Robot-geassisteerde chirurgie in de gynaecologische oncologie (Pro) Ignace Vergote MD, PhD, FSPS, FACS University Hospital Leuven, Belgium

Robotics in gynecologic oncology Radical hysterectomy Sentinel procedure with fluorescence imaging Radical trachelectomy Hysterectomy (especially in obese patients) Pelvic and/or para-aortic lymphadenectomy as staging procedure Parametrectomy Exenteration …

Robotics in gynecologic oncology Radical hysterectomy Sentinel procedure with fluorescence imaging Radical trachelectomy Hysterectomy (especially in obese patients) Pelvic and/or para-aortic lymphadenectomy as staging procedure Parametrectomy Exenteration …

Advantages for Surgeons Technological Comparison With Laparoscopy Features Laparascopy Robotics Instruments Rigid Articulated - 360° Movement Direct Downscaled Pressure below 8 mm Hg Difficult Easy Hand instruments Opposite Follows hand Haptics (No) Tremor Yes No Image 2-3D 3-D Surgeon Standing Sitting Arm fatigue Learning curve Longer & steep Faster & Easier Control of 3 arms + camera

Robotic Surgery in Gynecologic Oncology Robotics is not for every procedure, but will find a home in the female pelvis Image is courtesy of A. Maggioni

Pelvic plexus Hypogastric nerve Pelvic splanchnic nerves Courtesy of N. Sakuragi Line for incision Cut end of cardinal ligament Pelvic plexus Rectum Hypogastric nerve Pelvic splanchnic nerves Nerve-sparing radical hysterectomy is probably the best indication for robotic surgery in gynecologic oncology.

To Evaluate Performance Evidence-Based Medicine : Level of Evidence Level I Adequately powered, high quality randomized trial, or meta-analysis of randomised trials showing statistically consistent results Level II Randomised trials inadequately powered, possibly biased, or showing statistically inconsistent results Level III Non-randomised studies with concurrent controls Level IV Non-randomised studies with historical controls (ie, typical single-arm phase II studies) Level V Expert committee review, case reports, retrospective studies then comes the methodology And we have to look forthe best level of evidence Tannock IF, et al. Eur J Cancer Supplements. 2003;1(5):93-101.

FIRST REPORT : Childers JM, et al. Obstet Gynecol. 1994;83(4):597-600. Take into account the time it took to obtain level I evidence for laparoscopy early stage endometrial cancers, FIRST REPORT : Childers JM, et al. Obstet Gynecol. 1994;83(4):597-600.

Many RCT have been pulblished last year

Robotic RH compared with open RH: Meta-Analysis Comparing Robotic Wertheim (RH) With Open Wertheim O’Neill Arch Gynecol 2013 Robotic RH compared with open RH: Significantly different: Reduced blood loss Reduction for transfusion Shorter hospital stay Fewer complications (P = .06) Longer operation duration, but no longer significant after excluding 1 outlier (Schreuder < 30 patients) O’Neil M, et al. Arch Gynecol Obstet. 2013;287(5):907-918.

Robotic HT+Ln compared with open HT+Ln: Meta-Analysis Comparing Robotic HT+Ln With Open HT+Ln O’Neill Arch Gynecol 2013 Robotic HT+Ln compared with open HT+Ln: Significantly different: Reduced blood loss Reduction for transfusion Shorter hospital stay Fewer complications But, longer operation duration O’Neil M, et al. Arch Gynecol Obstet. 2013;287(5):907-918.

Robotic vs Laparoscopic Wertheim Reza Br J Surg 2013 Robotic RH compared with laparoscopic RH: Significantly different: Reduced blood loss Tendency but not significantly different (numbers very low for laparoscopy): Duration of hospitalization Need for conversion LN number Duration of operation Reza M, et al. Br J Surgery. 2010;97(12):1772-1783.

Robotic HT+LN compared with Laparoscopic HT + LN: Meta-Analysis Comparing Robotic HT+ LN With Laparoscopic HT +LN O’Neill Arch Gynecol 2013 Robotic HT+LN compared with Laparoscopic HT + LN: Significantly different: Reduced blood loss Shorter hospital stay Fewer complications Fewer conversions O’Neil M, et al. Arch Gynecol Obstet. 2013;287(5):907-918.

Robotic staging of endometrial cancer – obesity Seamon (2009): BMI > 30 (mean 40) n =109: Conversion rate 15% (Walker JCO 2009, LAP2 GOG study – unselected patients with endometrial cancer: 26% laparoscopy converted to -tomy) Compared with -tomy: Similar ln count (median: 25) Hospital stay, transfusion rate, wound complications less with robotics compared with matched controls operated with- tomy. Gehrig (2008) : similar population (n = 49) Similar experience as Seamon.

Further Criticial Evaluation of Robotic RH Learning curve Bladder function after nerve-sparing RRH Do robotics reduce the possibility for training fellows? Costs and RRH Oncologic follow-up

Further Criticial Evaluation of Robotic RH Learning curve Bladder function after nerve-sparing RRH Do robotics reduce the possibility for training fellows? Costs and RRH Oncologic follow-up

Robotic RH and Cost in Europe Reynisson (Sweden) Gynecol Oncol 2013 n = 180, one center - Lund First 30 cases: Open $12,986 vs $18,382 for robotic Last 30 cases: Robotic: $12,759, with a break-even compared with open RH after 90 cases The reduction of costs for robotic was mainly induced by shorter OR time and hospital stay with more experience Reynisson P, et al. Gynecol Oncol. 2013;130(1):95-99.

Learning Curve With Robotic RH: Operation Time Reynisson Gynecol Oncol 2013 Reynisson P, et al. Gynecol Oncol. 2013;130(1):95-99.

Evolution of Hospital Stay With Robotic RH Reynisson Gynecol Oncol 2013 Reynisson P, et al. Gynecol Oncol. 2013;130(1):95-99.

Robotic RH and Cost Cost of new technologies are always relatively high and drop as the market grows and industry competition drives down costs of equipment

Oncologic Follow-Up After Robotic Radical Hysterectomy Few data exist, but recently some interesting data were presented:

Oncologic Follow-Up After Robotic Radical Hysterectomy Jackson et al (North Carolina) ASCO 2013 121 robotic RH compared with 97 open RH (2005-2012) 80% Stage Ib1 No differences in age, stage, short-term and long-term complications and comorbidities Median follow-up 25 months PFS significantly better with robotic RH compared with open RH (HR: 3,12, CI: 0.01-0.98) 3 deaths in the robotic group and 10 with open RH (OS, NS) Jackson AL, et al. J Clin Oncol. 2013;31(Suppl): Abstract 5607.

Oncologic Follow-Up After Robotic Radical Hysterectomy Vergote et al (Belgium) SERGS 2013 102 Robotic RH 9% Ia, 66% Stage Ib1, 4% Ib2, 22% II 17 patients after neoadjuvant chemotherapy (Ib2-IIb) Median follow-up 24 months Recurrences: 14%, 10 recurrences in the pelvis, 5 with distant metastases, no port site metastases 3 deaths due to cancer Vergote I. Presented at: Society of European Robotic Gynaecological Surgery (SERGS) Meeting; 13-15 June 2013: London, United Kingdom.

European Institute on Oncology, Milano: Oncological Results ARH RRH Primary recurrences 3 (2.7%) 7 (7.1%) Time of rec.(median) 15 mts 12 mts Size of tumor < 2cm 3 > 2cm 3 4 Maggioni A, et al. Int J Gynecol Cancer. 2012;22(8): Abstract. (Presented at Vancouver IGCS 2012).

European Institute of Oncology, Milan: Oncologic Results ARH RRH Primary Recurrences 3 (2.7%) 7 (7.1%) Pelvis 2 (67%) 5 (71%) Pelvis+abdomen 2 Distance 1 Port site 3* DOD 0 1 *3 port site in a patient after adjuvant RT = median 18 mth ( 2 sq -1 adenocarc) Maggioni A, et al. Int J Gynecol Cancer. 2012;22(8): Abstract. (Presented at Vancouver IGCS 2012).

Robotic Radical Hysterectomy Leuven Technique Preparation of the vagina cuff vaginally Frozen section of the vaginal margin at the start of the operation The vaginal cuff is closed to avoid disemmination and the traction stitches are used to remove the uterus

Robot-assisted surgery is still in its infancy! Advanced Instrumentation Surgeon Training Fusion of MR and Robotic image Double teaching console Not only does the Si offer superior vision, precision and control, but we view it as the ultimate surgical cockpit where surgeons have access to all their tools from the surgeon console. And today we’re going to discuss 4 of our new platform technologies for the Si. Advanced instruments, surgeon training, advanced imaging and single-access surgery. Advanced Imaging Single Access Surgery

Comparison of laparoscopy with robotic surgery Annual SERGS Meeting on Robotic Gynaecological Surgery 22.–24.05.2014 · Essen / Germany Congress Center Essen Congress President: Professor Dr. Rainer Kimmig University Clinic Essen (UKE) – Dpt. Gynecology and Obstetrics Hufelandstr. 55 45147 Essen / Germany President SERGS: Professor Dr. Ignace Vergote University Clinic Leuven (UZL) – Dpt. Gynecology and Obstetrics Herestraat 49 3000 Leuven / Belgium www.sergs2014.org