SIG Robotics – Understanding the Robotic Surgery Controversy … · 2020-01-30 · 1. Hysterectomies are being performed less frequently in 2013 2. Outcomes are worse for low volumes

Sponsored by

AAGLAdvancing Minimally Invasive Gynecology Worldwide

SIG Robotics – Understanding

the Robotic Surgery Controversy and

Maximizing the Gains (Didactic)

PROGRAM CHAIR

Antonio R. Gargiulo, MD

PROGRAM CO-CHAIR

Douglas N. Brown, MD

Sawsan As-Sanie, MDMichael C. Pitter, MD

John P. Lenihan, MDSerene S. Srouji, MD

Mona E. Orady, MD

Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 3 Obeying Asimov’s First Law of Robotics: Safety, from Simulation to the Operating Room J.P. Lenihan ................................................................................................................................................... 4 Optimizing the Operating Environment for Robotic Surgery D.N. Brown ................................................................................................................................................. 11 Robotic Surgery Complications and Consideration for the Obese Patient S. As‐Sanie ................................................................................................................................................... 17 Robotic Surgeons Never Go Back: Madmen or Visionaries? A Critical Review of Benefits and Limitations of Gynecologic Robotics

A.R. Gargiulo .................................................................................................................................. 23 Robotic Myomectomy: Hybrid Technique to Single‐Incision S.S. Srouji ..................................................................................................................................................... 33 Robotic Hysterectomy: The Retroperitoneal Four‐Arm Approach M.C. Pitter ................................................................................................................................................... 39 Robotic Hysterectomy: Strategies for the Very Large Uterus M.E. Orady .................................................................................................................................................. 45 Resection of Endometriosis: When Is the Robot the Right Tool? A.R. Gargiulo ............................................................................................................................................... 55 Cultural and Linguistics Competency ......................................................................................................... 63

PG 105 SIG Robotics – Understanding the Robotic Surgery Controversy and Maximizing the Gains

(Didactic)

Antonio R. Gargiulo, Chair Douglas N. Brown, Co-Chair

Faculty: Sawsan As-Sanie, John P. Lenihan, Mona E. Orady, Michael C. Pitter, Serene S. Srouji

Robotic surgery in gynecology has entered the early majority phase of the innovation adoption curve with hundreds of surgeons training every year. Yet, a passionate controversy – highly reminiscent of the early days of video-assisted laparoscopy – envelops almost every aspect of this field. Robotic surgery, though implicitly enabling, creates a novel and unusual surgical environment where the patient is virtually displaced and a new type of operative proficiency is defined by the seamless integration of man and machine. It is widely recognized that most complications and dysfunctions of robotic surgery occur within the phase of transition from conventional surgery. This practice gap highlights the need for more intense preparation and training during this transition process. Led by an expert faculty of surgeons with decades of cumulative experience at the console, the course is divided into two sessions. Session one, in keeping with the goals stated above, will focus on safety and the optimal use of resources in the robotic program. Session two is composed exclusively of practical and interactive lectures, including high-definition video explaining safe techniques and best indications for the use of robotic surgical platforms. This didactic component is complemented by hands-on experience on fresh frozen cadavers and simulators. Both components represent a unique opportunity to close the knowledge and kinesthetic gaps between a surgeon using a robot and a robotic surgeon. Course Objectives: At the conclusion of this didactic activity, the clinician will be able to: 1) Discuss the current controversy surrounding the widespread adoption of robotic surgery in gynecology; 2) identify the appropriate cases to perform at any appropriate stage of the transition to robotic surgery; 3) recognize, troubleshoot and solve common and uncommon problems specific to robotic laparoscopy; 4) choose the most clinically-effective and cost-effective instrument and energy setups for their robotic operations; 5) integrate alternative robotic techniques (such as cosmetic, hybrid and single-incision approaches) to their armamentarium; and 6) define clear protocols for common robotic gynecologic operations.

Course Outline 8:00 Welcome, Introductions and Course Overview A.R. Gargiulo

8:05 Obeying Asimov’s First Law of Robotics: Safety, from Simulation to the Operating Room J.P. Lenihan

8:30 Optimizing the Operating Environment for Robotic Surgery D.N. Brown

8:55 Robotic Surgery Complications and Consideration for the Obese Patient S. As-Sanie

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9:20 Robotic Surgeons Never Go Back: Madmen or Visionaries? A Critical Review of Benefits and Limitations of Gynecologic Robotics A.R. Gargiulo

9:45 Questions & Answers All Faculty

9:55 Break

10:10 Robotic Myomectomy: Hybrid Technique to Single-Incision S.S. Srouji

10:35 Robotic Hysterectomy: The Retroperitoneal Four-Arm Approach M.C. Pitter

11:00 Robotic Hysterectomy: Strategies for the Very Large Uterus M.E. Orady

11:25 Resection of Endometriosis: When Is the Robot the Right Tool? A.R. Gargiulo

11:50 Questions & Answers All Faculty

12:00 Course Evaluation/Adjourn

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PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Kimberly A. Kho* Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathan Solnik* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Ceana H. Nezhat Consultant: Ethicon Endo-Surgery, Lumenis, Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Arnold P. Advincula Consultant: Blue Endo, CooperSurgical, Covidien, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical Linda D. Bradley* Victor Gomel* Keith B. Isaacson* Grace M. Janik Grants/Research Support: Hologic Consultant: Karl Storz C.Y. Liu* Javier F. Magrina* Andrew I. Sokol* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Sawsan As-Sanie* Douglas N. Brown* Antonio R. Gargiulo Consultant: OmniGuide John P. Lenihan, Jr. Speakers Bureau: Intuitive Surgical Other: Proctor: Intuitive Surgical Mona E. Orady Consultant: OmniGuide Michael C. Pitter Speakers Bureau: Intuitive Surgical Serene S. Srouji* Asterisk (*) denotes no financial relationships to disclose.

Obeying Asimov’s First Law of Robotics: Safety, from Simulation to the Operating Room

John P. Lenihan Jr., MDClinical Associate Professor, OB GYN

University of Washington School of MedicineMedical Director of Robotics and MISMultiCare Health Systems, Tacoma WA

Disclosure:

Speakers Bureau: Intuitive Surgical

Other: Proctor: Intuitive Surgical

LEARNING OBJECTIVES

• At the conclusion of this activity, the participant will be able to list and compare the value of utilizing simulation to:

– 1. learn basic robotic skills

– 2. practice to competency

– 3. renew skills after long periods of inactivity

– 4. Use simulation to augment credentialling

Isaac Asimov: 1942

• The Three Laws of robotics are incorporated into almost all of the positronic robots appearing in his fiction, and cannot be bypassed, being intended as a safety feature.

Asimov’s Three Laws of Robotics

• A robot may not injure a human being or, through inaction, allow a human being to come to harm.

• A robot must obey the orders given to it by human beings, except where such orders would conflict with the First Law.

• A robot must protect its own existence as long as such protection does not conflict with the First or Second Law.

Are Robots Dangerous?• WALL STREET JOURNAL• May 4, 2010

• Surgical Robot Examined in Injuries

• By JOHN CARREYROU• DOVER, N.H.—Wentworth‐Douglass Hospital, a small community

hospital in this coastal New England town, used a college hockey game to showcase its new technological marvel: a $1.4 million surgical robot named after Leonardo da Vinci.

• As the University of New Hampshire battled the University of Vermont last season before a crowd of 6,000, hospital representatives invited fans to try out the robot between breaks in the action.

• The da Vinci robot is a massive machine that is used to perform minimally invasive surgery. But some experts warn that the robot can do more harm than good when wielded by inexperienced doctors. WSJ's John Carreyrou reports.

• At Wentworth‐Douglass, however, the robot has been used in several surgeries where injuries occurred. One patient operated on days after the hockey game was so badly injured that she required four more procedures to repair the damage. In earlier robotic surgeries, two patients suffered lacerated bladders.

• There's no evidence to suggest the injuries at Wentworth‐Douglass were caused by technical malfunctions. Surgeons who use the da Vinci regularly say the robot is technologically sound and an asset in the hands of well‐trained doctors. But they caution that it requires considerable practice.

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Why Consider Simulation?

1. Hysterectomies are being performed less frequently in 20132. Outcomes are worse for low volumes surgeons and low volume centers3. Learning Curves are longer for robotic surgery than other forms4. Robotic Surgery Console Skills degrade faster than other approaches to surgery5. Surgical competency is harder to validate and certify for hospitals

Nationwide Trends in Hysterectomy

1998 543,812

2000 619,255

2002 681,234

2004 600,302

2006 568,350

2008 491,785

2010 433,621

• Increasing use of medications

• Mirena

• Endometrial Ablation

• Embolization, MRI Focused US

• Less Surgeries for fibroids and AUB

• More Outpat Hysts

• CostsWright JD et al. Nationwide Trends in Inpat Hysterectomy in the US. Obstet Gynecol. Aug 2013 122(2), Part 1. 233-41

Effect of Surgical Volume on Outcomes for Laparoscopic Benign Hysterectomy

Outcome Low Volume High Volume p

Complications 6.2% 4.2% <.001

Overall Morbidity 5.8% 4.7% <.001

% Cases 2000‐06 39% 61%

% Cases 2007‐10 51% 49%

Hospital Costs $6,527 $5,561 <.001

2000-2010: 124,615 patients

Low Vol: < 6/ lap hysts/yr High Vol: > 14 lap Hysts/yr

Wallenstein MR et. al. Effects of Surgical Volume on Outcomes for Laproscopic Hysterectomy for Benign Conditions. April 2012 Obstet Gynecol.119(4); 710-16.

It looks so Easy!

The Reality: Long Learning Curves GYN Robotic Learning Curve Data

Studies• Lenihan & Kovanda, JMIG

2007: 50 ‐75 Cases• Payne & Dauterie, JMIG 2007:

50 cases, >100 to excel• Kho, Hilger et al., AJOG 2007:

Docking times – 20 cases for team

• Chong, Park et al. Int J Gyn Ca 2009: 50 ‐80 cases GYO’s

• Woelk et. al. Obstet Gynecol 2013: 91 Cases for GYO’s and UroGyns (Cum Sum Analysis)

Therefore, consider

• Learning Curves are longer than you think

• Do simple (Basic) cases for the first 15‐30 surgeries.

• Need to operate Frequently to get through the learning curve

• Low Volume Surgeons may never get through the Learning Curve

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What happens to robotic skills if not used?

Reached Proficiency

12 weeks inactivity Post‐pig lab retraining

Dots and numbers 126 +/‐ 3(102‐150)

154 +/‐ 10(79‐236)

132 +/‐ 11(74‐315)

Peg board 266 +/‐ 3(229‐285)

356 +/‐ 10(293‐477)

316 +/‐ 10(252‐472)

Suture Pod 95 +/‐ 3(78‐129)

174 +/‐ 10(125‐282)

157 +/‐ 9(93‐231)

Adjusted time to complete trial … Mean +/- (range)

N=22 PG-2 to PG-5 Jennison E et al. Skills Degradation after Robotic Skills Training, Akron General Hospital 2010

P=.001 P=.001

Robotic Console Skills Degrade Quickly

Robotic Console Skills Degradation

• Jenison EL, et al Acquisition, Maintenance, and Degradation

– 4 weeks of inactivity can increase time needed for newly trained surgeons to perform robotic surgery exercises by 25% to 100%

• Training for 1hr bi‐weekly maintains surgical robot skills during robotic inactivity, and also decreases the time to complete a task that was not practiced

• Newly trained robotic surgeons should consider bi‐weekly practice during periods of Robotic Inactivity

Guseila LM, Jenison El et al. Maintaining Robotic Surgical Skills During Periods of Robotic Inactivity presented WRGC V, Chicago Aug 2013

What About Competency?

• Minimum Standards?

• Long Op Times?

• Excessive Complications?

• Anesthesia Concerns?

• Too many conversions?

The Future is Competency Based Credentialing

• Establish Metrics for Operative Standards

– Op Times, EBL, Complications rates, etc.

– Triggers should be determined locally or based on National Data Bases (> 2 SD’s from normal?)*

• Consider retraining or mentoring if a surgeon consistently falls outside standards

– Use of Simulators

– Use of Mentor Surgeons as assistants/proctors

• Include CME component

– Require Advanced courses, national or local meetings, etc.

Two Standard Deviations

MultiCare Health Systems RTLH Standards: 2009

Variable Mean Standard Dev. Median Sample Range

Age 44.85 10.37 44.00 27 ‐ 70

Body Mass

Index (BMI)

28.50 6.27 27.00 18 ‐ 51

Total Op Time

(TOT)

91.95 min 25.57 min 89.00 min 60 – 170 min

Robotic

Console Time

(RCT)

51.79 min 20.48 min 50.00 min 25 – 108 min

Estimated

Blood Loss

(EBL)

43.11 cc’s 25.72 cc’s 35.00 cc’s 10 – 150 cc’s

LOS 25 hours 6 hours 26 hours 10 – 84 hours

Uterine

Weights

189.91 grams 160.34 grams 141 grams 46‐1306 grams

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What do all of these people have in common?

Practice, Practice, Practice!Practice!

Practice, Practice, Practice!Practice!

How much practice does it take to really get good?

10,000 hours!

Can Simulation Help? • Practice and rehearsal without

clinical consequences

• Reduces reliance on animal models

• Provides standardized experience

• Reduces costs: independently led, less OR resources to practice

• Enables efficient skill development through new surgeon learning curve

Benefits of Simulation

• Long known in Aviation Industry– Can practice basics as well as emergencies

• Current Simulators cover only basic skills– Actual DaVinci Robot – dry lab– Mimic Simulator dV Trainer (stand alone)– DaVinci Backpack Skills Simulator (Si)– RoSS Simulator

• Procedures based trainers now being released– Mimic, Red Llama, Lap Sim and others

• Can be factored into “Currency” for surgeons• Recent studies show pre‐op benefit for experienced surgeons

Robotic Simulators

Intuitive Backpack Skills Simulator

Mimic Dv Trainer

RoSS Simulator

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Simulationis validated

• "Validating the Use of the Mimic dV‐Trainer for Robotic Surgery Skill Acquisition Among Urology Residents" Department of Urology, Columbia University: Korets R, Mues AC, Graversen JA, Gupta M, Benson MC, Cooper KL, Landman J, Badani KK.

• "Concurrent Validity Testing of a Virtual Reality Robotic Surgical Simulator"Lee JY, Kerbl DC, Mucksavage P, Etafy M, Huynh VB, McDougall EM

• Virtual reality simulator training equals mechanical robotic training in improving robotic‐assisted suturing skills. Halvorsen FH,Elle OJ,Dalinin VV et al. Surg Endos, 2006;20:1565‐69

• The role of surgical simulation in the learning curve of robotic assisted surgery.Al Bareeq R, Jayaraman S,Kiaii B et. al. J Robotic Surg 2008;2:11‐15.

• VR Robotic Surgery:Randomized blinded study of the dV‐Trainer robotic simulator. Lendvay TS. Stud Health Tech Inform. 2008;132:242‐44.

Warm Up Data

Benefit of Warm Up

In a study performed at Arizona State University, subjects performed standardized exercises as a preoperative warm-up, after which the standardized exercises were repeated in a randomized order. Performance metrics were measured during all trials.

VALIDATION:

Morristown NJ Protocol

Validation of a Robotic Surgery Simulator Protocol –Transfer of Simulator Skills to the Operating Room. Patrick Culligan, MD, Charbel Salamon, MS, MD Atlantic Health System, Morristown, NJ. AAGL, Las Vegas 11,2012

n=5 n=14 n=5

Results

First Supracervical Hysterectomy: Robotic Console TimeAverage time for novices to master protocols: 20 hrs. (9.7 – 38.2 hrs)

Instrument Precision

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Needle Control Energy Applications

Suturing and Knot Tying NEW PARADIGM

• SEE ONE

• DO ONE

• TEACH ONE

• SEE ONE

• SIMULATE MANY

• DO ONE

Proposed Simulation Training Pathways

New Surgeon

• Basic Skills Drill

– Camera targeting

– Ring Walk 1

– Energy Use ‐1

– Peg Board ‐ 1

Annual Recertification Advanced

• Basic Skills Games

• Advanced Skills Team– Energy use 2 Dual Console

– Three arm drills Level 3 skills

– Needle driving Three arm skills

– Knot tying

* Validation Studies in progress

Future Simulation Development

• BASIC SKILLS

• VR Procedures

• Complications

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Laparoscopic Hysterectomy Trainer for Residents

Port Placement Port & Instrument Selection

SimPraxis®

FRGS: Trains Psycho-Motor SkillsLap Hyst Trainer: Trains Cognitive Skills

SimPraxis® Platform Interactive Simulation Software

with High Fidelity Operating Room Video:

Medical Team

The Virtual Mentor

Back Table & Mayo Stand

HintsDidacticsText Box

Interactive Video

Steps

Tracking & Scoring

Verbal Prompts

Expandable Window

Simultaneous Alternate View

Other Current Developments: 2013• RTN: Residency Training Network:

– Baseline for standardized training of residents

• FLS, FRS, FRGS

• COEMIG (AAGL‐SRC)

• EMIG (ACOG)

Wright JD et al. Nationwide Trends in Inpat Hysterectomy in the US. Obstet Gynecol. Aug 2013 122(2), Part 1. 233-41

Wallenstein MR et. al. Effects of Surgical Volume on Outcomes for Laproscopic Hysterectomy for Benign Conditions. April 2012 Obstet Gynecol.119(4); 710-16.

Guseila LM, Jenison El et al. Maintaining Robotic Surgical Skills During Periods of Robotic Inactivity presented WRGC V, Chicago Aug 2013

Bareeq R, Jayaraman S, Kiaii B et. al. The role of surgical simulation in the learning curve of robotic assisted surgery. J Robotic Surg 2008;2:11-15.

Culligan P, Salamon C, Validation of a Robotic Simulator < Transferring SimulatorSkills to the Operating Room. AAGL, Las Vegas 11, 2012

Lenihan J. Navigating Credentialing, Privileging, and Learning Curves in Robotics With an Evidence and Experience-Based Approach., Clinical Obstetrics and Gynecology. Sep 2011, 54(3), 382-390. (Ed: Advincula A)

Thank You

10

Optimizing the Operating Room for

Robotic Surgery

Douglas N. Brown, MD, FACOG, FACS

Director, Center for Minimally Invasive Gynecologic Surgery

Massachusetts General Hospital

Harvard Medical School

Disclosure Slide

I have no financial relationships to disclose.

Objectives

At the conclusion of this activity, participants will be better able to:

Explain the evidenced based rational for the current controversy surrounding the adoption of robotic surgery in gynecology

Identify areas of pre-operative planning, operative set-up, and post-operative turnover, where a synergistic approach facilitates robotic operative productivity

Apply the knowledge learned to increase operating room efficiency in robotic surgery

Why Does Operating Room Optimization Matter ?

THE Major Criticism of Robotic Surgery

Takes Longer

Increase Cost

What Does the Data Tell Us ?

CONCLUSION: Robot-assisted laparoscopic hysterectomy andconventional laparoscopy compare well in most surgical aspects,but the robotic procedure is associated with longer operating times.

(Obstet Gynecol 2012;120:604–11)

CONCLUSION: Robotic-assisted sacrocolpopexy results in longeroperating time and increased pain and cost compared with theconventional laparoscopic approach.

(Obstet Gynecol 2011;118:1005–13)

CONCLUSION: Laparoscopy and robotics provided similar results for theperformance of adnexectomy, with similar blood loss, intraoperative andpostoperative complications, and length of hospital stay. Robotics meanoperating time was 12 minutes longer.


CONCLUSION: Robotic surgery for tubal anastomosis was successfullyaccomplished without conversion to laparotomy. The robotic techniquefor tubal anastomosis required significantly prolonged surgical andanesthesia times over outpatient minilaparotomy (P<.001).

(Obstet Gynecol 2007;109:1375–80)

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CONCLUSION: Robot-assisted laparoscopic myomectomy andlaparoscopic myomectomy have similar operative outcomes in a high-volume surgical practice. Operative time and intraoperative estimatedblood loss were significantly greater in the robot-assisted laparoscopicmyomectomy group, but the level of statistical significance forintraoperative estimated blood loss was marginal and the clinicalsignificance was undetermined. Use of barbed suture in thelaparoscopic myomectomy group may account for these differences.


CONCLUSION: Laparoscopy is the least expensive surgical approachfor the treatment of endometrial cancer. Robotic is less costly thanabdominal hysterectomy when the societal costs associated withrecovery time are accounted for and is most economically attractive ifdisposable equipment costs can be minimized.


How Can YouImprove Surgical Efficiency ?

Improve the Technology

Improve the Surgeon

Improve the Operating Environment

Improving Efficiency & TheOperating Environment

A Dedicated Robotic Operating Room

A Dedicated Robotic Surgery TEAM

A Dedicated Robotic Surgeon

The Surgeon Must Be All In...

MGH Operating Room

Photo/Video

A Dedicated Robotic Operating Room (s)

A Dedicated Robotic Surgery TEAM (s)

Surgeon

Circulator (s) (To start usually 2)

Surgical Scrub Tech (To start usually 2)

Surgical Assistant (s)

(Resident, Fellow, Physician Assistant)

Anesthesia

A Single Team is 5-7 Individuals

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MGH Team Photo

Tips for Pre-Operative Set-Up

Synergy

Anesthesia/Circulator #1 Get Patient from Pre-op

Scrub Tech # 1 & Circulator # 2 - Back Table

Scrub Tech # 2 - Drapes da Vinci Patient Cart

Surgical Assistant (s) - Help with EVERYTHING

The Surgeon Should be Present AND

Should Direct/Assist/Help with EVERYTHING

Tips for Pre-Operative Set-Up

The Surgeon is the Team LEADER

Select Patients Appropriately

Perform Similar Surgery on the SAME Day

i.e.., 2 Myomectomies, 2 Hysterectomies, etc…

Limit the Instrumentation Needed Per Procedure

Uterine Manipulator, Trocars, Suction/Irrigation, Suture,

da Vinci Instrument Selection

(Grasper, Energy Source, Needle Driver)

Tips for Pre-Operative Planning

Patient is in The Operating Room

Synergy

Anesthesia - Intubation, IV access

Surgical Assistant (s), Circulator # 1

Position Patient, Prep Patient, Final Time-Out

Scrub Tech # 1 & Circulator # 2

Confirm Back Table

Set-up Auxiliary Equipment

(Ready for Incision/Insufflation/Foley/Ut Manipulator)

Scrub Tech # 2 – Standby da Vinci Patient Cart

Docking Tips Insufflate Abdomen

Drive the Robot into Position

Tip: Keep Patient in Supine Position

Tip: Use tape on the OR floor for OR Table and Robot

Positioning (Side Docking Position Perfection)

Then Place into Trendelenburg

Tip: Use the Robot Camera to Place Additional Trocars

Photo Photo

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Video Demonstration

Port Placement

Once Trocars are Placed

Dock the Robotic Arms to the Ports

The Surgeon Moves to the Console

(If Dual Console, Fellow, Resident to Console)

The Surgery Begins…

Docking Tips

Driving & Docking the da Vinci System is a Team Event !Practice Continually !

Completion of Surgery

Synergy Anesthesia - Extubation

Circulator # 1 – Charting

Surgical Assistant (s), Scrub Tech # 1

Undock, Close Ports

Circulator # 2 & Scrub Tech # 2

Roll Out da Vinici System

Undrape, Clean, Prep for Next Case

Send Scopes/Instruments to Central Processing

Help Scrub Tech # 1 Clear Back Table

Completion of Surgery

Patient Exits the OR

Anesthesia & Circulator # 1

Recovery / Next Patient

Surgeon/Surgical Assistant (s)

Speak to Family / Next Patient

Circulator # 2 & Scrub Tech # 1 & # 2

Turnover & Set-Up for Next Case

Pause For Effect

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Dedicated Robotics Team Reduces Pre-Surgical Preparation Time

Lasser MS, Patel CK, Elsamra SE, Renzulli JF, Halebilian GE, Pareek G.

CONCLUSION: The use of a consistent staff candecrease preoperative setup times and, therefore,the overall length of surgery.

(Indian J Urol. 2012 Jul;28(3):263-6)


RESULTS: From July 2009 through June 2011, 1295 roboticcases were performed. Profitability was associated with case time,payor mix, and procedure type (all P < .05). Urogynecology casetime decreased from 220-179 minutes (P . .012) and pediatricsurgery from 418-258 minutes (P . .019)

CONCLUSION: Robotic operative efficiency has a large impact onoverall profitability regardless of surgical specialty.

(Am J Obstet Gynecol. 2013 Mar 25)

The 4 R’s

Right Patient

Right Surgical Procedure

Right Surgeon

Right Timing

The 7 P’s

Proper

Pre-Operative

Preparation

Prevents

Piss-Poor

Performance

Final Thoughts

This is a TEAM Effort

Move with a Purpose

Inspire Your Team to be Motivated

Be Positive, Be Gracious, Be Present...

Be a True LEADER!

References1. Dimitri Sarlos, MD, LaVonne Kots, MD, Nebojsa Stevanovic, MD, Stefanie von Felten, PhD, and Gabriel Scha¨r, MD.

Robotic Compared With Conventional Laparoscopic Hysterectomy. Obstet Gynecol 2012;120:604–11.

2. Marie Fidela R. Paraiso, MD, J. Eric Jelovsek, MD, Anna Frick, MD, MPH, Chi Chung Grace Chen, MD, and Matthew D. Barber, MD, MHS. Laparoscopic Compared With Robotic Sacrocolpopexy for Vaginal Prolapse. Obstet Gynecol2011;118:1005–13.

3. Javier F. Magrina, MD, Mercedes Espada, MD, Raquel Munoz, MD, Brie N. Noble, and Rosanne M. C. Kho, MD. Robotic Adnexectomy Compared With Laparoscopy for Adnexal Mass. Obstet Gynecol 2009;114:581–4.

4. Allison K. Rodgers, MD, Jeffrey M. Goldberg, MD, Jeffrey P. Hammel, MS, and Tommaso Falcone, MD. Tubal Anastomosis by Robotic Compared With Outpatient Minilaparotomy. Obstet Gynecol 2007;109:1375–80.

5. Jason C. Barnett, MD, John P. Judd, MD, Jennifer M. Wu, MD, Charles D. Scales Jr, MD, Evan R. Myers, MD, and Laura J. Havrilesky, MD. Cost Comparison Among Robotic, Laparoscopic, and Open Hysterectomy for Endometrial Cancer. Obstet Gynecol 2010;116:685–93.

6. Ehab E. Barakat, MD, Mohamed A. Bedaiwy, MD, Stephen Zimberg, MD, Benjamin Nutter, Mohsen Nosseir, MD, and Tommaso Falcone, MD. Robotic-Assisted, Laparoscopic, and Abdominal Myomectomy: A Comparison of Surgical Outcomes. Obstet Gynecol 2011;117:256–65.

7. Lasser MS, Patel CK, Elsamra SE, Renzulli JF, Halebilian GE, Pareek G. Dedicated Robotics Team Reduces Pre-Surgical Preparation Time. Indian J Urol. 2012 Jul;28(3):263-6.

8. Geller EJ, Matthews CA. Impact of robotic operative efficiency on profitability Am J Obstet Gynecol. 2013 Mar 25.

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Thank You

16

Robotic Surgery Complications and Considerations for the Obese Patient

Sawsan As‐Sanie, MD MPHAssistant Professor

Director, Minimally Invasive Gynecologic Surgery and Fellowship

University of Michigan

Disclosures


Objectives

1. Describe surgical complications associated with robotic surgery

2. Identify strategies to avoid such complications

3. Discuss special considerations for the obese patient

Surgical complications are uncommon

• Major surgical complications are uncommon

• Complications with robotic procedures are not more likely than with traditional laparoscopy

• Significantly less morbidity than open cases

Wright JD, et al. JAMA. 2013 Feb 20;309(7):689-98Patzkowsky KE, et al. JSLS. 2013 Jan-Mar;17(1):100-6.

Complications may be related to surgeon experience & hospital volume

Wallenstein MR, et al. Obstet Gynecol. 2012. Apr;119(4):709-16.

Robotics is a tool and most surgical complications are not unique to robotic approach

• Vascular

• Bowel

• Urinary tract (bladder, ureter)

• Know your anatomy!

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Perioperative Neuropathies

• Incidence varies, depending on type of surgery, surgical approach, patient position, length of surgery, patient risk factors

– Range 1.9 – 10 %

• Nerve injuries represent approximately 1/3 of all anesthesia ‐ associated medicolegal claims in the United States

Elevated risk of nerve injury ?

• Nerve injuries may be related to inappropriate or unstable patient positioning

• Risk elevated in prolonged surgery, patients with medical comorbidities, steep trendelenberg

• Surgeon is not in constant, direct contact with patient

Brachial Plexus•Anterior nerve roots of C5 – T1

•Pass behind clavicle, under axillary artery, over first rib

•Motor & sensory nerves innervate shoulder, scapula, and upper extremity

Brachial Plexus Ulnar nerve

• Passes across the elbow in the olecranon groove, between the medial epicondyle and the ulnar bone

• Sensory & motor innervation to medial 4th & 5th finger

Location of ulnar nerve in supination vs. pronation Peroneal nerve

• Arises from the posterior tibial branch of sciatic nerve

• Fixed at head of fibula

• Particularly sensitive to compression injury

• Symptoms: Sensory loss over the lateral aspect of the leg below the knee and the dorsum of the foot, foot drop

18

Complications to consider

• Combination of steep trendelenberg and prolonged surgery can increase risk of rare complications

– Orbital edema, retinal detachment, permanent loss of vision

– Cerebral edema, laryngeal edema

– Rhabdomyolysis, compartment syndrome of lower extremity

– Pressure alopeciaAwad H, et al. J Clin Anesth. 2012 Sep;24(6):494-504

Key aspects of appropriate position• Gel, foam, or beanbag to prevent slippage

• Avoid shoulder blocks

• Hip flexion 170°

• Hip abduction <90°

• Minimal external rotation of hip

• Arms padded at elbows and wrists, thumbs up or arms supinated

• Arms should not hang over side of bed, use bed extension if necessary

• Avoid bunching of foam or sheet in axilla

Robot Malfunction

• Uncommon, but may lead to conversion to alternative surgical approach

• Resultant patient injury extremely rare

• Fail‐safe mechanisms to prevent patient injury

• Reported robot malfunction rate may be inversely related to hospital volume of robotic procedures.

Zorn KC, et al. J Endourol. 2007 Nov;21(11):1341-4.

Robot Malfunction

• Insulation failures

• Uncontrolled arms

– Never leave arms in patient if away from console

– Always keep all arms in view

– Make sure don’t toggle arms accidentally

– Excessive force of arms

Obesity epidemic

• 35.7% of American adults and 16.9% of children are obese (BMI>30)

• By 2030, obesity rates could exceed 44% nationally, and over 50% in some states

• Obesity is associated with increased risk of other medical comorbidities that predispose patients to greater surgical risk

Increased surgical risks in the obese

Intraoperative challenges

• Difficult intubation

• Airway obstruction

• Higher expiratory airway pressure

Postoperative risks

• Wound infection

• Pneumonia

• Atelectasis

• DVT/PE

• ileus

19

Robotic surgery is feasible and safe in obese patients

Gallo et al. JSLS. 2012 Jul-Sep;16(3):421-7

Robotic surgery is feasible and safe in obese patients

Gallo et al. JSLS. 2012 Jul-Sep;16(3):421-7

Impact of abdominal wall thickness on trocar range of motion

Zorn KC. Robotic surgery techniques for obese patients. Can Urol Assoc J. 2010, 4(4):255-6.

Special considerations for the obese

• Patient positioning to reduce risk of nerve injury

• Distorted landmarks for trocar placement

• Adequate retraction of bowel to allow for adequate visualization of critical structures

Patient positioning

• Gel pad, foam pad, or bean bag in direct contact to patient back and buttocks

• Avoid use of shoulder brackets

• Padded elbows and wrists

• Extended arm supports

• Avoid bunching of padding or draping under axilla

Patient positioning

• Panniculus is stretched downward and taped to patient’s thigh

• Use bony landmarks, not umbilicus, to guide trocar placement

Geppert B, et al. Acta Obstet Gynecol Scand. 2011, 90(11):1210‐7.

20

Port Placement

Geppert B, et al. Acta Obstet Gynecol Scand. 2011, 90(11):1210‐7.

Tips for improving visualization

• Minimum trendelenburg necessary

• retract bowel prior to docking

• Additional 5mm assist trocar

• Suture sigmoid epiploica to left lower quadrant abdominal wall

• 10mm paddle retractor if above is insufficient

Caution!

Do not lose track of time… Prolonged operative time is a significant risk marker for surgical morbidity

Checklist for 2nd time‐out in extended robotic surgeries

1. Wright JD, Ananth CV, Lewin SN, Burke WM, Lu YS, Neugut AI, Herzog TJ, Hershman DL. Robotically assisted vs laparoscopic hysterectomy among women with benign gynecologic disease. JAMA. 2013 Feb 20;309(7):689‐98.

2. Patzkowsky KE, As‐Sanie S, Smorgick N, Song AH, Advincula AP. Perioperative outcomes of robotic versus laparoscopic hysterectomy for benign disease. JSLS. 2013 Jan‐Mar;17(1):100‐6.

3. Wallenstein MR, Ananth CV, Kim JH, Burke WM, Hershman DL, Lewin SN, Neugut AI, Lu YS, Herzog TJ, Wright JD. Effect of surgical volume on outcomes for laparoscopic hysterectomy for benign indications. Obstet Gynecol. 2012 Apr;119(4):709‐16.

4. Awad H, Walker CM, Shaikh M, Dimitrova GT, Abaza R, O'Hara J. Anesthetic considerations for robotic prostatectomy: a review of the literature. J Clin Anesth. 2012 Sep;24(6):494‐504.

5. Zorn KC, Gofrit ON, Orvieto MA, Mikhail AA, Galocy RM, Shalhav AL, Zagaja GP. Da Vinci robot error and failure rates: single institution experience on a single three‐arm robot unit of more than 700 consecutive robot‐assisted laparoscopic radical prostatectomies. J Endourol. 2007 Nov;21(11):1341‐4.

6. Andonian S, Okeke Z, Okeke DA, Rastinehad A, Vanderbrink BA, Richstone L, Lee BR. Device failures associated with patient injuries during robot‐assisted laparoscopic surgeries: a comprehensive review of FDA MAUDE database. Can J Urol. 2008 Feb;15(1):3912‐6.

7. Zorn KC. Robotic surgery techniques for obese patients. Can Urol Assoc J. 2010, 4(4):255‐6.

8. Song JB, Vemana G, Mobley JM, Bhayani SB. The second "time‐out": a surgical safety checklist for lengthy robotic surgeries. Patient Saf Surg. 2013 Jun 3;7(1):19

21

9. Geppert B, Lönnerfors C, Persson J. Robot‐assisted laparoscopic hysterectomy in obese and morbidly obese women: surgical technique and comparison with open surgery. Acta Obstet Gynecol Scand. 2011, 90(11):1210‐7.

10. Gallo T, Kashani S, Patel DA, Elsahwi K, Silasi DA, Azodi M. Robotic‐assisted laparoscopic hysterectomy: outcomes in obese and morbidly obese patients. JSLS. 2012 Jul‐Sep;16(3):421‐7

22

A Critical Review of the Benefits

and Limitations of Gynecologic Robotics

Antonio GargiuloMedical Director, Center for Robotic Surgery

Brigham and Women’s Health CareHarvard Medical School

Gargiulo 2013Gargiulo 2013

Consultant: OmniGuide

Participants should be able to :

• Interpret relevant scientific publications on benefits

and limitations of robotic gynecologic surgery

• Describe the ergonomic limitations of laparoscopy

and their occupational and bioethical correlates

• Identify relevant areas of clinical investigation in the

field of gynecologic robotics


The Most Expensive Hysterectomy.

MS Baggish. J Gynecol Surg, 1992

Operative Laparoscopy: Surgical Advance or

Technical Gimmick?

RM Pitkin. Obstet Gynecol, 1992

Breaking New Ground or Just Digging a Hole? An

Evaluation of Gynecologic Operative Laparoscopy.

FM Howard. J Gynecol Surg, 1992


23

Changing hysterectomy patterns after introduction of

laparoscopically-assisted vaginal hysterectomy

MB Harris and DL Olive. Am J Obstet Gynecol, 1994

LAVH can decrease the number of patients requiring

a laparotomy for hysterectomy, but at a much greater

cost (average cost $11,932 for LAVH vs. $7031 for

abdominal hysterectomy).


Hospital cost comparison between abdominal, vaginal

and laparoscopy-assisted vaginal hysterectomy.

C Nezhat et al. Obstet Gynecol, 1994

The use of laparoscopy to perform a hysterectomy was

associated with much higher cost.

Predicted savings associated with shorter hospital stay

failed to offset the exorbitant intraoperative costs.


Costs and charges associated with three alternative

techniques of hysterectomy.

JH Dorsey et al. N Engl J Med, 1996

Despite shorter hospital stays, in-hospital charges and

costs for laparoscopically assisted vaginal

hysterectomy are higher than for either alternative

procedure.


A randomized trial with a cost-consequence analysis after

laparoscopic and abdominal hysterectomy.

M Ellström et al. Obstet Gynecol, 1998

A randomized comparison and economic evauation of

laparoscopic-assisted hysterectomy and abdominal

hysterectomy. MA Lumsden et al. BJOG, 2000

Cost effectiveness analysis of laparoscopic hysterectomy

compared with standard hysterectomy: results from a

randomised trial. M Sculpher et al. BMJ, 2004


Surgical approach to hysterectomy for benign gynecological

disease N Johnson et al. Cochrane Datab Syst Rev, 2005

“Further research is required to define the role of the newer

approaches to hysterectomy, such as total laparoscopic

hysterectomy (TLH)”.

When robotic hysterectomy was approved by the FDA,

TLH was not a proven cost-effective alternative to TAH.

Only 14% of hysterectomies in the USA were

laparoscopic at 18 years from its introduction.


24

At 10 years from FDA approval, 90% of radical

prostatectomies performed robotically.

No definitive evidence of higher safety over open

prostatectomy to justify the increased cost.

Hu et al. JAMA, 2009 (RALP more complications than RP)

Bolenz et al. Eur Urol, 2010 (RALP costs more than RP)

WHY !?


The NSQIP database (identifies complications up to 30

days post-operatively) was queried 2005-2010 for robotic

plus laparoscopic vs. open prostatectomy.

JJ Liu et al. Urology, 2013

First evidence: clinical superiority of RALP/LP over RP

Using the right database for the question was key!


RALP/LP RRP P‐value

Blood Transfusion 1.34% 21.4% <0.0001

Major Complications 4.98% 9.04% <0.0001

Death 0.05% 0.39% 0.01

Tracking the rise of robotic surgery for prostatic cancer

“A large, randomized clinical trial comparing the

approaches seems out of the realm of possibility at this

point… and may not even be that informative.

If you have an expert surgeon doing either procedure you

are likely to have an excellent outcome.”

NCI Bulletin, August 2011


Recruitment period: 5 years

Number of Surgeons: 5

Number of robotic hysterectomies (RH): 26

Average number of enrolled RH/year/surgeon: 1

Paraiso et al. Am J Obstet Gynecol, 2013


JD Wright et al. JAMA 2013

25

• Largest non-inferiority study to date.

• The rise of robotic hysterectomy correlates with

the fall of abdominal hysterectomy.

• … but the focus is on the $2000 difference.

JD Wright et al. JAMA 2013Gargiulo 2013Gargiulo 2013

• DOES NOT REPORT ON CONVERSION RATE

(converted cases were billed as laparotomy).

Conversion rates are 6% for LH, vs 1% for RH, as

reported by advanced MIS teams.

KE Patzkowsky et al. JSLS, 2013

• The Perspective database does not capture post-

discharge complications (transfusions, readmissions)

• The above may artificially decrease the cost of LH


“A recent JAMA study found that… robotics added an average

of $2000 per procedure without any demonstrable benefit.”

Incorrect: the study showed decrease of open hysterectomy


“If most women… chose a vaginal or laparoscopic

procedure… dramatic savings to our health system.”

Unrealistic: will address in myomectomy section

“An estimated $960 million to 1.9 billion will be added

to the health care system if robotic surgery is used for

all hysterectomies each year”.

Incorrect: the direct and indirect savings from

avoidance of open hysterectomy would compensate!

26

ACOG is implying that minimally invasive

hysterectomy has a complexity comparable to

minimally invasive cholecystectomy.

After 20 years of stifling advanced minimally

invasive gynecologic surgery, ACOG is now

implying that our specialty is ready to offer it to

“most women”, hence we do not need robots.


RCTs show superior outcome of LM over AMMais et al. Am J Obstet Gynecol, 1996

Seracchioli et al. Hum Reprod, 2000

Palomba et al. Fertil Steril, 2007

“There are robust surgical outcome data supporting the use of a minimally invasive approach such as laparoscopy and hysteroscopy over laparotomy”.

Falcone and Parker, Obstet Gynecol, 2013


41.1% returned

39.9% included in analysis

94.7% practice gynecology

91.5% perform laparoscopy

3.1% perform LM in over 50% of cases

24.5% perform LM

Questionnaires distributed to 100% of Canadian Ob/Gyn

G Liu et al. J Obstet Gynecol Can, 2010


Intramural Fibroid (81%)

Fibroid > 5 cm (54%)

> 3 Fibroids (53%)

Posterior Fibroid (29%)

Previous surgery (14%)

Obese patient (25%)

Clinical deterrents to performing LM



Lack of training (71%)

Operative time constraints (53%)

Lack of equipment (52%)

Insufficient evidence to support (35%)

High cost (25%)

Higher complication rate (27%)

Barriers to performing LM



“…research in pure science leads to revolutions, and revolutions, whether political or industrial, are exceedingly profitable things if you are on the winning side.”

Sir J.J. Thomson, Nobel Prize in Physics, 1906

27

TIME since technique adoption

PR

OF

ICIE

NC

Y


• Ethically impossible to design studies like Stefanidis’ on

Human Subject: THEY WILL NEVER BE DONE

• Reported learning curves (LC) for gynecologic robotic

procedures vary with definition of technical competence

• A comparative study in gynecology does not yet exist.

• Radical prostatectomy (RP) comparative LC study:

LC Open RP: 250-1000 cases

LC Laparoscopic RP: 200-750 cases

LC Robotic RP: 40 cases

H Abboudi et al. Br J Urology, 2013

n Findings Limitations

Nezhat et al. 2009

15 vs. 34 Longer OR time for RM (234 vs. 203 min)

Small study, includes RM learning curve

Bedient et al. 2009

40 vs. 41 No difference(141 vs. 166 min)

Small study, includes RM learning curve

Barakat et al. 2011

89 vs. 93 Higher tumor load in RM.No difference (181 vs. 155 min)

High-volume RM vs. low-volume LM teams

Gargiulo et al. 2011

174 vs. 115

Longer OR time for RM (195 vs 118 min)

LM barbed suture 70%RM barbed suture 5%

Perioperative outcomes of RM and LM are comparable. Pundir et al, J Minim Invasive Gynecol, 2013 (Meta-analysis)


• Raising the threshold for open conversion• Cervical and retroperitoneal pathology

• Surgery in the frozen pelvis

• Surgery in the obese patient

• Minimizes assistant factor

• Posing ethical challenge as technical enabler • Shortened learning curve

• Standardized simulation

• Improved ergonomics (vision, dexterity, posture)


Patients benefit while surgeons suffer: an

impending epidemic.

A Park et al. J Am Coll Surg, 2010

87% of SAGES members respondents reported

physical symptoms or injuries.

Strongest predictor: high case volume

(eye and back symptoms also low case volume).

No relationship with height, age, practice length.

28

Work-related musculoskeletal disorders when

performing laparoscopic surgery.

MW Stomberg, Surg Laparosc Endosc Percutan

Tech, 2010

More than 70% of laparoscopists reported one or

more symptom (pain, fatigue, stiffness).

Lower back, neck shoulders most affected.

Headache and visual discomfort also reported.

Longer workload/ageing: more disorders (p<0.01).

Female surgeons: more disorders (p<0.01).

Physical strain and urgent need for ergonomic

training among gynecologic oncologists who

perform minimally invasive surgery.

J Franasiak et al, Gynecol Oncol, 2012

88% of SGO members respondents reported

physical discomfort related to MIS.

52% reported PERSISTENT pain.

29% received formal treatment:

• Physical therapy: 29%

• Medical management: 28%

• Surgery: 13%

• Time off: 1%

Physical strain and urgent need for ergonomic

training among gynecologic oncologists who

perform minimally invasive surgery.

J Franasiak et al, Gynecol Oncol, 2012

Direct relationship with: height, glove size, age

and female gender.

Association with Patient BMI: for laparoscopic, but

not for robotic surgery.

Pain avoidance behaviors:

• Modify positions: 78%

• Limited cases/day or total cases: 17%

• Spread cases in week: 6%

Work-related upper limb musculoskeletal

disorders in paediatric laparoscopic surgery.

A multicenter survey.

C Esposito et al, J Pediatr Surg, 2013

78.2% of laparoscopists with over 10 year

experience have work-related shoulder symptoms.

44% of these require analgesics ≥ twice weekly.

Attitudes:

1) 1) 55% think pain related to laparoscopy;

2) 2) 43% think laparoscopy good for patients but

damaging to surgeons;

3) 3) 65% think robotic surgery improves ergonomics

MM Lux et al. J Endourol, 2010

29

• Minimizing cosmetic impact in Women’s Health• Reduced port laparoscopy

• Single port laparoscopy

• Exponential development of electronics• Miniaturization and multi-channel technology

• Safe Natural Orifice Transluminal Endoscopic Surgery

• Enhanced vision and pathology targeting

• Centers of Excellence in Telesurgery

• Automation

• Decreased production/operation costsThe Singularity is Near: When Humans Transcend BiologyR Kurtzweil, 2005

The Singularity is Near: When Humans Transcend BiologyR Kurtzweil, 2005


30

Comparative study of outcome data on 6 procedures (open vs. MIS): cholecystectomy, colectomy, fundoplication, ventral hernia repair, appendectomy and hysterectomy.

• Reduced hospital stay

• Reduced hospital costs

• Reduced societal costs (faster return to work)

• Increased operating room time/costs

• Increased surgical equipment costs

“As both the outcome value and the level of operating room resources are greater, MIS warrants reimbursement that meets or exceeds that of open procedures”.AR Roumm et al. Surg Innov, 2005


The Most Expensive Hysterectomy.

MS Baggish. J Gynecol Surg, 8 (2) , 57-8, 1992

Operative Laparoscopy: Surgical Advance or Technical

Gimmick? RM Pitkin. Obstet Gynecol, 79:3, 441-2, 1992

Breaking New Ground or Just Digging a Hole? An Evaluation

of Gynecologic Operative Laparoscopy.

FM Howard. J Gynecol Surg, 8 (3): 143-58, 1992

Changing hysterectomy patterns after introduction of

laparoscopically-assisted vaginal hysterectomy

MB Harris and DL Olive. Am J Obstet Gynecol, 171 (2): 340-

3, 1994Gargiulo 2013Gargiulo 2013

Hospital cost comparison between abdominal, vaginal and

laparoscopy-assisted vaginal hysterectomy.

C Nezhat et al. Obstet Gynecol, 83 (5): 713-6, 1994

Costs and charges associatred with three alternative

techniques of hysterectomy.

JH Dorsey et al. N Engl J Med, 335 (7): 512-3, 1996

A randomized trial with a cost-consequence analysis after

laparoscopic and abdominal hysterectomy.

M Ellström et al. Obstet Gynecol, 91 (1) : 30-4, 1998


A randomized comparison and economic evauation of

laparoscopic-assisted hysterectomy and abdominal

hysterectomy. MA Lumsden et al. BJOG, 107 (11), 1386-91,

2000

Cost effectiveness analysis of laparoscopic hysterectomy

compared with standard hysterectomy: results from a

randomised trial. M Sculpher et al. BMJ, 328 (7432): 134,

2004

Surgical approach to hysterectomy for benign gynecological

disease. N Johnson et al. Cochrane Database Syst Rev, (1)

CD003677, 2005


Cost comparison of robotic, laparoscopic, and open radical

prostatectomy for prostate cancer. C Bolenz et al. Eur Urol,

57(3), 453-8, 2010

Comparative effectiveness of minimally invasive vs open

radical prostatectomy. J Hu et al. JAMA, 302(14): 1557-64

National Cancer Institute (NCI) Cancer Bulletin. August 9, Vol

8(16), 2011

Perioperative outcomes for laparoscopic and robotic

prostatectomy using the national surgical quality

improvement program (NSQIP) database.

JJ Liu et al. Urology, 189(4S):151


31

Robotically assisted vs laparoscopic hysterectomy among

women with benign gynecologic disease. JD Wright et al.

JAMA, 309(7): 689-98, 2013

Perioperative outcomes of robotic vs laparoscopic

hysterectomy for benign disease. KE Patzkowsky et al.

JSLS, 17(1): 100-6, 2013

Laparoscopic versus abdominal myomectomy: a prospective,

randomized trial to evaluate benefits in early outcome. V

Mais et al. Am J Obstet Gynecol 174: 654-8, 1996


Fertility and obstetric outcome after laparoscopic

myomectomy of large myomata: a randomized comparison

with abdominal myomectomy. R Seracchioli et al. Hum

Reprod 15: 2663-8, 2000

A multicenter randomized, controlled study comparing

laparoscopic versus minilaparotomic myomectomy:

reproductive outcomes. Palomba et al. Fertil Steril 88: 933-

41, 2007

Surgical management of leiomyomas for fertility or uterine

preservation. T Falcone and WH Parker, Obstet Gynecol 121

(4): 856-68, 2013


The laparoscopic myomectomy: a survey of Canadian

gynecologists. G Liu et al. J Obstet Gynecol Can 32 (2): 129-

148, 2010

Robotic assistance improves intracorporeal suturing

performance and safety in the operating room while

decreasing operator workload. D Stefanidis et al. Sug

Endosc 2492):377-82, 2010

A randomized trial comparing conventional and robotically

assisted laparoscopic hysterectomy. Paraiso et al. Am J

Obstet Gynecol, 208: 368, 2013


Learning curves for urological procedures. H Abboudi et al.

Br J Urology June 18, 2013 doi: 10.1111/bju.12315 [Epub]

Robotic-assisted vs. abdominal and laparoscopic

myomectomy: systematic review and meta-analysis. Pundir

et al, J Minim Invasive Gynecol 20 (3): 335-45, 2013

Patients benefit while surgeons suffer: an impending

epidemic. A Park et al. J Am Coll Surg, 2010

Work-related musculoskeletal disorders when performing

laparoscopic surgery. MW Stomberg, Surg Laparosc Endosc

Percutan Tech, 2010


Physical strain and urgent need for ergonomic training

among gynecologic oncologists who perform minimally

invasive surgery.J Franasiak et al. Gynecol Oncol, 2012

Work-related upper limb musculoskeletal disorders in

paediatric laparoscopic surgery. A multicenter survey. C

Esposito et al. J Pediatr Surg, 2013

The Singularity is Near: When Humans Transcend BiologyR Kurtzweil, Viking Press, 2005

Ergonomic evaluation and guidelines for for use of the

daVinci Robot system. MM Lux et al. J Endourol 24(3):371-5


Minimally invasive: minimally reimbursed? An examination of

six laparoscopic surgical procedures. AR Roumm et al. Surg

Innov 13(1):16, 2005


32

SERENE SROUJI MD

BRIGHAM AND WOMEN’S HOSPITAL


• Develope a preoperative assessment to plan appropriate surgical approach

• Describe the steps of a traditional robotic myomectomy and techniques utilized to optimize reproductive outcomes

• Identify suitable patients for different robotic myomectomy approaches including hybrid robot-assisted laparoscopic myomectomy, cosmetic robotic myomectomy, and single incision robotic myomectomy

HISTORY OF ROBOTIC MYOMECTOMY

Operative Outcomes Mean + SD (95% CI)

Diameter of Myomas (cm) 7.9 + 3.5, (6.63‐9.13)

Myoma weight (gm) 223.2 + 244.1 (135.8‐310.6)

Operating time (min) 230.8 + 83, (201.6‐260)

Estimated blood loss (mL) 169 + 198.7, (99.1‐238.4)

Number of myomas 1.6 (range 1‐5)

Advincula Journal Am Assoc Gyn Laparoscopists 2004

35 Cases attempted with conversion rate 8.6%

Barakat Obstet Gynecol 2011

ROBOTIC (RM) vs. LAPAROSCOPIC (LM) vs. ABDOMINAL MYOMECTOMY (AM)

RM (n=89) LM (n=93) AM (n=393)

Weight myoma (gm)* 223 (85,391) 96.7 (49, 227) 263 (90.5, 449)

Surgical time (min)** 181 (151, 265) 155 (98,200) 126 (95, 177)

Blood loss (mL)*** 100 (50, 212) 150 (100, 200) 200 (100, 437)

Hospital stay (d)*** 1 (1,1) 1 (0,1) 3 (2,3)

*RM=AM>LM**AM=LM, LM=RM, AM<RM***LM=RM<AM

PREGNANCY AFTER ROBOTIC MYOMECTOMY107 myomectomies, 127 pregnancies and 92 deliveriesPregnancy CharacteristicsMode of conception Spontaneous 77 (60.6%)

ART 50 (39.4%)Time to conception 9.3 months (0.71‐65.4)SAB (<14 weeks) 21 (16.5%)

Delivery CharacteristicsAge at Delivery 36 years (23‐51)AMA 59 (64%)EGA 37.3 weeks (24.4‐41.7)Premature delivery

< 28 weeks 2 (2.2%)28‐32 weeks 1 (1.1%)32‐35 weeks 13 (14.1%)

Adhesions 10 (11.4%)

** One uterine rupture (1.1%) occurred at 33 weeks Pitter Hum Repro 2013

33

PLANNING SURGERY

• MRI has superior sensitivity as compared to other imaging modalities for detecting myomas and ruling out adenomyosis

• MRI can be used to “map” out procedure, given lack of haptic feedback

Dueholm Fert Steril 2001

OPTIMIZING OUTCOMES

TREAT PREOPERATIVE ANEMIA

• Women with Hgb <9.0 g/dL given iron x 3wks,

• Intravenous iron increased Hgb 3.0 g/dL

• Oral iron increased Hgb 0.8 g/dL

• Women with Hgb ~10 g/dL treated for 12 weeks

• 74% had Hgb>12 g/dL on GnRH + iron

• 46% had Hgb >12g/dL on iron only

Kim Acta Haem 2009, Wurnig Eur Surg Res 2001

OPTIMIZING OUTCOMES

MINIMIZE BLOOD LOSS

• Vasopressin results in significant decrease in blood loss

• Utilize a 7‐inch, 22‐gauge needle through accessory port or suprapubic/transabdominal

• Use dilute solution 0.2 U/mL, and limit dose– Case reports of bradycardia, cardiac arrest and pulmonary edema

• Utilize horizontal hysterotomy if possible

Hobo Obstet & Gynecol 2009; Kongnyuy Cochrane Database Syst Rev 2011

OPTIMIZING OUTCOMESMINIMIZE BLOOD LOSS & DECREASE OPERATIVE TIME

44 women undergoing laparoscopic myomectomy randomized to unidirectional barbed suture vs. continuous suture with intracorporeal knots

• Less time for hysterotomy repair

• 11.5 + 4.1 minutes vs. 17.4 + 3.8 minutes, p<0.01

• Less blood loss

• ΔHgb 0.6 + 0.3 g/dL vs. 0.9 + 0.4 g/dL, p=0.004

Alessandri J Min Invas Gynecol 2010

OPTIMIZING OUTCOMES

AVOID MYOMETRIAL DAMAGE

• Review of risk factors for uterine rupture:

• Electrosurgery

• Hematoma formation due to lack of multilayer closure

• Utilize ultrasonic energy or laser energy for hysterotomy

Parker J Minim Invasive Gynecol 2010

OPTIMIZING OUTCOMES

AVOID ROBOTIC ARM COLLISIONS

• Utilize bariatric trocar for camera trocar (150mm)

• Elevates camera arm to decrease collisions and increases range of motion of robotic arms

34

OPTIMIZING OUTCOMES

DECREASE ADHESION FORMATION

• Robotic myomectomy resulted in only 11% adhesive disease at time of C‐section

• Antiadhesion barriers shown by Cochrane review to prevent adhesions at laparotomy

Pitter Human Reprod 2013

1

8 mmda Vinci port

8 mmda Vinci ports

12 mmassistant port

2

Uterine Mass

12 mm camera port(10 cm above top of mass)

1

8 mmda Vinci port

8 mmda Vinci ports

12 mmassistant port

2

Uterine Mass


3

HYBRID ROBOT-ASSISTED MYOMECTOMY

• Described in 2007 to overcome limitations of robot in cases with large myomata

– Decrease in traction/countertraction due to “pop off” safety feature in robotic tenaculum

– Reduced field of movement due to robotic arms


• Patient selection

– Multiple large myomata >8cm

– Uterine fundus at level of umbilicus

– Large exophytic fundal fibroid what would obstruct visualization


KEYS TO SUCCESS

• Supra‐umbilical camera port incision

• Utilize 4 arm approach

• Swift docking of robot after enucleation of myoma

• Repair of incision prior to enucleation of remaining myomata

35


1

8 mmda Vinci port

8 mmda Vinci ports

12 mmassistant port

3

Uterine Mass


COSMETIC PORT PLACEMENT

• 427 women surveyed regarding surgical incision preference

• 250 (58.5%) respondents

– Traditional Laparoscopy 56.4% **

– Single Incision 41.1%

– Robotic Surgery 2.5%

Bush Journ Min Invas Gyn 2011**p<0.05 over single and robotic

INCISION PREFERENCE

Bush Journ Min Invas Gyn 2011

COSMETIC ROBOTIC MYOMECTOMY

Characteristic Mean + Standard Deviation

BMI (kg/m2) 26.4 + 5.7

Weight myomas (gm) 99.6 + 76.2

Number myomas 3.2 + 2.5

Estimated blood loss (mL) 110.1 + 222.6

Operative time (mins) 159.9 + 46.7

Unpublished internal data


KEYS TO SUCCESS

• Uterus <12 week size

• Utilize short instruments through assistant port

• Not suitable for narrow pelvis

• Arm #3 should be used instead of Arm #2 to increase range of motion

36


18 mmda Vinci port

8 mmda Vinci ports3

Uterine Mass

12 mm camera port(30 degree “UP”)

SINGLE INCISION LAPAROSCOPY IN GYNECOLOGY

Metanalysis of 6 RCT and 15 observational studies to evaluate surgical outcomes in gynecology

• 2085 patients: 899 SIL, 1186 conventional

• Mean operative time 6.97 minutes longer for adnexal surgery (p=0.045)

• Mean operative time equal for hysterectomy

• No difference in risk of complications

Murji Obstet & Gynecol 2013

SINGLE INCISION ROBOTIC MYOMECTOMY

SINGLE INCISION ROBOTIC MYOMECTOMY SINGLE INCISION ROBOTIC MYOMECTOMY

KEYS TO SUCCESS

• Uterus <12 week size

• Utilize OMNI GUIDE laser for increased flexibility with enucleation

• Arm #3 should be used instead of Arm #2 to increase range of motion

• Ideal for women with BMI>25 kg/m2

37

SINGLE INCISION ROBOTIC MYOMECTOMY CONCLUSIONS

1. Performing adequate preoperative assessment with MRI and correction of anemia optimizes patient outcomes

2. Utilizing vasopressin and barbed suture will decrease blood loss

3. Utilizing a bariatric camera trocar and #3 arm for cosmetic and single port approach minimizes arm collisions

4. Tailoring robotic port placement in myomectomy patients will improve ease of myoma enucleation while maximizing cosmetic outcome

1. Advincula AP, Xu X, Goudeau S, Ransom SB. Robot-assisted laparoscopic myomectomy versus abdominal myomectomy: A comparison of short-term surgical outcomes and immediate costs, Journal of Minimally Invasive Gynecology, 2007, 14, 698-705.

2. Advincula AP, Song A, Burke W, Reynolds RK. Preliminary experience with robot-assisted laparoscopic myomectomy, The Journal of the American Associatin of Gynecologic Laparoscopists, 2004, 11, 511-518.

3. Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. Robot-assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes, Obstetrics & Gynecology, 2011, 117, 256-265.

4. Murji A, Patel VI, Leyland N, Choi M. Single-incision laparoscopic in gynecologic surgery, Obstetrics & Gynecology, 2013, 121, 819-828.

5. Bush AJ, Morris SN, Millham FH, Isaacson KB. Women’s preferences for minimally invasive incisions, The Journal of Minimally Invasive Gynecology, 2011, 18, 640-643.

6. HoboR, Netsu S, Koyasu Y, Tsutsumi O. Bradycardia and cariac arrest caused by intramyometrial injection of vasopressin during a laparoscopically assisted myomectomy, Obstetrics & Gynecology, 2009, 113, 484-486.

7. Alessandri F, Remorgida V, Venturini PL, Ferrero L. Unidirectional barbed suture vs. continuous suture with intracorporeal knots in laparoscopic myomectomy: a randomized study, Journal of Minimally Invasive Gynecology, 2008, 17, 725-729.

8. Einarsson KI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT. Use of bidirectional barbed suture in laparoscopic myomectomy: Evaluation of perioperative outcomes, safety, and efficacy, Journal of Minimally Invasive Gynecology, 2011, 18, 92-95.

9. Pitter MC, Gargiulo AR, Bonaventura LM, Lehman JS, Srouji SS. Pregnancy outcomes following robot-assisted myomectomy, Human Reproduction, 2013 28, 99-108.

10.Parker WH, Einarsson J, Istre O, Dubuisson JB. Risk factors for uterine rupture after laparoscopic myomectomy, Journal of Minimally Invasive Gynecology, 2010, 17, 551-554.

11. Dueholm M, Lundorf E, Hansen E, Ledertoug S, Olesen F. Evaluation of the uterine cavity with magnetic resonance imaging, transvaginal sonography, hystersonographic examination, and diagnostic hysteroscopy, Fertility and Sterility, 2001, 76, 350-357.

12.Kim YH, Chung, HH, Kang SB, Kim SC, Kim YT. Safety and usefulness of intravenous iron sucrose in the management of preoperative anemia in patients with menorrhagia: a phase IV, open label, prospective, randomzied study. Acta Haematol, 2009, 121, 37-41.

13.Stovall TG, Muneyyirci-Delale O, Summitt RL Jr, Scialli AR. GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: a randomized controlled trial, Obstetrics and Gynecology, 1995, 86, 65-71.

14.Ahmad G, Duffy JM, Farquhar C, Vail A, Vanderkerckhove P, Watson A. Barrier agents for adhesion prevention after gynecological surgery. The Cochrane Database of Systematic Reviews 2008, Art. No. CD000475.

38

Michael C Pitter, MD, FACOGChief, Minimally Invasive & Gyn Robotic Surgery

Newark Beth Israel Medical Center,Newark, NJ

Speakers Bureau: Intuitive Surgical

To review the controversies surrounding the use of the robot for hysterectomy for benign pathology.

To discuss the appropriate indications for robotic approach.

To illustrate the advantage of the 3rd instrument arm for addressing complex pathology.

To review pelvic anatomy – an absolute pre requisite for safe operation.

Laparoscopy circa 1990’s

Value of Randomized Control Trials

39

Wright JAMA Article Mar 2013

ACOG President Statement Mar 2013

Cost perceptions

Safety Perceptions Wall St Journal Kitsap Trial 1-800-BAD-ROBOT

Premier Data Base

Did not control for Learning Curve (2007-2010)

Did not control for BMI, Ut size, or prior surgery

Discarded Lap Conversions

Cost analyses done three ways, none normalized data

Robotic Surgery IS Laparoscopy.

It’s an enabling technology.

Has made a difference in converting from laparotomy to laparoscopy in Gyn Surgery.

Studies are ongoing as expected.

It’s not going away.

“When hysterectomy is necessary; the demonstrated safety, efficacy, and cost-effectiveness of vaginal hysterectomy and laparoscopic hysterectomy mandate that they be the procedure of choice.”

“Surgeons without the requisite training and skills required for the safe performance of VH or LH should enlist the aid of colleagues who do or should refer patients requiring hysterectomy to such individuals for their surgical care.”

JMIG October 2010

40

Surgical Field

Distorted Anatomy

Complex Pathology

Large Uterus

Obesity

Instrumentation

Learning Curves

Surgeon Experience/ Comfort Level

Training

Endometriosis.

Obliteration of anterior/posterior cul de sac.

Broad Ligament Myomas.

2 D Image4 – 6 fold magnificationRigid straight sticksCounter‐IntuitiveHaptics

Surgical FieldObesityInstrumentationLearning CurvesSurgeon ExperienceTraining

3 D Image10 fold magnificationWristed instrumentsIntuitive“Visual” Haptics

InstrumentationLearning CurvesSurgeon ExperienceTraining

CONVENTIONAL LAPAROSCOPY ROBOTIC ASSISTED LAPAROSCOPY

Open Surgery Through Laparoscopic AccessComparison of the Obstacles to MIS

• Lack of Haptics.• Surgeon is remote from the patient.• Different training paradigm.

• Visual Haptics.• Side Docking.• Review and learn pelvic anatomy !!• Think out of the box.• Use EEA Sizers.• Fill the Bladder.

Knowledge of Pelvic Anatomy !!!!

41

Knowledge of Pelvic Anatomy … Do you know where you are??? !!!!

Place the 4th arm on your dominant side*. Try to keep all instruments in view but avoid tunnel vision. You are your best assistant (but don’t get in your way). Think open surgery not rigid straight stick laparoscopy.When swapping, move the other instruments out of the way. Clutch and swap as often as necessary. 4th instrument arm is primarily used for retraction and exposure. 4th instrument is your suturing assistant.

Complex pathology. The 20 + week size uterus or large volume tumors. Prior Operations. Difficult to access pathology.

Multiple Myomectomy. Closure of the hysterotomy defect in layers. Large volume tumors.

Stage IV Endometriosis. The Obliterated Cul-de-sac.

Sacrocolpopexy Suture intensive operation.

42

43

Da Vinci platform is merely a tool…a means to an end.

Robotic surgery does not create a skilled surgeon or guarantee better outcomes.

May allow surgeons to address more complicated pathology in a minimally invasive fashion.

Use good clinical judgement when selecting cases.

Robotic Surgery is Laparoscopic Surgery.

Knowledge of Pelvic Anatomy is requisite.

Get Facile with the 3rd Arm !!!

44

Robotic Hysterectomy: Strategies for the Very

Large Uterus

Director of Robotic Surgery EducationWomen’s Health Institute

The Cleveland Clinic Foundation


Understand the advantages and disadvantages of robotic assistance and its use in complex hysterectomy.

Techniques for overcoming the challenges of the large uterus will be discussed. Umbilicus

Kidneys

Fibroid Uterus

3D HD visualization with 8 or 12 mm camera

Stability of camera and instruments

7-degrees of freedom in range of motion

Enhanced dexterity Tremor reduction Improved ergonomics

Large uteri pose difficulty laparoscopicallysecondary to difficult access to uterine vasculature and colpotomy with straight sticks.

May result in increased:

◦ Blood loss

◦ Complications

◦ Conversions

45

Robot has extended laparoscopic hysterectomy to larger uteri because of:

◦ Enhanced Vision 3D and HD

◦ Increased range of motion Dissection around large

Structures

◦ Improved Control: Stability of Camera Retraction Ability of Fourth

Arm

Provides dexterity for complex dissections (e.g endometriosis, adhesions, broad lig fibroids)

Improved visualization and access around the cervix for colpotomy

Easier vaginal cuff closure Complication rates are

comparable to conventional TLH Studies have reported

decreased EBL, conversion to laparotomy, and length of stay.

Overcoming Challenges: ◦ Exposure: 3D vision, 3rd Arm, Uterine

Manipulation, Assistant ports.◦ Finding the Anatomy: Dissecting the

ureters and uterine arteries.

Minimizing Blood Loss: ◦ Dissection is facilitated◦ Allows staying in the Correct Plane◦ Control of bleeding as you go along

MIS option for patients with indications that may have necessitated laparotomy:

◦ Multiple prior surgeries ◦ High body mass index ◦ Large fibroids ◦ Known severe adhesive disease ◦ Extensive endometriosis

Most patient’s with a large uterus is a potential robotic hysterectomy candidate.

Rule out possible malignancy first or consider bagging uterus for morcellation.

Consider exam under anesthesia and/or diagnostic laparoscopy before deciding to proceed.

Key is mobility and access into retro-peritoneal space.

Start slow and increase gradually

46

Many potential benefits over traditional surgical approaches, including: ◦ Significantly less pain than laparotomy◦ Minimal blood loss and need for transfusion ◦ Fewer complications◦ Shorter hospital stay (1-2 days)◦ Quicker recovery and return to nl activities (2-4 wks)◦ Small incisions for minimal scarring ◦ Better outcomes and patient satisfaction, in many

cases

Pre-robotic (n=100) da Vinci (n=100) Last 25

da Vinci

Age (years) 43.5 43.2

BMI 28.8 28.8

Estimated blood loss (ml) 113 61

Hospital stay (days) 1.6 1.1

TAH rate 20% 4% 0%

Conversions (subset of TAH) 9% 4% 0%

Avg uterine weight of conversions 359.5 1387.5

TAH due to adhesions 8% 0%

Operative times (skin-to-skin) 92.4 119 78.7

Retrospective Review of Hysterectomy: Pre-Robotic versus da Vinci

History◦ Parity – a consideration for vaginal access◦ Prior surgery – to anticipate adhesions◦ Symptomatology – for treatment counseling◦ Past Medical History – to assess anesthesia

concerns and peri-operative medical care

Examination:◦ Size - >16 wks size consider robotic approach◦ Fibroid Type - Broad Ligament or cervical Fibroids

Consider a robotic approach◦ Fibroid Location – Posterior and anterior may hinder

visualization. ◦ Mobility – lateral mobility most critical◦ Cervix characteristics - assess size, shape, position for

uterine manipulator placement.◦ Access to Vasculature – in lateral fornices above cervix◦ Scar Locations – to anticipate adhesions or fixed uterus.

Pathology◦ Endometrial Pathology recommended if

morcellation is likely in patient’s >35 or in patients at risk for hyperplasia: PCOS Obesity Prior history

◦ PAP smear history and recent pap to determine candidacy for supra-cervical hysterectomy if desired.

Imaging◦ Ultrasound For uteri <16 weeks is ok.

◦ CT scan May substitute for MRI if very large bulky uterus. Beware of hydronephrosis. May request Tri-axial CT scan images.

◦ MRI Gives best imaging indicating size and location of fibroids May be needed for pre-operative planning for extremely

complex cases.

47

Benefit of Robotic Surgery◦ Less pain and Faster Recovery.

Risks of Laparoscopy◦ Especially visceral injury.

Risk of Conversion to Laparotomy◦ Every patient must be counseled in this regard.

Pre and Post-operative care◦ Set expectations for discharge.

Same benefit of other minimally invasive techniques:◦ Significantly less pain than laparotomy◦ Minimal blood loss and need for transfusion ◦ Fewer complications◦ Shorter hospital stay (1-2 days)◦ Quicker recovery and return to nl activities (2-4 wks)◦ Small incisions for minimal scarring ◦ Better outcomes and patient satisfaction

Balance with time required for surgery.

A learning curve exists: 20-90 cases Need skilled assistant and a team approach Time for extraction of the uterus is added to

the time for the procedure. May increase cost significantly

Positioning and Padding to prevent injury

Work with anesthesia to restrict fluid

Examination under anesthesia is mandatory

Team approach allows for efficiency◦ Ask for special equipment ahead of time◦ Ensure everyone is aware of difficulties and the plan

of action at the beginning of the case.

DORSAL LITHOTOMY POSITION◦ Allen’s Stirrups with padded cushions.◦ Both Arms Tucked.◦ Take care with positioning to prevent nerve injury.

PREVENTION OF SLIDING IN MAXIMUM TRENDELENBURG◦ Tuck and Tape◦ Shoulder pads/brace◦ Egg crate sponge◦ Bean Bag

Shown to be most important during the Learning Curve.

Very important in more difficult cases.

May be determining factor for success of the case.

Uterine Positioning System assists with uterine manipulation, and can eliminate need for vaginal assist.

48

V-care

Rumi◦ Arch ◦ Pivoting◦ Strongly consider UPS The best assistant is you!

Others

Dependent on size of the Uterus

Considerations:◦ Size and shape of the uterus◦ May want to remain just above fundus

if adnexa is accessible.◦ Assess with 5 mm LUQ camera first

(this can remain as accessory)◦ 30 degree camera can lower your

camera port further

SMALL MEDIUM

LARGE JUMBO

THE TARGET ORGAN IS THE OVARY!!! NOT THE FUNDUS!!! Docking◦ Center docking – help if ports are very high◦ Side-docking - allows vaginal access

Assistant Port Placement◦ Left vs Right◦ Lateral vs Medial

Instruments◦ Coagulation PK cautery Fenestrated Bipolar Ligasure

◦ Cutting Monopolar scissors Monopolar hook

◦ Manipulation Prograsp Long tip forceps Tenaculum

Use your Landmarks:◦ Round Ligaments◦ Adnexa◦ Colpotomy ring◦ Anatomy is the “roadmap”

Approach is dependent on what you can see:◦ Anterior Approach◦ Posterior Approach◦ Side-wall Approach

49

Take what you can get! ◦ Start on easier side◦ If you are not making progress change to other side◦ Go as far as you can get down one side before

switching

Stay hemostatic!◦ Blood will distort tissue planes and anatomy.◦ Be gentle◦ Use pneumoperitoneum to help you

Fibroids may distort adnexa Find origin and course of IP ligament May need to take down in layers Be aware of uterine accessory vasculature

Ureter is easiest to find at pelvic brim medial and inferior to IP.

Use pneumoperitoneum and gentle dissection to enter broad ligaments hemostatically.

Entry into the Retroperitoneal Triagle◦ Gives you access to the vasculature.

Find the Landmarks!! ◦ Push up maximally on colpotomy ring

Beware of collateral vessels.◦ Stay far lateral to the uterus

Back-filling the bladder is helpful, especially with previous C-section

Take down to 1 cm below the colpotomy ring to allow for cuff closure.

Exposure is Key Efficient application of energy Consider starting at angles Troubleshooting if no manipulator present

50

EEA sizer may be placed to elevate cervix and delineate fornices for colpotomy when cervix is inaccessible.

Anchor the angles to the utero-sacral ligament for support

Take the bladder down further than 1 cm. Take wider bites including vaginal “fascia” Evert edges to visualize mucosa Always check vaginally after procedure Cystoscopy after vaginal cuff closure is

important. May use interrupted or V-lock suture

In situ Morcellation or Mechanical Morcellation

Bivalve or Quarter then string or bob

Vaginal Morcellation

Consider bagging the uterus if concern about pathology exists.

Consider Mini-laparotomy for extremely large uteri.

Same principles apply:◦ Exposure is Key! Pull, push, lift, or compress! Use angled camera if needed◦ Gain mobility by entering and opening

retroperitoneal space making peritoneal outline◦ Find the anatomy and release at adnexa and

round ligament◦ Start on easier side and Take what you can get May need to improvise. Keep moving!

51

Treat like the small uterus Early ambulation and early feeding

encourages fast recovery Start prophylactic GI regimen immediately Toradol reduces narcotic useage May discontinue foley catheter within 6 hours

after procedure

Several studies show good outcomes Key is decreased laparotomy in more complex

cases Greater ability to accomplish minimally invasive

procedure in complex cases Lower blood loss and length of stay has been

noted Equivalent complication rates to laparoscopic

or vaginal hysterectomy

Reference: JRS

The Effect of Uterine Weight on Robotic Assisted Total Laparoscopic

Hysterectomy Outcomes Study Design◦ Retrospective cohort analysis via chart review

Study Population (n=135):◦ All patients who underwent Robotic-assisted

hysterectomy at Henry Ford Health System (HFHS) Hospitals since the inception of this procedure at HFHS were included (January 2008-May2010)

◦ Surgeries were performed by 6 surgeons who were trained and began performing the procedure during this period.

Uterine weight was recorded from the pathology report

Outcomes were collected from the electronic medical record as follows:◦ Procedure duration (“cut” to “close” times)◦ Estimated blood loss (EBL)◦ Hemoglobin change (Pre minus Post-operative

Hgb)◦ Length of stay (LOS)◦ Complications (immediate and delayed major and

minor complications from detailed chart review)

Demographics and other covariates were also obtained from the medical record included Body Mass Index (kg/m2) and race. The effect of BMI on RH outcomes wee assessed in a separate analysis.

Patients with confounders were excluded including those: Who underwent supra-cervical hysterectomy With concomitant uro-gynecologic procedures Who underwent hysterectomy for malignancy

Statistical analyses included Spearman correlations and Wilcoxon rank sum tests.

52

N=110 Total Mean SD Min Median Max

Age (years) 135 45.7 7.4 30 45 68

Race Black White Other

(N, % of total) 83 (61.5%)

50 (37.0%)

2

(1.5%)

N=110 Total Mean SD Min Median Max

Uterine Weight

133 262.4 242.7 47 170 1290

Category < 250 grams 250-500 grams > 500 grams

(N, % of total) 87

(65.4%)

28

(21.1%)

18

(13.5%)

BMI (kg/m2) 135 31.1 7.6 14.8 30.3 56.2

BMI Category Underweight<18.5

Normal18.5-25

Overweight25-29.9

Obese30-34.9

Morbid35+

(N, % of total) 3 (2%)

28 (21%)

34(25%)

34 (25%)

36

(26%)

Procedure Duration

Estimated Blood Loss

Length of Stay

Hemoglobin Change

Spearman Correlation

0.53 0.30 0.14 -0.09

P-value <0.001 0.0005 0.10 0.30

There is statistically significant correlation between uterine weight and Procedure Duration.

There is statistically significant correlation between uterine weight and Estimated Blood Loss, BUT NOT hemoglobin change.

Procedure Duration

(min)

Estimated Blood Loss

(mL)

Length of Stay

(days)

Hemoglobin Change

(g/dL)

Uterine Weight(N)

Median (Range)

Median (Range)

Median (Range)

Median (Range)

<250 grams(N=87)

150

(80-534)

50

(10-450)

1

(1-14)

-1.3

(-3.7 - 0.4)

250-500 grams(N=26-28)

205.5

(96-388)

87.5

(10-1000)

1

(1-3)

-1.65

(-4.4 - 0.9)

≥500 grams(N=18)

294.5

(152-625)

100

(25-500)

1.5

(1-11)

-2.1

(-4.0 - 0.5)

Major Complication

Minor Complication

Any Complication

Number

(Rate %)

12

(8.9%)

15

(11.1%)

27

(20%)

Wilcoxon Rank Sum Test p-value

0.96 0.76 0.79

Major Complication was defined as an visceral injury, or complication that caused increased hospital stay, re-admission, or re-operation.

Minor Complication was defined as any complaint that required evaluation and treatment.

There were 10 re-admissions (7.4%) and 3 blood transfusionsthat were unrelated to uterine weight.

There is a strong correlation between uterine weight and procedure duration.

The increase in median was at a maximum of 145 minutes between the smallest and largest uterine weight categories.

This increase in procedure duration did nottranslate into an increase in length of stay or complications.

53

There is a correlation with estimated blood losswith a 50 mL increase in medians between the smallest and largest uterine weight groups.

Only reflected as a trend in decrease in peri-operative hemoglobin.

Possible small increased blood loss is not clinically significant and did not result in an increase in blood transfusions for patients with larger uteri.

Robotic-assisted total laparoscopic hysterectomy can be performed safely on patients with large Uteri.

Although procedure duration is increased slightly, there are no substantial impact on blood loss, post-operative length of stay, or complications.

MOST patients can be approached with a minimally invasive approach.

Studies have shown benefit to the patient without increasing risk.

Benefit for the Patient-◦ No need for Laparotomy!◦ Less Pain, Less Bleeding, Faster recovery.

The Future-◦ What is the limit of daVinci surgery? Only limited by what we will try........

Umbilicus

Kidneys

Fibroid Uterus

a) Abdominal Hysterectomyb) Vaginal Hysterectomyc) Total Laparoscopic Hysterectomyd) Laparoscopic Assisted Vaginal Hysterectomye) Robotic Hysterectomy

54

Antonio GargiuloMedical Director, Center for Robotic Surgery

Brigham and Women’s Health CareHarvard Medical School



Participants should be able to :

• Interpret available scientific publications on benefits

and limitations of robotics in endometriosis surgery

• Describe the role of robotics in the three different

manifestations of pelvic endometriosis

• Identify relevant areas of clinical investigation in the

use of robotics in endometriosis surgery


Endometriosis Fertility Index: is it better than the present staging systems? GD Adamson. Curr Opin Obstet Gynecol, 2013

• The revised ASRM classification system does not

predict pregnancy rates (either spontaneous or ART)

• The only classification system that predicts a clinical

outcome (spontaneous pregnancy rates) is the EFI

• The upcoming AAGL classification system will be

based on both pain and fertility


• Peritoneal Endometriosis

• Ovarian Endometriosis

• Deep Infiltrating Endometriosis

Laparoscopic management of peritoneal endometriosis, endometriotic cysts, and rectovaginal adenomyosis.

J Donnez et al. Ann NY Acad Sci, 2003


Laparoscopic surgery for pelvic pain associated with endometriosisTZ Jacobson et al. Cochrane Database Sys Rev, 2009

• Five RCT included in metanalysis

• Most patients with mild-minimal endometriosis

• Metanalysis demonstrated an advantage of

laparoscopic surgery compared to diagnostic

laparoscopy only (OR of 5.72, 95% CI 3.09 to 10.6)


55

Surgical treatment of endometriosis: location patterns of disease at reoperation.E Taylor and C Williams. Fertil Steril, 2010

• ASRM 1-2 endo recurred in 37% of pelvic regions

after surgical treatment

• More likely to recur in a treated pelvic region that an

adjacent or distant pelvic region (RR 2.54)


Laparoscopic surgery for subfertility associated with endometriosisTZ Jacobson et al. Cochrane Database Sys Rev, 2010

• Two RCT (Marcoux and Gruppo Italiano) included

• All patients with mild-minimal endometriosis

• Metanalysis demonstrated no advantage of

laparoscopic surgery compared to diagnostic

laparoscopy only (OR of 1.33, 95% CI 0.60 to 2.94)

when considering delivery rates.


• Sharp excision, bipolar diathermy and carbon dioxide

laser ablation are the three main treatment options

• Excision and ablation are preferred by many, based

on risk of neighboring tissue damage with diathermy

• However, animal data and human studies do not

show a significant advantage of either technique.

Wallwiener at al. Fertil Steril, 2009

MP Radosa et al. Eur J Obster Gynecol, 2010

J Wright et al. Fertil Steril, 2005


• The role of computer-assisted surgery in peritoneal

endometriosis is unclear

• Advantage of magnified stereoscopic vision in

identification and treatment of peritoneal lesions HAS

has not been studied

• Advantage of fluorescence imaging with intravenous

indocianine green in identification and treatment of

peritoneal lesions has not been studied


Case control study: longer operating times and similar

safety compared to conventional laparoscopy.


Robotic versus standard laparoscopy for the treatment of endometriosis C Nezhat et al. Fertil Steril, 2010


56

• Constitute oncologic risk

• Cause pelvic pain

• Decrease ovarian reserve

• Contribute to infertility

• Interfere with ART


• Observation with regular imaging

• Medical treatment

• Drainage-Biopsy-Coagulation (DBC)

• Stripping


Asymptomatic (no pain, no infertility)

• Without prior histologic diagnosis: surgery if over 4 cm, observation otherwise (ESHRE guidelines)

• With prior histologic diagnosis: observation

• Medical treatment to prevent recurrence or to slow growth


Pelvic Pain• Surgical treatment must be first line

• Medical treatment only after surgery

• Stripping and DBC both effective

• Stripping has advantages over DBC: Reduced recurrence rate of pain


RJ Hart et al

Cochrane Database of Systematic Reviews, 2008

Infertility: no other causes• Surgical treatment must be first line

• Cumulative pregnancy rate is substantial

• Stripping and DBC both effective

• Stripping has advantages over DBC:Higher rate of spontaneous pregnancy


Hart et al


Infertility: no other causes• Review of 14 studies (no RCTs)

• 1500 patients

• Overall weighted mean pregnancy rate was 50% with 24 month follow-up

• Even assuming half, NNT is 4

P Vercellini et al, Hum Reprod 2009


57

Mutifactorial Infertility• Surgery does not increase fecundity

• Swift access to ART should be considered

• No effect of Stripping or DBC on ART clinical pregnancy rate, and Stripping can decrease oocyte output.

Benschop et al



• We are removing ovarian cortex.

• However, normal follicles only in cyst wall pedicle at ovarian hilum

L Muzii et al. Fertil Steril, 2007

• Bipolar cauterization of the pseudo-cyst bed can damage the ovarian hilum

• Bilateral endometrioma: double trouble!

• Consider DBC over stripping in select cases


Control ovary Operated ovary

Nargund et al. 1996 8.9+5.1 6.3+5.2*

Loh et al. 1999 3.6 4.6

Donnez et al. 2001 6.6+3.5 5.2+3.0

Ho et al. 2002 6.1+4.1 2.9+2.6*

Somigliana et al. 2003 4.2+2.5 2.0+1.5*

Wong et al. 2004 5.2+0.8 5.6+0.9

* = significantly different

Oocytes retrieved by different surgical teams


• Skilled laparoscopists

• Hemostatic matrix

• Regenerated celluloseand

• Ovarian vasopressin injection

• Ovarian suturing

• Partial stripping with laser ablation

• Role of robotic surgery

Gargiulo 2013Gargiulo 2013 Gargiulo 2013Gargiulo 2013

58

• Definition: subperitoneal invasion by endometriotic lesions that exceeds 5 mm in depth

• Vaginal and rectal ultrasound and MRI imaging have high sensitivity and specificity in highly trained centers

M Bazot et al. Fertil Steril, 92(6): 1825-33, 2009

• Surgery is essential


M Bazot et al. Fertil Steril, 2009

M Bazot et al. Fertil Steril, 2009

Normal anatomy of the anterior compartment.

©2011 by Radiological Society of North America

Coutinho A et al. Radiographics 2011


Normal anatomy of the posterior compartment.

Coutinho A et al. Radiographics 2011©2011 by Radiological Society of North America

Normal anatomy of the posterior compartment.


59


Endometriosis of the vesico-uterione pouch

Coutinho A et al. Radiographics 2011©2011 by Radiological Society of North America

Bladder endometriosis with ureteral involvement



Endometriotic involvement of the retrocervical area


Endometriotic involvement of the uterosacral ligaments





Sigmoid endometriosis

• Expanding the horizons: robot-assisted reconstructive surgery of the distal ureter.

SK Williams et al. J Endourol, 2009

• Robotic-assisted laparoscopic partial bladder resection for the treatment of deep infiltrative endometriosis.

C Liu et al. J Min Gynecol Surg, 2009


60

• Robotic treatment of colorectal endometriosis: technique, feasibility and short-term results. A Ercoli et al. Hum Reprod, 2012

• Deep infiltrating colorectal endometriosis treatedwith robotic-assisted rectosigmoidectomy. RM Neme et al. JSLS, 2012


Endometriosis Fertility Index: is it better than the present staging systems? GD Adamson. Curr Opin Obstet Gynecol. 25(3):186-92, 2013

Laparoscopic management of peritoneal endometriosis, endometriotic cysts, and rectovaginal adenomyosis.J Donnez et al. Ann NY Acad Sci 997: 274-81, 2003

Laparoscopic surgery for pelvic pain associated with endometriosis. TZ Jacobson et al. Cochrane Database Sys Rev, 4, 2009

Surgical treatment of endometriosis: location patterns of disease at reoperation. E Taylor and C Williams. Fertil Steril, 93(1): 57-612010


The extent of adhesion induction through electrocoagulation and suturing in an experimental rat study. Wallwiener at al. Fertil Steril, 93(4):1040-4, 2009

Coagulation versus excision of primary superficial endometriosis: a 2 year follow-up. MP Radosa et al. Eur J Obster Gynecol, 150:195-8, 2010

A randomized trial of excision versus ablation for mild endometriosis. J Wright et al. Fertil Steril, 83:1830-6, 2005

Robotic versus standard laparoscopy for the treatment of endometriosis. C Nezhat et al. Fertil Steril 2010 94(7): 2758-60


The European Society for Human Reproduction and Embryology. Guidelines for the treatment of Endometriosis.(Guidelines.endometriosis.org). Updated 2007

Excisional surgery versus ablative surgery for ovarian endometriomata. RJ Hart et a. Cochrane Database Syst Rev, 2009

Surgery for endometriosis-associated infertility: a pragmatic approach. P Vercellini et al. Hum Reprod 24(2):254-69, 2009

Interventions for women with endometrioma prior to assisted reproductive technology. L Benshop et a. Cochrane Database Syst Rev, 2010

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Histologic analysis of endometriomas: what the surgeon needs to know. L Muzii et al. Fertil Steril, 87(2):362-6, 2007

Diagnostic accuracy of physical examination, transvaginalsonography, rectal endoscopic sonography, and magnetic resonance imaging to diagnose deep infiltrating endometriosis. M Bazot et al. Fertil Steril, 92(6): 1825-33, 2009

MR Imaging in Deep Pelvic Endometriosis: A Pictorial Essay. Coutinho A et al. Radiographics 2011;31:549-567


Expanding the horizons: robot-assisted reconstructive surgery of the distal ureter. SK Williams et al. J Endourol23(3): 257-61, 2009

Robotic-assisted laparoscopic partial bladder resection for the treatment of deep infiltrative endometriosis.C Liu et al. J Min Gynecol Surg, 16(2):244, 2009

Robotic treatment of colorectal endometriosis: technique, feasibility and short-term results. A Ercoli et a,. Hum Reprod27(3):722-6, 2012

Deep infiltrating colorectal endometriosis treated withrobotic-assisted rectosigmoidectomy. RM Neme et al. JSLS 17(2): 227-34, 2012

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CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

63

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

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