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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

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Foregut Surgeries

Bariatric Surgery Weight Loss Nissen Fundoplication GERD

Esophageal Hernia Repair Hiatal Hernia

Heller Myotomy Achalasia

Cholecystectomy Gallbladder Disease

Colorectal Surgery Benign and Malignant colon and rectal disease Gynecologic Surgery Benign and Malignant Uterine and Ovarian disease

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

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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

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¨  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

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¨  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

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)

3cm 1cm

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Stable 3DHD visualization of tissue plane and hernia site

Ability to suture from a variety of angles to repair defects

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Adoption of MIS for Hysterectomy

0%

5%

10%

15%

20%

25%

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

Year

Adop

tion

Laparoscopyda Vinci

¨  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

¡  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

vs. Traditional Lap Surgery

da Vinci Ventral Hernia Repair Potential Patient Benefits

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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

Note: Pain was not a measured outcome in this study.

Robotic Ventral

Hernia Repair (n=67)

Laparoscopic Ventral

Hernia Repair (n=67)

P-Value

Surgical Time (min) 107.6 88.4 0.016

Length of Hospital Stay (days)

2.5 3.7 0.461

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 (months) 17.1 21.8 0.006

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 Surgery (n=165)

Laparoscopic Surgery (n=165)

Robotic Surgery (n=165)

P-Value

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 Distal, cm

11.4 2.2

11.3 2.0

12.0 1.9

0.436 0.180

Overall Complications 24.8% 27.9% 20.6% 0.304

Time to resumed soft diet, days 6.4 5.2 4.5 OS vs. LS or RS <0.001

LS vs. RS =0.004

Length of Hospital Stay, days 16.0 13.5 10.8 OS vs. LS or RS <0.001

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

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No. Post-Op IV analgesics Opioids, mean ± SD

Open Surgery (n=165)

Laparoscopic Surgery (n=165)

Robotic Surgery (n=165)

P-Value

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

Post-Op Pain Status (mean ± SD) All P <0.001

SD = standard deviation VAS = visual analog scale POD = postoperative day

Robotic-assisted surgery compared to open and lap surgeries: ● Significant decrease

in post-op pain

● Significant decrease in analgesia usage

Laparoscopic Nissen Fundoplication

¨  Surgical Supplies - $95.02

¨  Surgical Instruments - $1480.52

¨  Total Cost = $1575.04

Robotic Nissen Fundoplication

Early Surgeries ¨  Surgical Supplies – $91.82 ¨  Surgical Instruments - $ 2656.77 ¨  Total Cost = $2738.59

Cost Controlled Cases ¨  Removal of extra instruments not

needed and supplies ¨  Total Cost = $1639.59

Laparoscopic Inguinal Hernia

¨  Tacker - $600 ¨  Trocars x3 - $90 ¨  Lap scissors - $85 ¨  Graspers, bipolar– $45-$225 ¨  Mesh $350

¨  Total = $820- $1000 ¨  Total w/ 2 tackers = $1,500

Robotic Inguinal Hernia

¨  Fenestrated Bipolar - $270 ¨  Mega Suture cut - $240 ¨  Suture x3 - $5 ¨  Drapes $200 ¨  Mesh $350

¨  Total = $775

¨  Bilateral – no tacker, Suture is cheap

¨  No use of extra instruments.

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§  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

¡  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

da Vinci Single-Site Cholecystectomy Potential Patient Benefits

https://www.youtube.com/watch?v=O4pO_RXELvE

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• 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

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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