Sponsored by
AAGLAdvancing Minimally Invasive Gynecology Worldwide
Fibroids: Myomectomy and New
Approaches (Didactic)
PROGRAM CHAIR
Tommaso Falcone, MD
Ted L. Anderson, MD Jon I. Einarsson, MD
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 radiologic-based 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 T.L. Anderson 8:55 What Limits a Conventional Laparoscopic Approach? J.I. Einarsson 9:20 Robotic Myomectomy -- Surgical Tips T. Falcone 9:45 Questions & Answers All Faculty 9:55 Break 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 T. Falcone
1
11:25 Abdominal Myomectomy as a Minimally Invasive Alternative to Hysterectomy
for Large Fibroids T.L. Anderson 11:50 Questions & Answers 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
Indications for Indications for MyomectomyMyomectomy
Tommaso Falcone, M.DTommaso Falcone, M.DProfessor & ChairProfessor & Chair
Department of Obstetrics & GynecologyDepartment of Obstetrics & GynecologyCleveland ClinicCleveland Clinic
Financial DisclosureFinancial Disclosure
I have no financial relationships to I have no financial relationships to di ldi ldisclose disclose
Learning ObjectivesLearning Objectives
Analyze the data on the impact of fibroids Analyze the data on the impact of fibroids on obstetric outcomeson obstetric outcomes
Li t th b fit f t f tilitLi t th b fit f t f tilit List the benefits of myomectomy on fertility List the benefits of myomectomy on fertility outcomesoutcomes
Discuss the impact of pregnancy on fibroid Discuss the impact of pregnancy on fibroid growth growth
Leiomyoma related hospitalizationLeiomyoma related hospitalization
Wechter et al AJOGWechter et al AJOG-- 20112011
2007 data from Nationwide inpatient 2007 data from Nationwide inpatient sample (NIS)sample (NIS)
355 135 h it li d355 135 h it li d 355, 135 women were hospitalized355, 135 women were hospitalized
Excludes all minimally invasive interventionsExcludes all minimally invasive interventions
Rates of myomectomyRates of myomectomy•• BlackBlack-- 9.2/10,000 women years9.2/10,000 women years
•• WhiteWhite-- 1.3/ 10,00 women years1.3/ 10,00 women years
•• By 2050By 2050--31 % increase in myomectomies31 % increase in myomectomies
Impact of RaceImpact of Race
Huyck et al AJOG 2008Huyck et al AJOG 2008 Black women present earlier ( 5.3 years) and Black women present earlier ( 5.3 years) and p ( y )p ( y )
more severe diseasemore severe disease
Natural History of FibroidsNatural History of Fibroids
MaverlosMaverlos et al. Ultrasound et al. Ultrasound ObstetObstet GynecolGynecol20102010 Women examined at least twice by a single Women examined at least twice by a single
sonographersonographer at least 8 months apart (medianat least 8 months apart (mediansonographersonographer at least 8 months apart (median at least 8 months apart (median 21 months)21 months)
Median age was 40 years; majority were Median age was 40 years; majority were under 5 cmunder 5 cm
21 % of fibroids showed evidence of 21 % of fibroids showed evidence of spontaneous regression. spontaneous regression.
5
Indication for SurgeryIndication for Surgery
Abnormal Uterine BleedingAbnormal Uterine Bleeding
Pelvic pressure and painPelvic pressure and pain
Urinary or rectal symptomsUrinary or rectal symptomsUrinary or rectal symptomsUrinary or rectal symptoms
InfertilityInfertility-- exclude other causesexclude other causes
Recurrent Pregnancy LossRecurrent Pregnancy Loss--exclude other exclude other causescauses
Adverse pregnancy outcomeAdverse pregnancy outcome
Myomectomy: Refuted reasonsMyomectomy: Refuted reasonsASRM practice committee 2008ASRM practice committee 2008
Size (>12 weeks)Size (>12 weeks)Cannot palpate the adnexaeCannot palpate the adnexae Symptoms will developSymptoms will develop Symptoms will developSymptoms will develop Surgery could be more difficult if surgery Surgery could be more difficult if surgery
delayeddelayed Possible leiomyosarcomaPossible leiomyosarcoma
Sarcoma does not relate to size or rate of Sarcoma does not relate to size or rate of growth and more related to age ( over 60)growth and more related to age ( over 60)
Fibroids and Pregnancy lossFibroids and Pregnancy loss
Klatsky et al AJOG 2008Klatsky et al AJOG 2008-- Systematic Systematic reviewreview
Submucosal fibroidsSubmucosal fibroids-- associated with associated with increased Spontaneous abortion rateincreased Spontaneous abortion rateincreased Spontaneous abortion rateincreased Spontaneous abortion rate OR 3.85 ( 1:12OR 3.85 ( 1:12--13.27)13.27)
Intramural fibroidsIntramural fibroids-- OR 1.34 ( 1.04OR 1.34 ( 1.04--1.65)1.65)
Early first trimester u/s OR 1.82 (1.43Early first trimester u/s OR 1.82 (1.43--2.3)2.3)
Number was more important than sizeNumber was more important than size
Fibroids and Pregnancy lossFibroids and Pregnancy loss
Saravelos et al Hum Reprod 2011Saravelos et al Hum Reprod 2011 8 % prevalence in patients with RPL (n=966)8 % prevalence in patients with RPL (n=966)
Cavity distorting fibroidCavity distorting fibroid--•• Early lossEarly loss no changeno change•• Early lossEarly loss-- no changeno change
•• MidMid--trimester lossestrimester losses-- reduced significantlyreduced significantly--Live Live birth 52 %birth 52 %
NonNon--cavity distorting fibroidscavity distorting fibroids--no surgery & no surgery & unexplained RPLunexplained RPL
•• Live birth rate was 70 %Live birth rate was 70 %
Leiomyomas and InfertilityLeiomyomas and Infertility Casini et al Gynecological Endocrinology 2006Casini et al Gynecological Endocrinology 2006--
Infertile patientsInfertile patients Only RCT of surgery vs. no surgery & fertility outcomeOnly RCT of surgery vs. no surgery & fertility outcome
SubMucous (SM) fibroidsSubMucous (SM) fibroids-- P<.05P<.05•• with surgerywith surgery--PRPR--43%43%•• Without surgeryWithout surgery PRPR 27 %27 %•• Without surgeryWithout surgery-- PRPR--27 %27 %
Intramural (IM) fibroidsIntramural (IM) fibroids-- NSNS•• with surgerywith surgery--PRPR--56%56%•• Without surgeryWithout surgery-- PRPR--41 %41 %
SMSM--IMIM-- P<.05P<.05•• with surgerywith surgery--PRPR--36%36%•• Without surgeryWithout surgery-- PRPR--15%15%
PR = pregnancy rate
Leiomyomas and InfertilityLeiomyomas and Infertility
Submucosal fibroidsSubmucosal fibroids PR after hysteroscopic resection up to 43%PR after hysteroscopic resection up to 43%y p py p p
•• Goldberg F&S 1995Goldberg F&S 1995
•• Hart Br J Obstet & Gynecol 1999Hart Br J Obstet & Gynecol 1999
•• Bernard Eur J Obstet Gynecol Reprod Biol 2000Bernard Eur J Obstet Gynecol Reprod Biol 2000
PR = pregnancy rate
6
Hysteroscopic myomectomy:Hysteroscopic myomectomy: ShokeirShokeir et al. 2010 Fertil Steril 2010 et al. 2010 Fertil Steril 2010
Randomized matched trialRandomized matched trial
Unexplained infertilityUnexplained infertility
Type 0 and Type 1Type 0 and Type 1 myomasmyomas Type 0 and Type 1 Type 0 and Type 1 myomasmyomas
HysteroscopicHysteroscopic surgery was performedsurgery was performed
PR significantly improved (63% vs. 28%)PR significantly improved (63% vs. 28%)
Cavity Distorting Intramural Cavity Distorting Intramural MyomasMyomas
Systematic Review Systematic Review –– Pritts, Parker and Pritts, Parker and Olive F&S 2009Olive F&S 2009 Clinical Pregnancy rate/ Implantation Clinical Pregnancy rate/ Implantation
rate/ongoing pregnancy rate/live birth raterate/ongoing pregnancy rate/live birth rate--rate/ongoing pregnancy rate/live birth raterate/ongoing pregnancy rate/live birth ratedecreaseddecreased
Spontaneous abortion rate is increasedSpontaneous abortion rate is increased
Myomectomy vs. women with no fibroidsMyomectomy vs. women with no fibroids•• Clinical pregnancy rate is similarClinical pregnancy rate is similar
Impact of Subserosal Fibroids on Impact of Subserosal Fibroids on Fertility outcomeFertility outcome
Systematic Review Systematic Review –– Pritts, Parker and Pritts, Parker and Olive F&S 2009Olive F&S 2009
Uniquely Subserosal fibroids have no Uniquely Subserosal fibroids have no impact on fertility or spontaneous abortion impact on fertility or spontaneous abortion ratesrates
Systematic Review Systematic Review –– Fibroids and Fibroids and FertilityFertility
Pritts, Parker and Olive 2009Pritts, Parker and Olive 2009 Effect on fertility Effect on fertility –– no intracavitary involvementno intracavitary involvement
•• Pregnancy rate ( 24 studies): RR .89 (.8Pregnancy rate ( 24 studies): RR .89 (.8--1.0)1.0)•• Implantation rate ( 14 studies): RR .79 (.69Implantation rate ( 14 studies): RR .79 (.69--.9).9)Implantation rate ( 14 studies): RR .79 (.69Implantation rate ( 14 studies): RR .79 (.69 .9).9)•• LiveLive--birth rate ( 16 studies): RR .78 ( .69birth rate ( 16 studies): RR .78 ( .69--.88).88)•• Spontaneous abortion (16 studies): RR 1.8 (1.47Spontaneous abortion (16 studies): RR 1.8 (1.47--2.4)2.4)
Myomectomy for intramural fibroids (controlsMyomectomy for intramural fibroids (controls--fibroids in situ) ( nonfibroids in situ) ( non--cavity distorting)cavity distorting)
•• Pregnancy rate ( 2 studies ): RR 3.7 ( .47Pregnancy rate ( 2 studies ): RR 3.7 ( .47--30)30)•• LiveLive--birth rate (1 study): RR .75 ( .29birth rate (1 study): RR .75 ( .29--1.9)1.9)
RR = relative risk
Impact of Fibroids on IVFImpact of Fibroids on IVF
Variables that explain differences in results:Variables that explain differences in results: Location of the fibroidsLocation of the fibroids
Size of leiomyoma: large (>5Size of leiomyoma: large (>5--7cm) often excluded7cm) often excluded
CaseCase--control studies: retrospective biascontrol studies: retrospective biaspp
Assessment of fibroids HSG vs. US vs. hysteroscopy Assessment of fibroids HSG vs. US vs. hysteroscopy (SIS was not used in the studies)(SIS was not used in the studies)
Contribution of the fibroid that does not distort Contribution of the fibroid that does not distort the cavity may not be appreciated if there is a the cavity may not be appreciated if there is a low PR or implantation ratelow PR or implantation rate
HSG = hysterosalpingogram; US = ultrasound; SIS = saline-infusion sonogram
Effect of Intramural Fibroids on IVF Effect of Intramural Fibroids on IVF OutcomeOutcome
Sunkara et al. HR 2010Sunkara et al. HR 2010 MetaMeta--analysisanalysis Intramural fibroids Intramural fibroids without cavity distortionwithout cavity distortion 19 studies: 6087 cycles19 studies: 6087 cyclesyy Significant decrease in liveSignificant decrease in live--birth (RR 0.79, birth (RR 0.79,
95% CI 95% CI --.70.70--.88) and clinical pregnancy rates .88) and clinical pregnancy rates (RR 0.85, 95% CI .77(RR 0.85, 95% CI .77--.94).94)
This does not mean that removal will restore This does not mean that removal will restore PR to the levels expected in women without PR to the levels expected in women without fibroidsfibroids
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Impact of Fibroids on IVF: Impact of Fibroids on IVF: ConclusionsConclusions
Because of the lack of consistent or wellBecause of the lack of consistent or well--designed studies and high reported PR, designed studies and high reported PR, prophylactic prophylactic myomectomymyomectomy prepre--IVF if the IVF if the p p yp p y y yy y ppcavity is normal should be individualized cavity is normal should be individualized and not routine. No data for fibroids >5and not routine. No data for fibroids >5--7 7 cm.cm.
Myomas & PregnancyMyomas & Pregnancy
Growth of Myomas during pregnancyGrowth of Myomas during pregnancy•• 4949--60 % no change60 % no change
•• 2222--32% increase in size32% increase in size
•• 88--27 % decrease in size27 % decrease in size
Most of the growth is in the first trimesterMost of the growth is in the first trimester
Mean increase is 12 %Mean increase is 12 %
90 % of women with fibroids detected in the 90 % of women with fibroids detected in the first trimester will have regression of volume first trimester will have regression of volume postpartumpostpartum
Adapted from Stout et alAdapted from Stout et al Leiomyomas at second trimester Leiomyomas at second trimester u/s Obstet Gynecol 2010u/s Obstet Gynecol 2010
Adapted from Stout et alAdapted from Stout et al Leiomyomas at second trimester Leiomyomas at second trimester u/s Obstet Gynecol 2010u/s Obstet Gynecol 2010
Klatsky et al AJOG 2007Klatsky et al AJOG 2007Nomenclature of Professional Communication
International Consensus Meeting 2005…
8
Acute versus Chronic AUBAcute versus Chronic AUBFor nonpregnant women of reproductive ageFor nonpregnant women of reproductive age
Chronic Abnormal Uterine BleedingChronic Abnormal Uterine Bleeding Bleeding from the uterine corpus, that is abnormal in Bleeding from the uterine corpus, that is abnormal in
duration, volume, regularity, and/or frequency and duration, volume, regularity, and/or frequency and has been present for the majority of the last six (6) has been present for the majority of the last six (6) monthsmonthsmonths.months.
Acute Abnormal Uterine Bleeding Acute Abnormal Uterine Bleeding is an episode of bleeding that is of sufficient quantity is an episode of bleeding that is of sufficient quantity
to require immediate intervention to prevent further to require immediate intervention to prevent further blood loss. blood loss.
Nomenclature of Professional Communication Nomenclature of Professional Communication
AUBAUB-- Recommended Descriptive Recommended Descriptive Nomenclature for SymptomsNomenclature for Symptoms
Fraser IS, Critchley HOD, Munro MG, Fraser IS, Critchley HOD, Munro MG, et al et al Hum ReprodHum Reprod 2007;222007;22::635635--43 and 43 and Fertil SterilFertil Steril 2007;87:4662007;87:466--7676
Nomenclature of Professional Communication Nomenclature of Professional Communication
AUBAUB-- Recommended Descriptive Recommended Descriptive Nomenclature for SymptomsNomenclature for Symptoms
Fraser IS, Critchley HOD, Munro MG, Fraser IS, Critchley HOD, Munro MG, et al et al Hum ReprodHum Reprod 2007;22:6352007;22:635--43 and 43 and Fertil Steril Fertil Steril 2007;87:4662007;87:466--7676
Nomenclature of Professional Communication Nomenclature of Professional Communication
AUBAUB-- Recommended Descriptive Recommended Descriptive Nomenclature for SymptomsNomenclature for Symptoms
Fraser IS, Critchley HOD, Munro MG, Fraser IS, Critchley HOD, Munro MG, et al et al Hum ReprodHum Reprod 2007;22:6352007;22:635--43 and 43 and Fertil Steril Fertil Steril 2007;87:4662007;87:466--7676
Unresolved IssuesUnresolved Issues VolumeVolume
•• Since the volumetric measurement of 5Since the volumetric measurement of 5--80 mL is 80 mL is NOT practical in the clinical environment, what are NOT practical in the clinical environment, what are practicable measures of menstrual volume?practicable measures of menstrual volume?
RegularityRegularity•• Is Is ±± 22--20 days a practical definition of a group who 20 days a practical definition of a group who
is primarily ovulatoryis primarily ovulatory??
Polyp
Adenomyosis
Leiomyoma
Malignancy & Hyperplasia
Structural Abnormality
Coagulopathy
Ovulatory Dysfunction
Endometrial
Iatrogenic
Not Yet Classified
Dysfunctional Uterine Bleeding
No Structural Abnormality
Leiomyoma Subclassification System
S M‐ Submucous 0 Pedunculated Intracavitary
1 <50% Intramural
2 ≥ 50% Intramural
O ‐ Other 3 Contacts endometrium; 100% Intramural
Polyp
Adenomyosis
Leiomyoma
Malignancy & Hyperplasia
Coagulopathy
Ovulatory Dysfunction
Endometrial
Iatrogenic
Not Yet Classified
O Other 3 Contacts endometrium; 100% Intramural
4 Intramural
5 Subserous ≥50% Intramural
6 Subserous < 50% Intramural
7 Subserous Pedunculated
8 Other (specify eg. cervical, parasitic)
Hybrid
Leiomyomas (impact both
endometrium and
serosa)
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.
9
Polyp
Adenomyosis
Leiomyoma
Malignancy & Hyperplasia
Coagulopathy
Ovulatory Dysfunction
Endometrial
Iatrogenic
Not Yet ClassifiedHow could / should FIGO’sHow could / should FIGO’sHow could / should FIGO’sHow could / should FIGO’sPALMPALM--COEIN system be used?COEIN system be used?PALMPALM--COEIN system be used?COEIN system be used?
Classification CategorizationClassification CategorizationSingle Entity ExamplesSingle Entity Examples
P0 A0 L1(SM) M0 - C0 O0 E 0 I0 N0
P0 A1 L0 M0 - C0 O0 E 0 I0 N0
P1 A0 L0 M0 - C0 O0 E 0 I0 N0
P0 A0 L0 M0 - C0 O0 E 0 I0 N0
Classification CategorizationClassification CategorizationMultiple Entity ExamplesMultiple Entity Examples
P0 A0 L1 (SM) M1 - C0 O0 E 0 I0 N0
P1 A1 L0 M0 - C0 O0 E 0 I0 N0
AUB-M
P1 A0 L1(O) M0 - C0 O0 E 0 I0 N0
P0 A1 L1(O) M0 - C1 O0 E 0 I0 N0
AUB-P, -A
AUB-P, -Lo
AUB-A, -Lo, -C
ReferencesReferences Sunkara SK, Khairy M, ElSunkara SK, Khairy M, El--Toukhy T, Khalaf Y, Coomarasamy A. The effect Toukhy T, Khalaf Y, Coomarasamy A. The effect
of intramural fibroids without uterine cavity involvement on the outcome of of intramural fibroids without uterine cavity involvement on the outcome of IVF treatment: a systematic review and metaIVF treatment: a systematic review and meta--analysis. Hum Reprod analysis. Hum Reprod 2010;25:4182010;25:418--429.429.
Pritts E, Parker W, Olive D. Fibroids and infertility: an updated systematic Pritts E, Parker W, Olive D. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril 2009;91:1215review of the evidence. Fertil Steril 2009;91:1215--1223.1223.
Saravelos S, Yan J, Rehmani H, Li TC. The prevalence and impact of Saravelos S, Yan J, Rehmani H, Li TC. The prevalence and impact of fibroids and their treatment on the outcome of pregnancy in women withfibroids and their treatment on the outcome of pregnancy in women withfibroids and their treatment on the outcome of pregnancy in women with fibroids and their treatment on the outcome of pregnancy in women with recurrent miscarriage. Hum Reprod 2011;26:3274recurrent miscarriage. Hum Reprod 2011;26:3274--3279.3279.
Shokeir T, ElShokeir T, El--Shafei M, Yousef H, Allam AF, Sadek E. Submucous myomas Shafei M, Yousef H, Allam AF, Sadek E. Submucous myomas and their implications in the pregnancy rates of patients with otherwise and their implications in the pregnancy rates of patients with otherwise unexplained primary infertility undergoing hysteroscopic myomectomy: a unexplained primary infertility undergoing hysteroscopic myomectomy: a randomized match control study. Fertil Steril 2010;94:724randomized match control study. Fertil Steril 2010;94:724--729.729.
Stout M, Odibo A, Graseck A, Macones G, Crane J, Cahill A. Leiomyomas Stout M, Odibo A, Graseck A, Macones G, Crane J, Cahill A. Leiomyomas at routine secondat routine second--trimester ultrasound examination and adverse obstetric trimester ultrasound examination and adverse obstetric outcomes. Obstet Gynecol 2010;116:1056outcomes. Obstet Gynecol 2010;116:1056--1063.1063.
ReferencesReferences Klatsky P, Tran N, Caughey A, Fujimoto V. Fibroids and Klatsky P, Tran N, Caughey A, Fujimoto V. Fibroids and
reproductive outcomes: a systematic literature review from reproductive outcomes: a systematic literature review from conception to delivery. Am J Obstet Gynecol 2008;198:357conception to delivery. Am J Obstet Gynecol 2008;198:357--366.366.
Mavrelos D, BenMavrelos D, Ben--Nagi J, Holland T, Hoo W, Naftalin J, Jurkovic D. Nagi J, Holland T, Hoo W, Naftalin J, Jurkovic D. The natural history of fibroids. Ultrasound Obstet Gynecol The natural history of fibroids. Ultrasound Obstet Gynecol 2010;35:2382010;35:238--242.242.
Huyck K, Panjuysen C, Cuenco K, Zhang J, Goldhammer H, Jones Huyck K, Panjuysen C, Cuenco K, Zhang J, Goldhammer H, Jones y , j y , , g , ,y , j y , , g , ,E, et al. The impact of race as a risk factor for symptom severity and 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 age at diagnosis of uterine leiomyomata among affected sisters. Am J Obstet Gynecol 2008; 198:168.e1J Obstet Gynecol 2008; 198:168.e1--168.e9.168.e9.
Practice Committee of American Society for Reproductive Medicine Practice Committee of American Society for Reproductive Medicine in collaboration with Society of Reproductive Surgeonsin collaboration with Society of Reproductive Surgeons. Fertil Steril . Fertil Steril 2008;90:S1252008;90:S125--S130.S130.
Wechter ME, Stewart E, Myers E, Kho R, Wu J. LeiomyomaWechter ME, Stewart E, Myers E, Kho R, Wu J. Leiomyoma--related related hospitalization and surgery: prevalence and predicted growth based hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol 2011; 205:492.e1on population trends. Am J Obstet Gynecol 2011; 205:492.e1--492.e5.492.e5.
10
Hysteroscopic Approach to Leiomyomata
11Minimally Invasive Gynecologic
Surgery
Ted L. Anderson, MD, PhD, FACOG, FACSAssociate Professor of Obstetrics & Gynecology
Director, Division of GynecologyVanderbilt University Medical Center, Nashville, TN
Disclosure
• I have no financial relationships to disclose.
22Minimally Invasive Gynecologic
Surgery
Objectives
• Participants will be able to:
– Assess submucosal leiomyomata appropriately
– Compare approaches to hysteroscopic resection
– Predict and manage common complications
33Minimally Invasive Gynecologic
Surgery
– Surgically manage submucosal leiomyoma patients
Background
• Affects approximatly 33% of women• Age and race variables up to 75%
• Varied symptoms, may be asymptomatic• Menorrhagia (30%), Pain (34%), Infertility (27%)
44Minimally Invasive Gynecologic
Surgery
• 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.
Interventions
• Indications for treatment• Abnormal uterine bleeding
• Pelvic pain / dysmenorrhea
• Infertility
G l id ti
55Minimally Invasive Gynecologic
Surgery
• General considerations• Desire for future fertility
• Desire for uterine preservation
• Aggressiveness vs expectations
• Co‐morbidities
Treatment Decisions
Fibroid Fibroid Patient Patient
MonopolarMonopolar
BipolarBipolar cations
66Minimally Invasive Gynecologic
Surgery
EvaluationEvaluation ManagementManagementBipolarBipolar
MechanicalMechanical
Compli
11
Treatment Decisions
Fibroid Fibroid Patient Patient
MonopolarMonopolar
BipolarBipolar cations
77Minimally Invasive Gynecologic
Surgery
EvaluationEvaluation ManagementManagementBipolarBipolar
MechanicalMechanicalCompli
Submucosal Fibroid Types
• ESGE classification
• Intramural extension• Type 0 None
• Type I < 50%
88Minimally Invasive Gynecologic
Surgery
• Type II > 50%
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.
The extension of the basewith respect to the wall of
the uterus
The extension of the basewith respect to the wall of
the uterus
The extension of the basewith respect to the wall of
the uterus
The penetration level ofthe myoma into the
myometrium
The penetration level ofthe myoma into the
myometrium
The penetration level ofthe myoma into the
myometrium
Preoperative Assessment (NC)
99Minimally Invasive Gynecologic
Surgery
The location at fundus,body or lower segmentThe location at fundus,body or lower segmentThe location at fundus,body or lower segment
< 2 cm = score 0< 2 cm = score 0
2 cm – 5 cm = score 12 cm – 5 cm = score 1
> 5 cm = score 2> 5 cm = score 2
< 2 cm = score 0
2 cm – 5 cm = score 1
> 5 cm = score 2
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.
Uterine Evaluation
Sensitivity 100%
Specificity 94%
Predictive Value• Abnormal scan 81%
N l 100%
1100
Minimally Invasive Gynecologic
Surgery
• Normal scan 100%
Precise mapping
Polyp vs fibroid
Fedele L et al (1991) Transvaginal ultrasonography versus hysteroscopy in the diagnosis of uterine submucous myomas. Obstet Gynecol 77(5):745‐48.
Ultrasound Mapping
1111
Minimally Invasive Gynecologic
Surgery
Saline Infusion Sonography
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Minimally Invasive Gynecologic
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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.
• As sensitive as hysteroscopy for intracavitary pathology
• Less uncomfortable than hysteroscopy when both performed in the office
• Added benefit of myometrial evaluation
12
3‐D Reconstruction
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Minimally Invasive Gynecologic
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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.
• As accurate as 2D saline infusion sonography
• Faster, more accurate interpertation, especially of submucosal component
• Comparable to hysteroscopy for intracavitary lesions
Magnetic Resonance (MRI)
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Minimally Invasive Gynecologic
Surgery
Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.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
• 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
Hysteroscopy
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Minimally Invasive Gynecologic
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High vs Low Pressure
1166
Minimally Invasive Gynecologic
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Treatment Decisions
Fibroid Fibroid Patient Patient
MonopolarMonopolar
BipolarBipolar cations
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Minimally Invasive Gynecologic
Surgery
EvaluationEvaluation ManagementManagementBipolarBipolar
MechanicalMechanical
Compli
ACTIVE
ELECTRODE
Monopolar Current
• Cuts and Desiccates Tissue
• High Current Density at Active Electrode
• Deep Necrosis
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Minimally Invasive Gynecologic
Surgery
CURRENT FLOW
DEEP THERMAL EFFECT
• Broad thermal margins
• Current flows through patient
• Electrolyte‐free fluid
• Current dispersed in saline
13
Monopolar Current
1199
Minimally Invasive Gynecologic
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Loop electrodes at 45° and 90° angulations
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Minimally Invasive Gynecologic
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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
• Most commonly used method
• Loop resection or bulk vaporization
• Risk for hyponatremia
Treatment Decisions
Fibroid Fibroid Patient Patient
MonopolarMonopolar
BipolarBipolar cations
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Minimally Invasive Gynecologic
Surgery
EvaluationEvaluation ManagementManagementBipolarBipolar
MechanicalMechanical
Compli
• Energy Flow
• Generator to active electrode
• Sodium Vapor Pocket
• Contacts tissue
• Instantaneous cellular rupture
Bipolar Current
2222
Minimally Invasive Gynecologic
Surgery
• Cutting is non‐mechanical
• Energy Flow
• Return electrode
• Controlled Thermal Effect
• Vapor pocket proportional to voltage
NaNa++NaNa++
4 x 2.5 mmActive Electrode
Return Electrode
Bipolar Resection
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Minimally Invasive Gynecologic
Surgery
Insulator
• 1.6 mm (5 Fr) in diameter• Focused Tissue Effects• Ball Tip
• Vaporization• Desiccation
Bipolar Resection
2244
Minimally Invasive Gynecologic
Surgery
• Spring Tip• Vaporization • Desiccation
• Twizzle Tip• Vaporization• Pin‐point cutting
14
• Just as effective as monopolar
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Minimally Invasive Gynecologic
Surgery
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 142:154–159Bradley L (2012) Hysteroscopic myomectomy. UpToDate. http://www.uptodate.com/contents/hysteroscopic‐myomectomy
• Just as effective as monopolar
• Pencil‐type electrode, loop, or bulk vaporization
• Decreased (not absent) risk of fluid absorption
Treatment Decisions
Fibroid Fibroid Patient Patient
MonopolarMonopolar
BipolarBipolar cations
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Surgery
EvaluationEvaluation ManagementManagementBipolarBipolar
MechanicalMechanical
Compli
Hysteroscopic Morcellator
• Operate in Saline
• Mechanical• No thermal injury
• Remove Tissue Pieces• Clear visual field
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Minimally Invasive Gynecologic
Surgery
Clear visual field
• Are Easy to Use ‐ Office use?
• Facilitate Removal Type 0 and I MyomasEmanuel 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
Hysteroscopic Morcellator ‐ TruClear
• FDA Approved 2005
Decreased Operative TimePolyps 2/3Type 0 or 1 1/2
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Minimally Invasive Gynecologic
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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.
Hysteroscopic Morcellator ‐MyoSure
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Minimally Invasive Gynecologic
Surgery
• 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
Cohen S, Greenberg JA (2011) Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol 4(2):73‐80.
Treatment Decisions
Fibroid Fibroid Patient Patient
MonopolarMonopolar
BipolarBipolar cations
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Minimally Invasive Gynecologic
Surgery
EvaluationEvaluation ManagementManagementBipolarBipolar
MechanicalMechanical
Compli
15
Complications
• Fluid absorption
• Gas embolism
• Perforation
• Hemorrhage
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Minimally Invasive Gynecologic
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Hemorrhage
• Incomplete resection
• Objectives of fluid distension• Overcoming myometrial resistance, maximize visualization
• Create and maintain elctrosurgical environment
• Challenges of fluid absorption• Minimize fluid medium absorption and consequences
Fluid Absorption
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Minimally Invasive Gynecologic
Surgery
Minimize fluid medium absorption and consequences
• Drivers of fluid absorption• Pressure, time, procedure invasiveness, comorbidities
• Pathways of fluid absorption• Direct vascular channels
• Peritoneal absorption
Nonionic (Hypotonic) Media
• 1.5% Glycine (200 mOsm/L)• Metabolized to ammonia/urea + water
• Hyperammonemia + hypo‐osmolal hyponatremia
• 3% Sorbitol (178 mOsm/L)
3333
Minimally Invasive Gynecologic
Surgery
• Metabolized to fructose + glucose
• Hyperglycemia + hypo‐osmolal hyponatremia
• 5% Mannitol (274 mOsm/L)• Essentially inert (only ~10% metabolized)
• Metabolized to glucose
• Half‐life ~15 min; acts as osmotic diuretic
Nonionic (Hypotonic) Media
• Significant Morbidity• Headache
• Nausea, vomiting
• Lethargy, confusion, stupor
• Muscle aches and twitches
• Seizure
MediumMedium
NaNa++
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Minimally Invasive Gynecologic
Surgery
• Significant Mortality• Cerebral edema
– herniation
• Pulmonary edema
• Cardiac arrhythmias
• Coma
• Death
HH22OO
Osmotic Osmotic PressurePressure
Ionic (Isotonic) Medium
• Normal Saline
• Lactated Ringers
• Pure fluid overload• Tissue edema
• Pulmonary edema
Normal Normal SalineSaline
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Minimally Invasive Gynecologic
Surgery
• Treat with lasixNaNa++
NaNa++ NaNa++
Factors Affecting Intravasation
• Surgery that opens larger vascular channels• Resection of myoma > endometrial ablation
• Lysis of intrauterine adhesions
• Division of uterine septum
• Partial perforation
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Minimally Invasive Gynecologic
Surgery
• Cervical/lower segment tear
• False passageway
• Excessive operating time
• Excessive intrauterine pressure• MAP aproximately 75 mm Hg
• 40‐110 mm Hg required to distend uterus
16
Mitigating Risk
• Iso‐osmolar fluids preferentially• Chilled fluid decreases absorption
• Appropriate distension pressure
• Cervical vasopressin or GnRH analogs
• Timely purposeful procedure
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Minimally Invasive Gynecologic
Surgery
• Timely purposeful procedure
• Fluid management system
• Pre‐designate STOP• 1000 cc for hypotonics
• 2500 cc for isotonics
• Communication between team members
Treatment of Hyponatremia
• Early detection, rapid initiation of treatment• Loop diuretic such as furosemide for rapid diuresis
• Regular monitoring of electrolytes, intake, and output
• Restrict fluid intake, provide supplemental oxygen
d l
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Minimally Invasive Gynecologic
Surgery
• Sodium <120 requires critical care setting• Engage a specialist in critical care medicine
• 3% saline with abnormal cardiac or neuromuscular function, or sodium <120 mmol/L
• Correct sodium gradually (1 ‐ 2 meq/l/hr) to 130
Gas Embolism
3399
Minimally Invasive Gynecologic
Surgery
Heart
LungsBlood Alveoli
CO2
O2
PulmonaryDead Space
• Pulmonary vasoconstriction
4400
Minimally Invasive Gynecologic
Surgery
y• Pulmonary vascular resistance• PAP
• RV ejection• RV end systolic/diastolic vol.
• Acute right heart failure• CVP• Cardiac Output
Gas Embolism with Electrosurgery
• No clinically significant difference in gas produced by monopolar or bipolar
• Composition – soluble: H+, CO, CO2, & O2
• Enters venous circulation
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Minimally Invasive Gynecologic
Surgery
– equilibrate with pulmonary clearance
– exceed pulmonary clearance
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
Factors Predisposing Gas Embolism
• 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
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Minimally Invasive Gynecologic
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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
17
Treatment of Gas Embolism
• Stop case• stops further air entry
• Stop nitrous oxide if using• prevent bubble expansion
• Left lateral decubitus
4433
Minimally Invasive Gynecologic
Surgery
• prevents air lock in the right heart
• Evacuate embolized air in through CVP or PA line
• Maintenance of cardiac output• raise BP and push air out
• Closed chest cardiac message / respiratory care
Uterine Perforation
• Rare overall
• 0.1 – 0.5% in simple hysteroscopy
• Up to 5% in operative hysteroscopy cases
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Minimally Invasive Gynecologic
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• Consequences• Inconsequential
• Vessel injury
• Visceral injury
Perforation Risk
• Cervical dilation (most often)
• Rigid instrument placement
• Challenging access
C i l i
4455
Minimally Invasive Gynecologic
Surgery
• Cervical stenosis
• Asherman’s syndrome
• Altered myometrium
• Uterine anomaly
• Menopause (up to 10x)
• EUA with empty bladder
• Cervical preparation, adequate dilation
• Avoid using dilators like a sound
• Gentle insertion of instruments
Perforation Prevention
4466
Minimally Invasive Gynecologic
Surgery
• Advance electrode only if unobstructed view
• Do not advance scope with electrode extended
• Do not advance activated electrode
• Ultrasound or laparoscopy assistance
• Fundal without RF Energy• Discontinue and observe
• Fundal with RF Energy• Laparoscopy / laparotomy to inspect for visceral injury
• Lateral
Management of Uterine Perforation
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Minimally Invasive Gynecologic
Surgery
• Lateral • Laparoscopy to inspect for broad ligament hematoma
• Anterior• Cystoscopy
• Remove excessive distention media• Delayed fluid absorption issues
Hemorrhage
• Greatest risk with myomectomy (2.5%)
• Look for cervical tear / partial perforations
Miti ti i k
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Minimally Invasive Gynecologic
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• Mitigating risk• vasopressin
• preop GnRH agonist
Mencaglia L, Tantini C (1993) GnRH agonist analogs and hysteroscopic recection of myomas. Int J Gynaecol Obstet. 43:285Phillips 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.
18
• Type II (ESGE) Hysteroscopic Myomectomy• Increased risk of:
– Excessive fluid absorption
– Electrolyte abnormalities with non‐electrolyte media
– Excessive bleeding
Need for Staged Procedures
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Minimally Invasive Gynecologic
Surgery
– Incomplete resection
– Need for additional procedure
– Increased operative time
• Applies even to experienced hysteroscopic surgeons
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.
Need for Staged Procedures
Type 0 Type I Type II Total
No. Patients73 97 108 278
No. Procedures
73 102 158 333
Complete N = 103 N = 271
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Minimally Invasive Gynecologic
Surgery
Complete Resection
N = 73 100% N = 95 98%N = 103 95%
N = 27197%
Repeat Procedures
‐ 5% 40% 17%
Mean Fluid Intravasation cc
437 971 1642 1110
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.
Need for Staged Procedures
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Minimally Invasive Gynecologic
Surgery
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.
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
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Minimally Invasive Gynecologic
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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.
Treatment Decisions
Fibroid Fibroid Patient Patient
MonopolarMonopolar
BipolarBipolar cations
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Minimally Invasive Gynecologic
Surgery
EvaluationEvaluation ManagementManagementBipolarBipolar
MechanicalMechanical
Compli
• Adequate pre‐opertive assessment• Measure twice, cut once
• Consider appropriateness of hysteroscopy
• Consider specific surgical tools available
C l i di fl id
Patient Management
5544
Minimally Invasive Gynecologic
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• Counsel patients regarding fluid management• Excessive absorption and consequences
• Procedure termination, need for additional procedure(s)
• Be aware of risks and vigilant for complications
• Know your surgical limits
19
References1. 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 lesions in premenopausal bleeding Middle East Fertil Soc 10(3):239 243
5555
Minimally Invasive Gynecologic
Surgery
uterine 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
References10. 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.
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Minimally Invasive Gynecologic
Surgery
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.
Questions?
5577
Minimally Invasive Gynecologic
Surgery
Ted L. Anderson, MD, PhD, FACOG, FACSAssociate Professor of Obstetrics & Gynecology
Director, Division of GynecologyVanderbilt University Medical Center, Nashville, TN
20
What limits a conventional laparoscopic approach?
Jon I Einarsson MD MPHDirector of MIGS
Brigham and Women’s HospitalAssociate Professor of Obstetrics and Gynecology
Harvard Medical School
DISCLOSUREI have the following financial relationship with a commercial entity producing health-care related
products and/or services
Consultant Ethicon Endo-Surgery
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
Our data – LM vs. RALM
289 women – 02/07-09/09 LM (n=115) RALM (n=174) p
Operative time (min) 118.3 195.1 <.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
Brief description of our technique
O Two parallel trocars on surgeon sideO Faciliates suturing – especially in the setting of a
horizontal hysterotomyO Inject dilute vasopressin subserosally – avoid
using more than 10 units every 30 minutesO 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
Step 1‐ Vasopressin injection
21
Step 2 – HysterotomyO Carry the incisioninto the fibroid– find the right planeO We prefer the Harmonic due tominimal lateralthermal spreadO A horizontal incision is preferredfor suturing with twoipsilateral trocars
Step 3 – Fibroid extractionO Rock and Roll O Needs quite a bit of forceO Avoid entering the cavity if
possible –will do this deliberatelyin women who havecompleted theirchildbearing – easy topluck out thesubmucosal fibroidsthis way
Step 4 – Closure of endometrial cavity
O Close cavity separately (if entered) with small (3/0) monofilament (Monocryl)
O Take care not to place sutures inside the uterine cavityinside the uterine cavity
O Intracorporeal knot tyingO We will not close the cavity
separately in patients who are not of reproductive potential
Step 5 – Hysterotomy closure
O Close hysterotomy in layers making sure to 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 Step 5 – Hysterotomy closure
O We tack the first needle into the anterior abdominal wall on the right side to avoid tangling
O First bite taken and suture pulled through until resistance is met (middle of suture)( )
O First layer completed, needle cut awayO Second layer taken with other needleO The hysterotomy closure is “time sensitive” –
as long as the hysterotomy is open there is going to be active bleeding
O Cover hysterotomy with adhesion barrier (interceed)
22
Step 5 – Hysterotomy closure
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 ‐ video
Hysterotomy closure – baseball Step 6 ‐MorcellationO We need better tissue
morcellatorsO Try to stay on the surface (peel
an orange)O Make sure to get all the pieces
outO Time consuming in the setting of
large or calcified fibroids O 12-40 grams per minuteO 1000 grams takes 25-83
minutes to morcellate
Limits
O Surgeon experienceO SizeO NumberO LocationO What is the ultimate goal of surgery? Fertility
preservation? Volume reductionO Blood loss – will the pt accept a
transfusion?
Surgeon experience
O Most important factorO Move strategically and control the situation
at all timesO Gradually build upO Need high volumes (>50/year) to become
really goodO 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 storyMUCH i t l g fib id th O MUCH easier to remove one large fibroid rather 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
O Hybrid procedureO Fibroids usually removed laparoscopically
and suturing and fibroid extraction performed through a minilaparotomy incision (4 5 cm)incision (4-5 cm)
O Challenging for posterior fibroidsO Longer recovery time than LMO 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
Hand assisted video
Number
O Have removed over over 60 fibroids in one 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
Location
O Intramural vs submucosal vs intracavitary vs subserosal
O Cervical – watch out for uterines – clip at forigin if necessary
O Broad ligament – usually pretty easy – open peritoneum and peel out – again stay away from major vessels
24
Preoperative evaluation
O MRI is obtained on most patients
O Delineates location, characteristics and size of fibroids
O Detects adenomyosisO Helps with
preoperative counseling and planning
Goal of surgery?
O Fertility preservationO prefer not to embolize or use permanent clips, but
OK to use clips and remove at end of caseO Important to take care of any fibroids in vicinity of
cavityO Close endometrium separately
O No Fertility preservationO OK to remove the whole top of uterus and close
en mass – shortens and simplifies procedureO No need to close endometrium separatelyO Remove submucosal fibroids laparoscopically
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 – may make dissection of fibroids more difficult IF the fibroids are already necroticIF the fibroids are already necrotic
O Be quickO Avoid making an incision close to ascending
uterinesO Use clips on the uterine arteriesO Consider preop embolizationO Consider using cell saver
Laparoscopic uterine artery occlusion
Case in point
O 39 y/o G0 – Jehovah's witnessO Heavy bleeding despite Lupron for 6 monthsO H/H 9/29 despite repeated iv iron infusions
fO Wants pregnancy in near futureO Multiple fibroids on imaging, overall uterine
size 19.5x17.2x8.6cm – 10 cm intracavitaryfibroid – total uterine weight approx 1500 grams
O EMB benign
Video
25
Thank youReferences
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.
O 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 Scand. 2012 May;91(5):613-9.y y; ( )
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.
O 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 Taniguchi et al Fertil Steril. 2004;81(4):1120-4
26
Robot –Assisted Laparoscopic Myomectomy
Tommaso Falcone,M.D.Professor and ChairDepartment of Obstetrics & Gynecology
Financial DisclosureFinancial Disclosure
•• I have no financial relationships to I have no financial relationships to ppdisclose.disclose.
Learning ObjectivesLearning Objectives•• Analyze if a laparoscopic approach to the Analyze if a laparoscopic approach to the
management of a fibroid uterus gives management of a fibroid uterus gives similar results to a laparotomysimilar results to a laparotomy
•• List the benefits of Laparoscopic List the benefits of Laparoscopic myomectomymyomectomy
•• Discuss the possible technical limitations Discuss the possible technical limitations of laparoscopic myomectomyof laparoscopic myomectomy
•• Discuss the role of robotics Discuss the role of robotics
27
Summary of Literature on Robotic Myomectomy SurgerySummary of Literature on Robotic Myomectomy Surgery
NumberNumber RemovedRemovedof Roboticof Robotic Type of Type of MyomasMyomas
Author Author Year Year Cases Cases Study Study WeightWeight ResultsResults
Advincula 2004 35 Preliminary Mean = Robotic myomectomyAP et al experience 223.2 + 244.1g is new promising
approach
Mao SP 2007 1 Case report Not Successfulet al available robotically-assistedet al available robotically-assisted
excision of large uterine myoma measuring 9x8x7cm
Bocca S 2007 1 Case report Not Achievement of et al available uncomplicated full
term pregnancy after robotic myomectomy
Summary of Literature on Robotic Myomectomy Summary of Literature on Robotic Myomectomy SurgerySurgery
NumberNumber RemovedRemovedof Roboticof Robotic Type ofType of MyomasMyomas
Author Author Year Year Cases Cases StudyStudy WeightWeight ResultsResults
Advincula 2007 29 Retrospective Mean = Robotic myomectomyAP, et al case matched 227.86 + 247.54g approach is
between comparable to openrobotic and approach regardingopen short term surgicalmyomectomy outcome and costs
Nezhat C 2009 15 Retrospective Mean = 116g Robotic myomectomy et al case matched (min 25-max 350)g had significant longer
between surgical time withoutrobotic and offering any majorlaparoscopic advantages
myomectomy
Summary of Literature on Robotic Myomectomy Summary of Literature on Robotic Myomectomy SurgerySurgery
NumberNumber RemovedRemovedof Roboticof Robotic Type ofType of MyomasMyomas
Author Author Year Year CasesCases StudyStudy WeightWeight ResultsResults
George A 2009 77 Effect of the Median = 235g Obesity is not aet al BMI on the (range 21.2 - 980)g risk factor for poor
surgical surgical outcome outcome in roboticoutcome in robotic
myomectomy
Bedient CE 2009 40 Comparing Mean = 210g No difference in et al robotic to (range 7 - 1076)g relation to short
laparoscopic term surgical myomectomy outcome measures
Robotic trialRobotic trial
•• Robotic myomectomy versus laparotomyRobotic myomectomy versus laparotomy–– AscherAscher-- Walsh & Capes JMIG 2010Walsh & Capes JMIG 2010–– Robot N= 75; 4 portsRobot N= 75; 4 ports-- 3 robotic and 1 assistant; 3 robotic and 1 assistant;
ControlControl N=50;N=50;ControlControl-- N=50;N=50;–– Inclusion criteria were 3 myomas or fewer Inclusion criteria were 3 myomas or fewer –– Mean BMI was 20Mean BMI was 20--2121–– Duration of surgery 192 minutes versus 138 minutesDuration of surgery 192 minutes versus 138 minutes–– Uterine Weight 320 g; LOS 0.5 days versus 3 daysUterine Weight 320 g; LOS 0.5 days versus 3 days–– Less blood loss; less febrile morbidityLess blood loss; less febrile morbidity
28
Robot vs. laparoscopic Robot vs. laparoscopic MyomectomyMyomectomy
•• 2 separate teams with 2 separate 2 separate teams with 2 separate expertise ( Gargiulo et al Obstet Gynecol expertise ( Gargiulo et al Obstet Gynecol 2012)2012)
•• N= 115 scope myomectomyN= 115 scope myomectomy•• N= 174 robot myomectomyN= 174 robot myomectomy•• Median # of myomasMedian # of myomas-- 2 vs 32 vs 3•• WeightWeight-- 201 ( 1201 ( 1--1.5 kg) vs 159 g (81.5 kg) vs 159 g (8--780 780
g)g)•• Median dimension 7.5 cm Median dimension 7.5 cm
Gargiulo et al 2012Gargiulo et al 2012
•• OR time: 118 minutes ( laparosocpy) vs. OR time: 118 minutes ( laparosocpy) vs. 195 minutes (robot)195 minutes (robot)
•• Robot case had a higher odds of Robot case had a higher odds of d i i h i l d h i ld i i h i l d h i ladmission to hospital and having a longer admission to hospital and having a longer
than 1 day hospital staythan 1 day hospital stay•• Risk of complications were the sameRisk of complications were the same--but but
note that transfusion rate was 0.9 % in note that transfusion rate was 0.9 % in the scope myomectomy group vs. 5.7 % the scope myomectomy group vs. 5.7 % in the robot groupin the robot group
Cleveland ClinicCleveland Clinic--Obstet Gynecol 2011Obstet Gynecol 2011
AbdominalAbdominal(n=393)(n=393)
Laparoscopic Laparoscopic (n=93) (n=93)
Robotic Robotic (n=89)(n=89)
p value p value
Age yearsAge years36.9336.93( 5 61)( 5 61)
39.5739.57( 9 17)( 9 17)
36.6236.62( 5 18)( 5 18)
< < 0 0010 001Age years Age years ( 5.61) ( 5.61) ( 9.17) ( 9.17) ( 5.18) ( 5.18) 0.001 0.001
Weight KgWeight Kg75.575.5(62.8,90.7) (62.8,90.7)
64.8 (59.1, 64.8 (59.1, 76.66) 76.66)
68.0468.04( 57.6, 82.5) ( 57.6, 82.5)
< < 0.001 0.001
Height cm Height cm 163.92163.92( 13.17) ( 13.17)
164.02164.02( 6.19) ( 6.19)
163.63163.63(6.62) (6.62) 0.97 0.97
BMI kg/m2BMI kg/m2 27(23,32) 27(23,32) 24.1 ( 22, 28.1) 24.1 ( 22, 28.1) 25.1 ( 22.1, 25.1 ( 22.1, 29.4) 29.4)
< < 0.001 0.001
Maximum Diameter of the Resected Maximum Diameter of the Resected Myoma (in cm) by Surgical ApproachMyoma (in cm) by Surgical Approach
20
30
0
10
Abdominal Laparascopic Robotic
(P=0.036)
Weight of the Resected Myomas Weight of the Resected Myomas (in grams) by Surgical Approach(in grams) by Surgical Approach
2,500
2,000 OverallP < 0.001
0
Abdominal Laparascopic Robotic
1,500
1,000
500
RM vs LM < 0.001
The Actual Operative Time (in minutes)The Actual Operative Time (in minutes)by Surgical Approachby Surgical Approach
300
250
350
Overall P < 0.001
150
50
Abdominal Laparascopic Robotic
100
200 RM vs LM NS
29
The Intra−operative Blood Loss (mL) The Intra−operative Blood Loss (mL) by Surgical Approachby Surgical Approach
2,500
2,000 Overall P < 0.001
0
Abdominal Laparascopic Robotic
1,500
1,000
500
RM vs. LM NS
The Postoperative Hemoglobin Drop The Postoperative Hemoglobin Drop (gm/dL) by Surgical Approach(gm/dL) by Surgical Approach
5
6
7
Overall P < 0.001
0
1
2
3
Abdominal Laparascopic Robotic
4RM vs LM NS
Technical LimitationsTechnical Limitations-- robot robot approachapproach-- What are the solutions?What are the solutions?
•• Procedures are longer Procedures are longer –– Requires trainingRequires training
•• Most important learning step is portMost important learning step is portMost important learning step is port Most important learning step is port placementplacement
•• Matthews et al JMIG 2010Matthews et al JMIG 2010•• Mean distance from symphysis pubis to Mean distance from symphysis pubis to
the umbilicus less than 16 cm, 100 % the umbilicus less than 16 cm, 100 % required port placement above the required port placement above the umbilicus.umbilicus.
Port placementPort placement
•• Should we use the fourth armShould we use the fourth armS ou d e use e ou aS ou d e use e ou a•• Accessory port/portsAccessory port/ports
Technical considerationsTechnical considerations
•• Uterine manipulatorUterine manipulator•• 88--10 cm between the endoscope and the10 cm between the endoscope and the•• 88 10 cm between the endoscope and the 10 cm between the endoscope and the
top of the elevated uterustop of the elevated uterus•• Accurate myoma “mapping”Accurate myoma “mapping”
–– No tactile feedbackNo tactile feedback
30
15°
10 cm
45°
8-10 cm
31
Side Docking Side Docking –– 4 arm4 arm
32
Cost analysisCost analysis
•• Advincula et al JMIGAdvincula et al JMIG--20072007•• hospital charges Robothospital charges Robot--$30,000 versus $ $30,000 versus $
13 000 f l t13 000 f l t13,000 for laparotomy13,000 for laparotomy•• Behera et al JMIF 2012Behera et al JMIF 2012--
–– CostCost-- AM $4937/ LM $6219 and RM $7299AM $4937/ LM $6219 and RM $7299•• ReimbursementReimbursement
–– What will we get in the future?What will we get in the future?
ConclusionConclusion
•• Robotic Surgery may have some Robotic Surgery may have some advantage over conventional surgery.advantage over conventional surgery.
•• Robotics may help the suturing taskRobotics may help the suturing task•• There is a learning curveThere is a learning curve•• Robotic times are longerRobotic times are longer•• Costs ?Costs ?
Case 1Case 1
•• 35 year old G1P0010 35 year old G1P0010 •• uterine fibroids and desires future fertility uterine fibroids and desires future fertility •• Patient has a history of menorrhagia in 2006.Patient has a history of menorrhagia in 2006.y gy g•• Missed AB at approx 8 weeks. Missed AB at approx 8 weeks. •• Severe vaginal bleeding and a drop in H&H that Severe vaginal bleeding and a drop in H&H that
necessitated a 2 unit transfusion of blood. necessitated a 2 unit transfusion of blood. •• Show MRIShow MRI--would you do this case robotically?would you do this case robotically?
33
Case 3Case 3
•• 29 year old G0 presents with a history of 29 year old G0 presents with a history of l i bd i l i th d h tl i bd i l i th d h tenlarging abdominal girth mass and what enlarging abdominal girth mass and what
was thought to be an umbilical hernia. was thought to be an umbilical hernia. •• Patient strongly desires future fertilityPatient strongly desires future fertility
34
referencesreferences
•• Mao SP, Lai HC, Chang FW, Yu MH, Chang CC. LaparoscopyMao SP, Lai HC, Chang FW, Yu MH, Chang CC. Laparoscopy--assisted robotic assisted robotic myomectomy using the da Vinci system. Taiwan J Obstet Gynecol 2007 myomectomy using the da Vinci system. Taiwan J Obstet Gynecol 2007 Jun;46(2):174Jun;46(2):174--6.6.
•• Bedient CE, Magrina JF, Noble BN, Kho RM. Comparison of robotic and Bedient CE, Magrina JF, Noble BN, Kho RM. Comparison of robotic and laparoscopic myomectomy. Am J Obstet Gynecol 2009 Dec;201(6):566 e1laparoscopic myomectomy. Am J Obstet Gynecol 2009 Dec;201(6):566 e1--5.5.
•• Ne hat C La ie O Hs S Watson J Ba nett O Lem e M RoboticNe hat C La ie O Hs S Watson J Ba nett O Lem e M Robotic assistedassisted•• Nezhat C, Lavie O, Hsu S, Watson J, Barnett O, Lemyre M. RoboticNezhat C, Lavie O, Hsu S, Watson J, Barnett O, Lemyre M. Robotic--assisted assisted laparoscopic myomectomy compared with standard laparoscopic laparoscopic myomectomy compared with standard laparoscopic myomectomymyomectomy----a retrospective matched control study. Fertil Steril 2009 a retrospective matched control study. Fertil Steril 2009 Feb;91(2):556Feb;91(2):556--9.9.
•• Advincula AP, Xu X, Goudeau St, Ransom SB. RobotAdvincula AP, Xu X, Goudeau St, Ransom SB. Robot--assisted laparoscopic assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of shortmyomectomy versus abdominal myomectomy: a comparison of short--term term surgical outcomes and immediate costs. J Minim Invasive Gynecol 2007 surgical outcomes and immediate costs. J Minim Invasive Gynecol 2007 NovNov--Dec;14(6):698Dec;14(6):698--705.705.
•• George A, Eisenstein D, Wegienka G. Analysis of the impact of body mass George A, Eisenstein D, Wegienka G. Analysis of the impact of body mass index on the surgical outcomes after robotindex on the surgical outcomes after robot--assisted laparoscopic assisted laparoscopic myomectomy. J Minim Invasive Gynecol 2009 Novmyomectomy. J Minim Invasive Gynecol 2009 Nov--Dec;16(6):730Dec;16(6):730--3.3.
•• Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. RoboticRobotic--assisted, laparoscopic, and abdominal myomectomy: a comparison assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes. Obstet Gynecol 2011 Feb;117(2 Pt 1):256of surgical outcomes. Obstet Gynecol 2011 Feb;117(2 Pt 1):256--265.265.
ReferencesReferences
•• Gargiulo A, Srouji S, Missmer S, Correia K, Vellinga T, Einarsson J. RobotGargiulo A, Srouji S, Missmer S, Correia K, Vellinga T, Einarsson J. Robot--Assisted laparoscopic myomectomy compared with standard laparoscopic Assisted laparoscopic myomectomy compared with standard laparoscopic myomectomy. Obstet Gynecol 2012;120:284myomectomy. Obstet Gynecol 2012;120:284--291291
•• AscherAscher--Walsh C, Capes T. RobotWalsh C, Capes T. Robot--assisted laparoscopic myomectomy is an assisted laparoscopic myomectomy is an improvement over laparotomy in women with a limited number of myomas. improvement over laparotomy in women with a limited number of myomas. J Minim Invasive Gynecol 2010;17:306J Minim Invasive Gynecol 2010;17:306--310.310.
•• Behera M Likes C Judd J Barnett J Havrilesky L Wu J Cost analysis ofBehera M Likes C Judd J Barnett J Havrilesky L Wu J Cost analysis of•• Behera M, Likes C, Judd J, Barnett J, Havrilesky L, Wu J. Cost analysis of Behera M, Likes C, Judd J, Barnett J, Havrilesky L, Wu J. Cost analysis of abdominal, laparoscopic, and roboticabdominal, laparoscopic, and robotic--assisted myomectomies. J Minim assisted myomectomies. J Minim Invasive Gynecol 2012;19:52Invasive Gynecol 2012;19:52--57.57.
•• Matthews C, Schubert C, Woodward A, Gill E. Variance in abdominal wall Matthews C, Schubert C, Woodward A, Gill E. Variance in abdominal wall anatomy and port placement in women undergoing robotic gynecologic anatomy and port placement in women undergoing robotic gynecologic surgery. J Minim Invasive Gynecol 2010;17:583surgery. J Minim Invasive Gynecol 2010;17:583--586.586.
•• Advincula AP, Song A, Burke W, Reynolds RK. Preliminary experience with Advincula AP, Song A, Burke W, Reynolds RK. Preliminary experience with robotrobot--assisted laparoscopic myomectomy. J Am Assoc Gynecol Laparosc assisted laparoscopic myomectomy. J Am Assoc Gynecol Laparosc 2004 Nov;11(4):5112004 Nov;11(4):511--8.8.
•• Bocca S, Stadtmauer L, Oehninger S. Uncomplicated full term pregnancy Bocca S, Stadtmauer L, Oehninger S. Uncomplicated full term pregnancy after da Vinciafter da Vinci--assisted laparoscopic myomectomy. Reprod Biomed Online assisted laparoscopic myomectomy. Reprod Biomed Online 2007 Feb;14(2):2462007 Feb;14(2):246--9.9.
35
Jon Ivar Einarsson MD MPHDirector of Minimally Invasive Gynecologic SurgeryBrigham and Women’s HospitalAssociate ProfessorHarvard Medical School
I have the following financial relationships witha commercial entity producing health‐carey p grelated products and/or services.
Consultant for Ethicon‐Endosurgery
Describe various available myoma ablation methods
Describe various availble UAO methodsDiscuss other treatment options on the Discuss other treatment options on the horizon
1813Modern vaginal h t t
1995Uterine artery embolization
1984GnRH agonists 2001
Laparoscopic
1989Myolysis
hysterectomy 1825
Total abdominal hysterectomy
1844Myomectomy
1956Hormonal treatment
1981Endometrial ablation
Laparoscopicuterine arteryocclusion
2004MRgFUS
1800 1850 1900 1950 2000
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
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 outcomesfibroids 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 <0 001)19.23 (P <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
Spies JB, et al. Obstet Gynecol. 2005;106:1309‐1318.
Embolization to nontarget organs and tissues (eg, ovaries) Ovarian failure as high as 13.6% (increased risk for women older than 45 years)1women older than 45 years)
Uterine necrosis and sepsisPassage of submucous myomata Postembolization syndromeLocal (hematoma, ecchymoses)Mortality
1Chrisman HB, et al. J Vasc Interv Radiol. 2000;11:699‐703.
Current status (ACOG):Based on current evidence, it appears that uterine artery embolization, when performed by experienced physiciansperformed by experienced physicians, provides good short‐term relief of bulk‐related symptoms and a reduction in menstrual flow. Remains investigational withregard to preservation of fertility
ACOG. Obstet Gynecol. 2004;103:403‐404.
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 abdominalmyomectomy myomectomy
Goodwin et al Fertil Steril. 2006;85(1):14‐21
One study found that UFE and laparoscopicmyomectomy have similar recovery rates –complications were more common in the UFE group
Ohgi et al J Obstet Gynaecol Res. 2007;33(4):506‐11
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 – however most complications in surgery p 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
Edwards et al. N Engl J Med. 2007;356(4):360-70
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
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
Mara et al. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85
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 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
Fennessy et al. Radiology 2007;243(3):885-93
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 pocketcosts $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
Stewart et al. Fertil Steril. 2006;85:22–29
NPV (%) Count Any symptom improvement (%)
Alternative treatment
0-10 69 38 4810-20 55 47 4420-30 37 57 3530-40 26 73 23Over 40
29 79 17
Stewart et al. Obstet Gynecol 2007 Dec;110(6):1428-9NPV – non perfused volume
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
R i t ti t 12% 34% (f ll 6 12 th ) Reintervention rate – 12%‐34% (follow‐up 6‐12 months) “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.”
National Institute for Health and Clinical Excellence. Magnetic resonance image‐guided transcutaneous focused ultrasound ablation for uterine fibroids. September 2007.
Study n Duration NPV SSSReduction
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
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 fib id h d i t i ti d h l t d fibroids who desire uterine conservation and have completed 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
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)
P i d i t i ifi tl hi h ft UAE Pain med requirements significantly higher after 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
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 pplace 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
Tenaculum Guide Rod
Tenaculum
Coupler
39
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
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
Study n Duration Reintervention SSSReduction
QOLImprovement
Volume Reduction
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%
devices with laparoscopic, percutaneous, and transvaginal approaches
Ultrasound guided laparoscopic RF fibroid ablation
FDA approved 2010 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
VizAblate® is an intrauterine ultrasound (IUUS)-guided radiofrequency ablation system designed to treat submucosal andsubmucosal and intramural fibroids
• Combines RF ablation with intrauterine ultrasound
• Inserted transcervically
• Performed by gynecologists
• Short procedure time
40
VizAblate CV Handpiece
Scalable ablation from
Treatment Planning Control Knob
Scalable ablation from 1cm to 4cm in diameter
8mm diameter shaft
• The graphical overlay enables the gynecologist to plan a safe and predictable ablation
Th d l• The red oval indicates the ablation zone
• The green oval indicates the thermal safety boundary. Outside this area, there is no significant risk of thermal injury.
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
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 improvementin fibroid volume and symptom improvement
No suturing required Can result in severe adhesion formation Not recommended for women planning childbearing Experimental and limited experience
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
d band recognition by payers 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
V lk t l A J Ob t t G l 6 Volkers et al. Am J Obstet Gynecol. 2007;196:519.e1–519.e11 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
Jon Ivar Einarsson MD MPHDirector of Minimally Invasive Gynecologic SurgeryBrigham and Women’s HospitalAssociate ProfessorHarvard Medical School
I have the following financial relationships witha commercial entity producing health‐carey p grelated products and/or services.
Consultant for Ethicon‐Endosurgery
Discuss the advent and current status of single port surgery in gynecology
Describe further innovations such as hybrid dNOTES procedures
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 Lack of instrumentation Lack interest from industry – focused on single port Resistance among hospital staff and administrators No reimbursement for “experimental procedures”
43
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
and elsewhere to adopt this via multiport 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
44
Single incision (n=35) Multiport (n=35) p
Duration of surgery (min) 71.7 48.4 <0.001
Pain score on POD #1 2.1 2.2 0.477
Return to work (days) 5.3 5.9 0.274
Cosmetic results 1 month post op 8 7 7 7 0 001Cosmetic results 1 month post op 8.7 7.7 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
Single port (n=50) Multiport (n=50) p
OR time (minutes) 121 127 0.44
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
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 multiportll f d ff No statistically significant difference in pain
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 dprocedure
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 i G l ( ) Invasive Gynecol 2010; 17(3):371‐373 Einarsson JI, Cohen SL, Puntambekar S. Orifice‐Assisted
Small‐Incision Surgery: Case Series in Benign andOncologic Gynecology. J Minim Invasive Gynecol. 2012 May‐Jun;19(3):365‐8
46
Techniques to minimize Techniques to minimize blood lossblood loss
Tommaso Falcone, M.D.Tommaso Falcone, M.D.
Professor & ChairProfessor & Chair
Cleveland ClinicCleveland Clinic
Financial DisclosureFinancial Disclosure
I have no financial relationships to I have no financial relationships to di ldi ldisclose.disclose.
Learning ObjectivesLearning Objectives
List some general approaches to List some general approaches to minimizing blood loss at a myomectomy minimizing blood loss at a myomectomy procedure procedure pp
Discuss the role of vasopressin in Discuss the role of vasopressin in minimizing blood lossminimizing blood loss
Discuss the role of uterine artery ligation Discuss the role of uterine artery ligation prior to myomectomy prior to myomectomy
Preoperative GnRH agonistPreoperative GnRH agonist
Lethaby A, Vollenhoven B, Sowter MCLethaby A, Vollenhoven B, Sowter MC Preoperative GnRH analogue therapy before Preoperative GnRH analogue therapy before
hysterectomy or myomectomy for uterine hysterectomy or myomectomy for uterine fibroids. Cochrane database 2011 CD 000547fibroids. Cochrane database 2011 CD 000547
Preoperative Treatment with GnRH Preoperative Treatment with GnRH agonistsagonists
Agonist and iron treatment increases Agonist and iron treatment increases preoperative hemoglobinpreoperative hemoglobin
Doesn’t seem to improve blood loss at Doesn’t seem to improve blood loss at surgerysurgerysurgerysurgery Campo et al Hum Reprod 1999Campo et al Hum Reprod 1999
Fibroids 107 were intramural & 67 were Fibroids 107 were intramural & 67 were subserosal; mean diameter 4.7 cm; blood loss subserosal; mean diameter 4.7 cm; blood loss about 200mlabout 200ml
Interventions to reduce Interventions to reduce hemorrhage during myomectomyhemorrhage during myomectomy
Cochrane reviewCochrane review--Kongnyuy EJ, Kongnyuy EJ, Wiysonge CS Cochrane database Syst Wiysonge CS Cochrane database Syst Rev 2011 CD005355 2011Rev 2011 CD005355 2011Rev 2011 CD005355 2011Rev 2011 CD005355 2011
Bupivacaine plus epinephrine vs. placeboBupivacaine plus epinephrine vs. placebo--not clinically differentnot clinically different
Oxytocin no differenceOxytocin no difference
No data on normal saline aloneNo data on normal saline alone
47
Cochrane reviewCochrane review
Misoprostol versus placeboMisoprostol versus placebo Significant reduction in blood loss; no effect Significant reduction in blood loss; no effect
on blood transfusion rate. 400mcg 1 hr on blood transfusion rate. 400mcg 1 hr before the procedurebefore the procedurepp
IV bolus of tranexamic acidIV bolus of tranexamic acid
Gelatin thrombin matrix ( ex. FloSeal)Gelatin thrombin matrix ( ex. FloSeal) Significantly reduced blood loss at Significantly reduced blood loss at
myomectomy and need for transfusionmyomectomy and need for transfusion
VasopressinVasopressin
Cochrane reviewCochrane review-- Compared with placebo 2 Compared with placebo 2 trialstrials-- significant reduction in blood losssignificant reduction in blood loss
Antidiuretic Hormone Analog; Hormone, Antidiuretic Hormone Analog; Hormone, Posterior PituitaryPosterior Pituitary Approved for central diabetes insipidusApproved for central diabetes insipiduspp ppp p
Pitressin®: 20 units/mL (1 mL)Pitressin®: 20 units/mL (1 mL) HalfHalf--life elimination: Nasal: 15 minutes; life elimination: Nasal: 15 minutes;
Parenteral: 10Parenteral: 10--20 minutes 20 minutes I.V. infiltration: May lead to severe I.V. infiltration: May lead to severe
vasoconstriction and localized tissue necrosis.vasoconstriction and localized tissue necrosis. Water intoxicationWater intoxication
Use with caution in these disease Use with caution in these disease statesstates
Asthma: Asthma: Cardiovascular diseaseCardiovascular diseaseGoiter: Use with caution in patients with a Goiter: Use with caution in patients with a
goiter with cardiac complicationsgoiter with cardiac complicationsgoiter with cardiac complications.goiter with cardiac complications.MigraineMigraineRenal impairmentRenal impairment SeizuresSeizures Vascular diseaseVascular disease
Vasopressin doseVasopressin dose-- different surgeon different surgeon recommendations from the Listservrecommendations from the Listserv
Inject into the myometrium surrounding Inject into the myometrium surrounding fibroid or the pseudocapsule areafibroid or the pseudocapsule area
1 amp1 amp 20 units in 500 cc=use 3020 units in 500 cc=use 30 50mL50mL 1 amp1 amp-- 20 units in 500 cc=use 3020 units in 500 cc=use 30--50mL50mL 10 units in 100ml of saline (use 400ml)10 units in 100ml of saline (use 400ml) 20 units in 400 ml and inject 10020 units in 400 ml and inject 100--150 mL150 mL 200 units in 100ml200 units in 100ml 20 units in 50 ml20 units in 50 ml
VasopressinVasopressin
Glasser MH Minilaparotomy myomectomy Glasser MH Minilaparotomy myomectomy JMIG 2005JMIG 2005
Ten mL of a dilute vasopressin solution Ten mL of a dilute vasopressin solution (six units in 60 mL NaCl) is then injected(six units in 60 mL NaCl) is then injected(six units in 60 mL NaCl) is then injected (six units in 60 mL NaCl) is then injected intracervically about 1 to 2 cm deep at intracervically about 1 to 2 cm deep at both the 8 o’clock and 4 o’clock positions.both the 8 o’clock and 4 o’clock positions.
VasopressinVasopressin
1 ampule of vasopressin was diluted in 1 ampule of vasopressin was diluted in 1000 mL of normal saline (10001000 mL of normal saline (1000--fold) and fold) and 150150--250 mL of diluted vasopressin was 250 mL of diluted vasopressin was injected in the uterus below interstitialinjected in the uterus below interstitialinjected in the uterus below interstitial injected in the uterus below interstitial pregnancy pregnancy
48
Use of barbed sutureUse of barbed suture
Alessandri et al JMIG 2010Alessandri et al JMIG 2010-- reduced blood reduced blood loss ( drop of hgb of 0.6 versus 0.9; no loss ( drop of hgb of 0.6 versus 0.9; no bl d t f i )bl d t f i )blood transfusion)blood transfusion)
Einarsson et al showed no difference in Einarsson et al showed no difference in blood lossblood loss
Cochrane reviewCochrane review
Pericervical tourniquetPericervical tourniquet
2 trials showed significant reduction in2 trials showed significant reduction in 2 trials showed significant reduction in 2 trials showed significant reduction in blood loss and need for blood transfusionblood loss and need for blood transfusion
Laparoscopic bulldog clampsLaparoscopic bulldog clamps YasargilYasargil--type Temporary type Temporary Occlusion ClampsOcclusion Clamps-- AesculapAesculap
Uterine Artery LigationUterine Artery Ligation
Bae JH et al F&S 2011Bae JH et al F&S 2011-- no difference in no difference in blood loss w/without ligationblood loss w/without ligation
Lubin Liu et al F&S 2011- less blood loss with temporary occlusion of the uterine artery
Other observationsOther observations
Perioperative cell salvage Perioperative cell salvage
Improper plane of dissectionImproper plane of dissection
Multiple uterine incisionsMultiple uterine incisions
49
ReferencesReferences
Lubin L, Yuyan L, Huicheng X, Chen Y, Zhang G, Liang Lubin L, Yuyan L, Huicheng X, Chen Y, Zhang G, Liang Z. Laparoscopic transient uterine artery occlusion and Z. Laparoscopic transient uterine artery occlusion and myomectomy for symptomatic uterine myoma. Fertil myomectomy for symptomatic uterine myoma. Fertil Steril 2011;95:254Steril 2011;95:254--258.258.
Bae JH, Chong GO, Seong WJ, Hong DG, Lee YS. Bae JH, Chong GO, Seong WJ, Hong DG, Lee YS. Benefit of uterine artery ligation in laparoscopic Benefit of uterine artery ligation in laparoscopic y g p py g p pmyomectomy. Fertil Steril 2011;95:775myomectomy. Fertil Steril 2011;95:775--778.778.
Campo S, Garcea N. Laparoscopic myomectomy in Campo S, Garcea N. Laparoscopic myomectomy in premenopausal women with and without preoperative premenopausal women with and without preoperative treatment using gonadotropnintreatment using gonadotropnin--releasing hormone releasing hormone analogues. Hum Reprod 1999;14:44analogues. Hum Reprod 1999;14:44--48.48.
Glasser M. Minilaparotomy myomectomy: A minimally Glasser M. Minilaparotomy myomectomy: A minimally invasive alternative for the large fibroid uterus. J Minim invasive alternative for the large fibroid uterus. J Minim Invasive Gynecol 2005;12:275Invasive Gynecol 2005;12:275--283.283.
ReferencesReferences Lethaby A, Vollenhoven B, Sowter MC. PreLethaby A, Vollenhoven B, Sowter MC. Pre--operative GnRH operative GnRH
analogue therapy before hysterectomy or myomectomy for uterine analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochrane Database of Systematic Reviews 2001; Issue 2, fibroids. Cochrane Database of Systematic Reviews 2001; Issue 2, Art. No.:CD000547Art. No.:CD000547
Kongnyuy E, Wiysonge C. Interventions to reduce haemorrhage Kongnyuy E, Wiysonge C. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database of Systematic during myomectomy for fibroids. Cochrane Database of Systematic Reviews 2011; Issue 11 Art. No.:CD005355.Reviews 2011; Issue 11 Art. No.:CD005355.
.. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT,
Greenberg JA. Use of bidiredtional barbed suture in laparoscopic Greenberg JA. Use of bidiredtional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol 2011;18:92efficacy. J Minim Invasive Gynecol 2011;18:92--95.95.
Alessandri F, Remorgida V, Venturini PL, Ferrero S. Unidirectional Alessandri F, Remorgida V, Venturini PL, Ferrero S. Unidirectional barbed suture versus continuous suture with intracorporeal knots in barbed suture versus continuous suture with intracorporeal knots in laparoscopic myomectomy: a randomized study. J Minim Invasive laparoscopic myomectomy: a randomized study. J Minim Invasive Gynecol 2010;17:725Gynecol 2010;17:725--729.729.
50
Abdominal Myomectomy: Minimally Invasive Alternative to Hysterectomy for Large Fibroids?
11Minimally Invasive Gynecologic
Surgery
Ted L. Anderson, MD, PhD, FACOG, FACSAssociate Professor of Obstetrics & Gynecology
Director, Division of GynecologyVanderbilt University Medical Center, Nashville, TN
Disclosure
I have no financial relationships to disclose.
22Minimally Invasive Gynecologic
Surgery
Objectives
Participants will be able to:
• Assess the impact of leiomyomata on patients
• Compare advantages / disadvantages of
33Minimally Invasive Gynecologic
Surgery
• Compare advantages / disadvantages of myomectomy and hysterectomy for fibroids
• Counsel patients knowledgeably regarding surgical options for fibroids
Leiomyomata Background
• Affects approximatly 33% of women• Age and race variables up to 75%
• Accounts for appx 30% of hysterectomies
(Pre) cancer10% Chronic pelvic pain 10%
44Minimally Invasive Gynecologic
Surgery
Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.Carlson KJ et al (1991) Indications for hysterectomy. NEJM 328(12):856‐860.
DUB 20%
Fibroids 30%
Endometriosis/Adenomyosis 20%
Chronic pelvic pain 10%Prolapse 15%
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
• 500,000 myomectomies
• Ave age: 35.6
• Rate 1979: 0.11/1000
• Rate 2001: 0.21/1000
• African Am: 0.4/1000
55Minimally Invasive Gynecologic
Surgery
/
• Caucasian: 1.8/1000
/
• Caucasian: 0.1/1000
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.
• Hysterectomy 12x more common than myomectomy
• Hysterectomy rate stable; myomectomy rate doubled
• No differences in morbidity with respect procedure or race
Why Myomectomy?
• Pain• Dysmenorrhea, dyspareunia, abdomino‐pelvic pain
• Bleeding• Amount, duration, anemia
• Infertility
66Minimally Invasive Gynecologic
Surgery
• Infertility• Submucous vs intramural fibroids
• Mass effect• Compression of bladder, bowel, ureter, stomach, etc
• Rapidly growing leiomyoma
Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.Carlson KJ et al (1991) Indications for hysterectomy. NEJM 328(12):856‐860.
51
Leiomyosarcoma
• Not from “malignant degeneration” of myomata• Distinct genetic origin
• Incidence between 0.13‐0.29% of leiomyomata
• Less than 0.26% of rapidly growing fibroids
77Minimally Invasive Gynecologic
Surgery
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.
Leiomyosarcoma
• Rapid uterine growth in premenopausal women• Almost never associated with leiomyosarcoma
• Rapid uterine growth in postmenopausal women• Often associated with pain and bleeding
88Minimally Invasive Gynecologic
Surgery
• Increased level of LDH isoenzyme 3
• Increased uptake of gadolinium on MRI (40‐60 seconds)
• Approaches 100% diagnostic accuracy
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 GynecolCancer. 12:354–361.
Impact on Fertility• 75 myomectomy patients
– No other cause of infertility– Uterus at least twice normal size or submucous fibroid– At least two years follow‐up
• 37 patients conceived – 49.3%
99Minimally Invasive Gynecologic
Surgery
Ingersoll FM, Malone LJ (1970) Myomectomy: An alternative to hysterectomy. Arch Surg 100:557‐561.
“…decision regarding operation on patients in their 40’s should depend upon how strongly the patient feels about childbearing.”
“…for some of those who never conceive, it is important to have been able to try.”
Impact on Fertility• Fibroids that distort cavity impact fertility
• Decrease pregnancy rate by 70% (RR 0.32; CI .13 ‐ .70)
• No evidence for intramural or subserosal impact• Assess fertility potential aside from fibroids• Possible increased risk
• myoma degeneration and pain
1100
Minimally Invasive Gynecologic
Surgery
y g p• Spontaneous abortion, premature labor and delivery• abnormal fetal lie, dysfunctional labor patterns• placental abruption, need for operative intervention• postpartum hemorrhage.
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.GuarnacciaMM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.
Laparoscopic vs Abdominal
• Guidelines for laparoscopic myomectomy• < 16 weeks uterus or, 1 or 2 fibroids, < 8 cm
• No difference with respect to fertility outcome
• LaparoscopicL i h t h it li ti h t
1111Minimally Invasive Gynecologic
Surgery
• Less pain, shorter hospitalization, shorter recovery
• Longer operative time, more blood lossStewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.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):2663–2668Campo S et al (2003) Reproductive outcome before and after laparoscopic or abdominal myomectomy for subserousor 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 ObstetGynecol Reprod Biol 108(2):194–198.Olive DL (2011) The surgical treatment of fibroids for infertility. Seminars in Reprod Med 29(2):113‐123.
Comparative Morbidity
• Retrospective cohort study, 3 year interval• 197 hysterectomies, 197 myomectomies
• Primary outcome – perioperative morbidity• 40% in hysterectomy, 39% in myomectomy
1122
Minimally Invasive Gynecologic
Surgery
• Secondary outcomes• Febrile morbidity, hemorrhage
• Unintended major procedures, rehospitalization
• Life threatening events
Sawin SW et al (2000) Comparability of perioperative morbidity between abdominal myomectomy and hysterectomy for women with uterine fibroids. Obstet Gynecol 183:1448‐1455.
52
Comparative Morbidity
1133
Minimally Invasive Gynecologic
Surgery
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
Sawin SW et al (2000) Comparability of perioperative morbidity between abdominal myomectomy and hysterectomy for women with uterine fibroids. Obstet Gynecol 183:1448‐1455.
Comparative Morbidity
1144
Minimally Invasive Gynecologic
Surgery
• 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
Sawin SW et al (2000) Comparability of perioperative morbidity between abdominal myomectomy and hysterectomy for women with uterine fibroids. Obstet Gynecol 183:1448‐1455.
Comparative Morbidity
• 89 hysterectomies
• Average age: 39.2
• Uterine size: 15.2 weeks
• GnRH agonist: 23.6%
• 103 myomectomies
• Average age: 34.4
• Uterine size: 11.5 weeks
• GnRH agonist: 55.3%
• Procedures over 5 year interval
1155
Minimally Invasive Gynecologic
Surgery
• Blood loss: 796 ml
• Complications:– 1 bladder, 2 ureteral injuries, 1 bowel
injury, 1 femoral nerve injury
• Blood loss: 464 ml
• Complications:– none
Iverson RE et al (1996) Relative morbidity of abdominal hysterectomy and myomectomy for management of uterine leiomyomas. Obstet Gynecol 88:415‐419.
• Myomectomy compares favorably to hysterectomy
Preoperative Preparation
• GnRH analogs prior to myomectomy• 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
1166
Minimally Invasive Gynecologic
Surgery
GnRH analogs prior to hysterectomy• 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. HormRes. 45:279–284.GuarnacciaMM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.
Intraoperative Management
• 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
1177
Minimally Invasive Gynecologic
Surgery
• Conflicting studies on superiority• Reperfusion issues
• Trapped blood issues
GuarnacciaMM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.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 duringmyomectomy. Obstet Gynecol. 87:1014–1018.
Women’s Attitudes
• 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
1188
Minimally Invasive Gynecologic
Surgery
• 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
Askew J (2009) A Qualitative Comparison of Women's Attitudes Toward Hysterectomy and Myomectomy, Health Care for Women International 30(8):728‐742
53
Women’s Attitudes
• 7/8 women with myomectomy “shopped around”• Did not necessarily believe doctors opinions were correct
• Willing to go out of state to get “right doctor”
• Women with hysterectomy more trusting• 6/10 had procedure with their “usual gynecologist”
D i i i fl d b i d f t
1199
Minimally Invasive Gynecologic
Surgery
• Decisions influenced by varied factors• Attitude toward body, opinion / experience of friends or family or partner, internet research, attitude toward doctors, relationship with doctor
• No differences with respect to gender of GYN
Askew J (2009) A Qualitative Comparison of Women's Attitudes Toward Hysterectomy and Myomectomy, Health Care for Women International 30(8):728‐742
Decision Making
• First decide IF, then decide HOW
• Abdominal myomectomy vs hysterectomy
• Exactly what is “minimally invasive”?
2200
Minimally Invasive Gynecologic
Surgery
Abdominal myomectomy vs hysterectomy
– Also consider
• vs laparoscopic myomectomy
• vs laparoscopic hysterectomy
• vs embolization
Myomectomy Surgical Counseling
• 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
2211
Minimally Invasive Gynecologic
Surgery
Conversion to hysterectomy for complications
• Discuss all alternatives• Data suggest patient hear less than we think
References• Askew J (2009) A Qualitative Comparison of Women's Attitudes Toward Hysterectomy and Myomectomy,
Health Care for Women International 30(8):728‐742
• 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.
• Carlson KJ et al (1991) Indications for hysterectomy. NEJM 328(12):856‐860.
• 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 of vasopressin and tourniquet as hemostatic agents
2222
Minimally Invasive Gynecologic
Surgery
( ) p p q gduring 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.
• GuarnacciaMM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.
• Ingersoll FM, Malone LJ (1970) Myomectomy: An alternative to hysterectomy. Arch Surg 100:557‐561.
References• 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.
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• 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.
• Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.
• 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.
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CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as
the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians
(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which
recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).
California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws
identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org
Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from
discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national
origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the
program, the importance of the services, and the resources available to the recipient, including the mix of oral
and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.
Executive Order 13166,”Improving Access to Services for Persons with Limited English
Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,
including those which provide federal financial assistance, to examine the services they provide, identify any
need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.
Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every
California state agency which either provides information to, or has contact with, the public to provide bilingual
interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.
~
If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.
A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.
US Population
Language Spoken at Home
English
Spanish
AsianOther
Indo-Euro
California
Language Spoken at Home
Spanish
English
OtherAsianIndo-Euro
19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%
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