Laparoscopic and Robot–Assisted Myomectomy

Tommaso Falcone,M.D.Professor and ChairDepartment of Obstetrics & Gynecology

Learning ObjectivesLearning ObjectivesAnalyze 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

Natural History of FibroidsNatural History of Fibroids

Maverlos et al Ultrasound Obstet Gynecol Maverlos et al Ultrasound Obstet Gynecol 20102010– Women examined at least twice by a single Women examined at least twice by a single

sonographer at least 8 months apart ( median sonographer at least 8 months apart ( median 21 months)21 months)

– Median age was 40; majority were under 5 cmMedian age was 40; majority were under 5 cm– 21 % of fibroids showed evidence of 21 % of fibroids showed evidence of

spontaneous regression. spontaneous regression.

Myomectomy: IndicationsMyomectomy: IndicationsASRM bulletin: November 2001ASRM bulletin: November 2001– Infertile patients, after excluding all other Infertile patients, after excluding all other

causes of infertility & in the presence of causes of infertility & in the presence of distorted uterine cavitydistorted uterine cavity

– Recurrent pregnancy loss or pregnancy Recurrent pregnancy loss or pregnancy complicationscomplications

– Symptomatic patients Symptomatic patients

Palomba et al F&S 2007: Multicenter randomized, Palomba et al F&S 2007: Multicenter randomized, controlled study comparing laparoscopic versus controlled study comparing laparoscopic versus

minilaparotomic myomectomyminilaparotomic myomectomy

Between the laparoscopic and Between the laparoscopic and minilaparotomic groups no difference minilaparotomic groups no difference was observed in cumulative pregnancy, was observed in cumulative pregnancy, live-birth, and abortion rates:live-birth, and abortion rates:

Live birth Rate per cycle: scope (5.8 %) Live birth Rate per cycle: scope (5.8 %) vs. minilap (3.1%)vs. minilap (3.1%)

Time to pregnancy- 5 months vs. 6 Time to pregnancy- 5 months vs. 6 months months

Palomba et al F&S 2007: Multicenter randomized, Palomba et al F&S 2007: Multicenter randomized, controlled study comparing laparoscopic versus controlled study comparing laparoscopic versus

minilaparotomic myomectomyminilaparotomic myomectomy

live-birth were significantly better after live-birth were significantly better after laparoscopic myomectomy in laparoscopic myomectomy in fertile fertile symptomatic patientssymptomatic patients, whereas all , whereas all reproductive outcomes were similar reproductive outcomes were similar between the two groups in patients with between the two groups in patients with unexplained infertility unexplained infertility

Effect of intramural fibroids on IVF Effect of intramural fibroids on IVF outcomeoutcome

Sunkara et al HR 2010Sunkara et al HR 2010– Meta-analysisMeta-analysis– Intramural fibroids without cavity distortionIntramural fibroids without cavity distortion– 19 studies-6087 cycles19 studies-6087 cycles– Significant decrease in live birth and clinical Significant decrease in live birth and clinical

pregnancy ratespregnancy rates– This does not mean that removal will restor This does not mean that removal will restor

PR to the levels expected in women without PR to the levels expected in women without fibroidsfibroids

Perioperative OutcomesPerioperative Outcomes

Seracchioli et al 2000 Human ReproductionSeracchioli et al 2000 Human Reproduction

RCT : Laparoscopic Myomectomy (LM) N=66 & RCT : Laparoscopic Myomectomy (LM) N=66 & Abdominal Myomectomy (AM) N=65Abdominal Myomectomy (AM) N=65

At least 1 intramural myoma >=5 cm (no more At least 1 intramural myoma >=5 cm (no more than 3);Most had 1 myomathan 3);Most had 1 myoma

Unipolar cautery, sutured in 2 layersUnipolar cautery, sutured in 2 layers

Three conversionsThree conversions

Only RCT in Cochrane databaseOnly RCT in Cochrane database

Perioperative OutcomesPerioperative Outcomes

Seracchioli et al 2000-Human ReproductionSeracchioli et al 2000-Human Reproduction

Fever: AM: 26% LM:12%Fever: AM: 26% LM:12%Hgb drop: Higher in AM (2.2 vs. 1.2)Hgb drop: Higher in AM (2.2 vs. 1.2)OR time: AM:89 min LM:100 minOR time: AM:89 min LM:100 minLOS: AM: 6 days LM:3 daysLOS: AM: 6 days LM:3 daysP values all significantly differentP values all significantly different

Clinical Trials: ConclusionClinical Trials: Conclusion

Shorter hospital stayShorter hospital stay

Quicker recoveryQuicker recovery

Difficult to quantify how muchDifficult to quantify how much

The RCT had between 1-3 myomas, The RCT had between 1-3 myomas, between 3-6 cmbetween 3-6 cm

Reproductive Outcome: Reproductive Outcome: Pregnancy ratesPregnancy rates

Seracchioli et al 2000Seracchioli et al 2000– RCT (RCT (only study Cochrane database)only study Cochrane database)– Pregnancy rate: over 3 yearsPregnancy rate: over 3 years

AM:56% LM:54%AM:56% LM:54%

– Spont Ab: AM 20% LM:12%Spont Ab: AM 20% LM:12%– Preterm labor:AM:7% LM:5%Preterm labor:AM:7% LM:5%– C/S: AM: 77% & LM:65%C/S: AM: 77% & LM:65%– No rupturesNo ruptures

Reproductive OutcomeReproductive Outcome

Similar between scope & Similar between scope & laparotomylaparotomy

Reproductive Outcome:Uterine Reproductive Outcome:Uterine rupturerupture

RCT-no uterine rupturesRCT-no uterine ruptures

Case SeriesCase Series– Dubuisson et al 2000 (N=100) reported 1 Dubuisson et al 2000 (N=100) reported 1

case.case.

13 reports of rupture13 reports of rupture– Three perinatal deaths, no maternal deathsThree perinatal deaths, no maternal deaths

Recurrence of MyomaRecurrence of Myoma

Generally, there is no difference in Generally, there is no difference in recurrence of myomas between recurrence of myomas between Laparoscopy & LaparotomyLaparoscopy & Laparotomy

Conversion to LaparotomyConversion to Laparotomy

With laparoscopic myomectomy, the With laparoscopic myomectomy, the reported conversion rate to an open reported conversion rate to an open procedure isprocedure is– 2-8%2-8%

Conversion to LaparotomyConversion to LaparotomyDubuisson et al 2001Dubuisson et al 2001– N=426N=426– Conversion to laparotomy 11%Conversion to laparotomy 11%– Preop risk (OR=odds ratio)Preop risk (OR=odds ratio)

Size 5 cm or greater OR: 10Size 5 cm or greater OR: 10

Intramural type OR:4Intramural type OR:4

Anterior location OR:3.4Anterior location OR:3.4

Preoperative use of GnRH agonists: 5.4Preoperative use of GnRH agonists: 5.4

Key Technique-laparoscopic Key Technique-laparoscopic suturingsuturing

Requires a high degree of expertise in Requires a high degree of expertise in laparoscopic suturing to be successfullaparoscopic suturing to be successful

EndoWristEndoWristTMTM Instrumentation Instrumentation

Modeled after the Modeled after the human wrist. Full human wrist. Full range of motionrange of motion

High-strength cable High-strength cable systemsystem– Transpose fingers to Transpose fingers to

instrument tipsinstrument tips

Summary of Literature on Robotic Myomectomy SurgerySummary of Literature on Robotic Myomectomy Surgery

NumberNumber RemovedRemoved of Roboticof Robotic Type ofType of MyomasMyomas

Author Author Year Year Cases Cases Study Study WeightWeight Results Results

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-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 SurgerySummary of Literature on Robotic Myomectomy Surgery

NumberNumber RemovedRemoved of Roboticof Robotic Type of Type of MyomasMyomas

Author Author Year Year Cases Cases Study Study WeightWeight Results Results

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 SurgerySummary of Literature on Robotic Myomectomy Surgery

NumberNumber RemovedRemoved of Roboticof Robotic Type of Type of MyomasMyomas

Author Author Year Year CasesCases StudyStudy WeightWeight Results Results

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 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– Ascher- Walsh & Capes JMIG 2010Ascher- Walsh & Capes JMIG 2010– Robot N= 75; 4 ports- 3 robotic and 1 assistant; Robot N= 75; 4 ports- 3 robotic and 1 assistant;

Control- N=50;Control- N=50;– Inclusion criteria were 3 myomas or fewer Inclusion criteria were 3 myomas or fewer – Mean BMI was 20-21Mean BMI was 20-21– 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

Cleveland Clinic- Cleveland 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 years Age years 36.9336.93( 5.61) ( 5.61)

39.5739.57( 9.17) ( 9.17)

36.6236.62( 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

0

10

20

30

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

0

2,500

Abdominal Laparascopic Robotic

2,000

1,500

1,000

500

Overall P < 0.001

RM vs LM < 0.001

The Actual Operative Time (in minutes)The Actual Operative Time (in minutes)by Surgical Approachby Surgical Approach

150

50

Abdominal Laparascopic Robotic

100

200

300

250

350

Overall P < 0.001

RM vs LM NS

The Intra−operative Blood Loss (mL) The Intra−operative Blood Loss (mL) by Surgical Approachby Surgical Approach

0

2,500

Abdominal Laparascopic Robotic

2,000

1,500

1,000

500

Overall P < 0.001

RM vs LM NS

The Postoperative Hemoglobin Drop The Postoperative Hemoglobin Drop (gm/dL) by Surgical Approach(gm/dL) by Surgical Approach

0

1

2

3

Abdominal Laparascopic Robotic

4

5

6

7

Overall P < 0.001

RM vs LM NS

Cost analysisCost analysis

Advincula et al JMIG-2007Advincula et al JMIG-2007

hospital chargeshospital charges– Robot-$30,000 versus $ 13,000 for Robot-$30,000 versus $ 13,000 for

laparotomylaparotomy

ReimbursementReimbursement– Robot-$13,000 versus $7000 for laparotomyRobot-$13,000 versus $7000 for laparotomy

Technical Limitations- robot Technical Limitations- robot approach- What are the solutions?approach- What are the solutions?

Procedures are longer Procedures are longer – Requires trainingRequires training

Most important learning step is port Most important learning step is port placementplacementMatthews et al JMIG 2010Matthews et al JMIG 2010Mean distance from symphysis pubus to Mean distance from symphysis pubus 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

Placement of the fourth arm to avoid Placement of the fourth arm to avoid collisioncollision

Angle of access may be difficultAngle of access may be difficult– Need to adjust the port placementNeed to adjust the port placement– If convert to traditional laparoscopy ports may If convert to traditional laparoscopy ports may

be inappropriatebe inappropriate

45°

8-10 cm

Da Vinci: LimitationsDa Vinci: Limitations

Hard to access the abdomen for Hard to access the abdomen for accessory portsaccessory ports

Assistants have difficulty moving aroundAssistants have difficulty moving around

Disengage the system if changing patient Disengage the system if changing patient positionposition

Solution: Side Docking – 4 armSolution: Side Docking – 4 arm

Technical considerationsTechnical considerations

Uterine manipulatorUterine manipulator

8-10 cm between the endoscope and the 8-10 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

Technical considerationsTechnical considerations

Dilute vasopressin ( off label use)Dilute vasopressin ( off label use)

Delayed reabsorbable barbed sutureDelayed reabsorbable barbed suture

ConclusionConclusionLaparoscopy offer some advantages of Laparoscopy offer some advantages of shortened recoveryshortened recovery

No difference in reproductive outcome (in No difference in reproductive outcome (in expert hands)expert hands)

Postoperative adhesions appear to be Postoperative adhesions appear to be quite common with scope myomectomyquite common with scope myomectomy

Main technical experience required-Main technical experience required-laparoscopic suturinglaparoscopic suturing

Robotics may help the suturing taskRobotics may help the suturing task

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.

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 MRI-would you do this case robotically?Show MRI-would you do this case robotically?

Case 2Case 2

50 year old woman presents for evaluation 50 year old woman presents for evaluation of fertility-donor oocyte programof fertility-donor oocyte program

Asymptomatic except heavy pressureAsymptomatic except heavy pressure

HSG showed a markedly abnormal cavityHSG showed a markedly abnormal cavity

Show MRI-would you do this case Show MRI-would you do this case robotically?robotically?

Case 3Case 3

29 year old G0 presents with a history of 29 year old G0 presents with a history of enlarging 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

Case 4Case 4

39 year old woman with anemia and 39 year old woman with anemia and myomas. Desires future fertilitymyomas. Desires future fertility

Uterus measures 10 by 7 by 6 cmUterus measures 10 by 7 by 6 cm– At least 9 myomasAt least 9 myomas– One is in the endometrial canal-3 cm and One is in the endometrial canal-3 cm and

several are submucosal.several are submucosal.