natural history of fibroids. Ultrasound Obstet Gynecol
2010;35:238--242.
2010;35:238
Huyck
y K,, Panjuysen
j y
C,, Cuenco K,, Zhang
g J,, Goldhammer H,, Jones
E, et al. The impact of race as a risk factor for symptom severity and
age at diagnosis of uterine leiomyomata among affected sisters. Am
J Obstet Gynecol 2008; 198:168.e1198:168.e1-168.e9.
Practice Committee of American Society for Reproductive Medicine
in collaboration with Society of Reproductive Surgeons.
Surgeons. Fertil Steril
2008;90:S125--S130.
2008;90:S125
Wechter ME, Stewart E, Myers E, Kho R, Wu J. LeiomyomaLeiomyoma-related
hospitalization and surgery: prevalence and predicted growth based
on population trends. Am J Obstet Gynecol 2011; 205:492.e1205:492.e1492.e5.
10
Sunkara SK, Khairy M, ElEl-Toukhy T, Khalaf Y, Coomarasamy A. The effect
of intramural fibroids without uterine cavity involvement on the outcome of
IVF treatment: a systematic review and metameta-analysis. Hum Reprod
2010;25:418--429.
2010;25:418
Pritts E, Parker W, Olive D. Fibroids and infertility: an updated systematic
review of the evidence. Fertil Steril 2009;91:12152009;91:1215-1223.
Saravelos S, Yan J, Rehmani H, Li TC. The prevalence and impact of
fibroids and their treatment on the outcome of pregnancy in women with
recurrent miscarriage. Hum Reprod 2011;26:32742011;26:3274-3279.
Shokeir T, ElEl-Shafei M, Yousef H, Allam AF, Sadek E. Submucous myomas
and their implications in the pregnancy rates of patients with otherwise
unexplained primary infertility undergoing hysteroscopic myomectomy: a
randomized match control study. Fertil Steril 2010;94:7242010;94:724-729.
Stout M, Odibo A, Graseck A, Macones G, Crane J, Cahill A. Leiomyomas
at routine secondsecond-trimester ultrasound examination and adverse obstetric
outcomes. Obstet Gynecol 2010;116:10562010;116:1056-1063.
Disclosure
Hysteroscopic Approach to Leiomyomata
• I have no financial relationships to disclose.
Ted L. Anderson, MD, PhD, FACOG, FACS
Associate Professor of Obstetrics & Gynecology
Director, Division of Gynecology
Vanderbilt University Medical Center, Nashville, TN
ted.anderson@vanderbilt.edu
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
1
Objectives
2
Background
• Participants will be able to:
• Affects approximatly 33% of women
• Age and race variables up to 75%
– Assess submucosal leiomyomata appropriately
– Compare approaches to hysteroscopic resection
– Predict and manage common complications
– Surgically manage submucosal leiomyoma patients
• Varied symptoms, may be asymptomatic
• Menorrhagia (30%), Pain (34%), Infertility (27%)
• Approximately 5% submucosal
• Definitions
• Identification
Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.
Fedele L et al (1991) Transvaginal ultrasonography versus hysteroscopy in the diagnosis of uterine submucous myomas. Obstet Gynecol 77(5):745‐
48.
Minimally Invasive
Gynecologic
Surgery
3
Interventions
4
Treatment Decisions
• Indications for treatment
• Abnormal uterine bleeding
• Pelvic pain / dysmenorrhea
• Infertility
Monopolar
Fibroid Evaluation
• G
General considerations
l
id ti
• Desire for future fertility
• Desire for uterine preservation
• Aggressiveness vs expectations
Bipolar
Mechanical
Complications
Minimally Invasive
Gynecologic
Surgery
Patient Management
• Co‐morbidities
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
5
11
6
Monopolar
Fibroid Evaluation
Bipolar
Mechanical
Complications
Treatment Decisions
Submucosal Fibroid Types
• ESGE classification
• Intramural extension
• Type 0 None
• Type I < 50%
• Type II > 50%
Patient Management
Wamsteker K et al (1993) Transcervical hysteroscopic resection of submucous fibroids for abnormal bleeding: results regarding the degree of intramural extension. Obstet Gynecol 82:736‐40.
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
7
Preoperative Assessment (NC)
The penetration level of
the myoma into the myometrium
< 2 cm = score 0
2 cm – 5 cm = score 1
Uterine Evaluation
Sensitivity 100%
Specificity 94%
Predictive Value
The extension of the base
with respect to the wall of the uterus
• Abnormal scan 81%
N
l
100%
• Normal scan 100%
The location at fundus,
body or lower segment
Precise mapping
Polyp vs fibroid
> 5 cm = score 2
Fedele L et al (1991) Transvaginal ultrasonography versus hysteroscopy in the diagnosis of uterine submucous myomas. Obstet Gynecol 77(5):745‐48.
Lasmar RB et al (2005) Submucous myomas: A new presurgical classification to evaluate the viability of hysteroscopic surgical treatment – preliminary report. JMIG 12:308‐311.
Minimally Invasive
Gynecologic
Surgery
8
Minimally Invasive
Gynecologic
Surgery
9
Ultrasound Mapping
1
0
Saline Infusion Sonography
• As sensitive as hysteroscopy for intracavitary pathology
• Less uncomfortable than hysteroscopy when both performed in the office
• Added benefit of myometrial evaluation
Kelekci S et al (2005) Comparison of transvaginal sonography, saline infusion sonography, and office hysteroscopy in reproductive‐aged women with or without abnormal uterine bleeding. Fertil Steril 84(3):682‐86.
Widrich T et al (1996) Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol. 174(4):1327‐34.
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
1
1
12
1
2
3‐D Reconstruction
Magnetic Resonance (MRI)
• As accurate as 2D saline infusion sonography
• Faster, more accurate interpertation, especially of submucosal component
• Comparable to hysteroscopy for intracavitary lesions
• Better visualization and mapping of individual fibroids
• More accurate characterization of number, location, and volume of fibroids
• Additional information gained may not justify additional cost
Benacerraf BR et al (2006) Improving the Efficiency of Gynecologic Sonography With 3‐Dimensional Volumes: A Pilot Study. JUM 25(2):165‐71.
Lee C et al (2006) Reproducibility of the measurement of submucous fibroid protrusion into the uterine cavity using three‐dimensional saline contrast sonohysterography. Ultrasound in Obstet Gynecol 28(6):837–841.
Haemila et al (2005) A prospective comparative study of 3‐D ultrasonography and hysteroscopy in detecting uterine lesions in premenopausal bleeding. Middle East Fertil Soc 10(3):239‐243.
Minimally Invasive
Gynecologic
Surgery
Spielmann AL et al (2006) Comparison of MRI and Sonography in the Preliminary Evaluation for Fibroid Embolization. AJR December 2006 vol. 187 no. 6 1499‐1504
Minimally Invasive
Gynecologic
Surgery
1
3
Hysteroscopy
Minimally Invasive
Gynecologic
Surgery
High vs Low Pressure
Minimally Invasive
Gynecologic
Surgery
1
5
Fibroid Evaluation
Bipolar
Mechanical
Complications
Treatment Decisions
Monopolar
1
6
Monopolar Current
•
ACTIVE •
ELECTRODE
•
Patient Management
CURRENT FLOW
DEEP THERMAL EFFECT
Minimally Invasive
Gynecologic
Surgery
1
4
Cuts and Desiccates Tissue
High Current Density at Active Electrode
Deep Necrosis
•
•
•
Broad thermal margins
Current flows through patient
Electrolyte‐free fluid •
Current dispersed in saline
Minimally Invasive
Gynecologic
Surgery
1
7
13
1
8
Monopolar Current
• Most commonly used method
• Loop resection or bulk vaporization
• Risk for hyponatremia
Loop electrodes at 45° and 90° angulations
Minimally Invasive
Gynecologic
Surgery
Roy KK et al (2010) Reproductive outcome following hysteroscopic myomectomy in patients with infertility and recurrent abortions. Arch Gynecol Obstet 282(5):553‐560. Bradley L (2012) Hysteroscopic myomectomy. http://www.uptodate.com/contents/hysteroscopic‐myomectomy
Minimally Invasive
Gynecologic
Surgery
1
9
Complications
Treatment Decisions
Monopolar
Fibroid Evaluation
Bipolar
Mechanical
Bipolar Current
Patient Management
Na++
Na
Na+
Na+
• Energy Flow
• Generator to active electrode
• Sodium Vapor Pocket
• Contacts tissue
• Instantaneous cellular rupture
• Cutting is non‐mechanical
• Energy Flow
• Return electrode
• Controlled Thermal Effect
•
Minimally Invasive
Gynecologic
Surgery
Vapor pocket proportional to voltage
Minimally Invasive
Gynecologic
Surgery
2
1
Bipolar Resection
Return Electrode
2
0
2
2
Bipolar Resection
• 1.6 mm (5 Fr) in diameter
• Focused Tissue Effects
• Ball Tip
Active Electrode
4 x 2.5 mm
• Vaporization
• Desiccation
• Spring Tip
• Vaporization • Desiccation
• Twizzle Tip
• Vaporization
• Pin‐point cutting
Insulator
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
2
3
14
2
4
Monopolar
Fibroid Evaluation
• Just
as effective as monopolar
Just as effective as monopolar
• Pencil‐type electrode, loop, or bulk vaporization
• Decreased (not absent) risk of fluid absorption
Bipolar
Mechanical
Complications
Treatment Decisions
Patient Management
Varma R et al (2009) Hysteroscopic myomectomy for menorrhagia using Versascope bipolar system: Efficacy and prognostic factors at a minimum of one year follow up. Eur J Obstet Gynecol Reprod Biol 142:154–159
Bradley L (2012) Hysteroscopic myomectomy. UpToDate. http://www.uptodate.com/contents/hysteroscopic‐
myomectomy
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
2
5
Hysteroscopic Morcellator Hysteroscopic Morcellator ‐ TruClear
• Operate in Saline
• Mechanical
Decreased Operative Time
Polyps 2/3
Type 0 or 1 1/2
• No thermal injury
• Remove Tissue Pieces
• Clear
visual field
Clear visual field
•
•
•
•
•
•
•
• Are Easy to Use ‐ Office use? • Facilitate Removal Type 0 and I Myomas
Emanuel MH et al (2005) The Intra Uterine Morcellator: A new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 12:62‐66. Cohen S, Greenberg JA (2011) Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol 4(2):73‐80. Miller C et al (2009) Clinical evaluation of a new hysteroscopic morcellator – retrospective case review. J Clin Med 2(3):163‐166
FDA Approved 2005
FDA Approved 2005
Dedicated Fluid Pump
Tissue Removed with Suction
Offset Lens Hysteroscope
Inner/Outer Rotating‐Oscillating Blades
Different Serrated Cutter for Polyps
Hysteroscopic Sheath 9 mm OD
Emanuel MH et al (2005) The Intra Uterine Morcellator: A new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 12:62‐66. Minimally Invasive
Gynecologic
Surgery
2
7
Hysteroscopic Morcellator ‐ MyoSure
2
8
Treatment Decisions
Monopolar
Fibroid Evaluation
FDA Approved 2009
Standard Set‐up Fluid/Suction
Tissue Removed with Suction
Offset Lens Hysteroscope
Inner/Outer Rotating‐Oscillating Blades
Hysteroscopic Sheath Outer Diameter 6.25 mm
Bipolar
Mechanical
Complications
Minimally Invasive
Gynecologic
Surgery
•
•
•
•
•
•
2
6
Patient Management
Cohen S, Greenberg JA (2011) Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol 4(2):73‐80. Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
2
9
15
3
0
Complications
•
•
•
•
•
Fluid Absorption
• Objectives of fluid distension
Fluid absorption
Gas embolism
Perforation
Hemorrhage
Incomplete resection
• Overcoming myometrial resistance, maximize visualization
• Create and maintain elctrosurgical environment
• Challenges of fluid absorption
• Minimize fluid medium absorption and consequences
Minimize fluid medium absorption and consequences
• Drivers of fluid absorption
• Pressure, time, procedure invasiveness, comorbidities
• Pathways of fluid absorption
• Direct vascular channels
• Peritoneal absorption
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
3
1
Nonionic (Hypotonic) Media
Nonionic (Hypotonic) Media
• Significant Morbidity
• 1.5% Glycine (200 mOsm/L)
•
•
•
•
•
Medium
• Metabolized to ammonia/urea + water
• Hyperammonemia + hypo‐osmolal hyponatremia
• 3% Sorbitol (178 mOsm/L)
Na+
• Metabolized to fructose + glucose
• Hyperglycemia + hypo‐osmolal hyponatremia
Osmotic
Pressure
H2O
Minimally Invasive
Gynecologic
Surgery
•
•
•
•
Pulmonary edema
Cardiac arrhythmias
Coma
Death Minimally Invasive
Gynecologic
Surgery
3
3
Ionic (Isotonic) Medium
3
4
Factors Affecting Intravasation
• Normal Saline
• Lactated Ringers
• Pure fluid overload
• Surgery that opens larger vascular channels
• Resection of myoma > endometrial ablation
• Lysis of intrauterine adhesions
• Division of uterine septum
• Tissue edema
• Pulmonary edema
Na+
• Cerebral edema
– herniation
• Essentially inert (only ~10% metabolized)
• Metabolized to glucose • Half‐life ~15 min; acts as osmotic diuretic
Na+
Headache Nausea, vomiting
Lethargy, confusion, stupor
Muscle aches and twitches
Seizure
• Significant Mortality
• 5% Mannitol (274 mOsm/L)
Normal
Saline
3
2
• Partial perforation
• Treat with lasix
• Cervical/lower segment tear
• False passageway
• Excessive operating time
• Excessive intrauterine pressure
Na+
• MAP aproximately 75 mm Hg
• 40‐110 mm Hg required to distend uterus
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
3
5
16
3
6
Mitigating Risk
Treatment of Hyponatremia
• Iso‐osmolar fluids preferentially
• Early detection, rapid initiation of treatment
• Chilled fluid decreases absorption
•
•
•
•
•
• Loop diuretic such as furosemide for rapid diuresis
Appropriate distension pressure
Cervical vasopressin or GnRH analogs
Timely
Timely purposeful procedure
purposeful procedure
Fluid management system
Pre‐designate STOP
• Regular monitoring of electrolytes, intake, and output
• Restrict fluid intake, provide supplemental oxygen
• Sodium <120 requires critical care setting
d
l
• Engage a specialist in critical care medicine
• 3% saline with abnormal cardiac or neuromuscular function, or sodium <120 mmol/L
• 1000 cc for hypotonics
• 2500 cc for isotonics
• Correct sodium gradually (1 ‐ 2 meq/l/hr) to 130
• Communication between team members
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
3
7
Gas Embolism
Blood
Heart
Lungs
Pulmonary
Dead Space
3
8
Alveoli
CO2
O2
• Pulmonary vasoconstriction
y
• Pulmonary vascular resistance
• PAP
• RV ejection
• RV end systolic/diastolic vol.
• Acute right heart failure
•
CVP
•
Cardiac Output
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
3
9
4
0
Factors Predisposing Gas Embolism
Gas Embolism with Electrosurgery
•
•
•
•
•
•
•
• No clinically significant difference in gas produced by monopolar or bipolar
• Composition – soluble: H+, CO, CO2, & O2
• Enters venous circulation
– equilibrate with pulmonary clearance
– exceed pulmonary clearance
Unpurged gas bubbles in the inflow line
Inadequate uterine flushing of bubbles
Piston‐like action of repetitive insertions
Excessive intrauterine pressure
Proportionate to size of instruments
p
Trendelenburg patient positioning
Presence of large intramural venous channels
• (e.g. vascular myoma)
• Surgical penetration into the myometrium
• Disruption and exposure of vasculature
• Excessive operating times
Munro MG et al (2001) Gas and air embolization during hysteroscopic electrosurgical vaporization: comparison of
gas generation using bipolar and monopolar electrodes in an experimental model. JAAGL 8(4), 488-94
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
4
1
17
4
2
Treatment of Gas Embolism
Uterine Perforation
• Stop case
• Rare overall
• 0.1 – 0.5% in simple hysteroscopy
• Up to 5% in operative hysteroscopy cases
• stops further air entry
• Stop nitrous oxide if using
• prevent bubble expansion
• Left lateral decubitus
• prevents air lock in the right heart
• Consequences
• Evacuate embolized air in through CVP or PA line
• Maintenance of cardiac output
• Inconsequential
• Vessel injury
• Visceral injury
• raise BP and push air out
• Closed chest cardiac message / respiratory care
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
4
3
Perforation Risk
4
4
Perforation Prevention
•
•
•
•
•
•
•
•
• Cervical dilation (most often) • Rigid instrument placement
• Challenging access
•C
Cervical stenosis
i l
i
• Asherman’s syndrome
• Altered myometrium
• Uterine anomaly
EUA with empty bladder
Cervical preparation, adequate dilation
Avoid using dilators like a sound
Gentle insertion of instruments
Advance electrode only if unobstructed view
Do not advance scope with electrode extended
Do not advance activated electrode
Ultrasound or laparoscopy assistance
• Menopause (up to 10x)
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
4
5
4
6
Hemorrhage
Management of Uterine Perforation
• Greatest risk with myomectomy (2.5%)
• Look for cervical tear / partial perforations
• Mitigating risk
Miti ti
ik
• Fundal without RF Energy
• Discontinue and observe
• Fundal with RF Energy
• Laparoscopy / laparotomy to inspect for visceral injury
• Lateral
Lateral • Laparoscopy to inspect for broad ligament hematoma
• vasopressin
• preop GnRH agonist
• Anterior
• Cystoscopy
Mencaglia L, Tantini C (1993) GnRH agonist analogs and hysteroscopic recection of myomas. Int J Gynaecol Obstet. 43:285
Phillips DR et al (1997) The effect of dilute vasopressin solution on the force needed for cervical dilation: a randomized controlled trial. Obstet Gynecol 89:507.
Phillips DR et al (1996) The effect of dilute vasopressin solution on blood loss during operative hysteroscopy: a randomized controlled trial. Obstet Gynecol 88:761.
• Remove excessive distention media
• Delayed fluid absorption issues
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
4
7
18
4
8
Need for Staged Procedures
• Type II (ESGE) Hysteroscopic Myomectomy
No. Patients
• Increased risk of:
–
–
–
–
–
–
Excessive fluid absorption
Electrolyte abnormalities with non‐electrolyte media
Excessive bleeding
Incomplete resection Need for additional procedure
Increased operative time
No. Procedures
• Applies even to experienced hysteroscopic surgeons
Minimally Invasive
Gynecologic
Surgery
Type I
Type II
Total
73
97
108
278
73
102
158
333
N = 271
N
= 271
97%
Complete Complete
Resection
N = 73 100%
N = 95 98%
N = 103 = 103
95%
Repeat Procedures
‐
5%
40%
17%
437
971
1642
1110
Mean Fluid Intravasation cc
Type 0
Minimally Invasive
Gynecologic
Surgery
4
9
5
0
Need for Stages Procedures
• 57 myomectomies compared with ESGE system
• NC more accurately predicted differences between groups I and II with respect to:
• completed procedures, fluid deficit, and operative time Lasmar RB et al (2005) Submucous myomas: A new presurgical classification to evaluate the viability of hysteroscopic surgical treatment – preliminary report. JMIG 12:308‐311.
Lasmar RB et al (2005) Submucous myomas: A new presurgical classification to evaluate the viability of hysteroscopic surgical treatment – preliminary report. JMIG 12:308‐311.
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
5
1
Monopolar
Fibroid Evaluation
Bipolar
Mechanical
Complications
Treatment Decisions
5
2
Patient Management
• Adequate pre‐opertive assessment
• Measure twice, cut once
• Consider appropriateness of hysteroscopy
• Consider specific surgical tools available
• Counsel patients regarding fluid management
C
l
i
di fl id
Patient Management
• Excessive absorption and consequences
• Procedure termination, need for additional procedure(s)
• Be aware of risks and vigilant for complications
• Know your surgical limits
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
5
3
19
5
4
References
References
Benacerraf BR et al (2006) Improving the Efficiency of Gynecologic Sonography With 3‐Dimensional Volumes: A Pilot Study. JUM 25(2):165‐71.
2. Bradley L (2012) Hysteroscopic myomectomy. http://www.uptodate.com/contents/hysteroscopic‐myomectomy
3. Cohen S, Greenberg JA (2011) Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol 4(2):73‐80. 4. Emanuel MH et al (2005) The Intra Uterine Morcellator: A new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 12:62‐66. 5. Fedele L et al (1991) Transvaginal ultrasonography versus hysteroscopy in the diagnosis of uterine submucous myomas. Obstet Gynecol 77(5):745‐48.
6. Haemila et al (2005) A prospective comparative study of 3‐D ultrasonography and hysteroscopy in detecting uterine
uterine lesions in premenopausal bleeding. Middle East Fertil Soc 10(3):239‐243.
lesions in premenopausal bleeding Middle East Fertil Soc 10(3):239 243
7. Kelekci S et al (2005) Comparison of transvaginal sonography, saline infusion sonography, and office hysteroscopy in reproductive‐aged women with or without abnormal uterine bleeding. Fertil Steril 84(3):682‐86.
8. Lasmar RB et al (2005) Submucous myomas: A new presurgical classification to evaluate the viability of hysteroscopic surgical treatment – preliminary report. JMIG 12:308‐311.
9. Lee C et al (2006) Reproducibility of the measurement of submucous fibroid protrusion into the uterine cavity using three‐dimensional saline contrast sonohysterography. Ultrasound in Obstet Gynecol 28(6):837–841.
10. Mencaglia L, Tantini C (1993) GnRH agonist analogs and hysteroscopic recection of myomas. Int J Gynaecol Obstet. 43:285
11. Miller C et al (2009) Clinical evaluation of a new hysteroscopic morcellator – retrospective case review. J Clin Med 2(3):163‐166
10. Phillips DR et al (1996) The effect of dilute vasopressin solution on blood loss during operative hysteroscopy: a randomized controlled trial. Obstet Gynecol 88:761.
11. Phillips DR et al (1997) The effect of dilute vasopressin solution on the force needed for cervical dilation: a randomized controlled trial. Obstet Gynecol 89:507.
12. Roy KK et al (2010) Reproductive outcome following hysteroscopic myomectomy in patients with infertility and recurrent abortions. Arch Gynecol Obstet 282(5):553‐560. 13. Spielmann AL et al (2006) Comparison of MRI and Sonography in the Preliminary Evaluation for Fibroid Embolization. AJR December 2006 vol. 187 no. 6 1499‐1504
14. Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.
15. Varma R et al (2009) Hysteroscopic myomectomy for menorrhagia using Versascope bipolar system: Efficacy and prognostic factors at a minimum of one year follow up. Eur J Obstet Gynecol Reprod Biol 142:154–159
16. Wamsteker K et al (1993) Transcervical hysteroscopic resection of submucous fibroids for abnormal bleeding: results regarding the degree of intramural extension. Obstet Gynecol 82:736‐
40.
17. Widrich T et al (1996) Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol. 174(4):1327‐34.
1.
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
5
5
Questions?
Minimally Invasive
Gynecologic
Surgery
5
7
20
5
6
DISCLOSURE
What limits a conventional laparoscopic approach?
I have the following financial relationship with a
commercial entity producing health-care related
products and/or services
Jon I Einarsson MD MPH
Director of MIGS
Brigham and Women’s Hospital
Associate Professor of Obstetrics and Gynecology
Harvard Medical School
Consultant Ethicon Endo-Surgery
Our data – LM vs. RALM
Objectives
O Discuss steps of conventional laparoscopic
myomectomy
O Describe the limitations of the conventional
laparoscopic approach
O Describe tips and tricks to overcome some
of those limitations
289 women – 02/07-09/09 LM (n=115)
RALM (n=174)
Operative time (min)
118.3
195.1
p
<.0001
EBL (ml)
85.9
110.0
0.04
Conversions to laparotomy
0
0
NS
Weight of fibroids (g)
201 (1-1473)
159 (8-780)
NS
Median n of fibroids
2 (1-21)
3 (1-16)
NS
Largest fibroid (cm)
7.5 (2.2-16.5)
7.3(3.1-13.8)
NS
Blood transfusions n(%)
1(0.9)
10(5.7)
NS
Hospital stay >1 day n(%)
4(3.5)
29(16.9)
OR 5.73
Step 1‐ Vasopressin injection
Brief description of our technique
O Two parallel trocars on surgeon side
O Faciliates suturing – especially in the setting of a
horizontal hysterotomy
O Inject dilute vasopressin subserosally – avoid
using more than 10 units every 30 minutes
O Consider diluting the vasopressin in a Marcaine
cocktail – possible pain relief at the hysterotomy
site
O We like to use large volumes, 20 units of
vasopressin in 400 ml of saline – we inject 200 ml
(10 units) at a time
O RCT ongoing comparing blood loss in using 200 vs
60 ml of diluted vasopressin solution
21
Step 2 – Hysterotomy
Step 3 – Fibroid extraction
O Carry the incision
O Rock and Roll
into the fibroid
– find the right plane
O We prefer the
Harmonic due to
minimal lateral
thermal spread
O A horizontal
incision is preferred
for suturing with two
ipsilateral trocars
O Needs quite a bit of force
O Avoid entering the cavity if
possible –
will do this deliberately
in women who have
completed their
childbearing – easy to
pluck out the
submucosal fibroids
this way
Step 4 – Closure of endometrial cavity
Step 5 – Hysterotomy closure
O Close cavity separately (if
O Close hysterotomy in layers making sure to
entered) with small (3/0)
monofilament (Monocryl)
O Take care not to place sutures
inside the uterine cavity
O Intracorporeal knot tying
O We will not close the cavity
separately in patients who are
not of reproductive potential
approximate all dead-space
O We use bidirectional barbed suture
routinelyy
O 0 PDO (equivalent to 2/0 PDS)
O This suture has a needle on each end and
barbs that are directed in an opposite
direction to the needles
O Use as many layers as needed to securely
approximate the edges
Bidirectional barbed suture
O We tack the first needle into the anterior
O
O
O
O
O
22
abdominal wall on the right side to avoid
tangling
First bite taken and suture pulled through until
resistance is met ((middle of suture))
First layer completed, needle cut away
Second layer taken with other needle
The hysterotomy closure is “time sensitive” –
as long as the hysterotomy is open there is
going to be active bleeding
Cover hysterotomy with adhesion barrier
(interceed)
Hysterotomy closure ‐ video
O We close the serosa in a baseball
configuration
O No evidence that a baseball closure reduces
adhesion risk
O A recent RCT in a sheep model showed no
difference in adhesion formation between
vicryl and barbed suture
Hysterotomy closure – baseball
Step 6 ‐ Morcellation
O We need better tissue
morcellators
O Try to stay on the surface (peel
an orange)
O Make sure to get all the pieces
out
O Time consuming in the setting of
large or calcified fibroids
O 12-40 grams per minute
O 1000 grams takes 25-83
minutes to morcellate
Limits
Surgeon experience
O Surgeon experience
O Most important factor
O Size
O Move strategically and control the situation
at all times
O Number
O Gradually build up
O Location
O Need high volumes (>50/year) to become
O What is the ultimate goal of surgery? Fertility
really good
preservation? Volume reduction
O Blood loss – will the pt accept a
transfusion?
O Rapid suturing is important
23
Size
O The largest specimen weight for a myomectomy
in our group is 3080 g
O Does not tell the whole story
O MUCH easier
i tto remove one llarge
g fib
fibroid
id rather
th
than multiple small ones (raisin bread)
O Time for extraction can be excessive – a
minilaparotomy may be advisable with manual
morcellation with a 10 blade
O Also consider hand assisted surgery
Laparoscopically assisted myomectomy
Hand assisted video
O Hybrid procedure
O Fibroids usually removed laparoscopically
and suturing and fibroid extraction
performed through a minilaparotomy
incision (4-5
(4 5 cm)
O Challenging for posterior fibroids
O Longer recovery time than LM
O Also can be done hand assisted, but then
the incision is larger – around 7 cm
Taniguchi et al Fertil Steril. 2004;81(4):1120-4
Number
Location
O Have removed over over 60 fibroids in one
O Intramural vs submucosal vs intracavitary vs
patient, but our median number is 2 per
case.
O Important to have a discussion with the
patient about limitations. It is not always
possible to remove all fibroids. Small ones
may be left behind
O Preoperative evaluation is very important for
mapping
subserosal
O Cervical – watch out for uterines – clip at
origin iff necessary
O Broad ligament – usually pretty easy – open
peritoneum and peel out – again stay away
from major vessels
24
Preoperative evaluation
Goal of surgery?
O MRI is obtained on
most patients
O Fertility preservation
O Delineates location,
O prefer not to embolize or use permanent clips, but
characteristics and
size of fibroids
O Detects adenomyosis
O Helps with
preoperative
counseling and
planning
OK to use clips and remove at end of case
O Important to take care of any fibroids in vicinity of
cavity
O Close endometrium separately
O No Fertility preservation
O OK to remove the whole top of uterus and close
en mass – shortens and simplifies procedure
O No need to close endometrium separately
O Remove submucosal fibroids laparoscopically
Laparoscopic uterine artery occlusion
Tips for limiting blood loss
O Use high volume vasopressin – 20 units in 400
ml of saline – inject 200 ml
O Use lupron preoperatively to build blood counts
O
O
O
O
O
– may make dissection of fibroids more difficult
IF the fibroids are already necrotic
Be quick
Avoid making an incision close to ascending
uterines
Use clips on the uterine arteries
Consider preop embolization
Consider using cell saver
Case in point
Video
O 39 y/o G0 – Jehovah's witness
O Heavy bleeding despite Lupron for 6 months
O H/H 9/29 despite repeated iv iron infusions
O Wants pregnancy in near future
f
O Multiple fibroids on imaging, overall uterine
size 19.5x17.2x8.6cm – 10 cm intracavitary
fibroid – total uterine weight approx 1500
grams
O EMB benign
25
Thank you
References
O
O
Einarsson JI, Grazul-Bilska AT, Vonnahme KA. Barbed vs. standard suture; a randomized
single-blinded comparison of adhesion formation and ease of use in an animal model. J
Minim Invasive Gynecol. 2011 Nov;18(6):716-9.
Einarsson JI, Vonnahme KA, Sandberg EM, Grazul-Bilska AT. Barbed compared to
standard suture: effects on cellular composition and proliferation of the healing wound in
the ovine uterus. Acta Obstet Gynecol
y
Scand. 2012 May;91(5):613-9.
y; ( )
O
O
Gargiulo AR, Srouji SS, Missmer SA, Correia KF, Vellinga T, Einarsson JI. Robot-assisted
laparoscopic myomectomy compared with standard laparoscopic myomectomy. Obstet
Gynecol. 2012 Aug;120(2 Pt 1):284-91.
Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of
bidirectional barbed suture in laparoscopic myomectomy: Evaluation of perioperative
outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011; 18(1):92-5.
O
26
Taniguchi et al Fertil Steril. 2004;81(4):1120-4
Robot –Assisted Laparoscopic
Myomectomy
• I have no financial relationships
p to
disclose.
Tommaso Falcone,M.D.
Professor and Chair
Department of Obstetrics & Gynecology
Learning Objectives
• Analyze if a laparoscopic approach to the
•
•
•
management of a fibroid uterus gives
similar results to a laparotomy
List the benefits of Laparoscopic
myomectomy
Discuss the possible technical limitations
of laparoscopic myomectomy
Discuss the role of robotics
27
Summary of Literature on Robotic Myomectomy
Surgery
Summary of Literature on Robotic Myomectomy Surgery
Author
Year
Advincula 2004
AP et al
Number
of Robotic
Cases
35
Type of
Study
Removed
Myomas
Weight
Preliminary
experience
Mean =
223.2 + 244.1g
Results
Author
Robotic myomectomy
is new promising
approach
Mao SP
et al
2007
1
Case report
Not
available
Successful
robotically-assisted
excision of large
uterine myoma
measuring 9x8x7cm
Bocca S
et al
2007
1
Case report
Not
available
Achievement of
uncomplicated full
term pregnancy
after robotic
myomectomy
Summary of Literature on Robotic Myomectomy
Surgery
Author
George A
et al
Number
of Robotic
Year Cases
Type of
Study
2009
77
Effect of the
BMI on the
surgical
outcome
Bedient CE 2009
et al
40
Comparing
robotic to
laparoscopic
myomectomy
Removed
Myomas
Weight
Obesity is not a
risk factor for poor
surgical outcome
in robotic
myomectomy
Mean = 210g
(range 7 - 1076)g
No difference in
relation to short
term surgical
outcome measures
Number
of Robotic
Cases
Type of
Study
Advincula 2007
AP, et al
29
Retrospective
case matched
between
robotic and
open
myomectomy
Nezhat C
et al
15
Retrospective
case matched
between
robotic and
laparoscopic
myomectomy
2009
Removed
Myomas
Weight
Mean =
227.86 + 247.54g
Results
Robotic myomectomy
approach is
comparable to open
approach regarding
short term surgical
outcome and costs
Mean = 116g
Robotic myomectomy
(min 25-max 350)g had significant longer
surgical time without
offering any major
advantages
Robotic trial
• Robotic myomectomy versus laparotomy
Results
Median = 235g
(range 21.2 - 980)g
Year
– AscherAscher- Walsh & Capes JMIG 2010
– Robot N= 75; 4 ports
ports-- 3 robotic and 1 assistant;
Control- N=50;
Control– Inclusion criteria were 3 myomas or fewer
– Mean BMI was 2020-21
– Duration of surgery 192 minutes versus 138 minutes
– Uterine Weight 320 g; LOS 0.5 days versus 3 days
– Less blood loss; less febrile morbidity
28
Robot vs. laparoscopic
Myomectomy
Gargiulo et al 2012
• 2 separate teams with 2 separate
• OR time: 118 minutes ( laparosocpy) vs.
•
•
•
•
•
195 minutes (robot)
expertise ( Gargiulo et al Obstet Gynecol
2012)
N= 115 scope myomectomy
N= 174 robot myomectomy
Median # of myomasmyomas- 2 vs 3
Weight-- 201 ( 1
Weight
1--1.5 kg) vs 159 g (8
(8--780
g)
Median dimension 7.5 cm
• Robot case had a higher odds of
•
Cleveland Clinic
Clinic-Obstet Gynecol 2011
admission
d i i to hospital
h
i l and
d having
h i a longer
l
than 1 day hospital stay
Risk of complications were the samesame-but
note that transfusion rate was 0.9 % in
the scope myomectomy group vs. 5.7 %
in the robot group
Maximum Diameter of the Resected
Myoma (in cm) by Surgical Approach
Abdominal
(n=393)
Laparoscopic
(n=93)
Robotic
(n=89)
p value
30
Age years
36.93
5 61)
( 5.61)
39.57
9 17)
( 9.17)
36.62
5 18)
( 5.18)
<
0 001
0.001
20
Weight Kg
75.5
(62.8,90.7)
64.8 (59.1,
76.66)
68.04
( 57.6, 82.5)
<
0.001
Height cm
163.92
( 13.17)
164.02
( 6.19)
163.63
(6.62)
BMI kg/m2
27(23,32)
25.1 ( 22.1,
24.1 ( 22, 28.1) 29.4)
10
(P=0.036)
0.97
<
0.001
0
Abdominal
Weight of the Resected Myomas
(in grams) by Surgical Approach
Laparascopic
Robotic
The Actual Operative Time (in minutes)
by Surgical Approach
2,500
350
2,000
300
Overall
P < 0.001
Overall
P < 0.001
250
1,500
200
RM vs LM
< 0.001
1,000
RM vs LM
NS
150
100
500
50
0
Abdominal
Laparascopic
Robotic
Abdominal
29
Laparascopic
Robotic
The Intra−operative Blood Loss (mL)
by Surgical Approach
The Postoperative Hemoglobin Drop
(gm/dL) by Surgical Approach
2,500
7
6
2,000
Overall
P < 0.001
Overall
P < 0.001
5
1,500
4
RM vs. LM
NS
1,000
RM vs LM
NS
3
2
500
1
0
0
Abdominal
Laparascopic
Robotic
Abdominal
Technical LimitationsLimitations- robot
approach-- What are the solutions?
approach
Laparascopic
Robotic
Port placement
• Procedures are longer
– Requires training
• SShould
ou d we
e use the
e fourth
ou
arm
a
• Accessory port/ports
• Most important learning step is port
•
•
placement
Matthews et al JMIG 2010
Mean distance from symphysis pubis to
the umbilicus less than 16 cm, 100 %
required port placement above the
umbilicus.
Technical considerations
• Uterine manipulator
• 8-10 cm between the endoscope and the
top of the elevated uterus
• Accurate myoma “mapping”
– No tactile feedback
30
10 cm
15°
8-10 cm
45°
31
Side Docking – 4 arm
32
Cost analysis
• Advincula et al JMIGJMIG-2007
• hospital charges RobotRobot-$30,000 versus $
•
13,000
13 000 for
f laparotomy
l
t
Behera et al JMIF 2012
2012--
– Cost
Cost-- AM $4937/ LM $6219 and RM $7299
• Reimbursement
– What will we get in the future?
Conclusion
• Robotic Surgery may have some
advantage over conventional surgery.
• Robotics may help the suturing task
• There is a learning curve
• Robotic times are longer
• Costs ?
Case 1
•
•
•
•
•
35 year old G1P0010
uterine fibroids and desires future fertility
Patient has a historyy of menorrhagia
g in 2006.
Missed AB at approx 8 weeks.
Severe vaginal bleeding and a drop in H&H that
necessitated a 2 unit transfusion of blood.
• Show MRI
MRI--would you do this case robotically?
33
Case 3
• 29 year old G0 presents with a history of
•
34
enlarging
l i abdominal
bd i l girth
i th mass and
d what
h t
was thought to be an umbilical hernia.
Patient strongly desires future fertility
references
• Mao SP, Lai HC, Chang FW, Yu MH, Chang CC. Laparoscopy
Laparoscopy--assisted robotic
myomectomy using the da Vinci system. Taiwan J Obstet Gynecol 2007
Jun;46(2):174--6.
Jun;46(2):174
• Bedient CE, Magrina JF, Noble BN, Kho RM. Comparison of robotic and
laparoscopic myomectomy. Am J Obstet Gynecol 2009 Dec;201(6):566 e1e15.
• Nezhat
Robotic-assisted
Ne hat C,
C Lavie
La ie O,
O Hsu
Hs S,
S Watson J,
J Barnett
Ba nett O,
O Lemyre
Lem e M.
M Robotic•
•
•
References
• Gargiulo A, Srouji S, Missmer S, Correia K, Vellinga T, Einarsson J. Robot
Robot-Assisted laparoscopic myomectomy compared with standard laparoscopic
myomectomy. Obstet Gynecol 2012;120:2842012;120:284-291
• Ascher
Ascher--Walsh C, Capes T. RobotRobot-assisted laparoscopic myomectomy is an
improvement over laparotomy in women with a limited number of myomas.
J Minim Invasive Gynecol 2010;17:3062010;17:306-310.
• Behera M,
M Likes C,
C Judd J,
J Barnett J,
J Havrilesky L,
L Wu J.
J Cost analysis of
abdominal, laparoscopic, and roboticrobotic-assisted myomectomies. J Minim
Invasive Gynecol 2012;19:522012;19:52-57.
• Matthews C, Schubert C, Woodward A, Gill E. Variance in abdominal wall
•
•
anatomy and port placement in women undergoing robotic gynecologic
surgery. J Minim Invasive Gynecol 2010;17:5832010;17:583-586.
Advincula AP, Song A, Burke W, Reynolds RK. Preliminary experience with
robot--assisted laparoscopic myomectomy. J Am Assoc Gynecol Laparosc
robot
2004 Nov;11(4):511Nov;11(4):511-8.
Bocca S, Stadtmauer L, Oehninger S. Uncomplicated full term pregnancy
after da Vinci
Vinci--assisted laparoscopic myomectomy. Reprod Biomed Online
2007 Feb;14(2):246Feb;14(2):246-9.
35
laparoscopic myomectomy compared with standard laparoscopic
myomectomy-myomectomy
--a
a retrospective matched control study. Fertil Steril 2009
Feb;91(2):556--9.
Feb;91(2):556
Advincula AP, Xu X, Goudeau St, Ransom SB. RobotRobot-assisted laparoscopic
myomectomy versus abdominal myomectomy: a comparison of short
short--term
surgical outcomes and immediate costs. J Minim Invasive Gynecol 2007
NovNov-Dec;14(6):698Dec;14(6):698-705.
George A, Eisenstein D, Wegienka G. Analysis of the impact of body mass
index on the surgical outcomes after robotrobot-assisted laparoscopic
myomectomy. J Minim Invasive Gynecol 2009 Nov
Nov--Dec;16(6):730Dec;16(6):730-3.
Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T.
Robotic--assisted, laparoscopic, and abdominal myomectomy: a comparison
Robotic
of surgical outcomes. Obstet Gynecol 2011 Feb;117(2 Pt 1):2561):256-265.
I have the following financial relationships with
g health‐care
a commercial entityy p
producing
related products and/or services.
Jon Ivar Einarsson MD MPH
Director of Minimally Invasive Gynecologic Surgery
Associate Professor



Consultant for Ethicon‐Endosurgery
Describe various available myoma ablation methods
Describe various availble UAO methods
Discuss other treatment options on the horizon
1989
Myolysis
1813
Modern vaginal h t
hysterectomy t




1825
Total abdominal hysterectomy

Uterine artery embolization (UAE)
Magnetic resonance‐guided focused ultrasound (MRgFUS)
Laparoscopic uterine artery occlusion (L‐UAO)
Doppler‐guided uterine artery occlusion (D‐UAO)
pp g
y
(
)
Radiofrequency ablation (RFA)
 Halt
 VizAblate
Cryomyolysis



1850
1981
Endometrial ablation
1995
Uterine artery embolization 2001
Laparoscopic
uterine artery
occlusion
1956
Hormonal treatment
1844
Myomectomy
1800


1984
GnRH agonists
1900
1950
2004
MRgFUS
2000
Involves an injection of trisacryl gelatin microspheres, polyvinyl alcohol particles, or gelatin sponge into the uterine arteries for occlusion
Effective in appropriately selected patients
Patients with multiple fibroids or large fibroids have less favorable outcomes
Patients with submucosal fibroids or pedunculated fibroids on a stalk smaller than 2 cm are not ideal candidates
Goodwin et al. Obstet Gynecol. 2008;111(1):22-33
36
Clinical Efficacy From Fibroid Registry Data
 Significant and durable improvement in symptoms and quality of life, measured at 6 and 12 months
 Mean symptom score (UFS‐QOL) reduced from 58.61 to 19.23 (P
19 23 (P <0.001)
<0 001)
 Mean quality of life score rose to 86.68 from 46.95 (P <0.001)
 >85% of patients had at least a 10‐point improvement in symptoms  82% of patients were pleased with their outcome
 Embolization to nontarget organs and tissues (eg, ovaries)
 Ovarian failure as high as 13.6% (increased risk for women older than 45 years)
women
older than 45 years)1
 Uterine necrosis and sepsis
 Passage of submucous myomata  Postembolization syndrome
 Local (hematoma, ecchymoses)
 Mortality
1Chrisman HB, et al. J Vasc Interv Radiol. 2000;11:699‐703.
Spies JB, et al. Obstet Gynecol. 2005;106:1309‐1318.
Current status (ACOG):
Based on current evidence, it appears that uterine artery embolization, when performed by experienced physicians, performed by experienced physicians
provides good short‐term relief of bulk‐
related symptoms and a reduction in menstrual flow.
 Remains investigational with
regard to preservation of fertility

UFE is associated with shorter hospital stay (1 vs 2.5 days) and quicker return to normal activities (15 vs 44 days) when compared with abdominal
myomectomy 
One study found that UFE and laparoscopic
myomectomy have similar recovery rates –
complications were more common in the UFE group


Goodwin et al Fertil Steril. 2006;85(1):14‐21
Ohgi et al J Obstet Gynaecol Res. 2007;33(4):506‐11
ACOG. Obstet Gynecol. 2004;103:403‐404.






106 pts UFE vs 51 surgery (43 hyst, 8 myomect) via laparotomy
No significant differences in SF‐36 scores at one year (POM)
UFE with shorter hospital stay (1 vs 5 days) and quicker return to work
At one year symptom scores were better in surgery group
Complication rates similar –
p
however most complications in surgery p
g y
group were during initial hospitalization while most of the UFE complications occurred after hospital discharge
Nine percent of the UFE group required re‐embolization or hysterectomy at one year of follow‐up






RCT comparing 88 UAE vs 89 abdominal hyst pts
Rate of minor complications higher for UAE
Shorter hospital stay in UAE group
Similar symptom relief in both groups
23.5% of the women in the UFE group had undergone a g p
g
hysterectomy at 24 months and 28.4% at 5 years.
This trial has been faulted for high rates of technical failure during UAE – perhaps indicating lack of expertize by the radiologists in this trial
Volkers et al. Am J Obstet Gynecol. 2007;196:519.e1–519.e11
Edwards et al. N Engl J Med. 2007;356(4):360-70
Van Der Kooii SM et al. Am J Obstet Gynecol 2010;230(2):105.e1-13
37






RCT between UFE and myomectomy among 121 women with reproductive plans with an intramural fibroid larger than 4 cm
Mean follow up at interval report was 2 years
Embolization was less invasive (shorter hospital stay, shorter recovery)
Statistically significantly more pregnancies (78% vs 50%), live births (48% vs 19%) and fewer miscarriages (23% vs 64%) in the myomectomy group 

Fibroids located and mapped with MRI
Ultrasound beams are focused on fibroids and cause intense heat and destruction
Patient prone on MRI table for 2‐4 hours
Not recommended for women of childbearing potential, or for submucosal fibroids, multiple fibroids, fibroids near bowel or bladder or where abdominal scars are in the way of the ultrasound beams
Mara et al. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85





Fennessy et al. Radiology 2007;243(3):885-93
NPV (%)
A study of 109 women found a 13.5% and 9.4% myoma volume reduction at 6 and 12 months
80% reported symptom improvement at 6 months
28% required alternative treatment within 12 months
This treatment is not covered by most insurance plans –
costs $18,000 to $26,000 out of pocket
costs $18 000 to $26 000 out of pocket
Treatment times were conservative (on average 10% NPV) in the early trials and further refinements are underway
Count
Any symptom
improvement (%)
Alternative
treatment
0-10
69
38
48
10-20
55
47
44
20-30
37
57
35
30-40
26
73
23
Over
40
29
79
17
NPV – non perfused volume
Stewart et al. Obstet Gynecol 2007 Dec;110(6):1428-9
Stewart et al. Fertil Steril. 2006;85:22–29
Based on 4 published case series
 71%‐88% and 51%‐91% achieved a 10‐point reduction in UFS symptom severity scale at 6 and 12 months, respectively
 Reintervention rate –
R i t
ti
t 12%‐34% (follow‐up 6‐12 months)
12% 34% (f ll
6 12
th )
 “Current evidence on the safety and efficacy of magnetic resonance image (MRI)‐guided transcutaneous focused ultrasound for uterine fibroids is such that this procedure should only be used with special arrangements for consent and for audit or research.”

Study
n
Duration NPV
SSS
Reduction
Volume Reduction
Stewart et al, 2007
416
24 months
38.0%
~ 50%
20% (6 months)
Funaki et al, 2009
91
24 months
~ 54%
57%
39.5%
Lénárd et al, 2008
135
12 months
16.3%
39% 17.0%
Fennessey et al, 2007
160
12 months
16.7%‐
25.8%
47%
N/A
Kim et al, 2011*
40
36 months
32%
48%
32%
*9 (22.5%) patients had needed reintervention at 3 years, 2 hysts, 2 myomectomies, 5 UFEs
National Institute for Health and Clinical Excellence. Magnetic resonance image‐guided transcutaneous focused ultrasound ablation for uterine fibroids. September 2007. 38










The uterine arteries are located and permanently occluded laparoscopically
Requires dissection of the origin of the uterine artery from the internal iliac vessels
Currently being performed at BWH in women with multiple fibroids who desire uterine conservation and have completed fib id h d i t i ti d h l t d their childbearing
The largest fibroids are removed concurrently – this may reduce the necrosis and pain following the occlusion of the uterine arteries
Allows for diagnosis and treatment of other potential pathology Good for “bag of marbles”
Requires advanced laparoscopic skills


Proximal laparoscopic UA occlusion might not block distal cervicovaginal anastomoses
Greater propensity towards technical failure of the laparoscopic approach?



 Visualization of retroperitoneal vessels is more tenuous with laparoscopy, especially with large uteri
 Unlike angiography, cannot rule out vascular anomalies (aberrant UA, duplicate UA)
The uterine vessels are located and clamped transvaginally without an incision
A doppler sensor at the end of the clamp recognizes the pulsation of the uterine artery
The patient has an epidural and the clamp is left in p
p
p
place for 6 hours
Cystoscopy is performed prior to and after clamp placement
Lichtinger et al. J Minim Invasive Gynecol. 2005;12(1):40-2
Uterine
Sound
Transvaginal
Doppler
Clam
Hald and Istre 2007: 58 women randomized to UAE or L‐UAO (29 in each group) followed for six months
 No significant difference in mean reduction in PBAC scores
 Fewer women in the UAE group complained of menorrhagia at six months, however (4% vs 21%, P = 0.044)
 Pain med requirements significantly higher after UAE
P i
d
i
t i ifi tl hi h
ft UAE
Hald and Istre 2009: same patients followed up to 73 months (median 48 months)
 Higher hysterectomy rate in L‐UAO group (28% vs 7%; P = 0.041)
 Clinical failure/symptom recurrence rate higher in L‐UAO group (48% vs 17%; P = 0.02)
 All UAE patients had complete infarction vs 23% of L‐UAO pts
Coupler
Tenaculum
Guide Rod
Tenaculum
39

RF volumetric ablation has been used in many organs in the body, including uterine fibroids, liver, lung, kidney, spine, and pancreas
 Studies in uterine fibroids have used off‐the‐shelf RF ablation devices with laparoscopic percutaneous and transvaginal
devices with laparoscopic, percutaneous, and transvaginal approaches

Volumetric, image‐guided ablation
 Optimizes ablated volume of targeted fibroid
 Avoids multiple passes of energized needles through the serosa
 Not a global therapy‐treats the fibroids that are likely to be symptomatic
 Incites thermal fixation and coagulative necrosis
▪ Avoids infarction‐related postembolization syndrome seen with UAE




Study
n
Duration Reintervention
SSS
Reduction
QOL
Improvement
Carrafiello 2009
11
3‐12 months
9% (1/11)
73%
46%
82%
Ghezzi 2007
25
12‐36 months
4% (1/25)
100%
59%
84%
Cho 2008
153
18 months
4% (6/153)
66% 43%
73%
VizAblate® is an
intrauterine ultrasound
(IUUS)-guided
radiofrequency ablation
system designed to treat
submucosal and
intramural fibroids
• Combines RF ablation
with intrauterine
ultrasound
• Inserted transcervically
• Performed by
gynecologists
• Short procedure time
Ultrasound guided laparoscopic RF fibroid ablation
FDA approved 2010
Currently completing a clinical trial in the US
Preliminary data from Garza et al on 31 pts showed promising results at 12 months follow up
40
Volume Reduction
VizAblate CV Handpiece
• The graphical
overlay enables the
gynecologist to plan
a safe and
predictable ablation
• The
Th red
d ovall
indicates the
ablation zone
• The green oval
indicates the thermal
safety boundary.
Outside this area,
there is no
significant risk of
thermal injury.
Treatment Planning Control Knob
Scalable ablation from Scalable
ablation from
1cm to 4cm in diameter
8mm diameter shaft


Involves localizing fibroids laparoscopically, with ultrasound or MRI and destroying them with extreme cold
 Preliminary studies have shown significant reduction in fibroid volume and symptom improvement
 No suturing required
 Can result in severe adhesion formation
 Not recommended for women planning childbearing
 Experimental and limited experience

The VizAblate System was
granted the CE Mark in
December, 2010
Safety has been demonstrated
 > 120 peri- and
prehysterectomy procedures
 Treatment of > 55 women for
symptomatic relief without any
issues relating to ablation
safety
Zupi et al. Clin Obstet Gynecol. 2006;49(4):821-33




Several non‐surgical methods available
UFE has the longest track‐record
MRgFUS is promising, but needs refinement and recognition by payers
d
b
Other non‐invasive options on the horizon, time will tell where they will fit into current landscape of treatment options
41














Goodwin et al. Obstet Gynecol. 2008;111(1):22‐33
Spies JB, et al. Obstet Gynecol. 2005;106:1309‐1318
Chrisman HB, et al. J Vasc Interv Radiol. 2000;11:699‐703
ACOG. Obstet Gynecol. 2004;103:403‐404
Goodwin et al Fertil Steril. 2006;85(1):14‐21
Ohgi et al J Obstet Gynaecol Res. 2007;33(4):506‐11
Edwards et al. N Engl J Med. 2007;356(4):360‐70
Volkers et al. Am J Obstet Gynecol. 2007;196:519.e1–519.e11
V lk t l A J Ob t t G
l 6
Van Der Kooii SM et al. Am J Obstet Gynecol 2010;230(2):105.e1‐13
Mara et al. Cardiovasc Intervent Radiol. 2008 Jan‐Feb;31(1):73‐85
Fennessy et al. Radiology 2007;243(3):885‐93
Stewart et al. Fertil Steril. 2006;85:22–29
Stewart et al. Obstet Gynecol 2007 Dec;110(6):1428‐9
Lichtinger et al. J Minim Invasive Gynecol. 2005;12(1):40‐2
42
I have the following financial relationships with
g health‐care
a commercial entityy p
producing
related products and/or services.
Jon Ivar Einarsson MD MPH
Director of Minimally Invasive Gynecologic Surgery
Associate Professor



Consultant for Ethicon‐Endosurgery

Discuss the advent and current status of single port surgery in gynecology
Describe further innovations such as hybrid NOTES procedures
d
Discuss tips and tricks for performing single port myomectomy



The current trend began in 2007 with the successful completion of a single incision cholecystectomy by Rao and Curcillo (two separate sites)
Single incision surgery has been performed for years and was a common approach for a laparoscopic tubal ligation 20 years ago
This time around a lot of progress had been made in the field of This time around, a lot of progress had been made in the field of endoscopy and surgeons and industry were looking for the next “new thing”
Natural Orifice Trans‐Endoluminal Surgery (NOTES) was proposed as the next new thing, but progress has been very slow in this field




43
Lack of instrumentation
Lack interest from industry – focused on single port
Resistance among hospital staff and administrators
No reimbursement for “experimental procedures”

Benefits
 Better cosmetic outcome – maybe for some patients
 Less pain ‐ ??
 Faster recovery Faster recovery ‐ ??

Disadvantages/limitations
 Increased cost and disposable instruments
 Triangulation is limited with traditional instruments
 Challenging to perform suturing and fine dissection
 Longer operative times for some procedures

May add value for certain procedures
 Cholecystectomy
 Adnexectomy
 Hysterectomy? – Has been difficult to get gynecologists in USA 
Robotic surgery may enable more suture intense tasks to be performed g y y
p
through a single incision
IF the only benefit of single incision surgery is cosmetic who should absorb the added cost?
 The hospital?
 The surgeon?  The patient?
Well designed prospective trials are urgently needed
Enthusiasm for single port surgery seems to be less now than a couple of years ago
and elsewhere to adopt this via multiport



44
Single incision (n=35)
Multiport (n=35)
p
Single port (n=50)
Multiport (n=50)
Duration of surgery (min)
71.7
48.4
<0.001
OR time (minutes)
121
127
0.44
Pain score on POD #1
2.1
2.2
0.477
Estimated blood loss (ml)
146
166
.36
Pain score (24h)
3.64
5.08
0.01
Pain score (48 h)
1.94
2.84
0.04
Cumulative Post op analgesics
74.4 mg
104.8
0.001
Hospital stay (days)
3.7
3.9
0.25
Return to work (days)
5.3
5.9
0.274
Cosmetic results 1 month post op
8.7
87
7.7
77
0.001
0 001
Cosmetic results 6 months post op
9.1
8.4
0.04
Lee et al. British Journal of Surgery
2010;97:1007-12
p
Chen et al. Obstet Gynecol 2011;117(4):906-12




68 patients randomized to TLH with single port vs multiport
4 cases of single port converted to multiport
No statistically significant difference in pain ll
f
d ff
scores
Significantly higher total requests for analgesics in the single port group
 11.3 vs 7.7, p<0.001
 Jung et al. Surg Endosc 2011 Feb 7
Einarsson JI. Single Port Laparoscopic Myomectomy. J Minim Invasive Gynecol. 2010;17(3):371-373.
45

Problems with single port surgery
 Optical access and operative access are meshed together
 Cramming 3‐4 tubes through a small hole

Potential improvement
 Decouple the optical access from the operative access
 Optical access through the posterior cul‐de‐sac
 OASIS = Orifice Assisted Small Incision Surgery





Select your patients appropriately
 Is this the right procedure for this patient?
Consider OASIS – much easier suturing and triangulation
Consider using barbed suture for myometrial closure
 Growing data demonstrating safety and increased efficacy
Use high volume vasopressin – we use 20 units in 400 ml saline and inject 200 ml
Morcellate through the umbilicus



The potential advantages and future role of single port surgery are uncertain at this time
Single port myomectomy is a challenging procedure
d
Using hybrid NOTES or OASIS may facilitate the performance of a small port myomectomy
Lee et al. British Journal of Surgery 2010;97:1007‐12
Chen et al. Obstet Gynecol 2011;117(4):906‐12
Jung et al. Surg Endosc 2011 Feb 7
Einarsson JI. Single port laparoscopic myomectomy. J Minim I
Invasive Gynecol 2010; 17(3):371‐373 i G
l ( )
 Einarsson JI, Cohen SL, Puntambekar S. Orifice‐Assisted Small‐Incision Surgery: Case Series in Benign and Oncologic Gynecology. J Minim Invasive Gynecol. 2012 May‐
Jun;19(3):365‐8




46
Techniques to minimize
blood loss
I
have no financial relationships to
di l
disclose.
Tommaso Falcone, M.D.
Professor & Chair
Cleveland Clinic
Preoperative GnRH agonist
Learning Objectives
 Lethaby
 List
some general approaches to
minimizing blood loss at a myomectomy
p
procedure
 Discuss the role of vasopressin in
minimizing blood loss
 Discuss the role of uterine artery ligation
prior to myomectomy

Preoperative Treatment with GnRH
agonists
A, Vollenhoven B, Sowter MC
Preoperative GnRH analogue therapy before
hysterectomy or myomectomy for uterine
fibroids. Cochrane database 2011 CD 000547
Interventions to reduce
hemorrhage during myomectomy
 Agonist
and iron treatment increases
preoperative hemoglobin
 Doesn’t seem to improve blood loss at
surgery


 Cochrane
review-Kongnyuy EJ,
reviewWiysonge CS Cochrane database Syst
Rev 2011 CD005355 2011
 Bupivacaine plus epinephrine vs. placeboplacebonot clinically different
 Oxytocin no difference
 No data on normal saline alone
Campo et al Hum Reprod 1999
Fibroids 107 were intramural & 67 were
subserosal; mean diameter 4.7 cm; blood loss
about 200ml
47
Cochrane review
 Misoprostol

Vasopressin

versus placebo
Significant reduction in blood loss; no effect
on blood transfusion rate. 400mcg 1 hr
before the procedure
p



 IV
bolus of tranexamic acid
 Gelatin thrombin matrix ( ex. FloSeal)

Cochrane reviewreview- Compared with placebo 2
trialstrials- significant reduction in blood loss
Antidiuretic Hormone Analog; Hormone,
Posterior Pituitary


Significantly reduced blood loss at
myomectomy and need for transfusion

Approved
pp
for central diabetes insipidus
p
Pitressin®: 20 units/mL (1 mL)
Half--life elimination: Nasal: 15 minutes;
Half
Parenteral: 1010-20 minutes
I.V. infiltration: May lead to severe
vasoconstriction and localized tissue necrosis.
Water intoxication
Use with caution in these disease
states
Vasopressin dosedose- different surgeon
recommendations from the Listserv
 Asthma:
 Cardiovascular
disease
Use with caution in patients with a
goiter with cardiac complications
complications.
 Migraine
 Renal impairment
 Seizures
 Vascular disease
 Inject
into the myometrium surrounding
fibroid or the pseudocapsule area
 1 amp
amp-- 20 units in 500 cc=use 30
30--50mL
 10 units in 100ml of saline (use 400ml)
 20 units in 400 ml and inject 100100-150 mL
 200 units in 100ml
 20 units in 50 ml
 Goiter:
Vasopressin
Vasopressin
 Glasser
MH Minilaparotomy myomectomy
JMIG 2005
 Ten mL of a dilute vasopressin solution
(six units in 60 mL NaCl) is then injected
intracervically about 1 to 2 cm deep at
both the 8 o’clock and 4 o’clock positions.
1
ampule of vasopressin was diluted in
1000 mL of normal saline (1000(1000-fold) and
150
150--250 mL of diluted vasopressin was
injected in the uterus below interstitial
pregnancy
48
Use of barbed suture
Cochrane review
 Alessandri
et al JMIG 20102010- reduced blood
loss ( drop of hgb of 0.6 versus 0.9; no
blood
bl d ttransfusion)
f i )
 Einarsson et al showed no difference in
blood loss
 Pericervical
tourniquet
 2 trials showed significant reduction in
blood loss and need for blood transfusion
Laparoscopic bulldog clamps
YasargilYasargil-type Temporary
Occlusion ClampsClamps- Aesculap
Uterine Artery Ligation
Other observations
 Perioperative
cell salvage
plane of dissection
 Multiple uterine incisions
 Bae
JH et al F&S 20112011- no difference in
blood loss w/without ligation
 Lubin Liu et al F&S 2011- less blood loss
with temporary occlusion of the uterine
artery
 Improper
49
References
References


Lubin L, Yuyan L, Huicheng X, Chen Y, Zhang G, Liang
Z. Laparoscopic transient uterine artery occlusion and
myomectomy for symptomatic uterine myoma. Fertil
Steril 2011;95:2542011;95:254-258.
 Bae JH, Chong GO, Seong WJ, Hong DG, Lee YS.
Benefit of uterine arteryy ligation
g
in laparoscopic
p
p
myomectomy. Fertil Steril 2011;95:7752011;95:775-778.
 Campo S, Garcea N. Laparoscopic myomectomy in
premenopausal women with and without preoperative
treatment using gonadotropningonadotropnin-releasing hormone
analogues. Hum Reprod 1999;14:441999;14:44-48.
 Glasser M. Minilaparotomy myomectomy: A minimally
invasive alternative for the large fibroid uterus. J Minim
Invasive Gynecol 2005;12:2752005;12:275-283.




50
Lethaby A, Vollenhoven B, Sowter MC. PrePre-operative GnRH
analogue therapy before hysterectomy or myomectomy for uterine
fibroids. Cochrane Database of Systematic Reviews 2001; Issue 2,
Art. No.:CD000547
Kongnyuy E, Wiysonge C. Interventions to reduce haemorrhage
during myomectomy for fibroids. Cochrane Database of Systematic
Reviews 2011; Issue 11 Art. No.:CD005355.
.
Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT,
Greenberg JA. Use of bidiredtional barbed suture in laparoscopic
myomectomy: evaluation of perioperative outcomes, safety, and
efficacy. J Minim Invasive Gynecol 2011;18:922011;18:92-95.
Alessandri F, Remorgida V, Venturini PL, Ferrero S. Unidirectional
barbed suture versus continuous suture with intracorporeal knots in
laparoscopic myomectomy: a randomized study. J Minim Invasive
Gynecol 2010;17:7252010;17:725-729.
Disclosure
Abdominal Myomectomy: Minimally Invasive Alternative to Hysterectomy for Large Fibroids?
I have no financial relationships to disclose.
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
1
Objectives
2
Leiomyomata Background
Participants will be able to:
• Affects approximatly 33% of women
• Age and race variables up to 75%
• Assess the impact of leiomyomata on patients
• Accounts for appx 30% of hysterectomies
(Pre) cancer10%
• Compare
Compare advantages / disadvantages of advantages / disadvantages of
myomectomy and hysterectomy for fibroids
Chronic pelvic pain 10%
Prolapse 15%
DUB 20%
Endometriosis/
Adenomyosis 20%
• Counsel patients knowledgeably regarding surgical options for fibroids
Fibroids 30%
Carlson KJ et al (1991) Indications for hysterectomy. NEJM 328(12):856‐860.
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
3
Hospital Discharges 1979‐2001
•
•
•
•
•
•
6,091,700 hysterectomies
Ave age: 45.2
Rate 1979: 2.4/1000
Rate 2001: 2.3/1000
African Am: 3.3/1000
/
Caucasian: 1.8/1000
•
•
•
•
•
•
Why Myomectomy?
• Pain
500,000 myomectomies
Ave age: 35.6
Rate 1979: 0.11/1000
Rate 2001: 0.21/1000
African Am: 0.4/1000
/
Caucasian: 0.1/1000
• Dysmenorrhea, dyspareunia, abdomino‐pelvic pain
• Bleeding
• Amount, duration, anemia
• Infertility
• Submucous vs intramural fibroids
• Mass effect
• Hysterectomy 12x more common than myomectomy
• Hysterectomy rate stable; myomectomy rate doubled
• No differences in morbidity with respect procedure or race
• Compression of bladder, bowel, ureter, stomach, etc
• Rapidly growing leiomyoma
Burrows LJ et al (2005) Rates of Hysterectomy for Uterine Myomas and Myomectomy in the United States, 1979–2001. J Pelvic Med Surg 11(2):84. Minimally Invasive
Gynecologic
Surgery
4
Minimally Invasive
Gynecologic
Surgery
5
51
6
Leiomyosarcoma
Leiomyosarcoma
• Not from “malignant degeneration” of myomata
• Rapid uterine growth in premenopausal women
• Distinct genetic origin
• Almost never associated with leiomyosarcoma
• Incidence between 0.13‐0.29% of leiomyomata
• Less than 0.26% of rapidly growing fibroids
• Rapid uterine growth in postmenopausal women
•
•
•
•
Parker WH, Fu YS, Berek JS (1994) Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma. Obstet Gynecol. 83:414–418.
Goto A et al (2002) Usefulness of Gd‐DTPA contrast‐enhanced dynamic MRI and serum determination of LDH and its isozymes in the differential diagnosis of leiomyosarcoma from degenerated leiomyoma of the uterus. Int J Gynecol
Cancer. 12:354–361.
Flake GP, Andersen J, Dixon D (2003) Etiology and pathogenesis of uterine leiomyomas: a review. Environ Health Perspect. 111:1037–1054.
Leibsohn S et al (1990) Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. Am J Obstet Gynecol 162(4):968‐74.
Minimally Invasive
Gynecologic
Surgery
Often associated with pain and bleeding
Increased level of LDH isoenzyme 3
Increased uptake of gadolinium on MRI (40‐60 seconds)
Approaches 100% diagnostic accuracy
Minimally Invasive
Gynecologic
Surgery
7
Impact on Fertility
8
Impact on Fertility
• Fibroids that distort cavity impact fertility
• 75 myomectomy patients
• Decrease pregnancy rate by 70% (RR 0.32; CI .13 ‐ .70)
– No other cause of infertility
– Uterus at least twice normal size or submucous fibroid
– At least two years follow‐up
• No evidence for intramural or subserosal impact
• Assess fertility potential aside from fibroids
• Possible increased risk
• 37 patients conceived – 49.3%
•
•
•
•
•
“…decision regarding operation on patients in their 40’s should depend upon how strongly the patient feels about childbearing.”
Parker WH (2008) Uterine fibroids: childbearing, cancer, and hormone effects. OBG Management 20(5):42‐52.
Pritts EA (2001) Fibroids and infertility: asystmatic rviewof the evidence. Obstet Gynecol Surv 56:483‐491.
Guarnaccia MM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.
“…for some of those who never conceive, it is important to have been able to try.”
Ingersoll FM, Malone LJ (1970) Myomectomy: An alternative to hysterectomy. Arch Surg 100:557‐561.
Minimally Invasive
Gynecologic
Surgery
myoma
y
degeneration and pain
g
p
Spontaneous abortion, premature labor and delivery
abnormal fetal lie, dysfunctional labor patterns
placental abruption, need for operative intervention
postpartum hemorrhage.
Minimally Invasive
Gynecologic
Surgery
9
Laparoscopic vs Abdominal
1
0
Comparative Morbidity
• Guidelines for laparoscopic myomectomy
• Retrospective cohort study, 3 year interval
• < 16 weeks uterus or, 1 or 2 fibroids, < 8 cm
• 197 hysterectomies, 197 myomectomies
• No difference with respect to fertility outcome
• Laparoscopic
• Primary outcome – perioperative morbidity
• 40% in hysterectomy, 39% in myomectomy
• Less pain, shorter hospitalization, shorter recovery
L
i h t h it li ti
h t
• Longer operative time, more blood loss
• Secondary outcomes
• Febrile morbidity, hemorrhage
• Unintended major procedures, rehospitalization
• Life threatening events
Dubuisson JB et al (1999) Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol 9:233‐238.
Seracchioli R et al (2000) Fertility and obstetric outcome after laparoscopic myomectomy of large myomata: a randomized comparison with abdominal myomectomy. Hum Reprod 15(12):2663–2668
Campo S et al (2003) Reproductive outcome before and after laparoscopic or abdominal myomectomy for subserous
or intramural myomas. Eur J Obstet Gynecol Reprod Biol 110(2):215–219.
Soriano D et al (2003) Pregnancy outcome after laparoscopic and laparoconverted myomectomy. Eur J Obstet
Gynecol Reprod Biol 108(2):194–198.
Olive DL (2011) The surgical treatment of fibroids for infertility. Seminars in Reprod Med 29(2):113‐123.
Sawin SW et al (2000) Comparability of perioperative morbidity between abdominal myomectomy and hysterectomy for women with uterine fibroids. Obstet Gynecol 183:1448‐1455.
Minimally Invasive 11
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
52
1
2
Myomectomy patients younger, weighed less, smaller uterine size
• Crude morbidity odds ratio for myomectomy 0.93 (0.63 – 1.40) ns
• Adjusted odds ratio for myomectomy 1.46 (0.77 – 2.77) ns
• Hysterectomy group: more blood loss, 13% complications
• 1 cystotomy, 1 ureteral injury, 3 bowel injuries, 8 cases of ileus, 6 pelvic abscesses
• Myomectomy Group: 5% complications
• 1 cystotomy, 2 reoperations for obstruction, 6 cases of ileus
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
1
3
Preoperative Preparation
• Procedures over 5 year interval
•
•
•
•
•
•
89 hysterectomies
Average age: 39.2
Uterine size: 15.2 weeks
GnRH agonist: 23.6%
Blood loss: 796 ml
Complications:
– 1 bladder, 2 ureteral injuries, 1 bowel injury, 1 femoral nerve injury
•
•
•
•
•
•
• GnRH analogs prior to myomectomy
103 myomectomies
Average age: 34.4
Uterine size: 11.5 weeks
GnRH agonist: 55.3%
Blood loss: 464 ml
Complications:
•
•
•
•
• 3 months therapy, reversible in 3 months
• Smaller uterus, less blood loss
• Increased likelihood of transverse incision or vaginal hysterectomy
Stovall TG et al (1995) GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: A randomized, controlled trial. Leuprolide Acetate Study Group. Obstet Gynecol 86:65–71.
Gerris J et al (1996) The place of Zoladex in deferred surgery for uterine fibroids. Zoladex Myoma Study Group. Horm
Res. 45:279–284.
• Myomectomy compares favorably to hysterectomy
Iverson RE et al (1996) Relative morbidity of abdominal hysterectomy and myomectomy for management of uterine leiomyomas. Obstet Gynecol 88:415‐419.
Minimally Invasive
Gynecologic
Surgery
1
5
Intraoperative Management
1
6
Women’s Attitudes
• Vasopressin (20 units in 50‐100 cc saline)
•
•
•
•
•
•
• Inject into serosa or pseudocapsule
• Penrose tourniquet at uterine base
• Through windows in broad ligament
• Conflicting studies on superiority
Conflicting studies on superiority
• Reperfusion issues
• Trapped blood issues
18 women, age 31‐49, 14 Caucasian, 4 African Am
All had uterine fibroids
Hysterectomy (10) or myomectomy (8) All with college degree, all but 1 advanced degree
Sample distributed across 12 states
17/18 proactive in researching information
• Books, internet, friends
• Given pamphlets by gynecologists; invited to ask questions
• Did not know what questions to ask
Ginsburg ES et al (1993) The effect of operative technique and uterine size on blood loss during myomectomy: A prospective randomized study. Fertil Steril. 60:956–962.
Fletcher H et al (1996) A randomized comparison of vasopressin and tourniquet as hemostatic agents during
myomectomy. Obstet Gynecol. 87:1014–1018.
Minimally Invasive
Gynecologic
Surgery
3 months therapy, reversible in 3 months
Decreased blood flow and decreased arterial size
alterations in the extracellular matrix of the myoma
Necrosis, especially in submucosal myomas.
• GnRH analogs prior to hysterectomy
analogs prior to hysterectomy
– none
Minimally Invasive
Gynecologic
Surgery
1
4
Askew J (2009) A Qualitative Comparison of Women's Attitudes Toward Hysterectomy and Myomectomy, Health Care for Women International 30(8):728‐742
Minimally Invasive
Gynecologic
Surgery
1
7
53
1
8
Women’s Attitudes
Decision Making
• 7/8 women with myomectomy “shopped around”
• First decide IF, then decide HOW
• Did not necessarily believe doctors opinions were correct
• Willing to go out of state to get “right doctor”
• Exactly what is “minimally invasive”?
• Women with hysterectomy more trusting
• 6/10 had procedure with their “usual gynecologist”
• Abdominal myomectomy vs
Abdominal myomectomy vs hysterectomy
• Decisions influenced by varied factors
D ii
i fl
db
i df t
– Also consider
• Attitude toward body, opinion / experience of friends or family or partner, internet research, attitude toward doctors, relationship with doctor
• vs laparoscopic myomectomy
• vs laparoscopic hysterectomy
• vs embolization
• No differences with respect to gender of GYN
Minimally Invasive
Gynecologic
Surgery
Minimally Invasive
Gynecologic
Surgery
1
9
Myomectomy Surgical Counseling
References
•
•
•
•
•
•
Focus on expectations of patient
Risk of new fibroid growth (up to 30%)
Growth of fibroid too small to detect
Conversion to hysterectomy for complications
Conversion to hysterectomy for complications
Discuss all alternatives
•
•
•
•
•
•
•
•
• Data suggest patient hear less than we think
•
•
•
Minimally Invasive
Gynecologic
Surgery
•
•
•
•
•
•
•
•
•
•
Iverson RE et al (1996) Relative morbidity of abdominal hysterectomy and myomectomy for management of uterine leiomyomas. Obstet Gynecol 88:415‐419.
Leibsohn S et al (1990) Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. Am J Obstet Gynecol 162(4):968‐74.
Parker WH (2008) Uterine fibroids: childbearing, cancer, and hormone effects. OBG Management 20(5):42‐52.
Olive DL (2011) The surgical treatment of fibroids for infertility. Seminars in Reprod Med 29(2):113‐123.
Parker WH, Fu YS, Berek JS (1994) Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma. Obstet Gynecol. 83:414–418.
Pritts EA (2001) Fibroids and infertility: asystmatic rviewof the evidence. Obstet Gynecol Surv 56:483‐491.
Seracchioli R et al (2000) Fertility and obstetric outcome after laparoscopic myomectomy of large myomata: a randomized comparison with abdominal myomectomy. Hum Reprod 15(12):2663–2668
Soriano D et al (2003) Pregnancy outcome after laparoscopic and laparoconverted myomectomy. Eur J Obstet Gynecol Reprod Biol 108(2):194–198.
Stovall TG et al (1995) GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: A randomized, controlled trial. Leuprolide Acetate Study Group. Obstet Gynecol 86:65–
71.
Minimally Invasive
Gynecologic
Surgery
Burrows LJ et al (2005) Rates of Hysterectomy for Uterine Myomas and Myomectomy in the United States, 1979–2001. J Pelvic Med Surg 11(2):84. Campo S et al (2003) Reproductive outcome before and after laparoscopic or abdominal myomectomy for subserous or intramural myomas. Eur J Obstet Gynecol Reprod Biol 110(2):215–219.
Dubuisson JB et al (1999) Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol 9:233‐238.
Flake GP, Andersen J, Dixon D (2003) Etiology and pathogenesis of uterine leiomyomas: a review. Environ Health Perspect. 111:1037–1054.
Fletcher H et al ((1996) A randomized
)
comparison
p
of vasopressin
p
and tourniquet
q
as hemostatic agents
g
during myomectomy. Obstet Gynecol. 87:1014–1018.
Gerris J et al (1996) The place of Zoladex in deferred surgery for uterine fibroids. Zoladex Myoma Study Group. Horm Res. 45:279–284.
Ginsburg ES et al (1993) The effect of operative technique and uterine size on blood loss during myomectomy: A prospective randomized study. Fertil Steril. 60:956–962.
Goto A et al (2002) Usefulness of Gd‐DTPA contrast‐enhanced dynamic MRI and serum determination of LDH and its isozymes in the differential diagnosis of leiomyosarcoma from degenerated leiomyoma of the uterus. Int J Gynecol Cancer. 12:354–361.
Ingersoll FM, Malone LJ (1970) Myomectomy: An alternative to hysterectomy. Arch Surg 100:557‐561.
Minimally Invasive
Gynecologic
Surgery
2
1
References
•
2
0
2
3
54
2
2
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).
US Population
Language Spoken at Home
California
Language Spoken at Home
Spanish
English
Spanish
Indo-Euro
Asian
Other
Indo-Euro
English
Asian
Other
19.7% of the US Population speaks a
language other than English at home
In California, this number is 42.5%
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.
55

Fibroids: Myomectomy and New Approaches (Didactic)

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