Joel E. Rand, MPAS, PA-C DMU Luncheon May 1, 2014 No financial relationship or commercial interest in any of the technologies discussed Not supporting any non-fda off label uses of any product or service Some of the slides were obtained from the vendor s website with their permission Eat lunch and have fun no quiz to follow Recognize common surgical conditions Learn the current treatment options available Review the risks and benefits of different surgical modalities Discuss the dramatic progress that has taken place in the last 20 years Prognosticate what the next 10-30 years may look like 1
Cholecystectomy Gallbladder Disease Colorectal Surgery Benign and Malignant colon and rectal disease Gynecologic Surgery Benign and Malignant Uterine and Ovarian disease Foregut Surgeries Bariatric Surgery Weight Loss Nissen Fundoplication GERD Esophageal Hernia Repair Hiatal Hernia Heller Myotomy Achalasia Ventral Hernia Repair Abdominal Hernia Inguinal Hernia Repair Groin Hernia Pros: Efficacious and historically the gold standard Readily available instruments Easily collaborative Cons: Highly invasive Ergonomically challenging for the surgeon and assistant Long and painful recovery High postoperative complication rates 2
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Pros: Minimally invasive Faster recovery time Less scaring and risk of infection Less blood loss and subsequent transfusion Less pain and complications from narcotics Better visualization Cons: Counterintuitive motion Two-dimensional vision with poor depth perception Ergonomically challenging Longer operative time Decreased venous return due to CO2 insufflation of peritoneal cavity Expensive instruments 4
Reduced postoperative pain Lower morbidity Faster recovery time (i.e. earlier return to normal ADLs & work) Fewer wound complications Possible lower cost due to shorter hospital stay Cosmesis Reduced trocars equals less site herniation and infection, less puncture risk Ability to rapidly and readily convert SILS to conventional laparoscopic procedure 5
Potential risks Increased wound complications Increased incisional hernia Prolonged operative time Plus all risks inherent in laparoscopic surgery SILS versus standard laparoscopy Single portal of entry Altered ergonomics Fencing/Crossing of Instruments Difficulty maintaining pneumoperitoneum Need of new Instrumentation (multi-lumen ports, articulating/flexible instrumentation) Learning curve issues Insurance reimbursement concerns da Vinci Surgery overcomes the limitations of open and traditional laparoscopic surgery 3cm 1cm High Definition 3D Vision Surgeon-controlled Stable and immersive view Up to 10x zoom Precision & Dexterity Mimics surgeon s hands Scales down movements With tremor filtration Intuitive Motion Advanced software enables intuitive control (instead of cross-handed) 6
Stable 3DHD visualization of tissue plane and hernia site Ability to suture from a variety of angles to repair defects 7
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Adoption of MIS for Hysterectomy 25% 20% Adoption 15% 10% Laparoscopy da Vinci 5% 0% 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 Year Inguinal hernia Ventral hernia Cholecystectomy Low anterior resection Right colon Sigmoid colon Nissen fundoplication and Heller myotomy Sleeve gastrectomy Hysterectomy Appendectomy Roux en Y gastric bypass da Vinci Ventral Hernia Repair Potential Patient Benefits vs. Traditional Lap Surgery Reduced complications Short Hospital Stay Low rate of conversion to open surgery Low rate of recurrence Ventral Hernia Repair, incl. da Vinci Ventral Hernia Repair, Potential Patient Risks Pain Infection Hernia recurrence Adhesion Obstruction of small/large intestine MIS incl. da Vinci Surgery Potential Patient Risks Longer operative time than anticipated Conversion to open surgery Need for additional or larger incision(s) Temporary pain or discomfort from pneumoperitoneum 9
Ia Systemic reviews of randomized controlled trials Ib Randomized controlled trials Ic Randomized controlled trials for robotic technique studies IIa Systematic reviews of only comparison studies and independent database population studies IIb Prospective non-randomized studies and RCTs with N<20 IIIa Systematic reviews of mixed studies (comparison and single arm) IIIb Retrospective non-randomized studies and prospective comparison studies with N<20 IVa Literature reviews IVb Single arm studies and retrospective comparison studies with N<20 V Case reports, Animal and Cadaver studies, Expert Opinion and Editorials Robotic Laparoscopic Ventral Ventral P-Value Hernia Repair Hernia Repair (n=67) (n=67) Surgical Time 107.6 88.4 0.016 (min) Length of Hospital Stay 2.5 3.7 0.461 (days) Complications 2 (3%) 9 (13%) 0.028 Recurrence 1 (1.5%) 5 (7.5%) 0.095 Conversions 1 (1.5%) 3 (4.5%) 0.310 Follow up 17.1 21.8 0.006 (months) Note: Pain was not a measured outcome in this study. Compared to Traditional Lap Ventral Hernia Repair, Robotic Ventral Hernia Repair resulted in: Longer surgical time (avg. 19min.) Fewer complications A trend towards reduced rate of recurrence Short hospital stay Low rate of conversion to open surgery Open Laparoscopic Robotic Surgery Surgery Surgery P-Value (n=165) (n=165) (n=165) Age, mean ± SD 59.2 ± 11.0 60.4 ± 11.8 61.2 ± 11.4 0.277 BMI, mean ± SD 23 ± 3 23.2 ± 3.1 23.1 ± 2.8 0.721 Est. Blood Loss, ml 275 140 133 OS vs. LS or RS <0.001 LS vs. RS = NS Tumor Size, cm 3.7 3.3 3.4 0.104 Distance of Resection Margin Proximal, cm 11.4 11.3 12.0 0.436 Distal, cm 2.2 2.0 1.9 0.180 Overall 24.8% 27.9% 20.6% 0.304 Complications Time to resumed soft OS vs. LS or RS <0.001 6.4 5.2 4.5 diet, days LS vs. RS =0.004 Length of Hospital OS vs. LS or RS <0.001 16.0 13.5 10.8 Stay, days LS vs. RS =0.003 Robotic-assisted surgery compared to open and lap surgeries: Comparable resection margins and overall complications Faster return to soft diet Shorter hospital stay 10
Post-Op Pain Status (mean ± SD) All P <0.001 SD = standard deviation VAS = visual analog scale POD = postoperative day No. Post-Op IV Open Laparoscopic Robotic analgesics Surgery Surgery Surgery P-Value Opioids, mean ± SD (n=165) (n=165) (n=165) Post-Op, Day 1 0.7 ± 1.0 0.4 ± 0.7 0.2 ± 0.6 <0.001 Post-Op, Day 2 0.8 ± 1.0 0.6 ± 1.0 0.2 ± 0.6 <0.001 Post-Op, Day 3 0.5 ± 0.9 0.4 ± 0.7 0.2 ± 0.6 0.004 Post-Op, Day 4 0.3 ± 0.7 0.2 ± 0.7 0.1 ± 0.5 0.229 Post-Op, Day 5 0.2 ± 0.6 0.2 ± 0.5 0.1 ± 0.3 0.015 Robotic-assisted surgery compared to open and lap surgeries: Significant decrease in post-op pain Significant decrease in analgesia usage Laparoscopic Nissen Fundoplication Robotic Nissen Fundoplication Laparoscopic Inguinal Hernia Robotic Inguinal Hernia Surgical Supplies - $95.02 Surgical Instruments - $1480.52 Total Cost = $1575.04 Early Surgeries Surgical Supplies $91.82 Surgical Instruments - $ 2656.77 Total Cost = $2738.59 Tacker - $600 Trocars x3 - $90 Lap scissors - $85 Graspers, bipolar $45-$225 Mesh $350 Fenestrated Bipolar - $270 Mega Suture cut - $240 Suture x3 - $5 Drapes $200 Mesh $350 Cost Controlled Cases Removal of extra instruments not needed and supplies Total Cost = $1639.59 Total = $820- $1000 Total w/ 2 tackers = $1,500 Total = $775 Bilateral no tacker, Suture is cheap No use of extra instruments. 11
Curved cannula & semi-rigid instruments Access from many angles & no instrument crowding Designed to limit cannula shift Minimize potential port-site trauma & post-op pain A single incision in the belly button Virtually scarless da Vinci Single-Site Cholecystectomy Potential Patient Benefits Low rate of major complications Low conversion rate to open surgery Virtually scarless High patient satisfaction Minimal pain Cholecystectomy, incl. da Vinci Cholecystectomy Potential Patient Risks Bile duct injury Bile leakage Pancreatitis Incision-site hernia MIS, incl. da Vinci Surgery Potential Patient Risks Longer operative time than anticipated Conversion to open surgery Need for additional or larger incision(s) Temporary pain or discomfort from pneumoperitoneum https://www.youtube.com/watch? v=o4po_rxelve 12
Decreased postoperative pain Improved cosmesis Reduced physiologic, psychological and immune response to surgery Decreased wound complications Decreased anesthesia requirements Accelerated patient recovery Improved access to organs that are otherwise difficult to visualize with conventional tools Developing training programs Managing intraoperative complications Determining optimal orifice to use Reliably closing the viscotomy Minimizing infection with instruments passing through a nonsterile orifice Create an endoscopic suturing device Address difficulty with spatial orientation Maintain stable pneumoperitoneum Transvaginal access only in women obviously 13
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Questionnaire-based study asked people to share their preferences in a hypothetical acute appendicitis scenario 80.6% chose SILS over NOTES at this point More education of the public as surgeons perfect techniques NOTES over the next 10-15 years will see incremental gains, not the overnight success of da Vinci Perhaps NOTES and da Vinci will combine 15