1. Laparoscopic and Robot–Assisted Myomectomy Tommaso Falcone,M.D. Professor and Chair Department of Obstetrics & Gynecology

2. Learning Objectives Analyze if a laparoscopic approach to the management of a fibroid uterus gives similar results to a laparotomy List the benefits of Laparoscopic myomectomy Discuss the possible technical limitations of laparoscopic myomectomy Discuss the role of robotics

4. Natural History of Fibroids Maverlos et al Ultrasound Obstet Gynecol 2010 –Women examined at least twice by a single sonographer at least 8 months apart ( median 21 months) –Median age was 40; majority were under 5 cm –21 % of fibroids showed evidence of spontaneous regression.

5. Myomectomy: Indications ASRM bulletin: November 2001 –Infertile patients, after excluding all other causes of infertility & in the presence of distorted uterine cavity –Recurrent pregnancy loss or pregnancy complications –Symptomatic patients

6. Palomba et al F&S 2007: Multicenter randomized, controlled study comparing laparoscopic versus minilaparotomic myomectomy Between the laparoscopic and minilaparotomic groups no difference was observed in cumulative pregnancy, live-birth, and abortion rates: Live birth Rate per cycle: scope (5.8 %) vs. minilap (3.1%) Live birth Rate per cycle: scope (5.8 %) vs. minilap (3.1%) Time to pregnancy- 5 months vs. 6 months

7. Palomba et al F&S 2007: Multicenter randomized, controlled study comparing laparoscopic versus minilaparotomic myomectomy live-birth were significantly better after laparoscopic myomectomy in fertile symptomatic patients, whereas all reproductive outcomes were similar between the two groups in patients with unexplained infertility

8. Effect of intramural fibroids on IVF outcome Sunkara et al HR 2010 –Meta-analysis –Intramural fibroids without cavity distortion –19 studies-6087 cycles –Significant decrease in live birth and clinical pregnancy rates –This does not mean that removal will restor PR to the levels expected in women without fibroids

11. Perioperative Outcomes Seracchioli et al 2000 Human Reproduction RCT : Laparoscopic Myomectomy (LM) N=66 & Abdominal Myomectomy (AM) N=65 At least 1 intramural myoma >=5 cm (no more than 3);Most had 1 myoma Unipolar cautery, sutured in 2 layers Three conversions Only RCT in Cochrane database

12. Perioperative Outcomes Seracchioli et al 2000-Human Reproduction Fever: AM: 26% LM:12% Hgb drop: Higher in AM (2.2 vs. 1.2) OR time: AM:89 min LM:100 min LOS: AM: 6 days LM:3 days P values all significantly different

13. Clinical Trials: Conclusion Shorter hospital stay Quicker recovery Difficult to quantify how much The RCT had between 1-3 myomas, between 3-6 cm

14. Reproductive Outcome: Pregnancy rates Seracchioli et al 2000 –RCT (only study Cochrane database) –Pregnancy rate: over 3 years AM:56% LM:54% –Spont Ab: AM 20% LM:12% –Preterm labor:AM:7% LM:5% –C/S: AM: 77% & LM:65% –No ruptures

15. Reproductive Outcome Similar between scope & laparotomy

16. Reproductive Outcome:Uterine rupture RCT-no uterine ruptures Case Series –Dubuisson et al 2000 (N=100) reported 1 case. 13 reports of rupture –Three perinatal deaths, no maternal deaths

17. Recurrence of Myoma Generally, there is no difference in recurrence of myomas between Laparoscopy & Laparotomy

18. Conversion to Laparotomy With laparoscopic myomectomy, the reported conversion rate to an open procedure is –2-8%

19. Conversion to Laparotomy Dubuisson et al 2001 –N=426 –Conversion to laparotomy 11% –Preop risk (OR=odds ratio) Size 5 cm or greater OR: 10 Intramural type OR:4 Anterior location OR:3.4 Preoperative use of GnRH agonists: 5.4

20. Key Technique-laparoscopic suturing Requires a high degree of expertise in laparoscopic suturing to be successful

23. EndoWrist TM Instrumentation Modeled after the human wrist. Full range of motion High-strength cable system –Transpose fingers to instrument tips

24. Summary of Literature on Robotic Myomectomy Surgery NumberRemoved of Robotic Type of Myomas of Robotic Type of Myomas Author Year Cases Study Weight Results Advincula200435PreliminaryMean = Robotic myomectomy AP et alexperience 223.2 + 244.1gis new promising approach Mao SP2007 1Case reportNot Successful et alavailablerobotically-assisted excision of large uterine myoma measuring 9x8x7cm Bocca S2007 1Case reportNotAchievement of et alavailableuncomplicated full term pregnancy after robotic myomectomy

25. Summary of Literature on Robotic Myomectomy Surgery NumberRemoved of Robotic Type ofMyomas of Robotic Type of Myomas Author Year Cases StudyWeight Results Author Year Cases Study Weight Results Advincula200729RetrospectiveMean = Robotic myomectomy AP, et alcase matched227.86 + 247.54gapproach is between comparable to open robotic and approach regarding open short term surgical myomectomyoutcome and costs Nezhat C200915Retrospective Mean = 116gRobotic myomectomy et alcase matched (min 25-max 350)ghad significant longer between surgical time without robotic and offering any major laparoscopic advantages myomectomy

26. Summary of Literature on Robotic Myomectomy Surgery Number Removed of Robotic Type ofMyomas of Robotic Type ofMyomas Author Year CasesStudyWeight Results George A200977Effect of theMedian = 235gObesity is not a et alBMI on the(range 21.2 - 980)grisk factor for poor surgical surgical outcome outcomein robotic myomectomy Bedient CE200940Comparing Mean = 210gNo difference in et alrobotic to (range 7 - 1076)g relation to short laparoscopicterm surgical myomectomy outcome measures

27. Robotic trial Robotic myomectomy versus laparotomy –Ascher- Walsh & Capes JMIG 2010 –Robot N= 75; 4 ports- 3 robotic and 1 assistant; Control- N=50; –Inclusion criteria were 3 myomas or fewer –Mean BMI was 20-21 –Duration of surgery 192 minutes versus 138 minutes –Uterine Weight 320 g; LOS 0.5 days versus 3 days – Less blood loss; less febrile morbidity

28. Cleveland Clinic- Obstet Gynecol 2011 Abdominal(n=393) Laparoscopic (n=93) Robotic (n=89) p value Age years 36.93 ( 5.61) 39.57 ( 9.17) 36.62 ( 5.18) < 0.001 Weight Kg 75.5(62.8,90.7) 64.8 (59.1, 76.66) 68.04 ( 57.6, 82.5) < 0.001 Height cm 163.92 ( 13.17) 164.02 ( 6.19) 163.63(6.62)0.97 BMI kg/m2 27(23,32) 24.1 ( 22, 28.1) 25.1 ( 22.1, 29.4) < 0.001

29. Maximum Diameter of the Resected Myoma (in cm) by Surgical Approach 0 10 20 30 AbdominalLaparascopicRobotic ( P=0.036)

30. Weight of the Resected Myomas (in grams) by Surgical Approach 0 2,500 AbdominalLaparascopicRobotic 2,000 1,500 1,000 500 Overall P < 0.001 RM vs LM < 0.001

31. The Actual Operative Time (in minutes) by Surgical Approach 150 50 AbdominalLaparascopicRobotic 100 200 300 250 350 Overall P < 0.001 RM vs LM NS

32. The Intra−operative Blood Loss (mL) by Surgical Approach 0 2,500 AbdominalLaparascopicRobotic 2,000 1,500 1,000 500 Overall P < 0.001 RM vs LM NS

33. The Postoperative Hemoglobin Drop (gm/dL) by Surgical Approach 0 1 2 3 AbdominalLaparascopicRobotic 4 5 6 7 Overall P < 0.001 RM vs LM NS

34. Cost analysis Advincula et al JMIG-2007 hospital charges hospital charges –Robot-$30,000 versus $ 13,000 for laparotomy Reimbursement –Robot-$13,000 versus $7000 for laparotomy

35. Technical Limitations- robot approach- What are the solutions? Procedures are longer –Requires training Most important learning step is port placement Matthews et al JMIG 2010 Mean distance from symphysis pubus to the umbilicus less than 16 cm, 100 % required port placement above the umbilicus.

36. Port placement Placement of the fourth arm to avoid collision Angle of access may be difficult –Need to adjust the port placement –If convert to traditional laparoscopy ports may be inappropriate

39. 45° 8-10 cm

41. Da Vinci: Limitations Hard to access the abdomen for accessory ports Assistants have difficulty moving around Disengage the system if changing patient position

42. Solution: Side Docking – 4 arm

44. Technical considerations Uterine manipulator 8-10 cm between the endoscope and the top of the elevated uterus Accurate myoma “mapping” –No tactile feedback

45. Technical considerations Dilute vasopressin ( off label use) Delayed reabsorbable barbed suture

50. Conclusion Laparoscopy offer some advantages of shortened recovery No difference in reproductive outcome (in expert hands) Postoperative adhesions appear to be quite common with scope myomectomy Main technical experience required- laparoscopic suturing Robotics may help the suturing task

51. Case 1 35 year old G1P0010 uterine fibroids and desires future fertility Patient has a history of menorrhagia in 2006. Missed AB at approx 8 weeks. Severe vaginal bleeding and a drop in H&H that necessitated a 2 unit transfusion of blood. Show MRI-would you do this case robotically?

54. Case 2 50 year old woman presents for evaluation of fertility-donor oocyte program Asymptomatic except heavy pressure HSG showed a markedly abnormal cavity Show MRI-would you do this case robotically?

56. Case 3 29 year old G0 presents with a history of enlarging abdominal girth mass and what was thought to be an umbilical hernia. Patient strongly desires future fertility

60. Case 4 39 year old woman with anemia and myomas. Desires future fertility Uterus measures 10 by 7 by 6 cm –At least 9 myomas –One is in the endometrial canal-3 cm and several are submucosal.